|
- Abacavir (marketed as Ziagen) and Abacavir-containing Medications
- Audience: Infectious disease and medical genetics healthcare professionals
[Posted 07/24/2008]
FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
[July 24, 2008 - Information for Healthcare Professionals - FDA]
 Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
- Audience: Radiological healthcare professionals, cardiologists, hospital risk managers
[Posted 07/17/2008]
FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.
[July 17, 2008 - Information for Healthcare Professionals - FDA]
[June 2008 - Dear Healthcare Professional Letter - GE]
[May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]
Previous MedWatch Alerts:
[10/12/2007]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Electronic Medical Devices
- Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
[July 14, 2008 - Public Health Notification - FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Sodium Polystyrene Sulfonate Suspension
- Audience: Pharmacists, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.
[July 14, 2008 - Recall -
Roxane Laboratories, Inc.]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Avastin (bevacizumab)
- Audience: Oncologists, other healthcare professionals
[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.
[July 11, 2008 - Dear Healthcare Professional Letter -
Genentech]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Herceptin 440 mg Vials and BWFI Diluent
- Audience: Healthcare professionals
[Posted 07/10/2008] Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.
Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered.
[June 28, 2008 - Dear Healthcare Professional Letter -
Genentech]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Fluoroquinolone Antimicrobial Drugs
- Audience: Healthcare professionals, consumers
[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.
[July 08, 2008 - Drug Information Page -
FDA]
[July 08, 2008 - Information for Healthcare Professionals
-
FDA]
[July 08, 2008 - News Release - FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Rize 2 The Occasion Capsules
Rose 4 Her Capsules
- Audience: Consumers, healthcare professionals
[Posted 07/02/2008] Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products.
[July 01, 2008 - Press Release -
Jack Distribution, LLC]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
- Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff
[Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.
[July 01, 2008 - Public Health Notification -
FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
- Audience: Hospital risk managers, pharmacists
[Posted 06/30/2008] Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF.
The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
[June 27, 2008 - Press Release -
Sage Products]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Antipsychotics, Conventional and Atypical
- Audience: Neuropsychiatric and geriatrics healthcare professionals
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics.
Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.
[June 16, 2008 - Information for Healthcare Professionals -
FDA]
[June 16, 2008 - News Release -
FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Morphine Sulfate 60 mg Extended Release Tablets
Morphine Sulfate 30 mg Extended Release Tablets
- Audience: Pharmacists, other healthcare professionals
[UPDATE 06/16/2008] Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.
[Posted 06/10/2008]
ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual.
If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.
[June 13, 2008 - Press Release -
ETHEX Corp.]
[June 09, 2008 - Press Release -
ETHEX Corp.]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
- Audience: Rheumatologists, gastroenterologists, oncologists, other healthcare professionals
[Posted 06/03/2008]
FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.
[June 04, 2008 - Early Communication About an Ongoing Safety Review of TNF Blockers -
FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder
- Audience: Consumers, pediatricians, other healthcare professionals
[Posted 06/02/2008]
Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.
[May 30, 2008 - Press Release -
FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Viril-ity Power (VIP) Tablets
- Audience: Consumers, healthcare professionals
[Posted 05/30/2008]
International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.
[May 29, 2008 - Press Release -
International Pharmaceuticals, Ltd.]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Mommy's Bliss Nipple Cream
- Audience: Nursing mothers, pediatricians, other healthcare professionals
[Posted 05/29/2008]
FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of decreases in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color.
[May 23, 2008 - News Release - FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Xiadafil VIP Tablets
- Audience: Consumers, healthcare professionals
[Posted 05/27/2008]
FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.
[May 27, 2008 - News Release - FDA]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Solodyn (minocycline HCL) Extended Release Tablets 90 mg
- Audience: Pharmacists, other healthcare professionals
[Posted 05/19/2008]
Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.
[May 16, 2008 - Press Release - Medicis]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Mycophenolate Mofetil
[MMF] (marketed as CellCept)
Mycophenolic Acid [MPA] (marketed as Myfortic)
Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants
- Audience: Transplantation
specialists, infectious disease specialists, other healthcare
professionals
- [Posted 05/16/2008] FDA is aware of reports of infants born
with serious congenital anomalies, including microtia and cleft
lip and palate, following exposure to mycophenolate mofetil (MMF)
during pregnancy. MMF, the active drug substance in CellCept,
is an ester of the active metabolite mycophenolic acid (MPA),
the active drug substance in Myfortic. In most cases, the mothers
were taking MMF following an organ transplant to prevent organ
rejection. However, some mothers taking MMF were being treated
for immune-mediated conditions such as systemic lupus erythematosus
(SLE) and erythema multiforme. Treatment began before their pregnancies
and continued into the first trimester or until the pregnancy
was detected. MMF and MPA increase the risk of spontaneous abortion
in the first trimester and can cause congenital malformations
in the offspring of women who are treated during pregnancy.
