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FDA Warns Against Use of Topamax by Women of Childbearing Age
By Dr. Jeffrey J. Roth Mon, March 07, 2011 4:50 pm MDT
Topamax was developed for use as an anti seizure medication. Topamax has also been used to prevent migraines. The drug has been found to decrease appetite in some people, and this unintended side effect has made it popular as a weight loss drug. However, this drug and some of its side effects are not to be taken lightly. At our practice in Las Vegas we have seen some patients who got the shakes while they were taking it. A recent statement by the FDA may also give physicians and cosmetic surgeons pause when prescribing Topamax to women of childbearing age.
Today the American Medical Association (AMA) released a communiqué stating that based on information gathered, the FDA is indicating that Topamax is not indicated for women of childbearing age.
The Associated Press reported that the FDA is "warning women of child-bearing age that the epilepsy drug Topamax (topiramate) can increase the risk of birth defects around the mouth." The FDA said that data collected from "a registry of pregnant women showed a higher rate of cleft lip and cleft palate in babies whose mothers were taking the drug during the first trimester."
Data from the North American Antiepileptic Drug Registry indicates that oral clefts occurred in "1.4% of pregnancies among women taking topiramate alone during the first trimester of pregnancy, compared with a prevalence of 0.38% to 0.55% among those taking other epilepsy drugs." Notably, the rate of the birth defect is "0.07% among women taking no drugs during pregnancy, indicating a 21-fold increase in risk for this group."
The findings have prompted the FDA to "strengthen the label warning for topiramate by changing its pregnancy classification to category D." The FDA raised the drug’s pregnancy category to D, which means there is evidence the drug can harm a human fetus, but there are situations where the drug’s benefits to the mother could outweigh its risks.
Russell Katz, MD, Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in an official statement that health care professionals "should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age." Dr. Katz recommended that "alternative medications that have a lower risk of birth defects" be considered.
Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate do not fuse together during the first trimester of pregnancy. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose that can lead to problems with eating and talking and to ear infections.
Researchers say with treatment, usually corrective plastic surgery, most children with cleft lip or cleft palate do well. Prevention, of course, is always being preferred over surgical intervention.
FDA officials warn that pregnant women and women of childbearing age should discuss other treatment options with their health care professional before taking topiramate. Women taking topiramate should tell their health care professional immediately if they are pregnant or planning to become pregnant.
People taking topiramate should not stop taking it unless told to do so by their doctor.
In our Las Vegas Plastic Surgery practice, we see people attempting to manage the way their body looks. Diet and exercise are always the best initial step towards maintaining a healthy weight. Sometimes medical intervention and close supervision is warranted to help patients achieve the weight and physical attributes they desire. Cosmetic surgery can help with anatomical concerns related to weight and health. Like anything else, it is important to communicate with your doctor or plastic surgeon, set reasonable goals, and together work toward them through a combination of diet, exercise, and cosmetic or medical treatments.
Jeffrey J. Roth, M.D., F.A.C.S.
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