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- Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
- Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
[Posted 09/04/2008]
FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified.
[September 4, 2008 - Information for Healthcare Professionals - FDA]
[September 4, 2008 - Press Release - FDA]
Previous MedWatch Alerts:
[June 3, 2008]
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- Pacific Consolidated brand Mobile Oxygen Storage Tank
- Audience: Emergency healthcare professionals, military emergency/disaster/field hospital/aviation personnel
[Posted 08/28/2008] Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.
[August 28, 2008 - Recall Notice - FDA]
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- Tysabri (natalizumab)
- Audience: Neurologists, other healthcare professionals, patients
[Posted 08/25/2008]
FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,500 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Crohn's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.
[August 25, 2008 - Information for Healthcare Professionals - FDA]
Previous MedWatch Alert:
[February 27, 2008]
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- Ezetimibe/Simvastatin (marketed as Vytorin)
Simvastatin (marketed as Zocor)
Ezetimibe (marketed as Zetia)
- Audience: Endocrinologists, cardiologists, other healthcare professionals, patients
[Posted 08/21/2008]
FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.
[August 21, 2008 - Early Communication about an Ongoing Safety Review - FDA]
Previous MedWatch Alerts:
[January 25, 2008]
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- Boston Scientific NexStent Monorail
NexStent Carotid Stent and Monorail Delivery System
- Audience: Cardiologists, hospital risk managers
[Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.
[August 14, 2008 - Recall Notice - FDA]
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- Vivitrol (naltrexone)
- Audience: Primary healthcare physicians, internists, other healthcare professionals
[Posted 08/12/2008] FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.
[August 12, 2008 - Drug Information Page - FDA]
[August 12, 2008 - Information for Healthcare Professionals - FDA]
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- Simvastatin Used With Amiodarone
- Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals
[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.
[August 08, 2008 - Drug Information Page - FDA]
[August 08, 2008 - Information for Healthcare Professionals - FDA]
[Labels - Simvastatin - DailyMed]
[Labels - Amiodarone - DailyMed]
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- Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
- Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers
[Posted 08/01/2008] Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.
[August 01, 2008 - Recall Notice - FDA]
[July 24, 2008 - Letter - Levitronix] 
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- Viapro 375mg Capsules
- Audience: Consumers, healthcare professionals
[Posted 07/31/2008] EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.
[July 23, 2008 - Press Release - FDA]
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- Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
- Audience: Oncologists, other healthcare professionals
[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.
[August 7, 2008 - Letter - Amgen, Ortho Biotech]
[July 30, 2008 - Follow Up to Ongoing Safety Review - FDA]
[July 30, 2008 - Label - Aranesp]
[July 30, 2008 - Label - Procrit]
[July 30, 2008 - Label - Epogen]
Previous MedWatch Alerts:
[03/12/2008]
[01/03/2008]
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- Mitoxantrone Hydrochloride (marketed as Novantrone and generics)
- Audience: Neurological and Oncological healthcare professionals, risk managers
[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.
These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.
[July 29, 2008 - Information for Healthcare Professionals - FDA]
[March 2005 - Label - Novantrone - Serono, Inc.]
Previous MedWatch Alerts:
[05/24/2005]
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- 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]
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- 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]
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- 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]
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- 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.]
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- 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]
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- 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]
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- 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]
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- Rize 2 The Occasion Capsules
Rose 4 Her Capsules
- Audience: Consumers, healthcare professionals
[UPDATE 07/30/2008] Jack Distribution, LLC, announced a nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. Lab analysis by FDA of samples of random lots found the product contains a potentially harmful, undeclared ingredient, thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for erectile dysfunction.
[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 28, 2008 - Press Release - Jack Distribution, LLC]
[July 01, 2008 - Press Release -
Jack Distribution, LLC]
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- 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]
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- 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]
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- 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]
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- 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.]
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- 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]
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- 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]
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- 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.]
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- 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]
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- 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]
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- 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]
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- 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.]
-
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- 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]
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- 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 | |
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