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FDA's MedWatch Safety Alerts: December 2009

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After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by fax, or by phone.

  • Online
  • Fax: 1-800-FDA-0178
  • Phone: 1-800-332-1088

MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Here are a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.


Recall: Tylenol Arthritis Pain Caplet, 100 Count Bottles

McNeil Consumer Healthcare expanded its recall to include all product lots of Tylenol Arthritis Pain Caplet, 100 count bottles, with the distinctive red EZ-open cap. In November 2009, McNeil recalled five lots of this product due to reports of an unusual moldy, musty, or mildew-like odor that was related to nausea, stomach pain, vomiting, and diarrhea.

The odor is caused by the presence of a compound believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.

The risk: The health effects of the compound believed to cause the symptoms have not been well studied. To date, all of the observed events reported were temporary and not serious.

• Stop using any Tylenol Arthritis Pain Caplet, 100 count bottles, with the distinctive red EZ-open cap.
• Contact the company, McNeil Consumer Healthcare, at 888-222-6036 or at, for instructions on how to get a refund or replacement, and how to return or dispose of the product.

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Birth Defects Related to Depakote and Similar Drugs

FDA has notified health care professionals and patients about the increased risk of major birth defects in babies exposed to valproate sodium and related products during pregnancy.

The products are marketed under the following brand names:

  • Depacon (valproate sodium)
  • Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
  • Depakene (valproic acid)
  • Stavzor (valproic acid)

Depending on the products, they may be used to treat epilepsy, bipolar disorder, and migraine headaches.

The risk: There is an increased risk of neural tube defects, such as defects of the brain and spinal cord, and other major birth defects, such as craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels), in babies exposed to valproate sodium and related products during pregnancy.

The medication guide for valproate that is provided with each prescription explains the benefits and risks of valproate and encourages patients to discuss options with their health care professional.


  • Women who are planning a pregnancy or who become pregnant while taking valproate should contact their health care professionals immediately.
  • Valproate should not be stopped without talking to a health care professional, even in pregnant women. Stopping valproate suddenly can cause serious problems.
  • Women who may bear children should only use valproate if it is necessary to manage their medical condition. Talk to your health care professional about the risks and options if you use valproate and you may become pregnant.
  • Women who use valproate and are not planning to get pregnant should use effective birth control.
  • Pregnant women who use valproate or other drugs to treat epilepsy should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or visiting

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Recall: Sexual Enhancement Products from Atlas Operations

Atlas Operations Inc. has recalled certain lots of its dietary supplements for sexual enhancement, which are sold throughout the United States. The recalled products are sold under more than two dozen brand names as well as in bulk, unlabeled.

FDA lab analyses found that the products tested from certain batches contain sulfoaildenafil, a form of an FDA-approved drug used as a treatment for erectile dysfunction. The active drug ingredient is not listed on the product labels.

The risk: The presence of sulfoaildenafil makes these products unapproved drugs. Sulfoaildenafil may interact with some prescription drugs, such as nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take prescription drugs.


  • If you have unexpected side effects from sexual enhancement products, contact your health care professional.
  • Stop using the recalled products and return them to the place of purchase. You may also return products directly to Atlas Operations for a refund; call 800-466-4444 for instructions.

For more information, see Hidden Risks of Erectile Dysfunction "Treatments" Sold Online.

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Recall: Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels

Bayer has recalled one product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot was printed with the label reversed. The product was sold at retail outlets throughout the United States.

The details of the recalled Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels are as follows:

  • Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
  • UPC#: 016500537779
  • Lot #: 296939L
  • Expiration: 5/11

You can find the product lot number on both the interior blister package (in black text next to the expiration date) and the exterior carton containing the blister packaging (embossed on the side panel under the Bayer company logo).

The risk: The label for the green night product appears under some of the blue day product and vice versa. Consumers using the affected product may not be aware of the warnings regarding an antihistamine in the product that could cause drowsiness.


  • Stop using the recalled product.
  • Contact your health care professional if you have a medical concern.
  • Contact Bayer Consumer Care at 800-986-3307 with any other questions or for instructions on a refund or replacement.

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Recall: Thermoflect Products

Encompass Group has recalled its Thermoflect product line for relabeling regarding its use with magnetic resonance (MR).

FDA has recommended that Thermoflect blankets and other Thermoflect products not be used for patients undergoing magnetic resonance imaging (MRI), a technology that uses the body’s natural magnetic properties to produce detailed images of parts of the body.

In addition to being used in hospitals and by the military, Thermoflect products may be used by consumers for camping or other outdoor activities because they can help prevent dangerously low body temperature (hypothermia). In addition to blankets, Thermoflect products include jackets, pants, vests, and caps for adults and children.

The risk: An injury occurred in a patient undergoing MRI, which may have been related to the Thermoflect blanket used.

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Voltaren Gel and Liver Damage

New warnings and precautions regarding the risk of liver damage have been added to the labeling of Voltaren Gel (diclofenac sodium topical gel) 1% and other drugs that contain diclofenac sodium. Voltaren Gel is a non-steroidal anti-inflammatory drug used to relieve pain from osteoarthritis of the joints, such as the knees and those of the hands.

The risk: Liver damage (hepatotoxicity) has been reported in people in the first month of using diclofenac-containing products, although this damage can occur at any time during the use of these products. Severe reactions including liver cell death (necrosis), yellowing of the skin and whites of the eyes (jaundice), hepatitis, and liver failure have been reported. Some of these cases resulted in death or liver transplantation.


  • Let your health care professional know if you have any liver problems before you use Voltaren Gel or any diclofenac-containing products.
  • Contact your health care professional if, after using Voltaren Gel or any diclofenac-containing products, you have side effects, such as nausea, fatigue, lethargy, diarrhea, itching, jaundice, stomach tenderness, or flu-like symptoms.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated February 12, 2010

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