FDA's MedWatch Safety Alerts: January 2012
On This Page:
- Recall: Renastart Due to Incorrectly Labeled Cans
- Potential Mix-up in Opiate Tablets
- Recall: Excedrin, NoDoz, Bufferin, Gas-X Prevention
- Recall: Hair Regrowth Products Sold on Internet
- Recall: Vagifresh Ball, Vagifresh Gel, Female One
- Tysabri and New Risk Factor for PML
- Adcetris: PML and Lung Damage
- Recall: Respironics Trilogy 100 Ventilators
- Drug Safety Labeling Changes
FDA encourages health care professionals and consumers to report problems with medical products, including
- unexpected and undesirable side effects
- quality problems, such as a drug with an unusual odor or color, or a device with defective parts
- unclear or confusing instructions
- failure to deliver the expected benefit
Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
- Regular Mail: Use postage-paid, pre-addressed FDA form 3500
- Fax: 800-FDA-0178
- Phone: 800-332-1088
MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
A powdered medical food for children has been recalled because it was incorrectly labeled.
The recall applies to Renastart 14.11 oz (400g) cans, batch number 12832, shipped throughout the U.S. from Dec. 29, 2011, through Jan. 26, 2012. Following a customer complaint about the way the product was dissolving, the distributor, Vitaflo USA, determined that a small number of cans of a different product may have been wrongly labeled as Renastart.
Renastart is used in children one year and older for the dietary management of kidney disease.
Risk: Using the incorrectly labeled product may result in high levels of potassium or sodium in the blood. Symptoms may be hard to detect, but can result in health problems that are potentially fatal.
- Immediately stop using Renastart 14.11 oz (400g) cans, batch number 12832 (found on the bottom of the can).
- If your child has consumed any Renastart from this batch, contact your child’s health care professional immediately to determine what to do next and how else you can help your child get the nutrition that he or she needs.
- Contact Vitaflo USA toll-free at 888-848-2356 for answers to your questions or arrange to return the recalled product at Vitaflo’s expense.
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Tablets from one opiate medicine may have ended up in the bottle of another one due to problems that occurred during packaging and labeling. The products affected are manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health Inc. and include:
- Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
- Opana (oxymorphone hydrochloride) Tablets CII
- Oxymorphone hydrochloride Tablets CII
- Percocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII
- Percodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
- Endocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII
- Endodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
- Morphine Sulfate Extended-Release Tablets CII
- Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
Opiates are strong medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three mix-ups involving these products since 2009; all three were detected by pharmacists before they were dispensed to consumers.
In the coming weeks, FDA expects there will be shortages of these medications while the manufacturing issues are resolved. The agency is working with Endo Pharmaceuticals and Novartis to minimize the impact to consumers. The extent of the shortage will depend upon how quickly safeguards can be put in place to prevent this mix-up from happening again and then how soon manufacturing can be restarted.
- Examine all opiate medicines made by Endo Pharmaceuticals to ensure that all the tablets are the same and match the pictures of tablets in the visual guide.
- Bring your medicine bottle to your pharmacist and do not take any of the tablets if:
- one or more tablets in your bottle look different from the others
- there are tablets that are different in shape, color or size, or the markings are different
- If you have questions about your medicine, call your pharmacist or health care professional, or call Endo Pharmaceuticals at 800-462-3636.
- Dispose of any unused opiate tablets according to FDA’s recommendations.
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The following over-the-counter products have been recalled:
- Excedrin – all lots with expiration dates of December 20, 2014, or earlier
- Bufferin – all lots with expiration dates of December 20, 2013, or earlier
- Gas-X Prevention – all lots with expiration dates of December 20, 2013, or earlier
- NoDoz – all lots with expiration dates of December 20, 2014, or earlier
Reports of chipped and broken pills and inconsistent packaging practices at Novartis Consumer Health’s Lincoln, Neb., facility could result in pill bottles containing the wrong tablets, caplets or capsules.
Risk: Mixing different products in the same bottle could result in overdose, interaction with other medications you may be taking, or a bad reaction if you are allergic to an unintended ingredient.
- If you have a recalled product, do not use it. Contact Novartis at 888-477-2403 (available Monday–Friday 9 a.m. to 8 p.m. ET) for information on how to return the product for a full refund.
- If you find a pill in any medicine bottle that is different in shape, size, color or markings than the other pills in the bottle, do not use the medicine. Take the medicine bottle to your pharmacist.
