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FDA MedWatch Safety Alerts: December 2009

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Recommendations:

  • 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 www.aedpregnancyregistry.org.

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. See the Atlas Operations press release for a full list of the recalled products and lot numbers.

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.

Recommendations:

  • 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.

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).

WebMD Public Information from the FDA