FDA is continuing to work with the manufacturers of these drug
products to develop and implement means to mitigate the risks
of fetal exposure. See the FDA Healthcare Professional Information
Sheet containing considerations and recommendations for clinicians
prior to prescribing MMF or MPA to women of childbearing potential.
[May 16, 2008 - Healthcare
Professional Sheet - FDA]
-
Previous MedWatch Alerts:
[04/10/2008]
[11/27/2007]
[10/29/2007]
[02/22/2007]
- Return
to Top | MedWatch Home | MedWatch
Safety Info | Online
MedWatch Report | Contact
MedWatch
- Cardinal Alcohol-Free Mouthwash
- Audience: Consumers, hospital and nursing home risk managers, healthcare professionals
[UPDATE 05/19/2008] Hydrox Labs issued a voluntary recall of another lot of Alcohol-Free Mouthwash because samples of the product tested were positive for Burkholderia cepacia (B. cepacia). The affected product lot number is 26230.
[Posted 05/06/2008] Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.
[May 16, 2008 - Press Release - Hydrox Labs]
[May 02, 2008 - Press Release - Hydrox Labs]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Enbrel (etanercept)
- Audience: Rheumatologists, dermatologists, other healthcare professionals, patients
[Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
[March 14, 2008 - Dear Healthcare Professional Letter - Amgen/Wyeth] 
[February, 2008 - Label - Amgen/Wyeth]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Digitek (digoxin tablets, USP)
- Audience: Cardiologists, family physicians, pharmacists, other healthcare professionals, patients
[Posted 04/28/2008] Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
[April 25, 2008 - Press Release - Actavis Totowa LLC]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Herbal Science International, Inc. Dietary Herbal Supplements
- Audience: Consumers, healthcare professionals
[Posted 04/14/2008] Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.
[April 10, 2008 - Press Release - Herbal Science International]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid)
- Audience: Transplantation specialists, infectious disease specialists, other healthcare professionals
[Update] Novartis informed healthcare professionals
of changes to the WARNINGS and ADVERSE REACTIONS sections of the
Myfortic prescribing information. The changes are based on postmarketing
data regarding cases of Progressive Multifocal Leukoencephalopathy
(PML) in patients treated with Myfortic.
[Update] Roche Laboratories informed healthcare professionals
of changes to the WARNINGS and ADVERSE REACTIONS sections of the
CellCept prescribing information. The changes are based on postmarketing
data regarding cases of Progressive Multifocal Leukoencephalopathy
(PML) in patients treated with CellCept.
[Posted 04/10/2008] FDA informed healthcare professionals that
the Agency is investigating a potential association between the use
of CellCept and Myfortic, medicines used to prevent organ rejection,
and the development of progressive multifocal leukoencephalopathy
(PML), a life-threatening disease. PML is a rare disorder that affects
the central nervous system usually occurring in patients with immune
systems suppressed by disease or medicines. FDA is reviewing data
submitted by Roche, including postmarketing reports it has received
of PML in patients who took CellCept or Myfortic, and the proposed
revisions to the CellCept prescribing information. FDA has asked
Novartis, the maker of Myfortic, for data on PML cases and to revise
the Myfortic prescribing information to include the same information
about PML included in the CellCept prescribing information. FDA
anticipates it may take about 2 months to complete its review of
the postmarketing reports and the proposed revisions to the prescribing
information. As soon as the review is completed, FDA will communicate
the conclusions and recommendations to the public. -
Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.
[June 2008 -- Dear
Healthcare Professional Letter - Novartis]
[June 2008 -- Dear
Healthcare Professional Letter - Roche]
[April 10, 2008 - Communication About an Ongoing Safety Review - FDA]
Previous MedWatch Alerts:
[11/27/2007]
[10/29/2007]
[02/22/2007]
- Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Neupro (rotigotine transdermal system)
- Audience: Neurologists, other healthcare professionals, patients
[Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, at the end of April 2008, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.
[April 8, 2008 - Drug Shortage Information - FDA.]
-
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Exubera (insulin human rDNA origin) Inhalation Powder
- Audience: Endocrinologists, pulmonologists, pharmacists, patients
[Posted 04/09/2008]
Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.
[April 9, 2008 - Dear Healthcare Professional Letter - Pfizer, Inc.]
[April 9, 2008 - Dear Patient Letter - Pfizer, Inc.]
-
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Cubicin (daptomycin for injection)
- Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers
[Posted 04/09/2008]
Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.
[April, 2008 - Letter - Cubist Pharmaceuticals, Inc.]
-
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Heparin Sodium USP Pre-Filled Syringes
- Audience: Surgeons, hospital risk managers, pharmacists, other healthcare professionals
[Posted 04/02/2008]
Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.
[March 28, 2008 - Press Release - Covidien]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Relenza (zanamivir)
- Audience: Pediatric and infectious disease healthcare professionals
[Posted 04/01/2008]
GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
[March, 2008 - Letter - GlaxoSmithKline]
[Feb, 2008 - Label - GlaxoSmithKline]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Total Body Formula, Total Body Mega Formula
- Audience: Consumers, healthcare professionals
[UPDATE 05/01/2008] FDA notified healthcare professionals and consumers that the Agency's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous amounts of chromium in addition to selenium. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake can also interfere with certain medications. FDA continues to investigate how excessive amounts of selenium and chromium got into the products.