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All topical hair regrowth products made by Perfect Image Solutions LLC have been recalled because they are “unapproved new drugs” under FDA regulations and may be hazardous to your health.
The recalled products, which are distributed nationwide through the Internet, include
- Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL
- Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
- Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
- Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
- Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL
Risk: Minoxidil 15% and 10% could cause low blood pressure, a rapid or irregular heartbeat, and other heart-related symptoms. Azelaic acid can make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation or stinging.
These products are used by men and women to slow or stop hair loss and to help hair regrow. They are packaged in glass-dropper containers or plastic shampoo bottles and sold in single units.
- If you have any of these recalled products, throw them out.
- Contact Perfect Image Solutions LLC with any questions at 916-791-3230 Monday–Friday from 9 a.m. to 5 p.m. PST or email email@example.com.
- Contact your health care professional if you have had any problems that you think may be related to using these products.
Vaginal products sold as cosmetics have been recalled because they contain a drug ingredient or harmful bacteria.
FDA’s analysis found that Vagifresh Gel contains benzocaine—an active ingredient in many anesthetic drug products—and Vagifresh Ball is contaminated with bacteria. FDA also determined that marketing material for these products contains unproven treatment claims related to various gynecologic conditions. These claims could have caused women who use these products from getting proper medical care for potentially serious conditions.
Vagifresh Gel and Vagifresh Ball were sold in herbal stores, beauty shops, drug stores and by Internet and mail order. The two products were also sold together with Vagifresh Liquid in a package named Female One. (The Vagifresh Liquid product has not been recalled.)
- Stop using these products immediately and contact your health care professional if you have any problems that you think may be related to using them.
- Return unused products to the place of purchase for a refund.
- Call the product distributor, USA Far Ocean Group Inc., with any questions at 626-560-2435 Monday–Sunday between 9 a.m. and 5 p.m. PST.
For More Information
Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for developing progressive multifocal leukoencephalopathy (PML). This rare but serious brain infection that can result in death is associated with the use of Tysabri (natalizumab) to treat multiple sclerosis or Crohn's disease. FDA has updated the drug label for Tysabri to include this information.
In January, FDA approved the first test to detect anti-JCV antibodies, helping doctors determine if people with multiple sclerosis or Crohn’s disease who use Tysabri are at an increased risk for developing PML.
Recommendation: You and your health care professional should consider the risks and benefits of using Tysabri if you have one or more of the three known risk factors for PML:
- presence of anti-JCV antibodies
- longer duration of Tysabri treatment, especially beyond two years
- prior treatment with a medication that suppresses the immune system, such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide or mycophenolate mofetil
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Two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported in patients using the lymphoma drug Adcetris (brentuximab vedotin). At the time of Adcetris' approval in August 2011, one case of PML was described in the drug label.
A new boxed warning highlighting this risk has been added to the drug label, as well as a warning against using Adcetris with the cancer drug bleomycin due to an increased risk of lung damage.
- Contact your health care professional immediately if you develop any signs or symptoms of PML. These may include:
- changes in mood or usual behavior
- confusion, thinking problems, loss of memory
- changes in vision, speech or walking
- decreased strength or weakness on one side of the body
- If you take Adcetris in combination with bleomycin, talk to your health care professional about stopping this combination of medications.
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The Respironics Trilogy 100 ventilator manufactured from Feb. 1, 2011, to April 30, 2011, has been recalled because of a manufacturing problem that can cause the product to stop helping a patient breathe.
Risk: Part of the blower that circulates air and other gases through the ventilator may move out of position, stop working, and cause the device’s alarm to sound. Failure of a caregiver to respond could potentially harm or cause the death of a patient dependent on the ventilator.
The Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of infants weighing at least 11 pounds, through adult patients who require mechanical ventilation.
- Check the list of serial numbers to see if your Respironics Trilogy 100 ventilator has been recalled.
- Arrange for the return or repair of your recalled ventilator by contacting Respironics Customer Service toll-free at 877-387-3311.
In December 2011, FDA required safety labeling changes to be made to 40 drug products, including Dilantin (phenytoin), Relenza (zanamivir), Heparin, Plavix (clopidogrel bisulfate) and Singulair (montelukast sodium).
Changes were made to the prescribing information for health care professionals and, in some cases, to the information that is provided to patients when they receive the drug to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Feb. 15, 2012