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FDA MedWatch Safety Alerts: December 2009

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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.

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.