Epilepsy Drug Topiramate May Increase Birth Defect Risk

New data suggest that the drug Topamax and its generic versions (topiramate) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

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Epilepsy Drug Topamax Helps Alcoholism Treatment

A drug called Topamax (topiramate) has been found to help alcoholics quit drinking excessively, according to a University of Virginia study. The drug is not FDA approved for treatment of alcoholism, but has been prescribed off-label by doctors to treat the condition.

Topiramate (brand name Topamax) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. The drug is FDA-approved for treatment of epilepsy and for the prevention of migraines.

To test the drug’s efficacy in treating alcoholism, researchers conducted a 14-week study of 317 alcoholics. Half of the participants were given a placebo and the other half were given Topamax.

The study found that participants on Topamax reduced their alcohol intake from 11 drinks per day on average, to just 3.5 drinks per day. Furthermore, while only abstaining from drinking 3 days per month at the start of the study, by the end of the study they were abstaining from drinking about 15 days per month.

The placebo group also drank less during the study. However, by the end of the study, they abstained from drinking 10 days per month and consumed six drinks per day on average.

The most common side effects of Topamax include a change in taste (carbonated beverages, especially diet sodas and beer, taste particularly bad) and feelings of pins and needles in the head and extremities. Less common side effects include cognitive deficiency (particularly word-finding difficulty); grogginess; lethargy; renal stones, impairment of fine motor skills; vision abnormality and transient or permanent vision loss; weight loss; breast pain; abdominal pain; intense sweating; menstrual disorder; taste changes; pharyngitis; sinusitis; diplopia; rash; leukopenia; fatigue; dizziness; insomnia; anxiety; depression; paresthesia; diarrhea; nausea; dyspepsia; constipation; dry-mouth; dysmenorrhea.

Sources:

  • New Scientist October 10, 2007
  • FDA