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FDA MedWatch Safety Alerts: December 2009

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 regular mail, by fax, or by phone.

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  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • 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.

Recommendations:
• 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 www.tylenol.com, for instructions on how to get a refund or replacement, and how to return or dispose of the product.

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.

WebMD Public Information from the FDA