[UPDATE 04/10/2008] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.
[Posted 03/28/2008]
The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.
[May 01, 2008 - News Release - FDA]
[April 09, 2008 - News Release - FDA]
[March 27, 2008 - News Release - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Ziagen (abacavir)
Videx (didanosine)
- Audience: Infectious disease specialists, other healthcare professionals, patients
[Posted 03/27/2008]
The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Regranex (becaplermin) Gel
- Audience: Endocrinologists, other healthcare professionals, patients
[UPDATE 06/06/2008] FDA informed healthcare professionals that a Boxed Warning was added to prescribing information for Regranex that describes an increased risk of death from cancer in patients treated with three or more tubes of Regranex compared with those patients who did not use the product. FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks.
[Posted 03/27/2008]
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
[June 06, 2008 - Drug Information Page - FDA]
[March 27, 2008 - Communication About an Ongoing Safety Review - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Singulair (montelukast)
- Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
[Posted 03/27/2008]
FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- "Blue Steel" and "Hero" Dietary Supplement Products
- Audience: Consumers
[Posted 03/25/2008]
The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.
[March 25, 2008 - Press Release - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution
- Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals
[Posted 03/21/2008]
B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.
[March 21, 2008 - Press Release - B. Braun Medical]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
- Audience: Physiatry and Pain management healthcare professionals
[Posted 03/21/2008]
FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps,
implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps.
[March 21, 2008 - Recall Notice - FDA]
[January, 2008 - Dear Healthcare Professional Letter - Medtronic]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Tiotropium (marketed as Spiriva HandiHaler)
- Audience: Pulmonary care health professionals and patients
[Posted 03/18/2008]
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.
It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
[March 18, 2008 - Early Communication about an Ongoing Safety Review - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Medtronic AneuRx Stent Graft System
- Audience: Vascular surgery healthcare professionals, hospital surgical service managers
[Posted 03/18/2008]
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.
[March 17, 2008 - Public Health Notification - FDA]
Previous MedWatch Alerts:
[12/17/2003]
[04/30/2001]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
- Audience: Oncological healthcare professionals
[Posted 03/12/2008]
Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.
[March 07, 2008 - Dear Healthcare Professional Letter - Amgen]
Previous MedWatch Alert:
[11/08/2007]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Prezista (darunavir)
- Audience: Infectious disease healthcare professionals
[UPDATE 3/21/2008] FDA issued a new "Information for Healthcare Professionals" sheet highlighting the addition of hepatotoxicity information to the WARNINGS section of prescribing information for Prezista.
[Posted 03/12/2008]
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
[March 21, 2008 - Information for Healthcare Professionals - FDA]
[March 2008 - Dear Healthcare Professional Letter - Tibotec]
[February 2008 - Prescribing Information - Tibotec]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)
- Audience: Healthcare professionals, pharmacists, patients
[UPDATE 04/24/2008] Dear Healthcare Professional Letter issued by UCB, Inc.
[Posted 03/11/2008]
FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.
Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.
[April 16, 2008 - Dear Healthcare Provider Letter - UCB]
[March 11, 2008 - Drug Information Page - FDA]
[March 11, 2008 - Public Health Advisory - FDA]
[January 2008 - Prescribing Information - UCB]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Blood Glucose Meters and Test Strips
- Audience: Diabetes healthcare professionals, pharmacists and patients
[Posted 03/11/2008]
FDA reminded glucose meter users to only use strips recommended for their specific brand of meter and to read the instructions for use carefully. It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results. While this problem has been identified recently as occurring with a unique meter-strip configuration, FDA recognizes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination.
[March 10, 2008 - News Release - FDA/CDRH/OIVD]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs
- Audience: Healthcare professionals, consumers
[Posted 03/06/2008]
FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The products pose a serious health threat to unsuspecting consumers who don't know that these products are not FDA approved and have not been proven safe or effective. Consumers who are currently using these products should stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products.
[March 06, 2008 - News Release - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Aspire36, Aspire Lite Dietary Supplements
- Audience: Consumers, healthcare professionals
[Posted 03/04/2008]
Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase.
[February 28, 2008 - Press Release - Palo Alto Labs]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
- Tamiflu (oseltamivir phosphate)
- Audience: Pediatric and infectious disease healthcare professionals
[Posted 03/04/2008, UPDATED 03/04/2008]
Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
[February, 2008 - Dear Healthcare Professional Letter - Roche]
[January, 2008 - Tamiflu Prescribing Information - Roche]
Previous MedWatch alert:
[November 13, 2006]
| |
![Adobe Acrobat [pdf] file](../../IMAGES/PDF.GIF){kind=small}
symbol indicates an Adobe Acrobat file. To read this format, use
the free Acrobat Reader software. Select the "Get Acrobat"
button to open the Adobe Acrobat download site in a new window browser
window. 