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Topamax Study May Encourage Off Label Use, Despite Alarming Side Effects

An off-label use of Topamax could put patients at risk for increased suicidal tendencies and cause adverse effects on unborn babies, according to a Drug Safety Communication issued by the Food and Drug Administration (FDA) on March 4. Topamax has already been used to treat alcohol dependency, eating disorders and migraines, but a new study showing the weight-loss uses for the drug adds to concern about the risks associated with Topamax.

The FDA report said that data have shown that babies born to mothers taking Topamax, an anti-convulsant used primarily to treat seizures and epilepsy, are 20 times more likely to be born with defects, specifically a cleft lip or a cleft palate. This risk becomes even more significant when coupled with evidence that Topamax may also decrease the effectiveness of oral contraceptives, thereby increasing the risk of pregnancy while on Topamax.

Duke University study shows weight-loss
A recent study undertaken at the Obesity Clinical Trials Program of Duke University Medical Center observed the effectiveness and safety of controlled doses of the drugs phentermine and topiramate (the generic name for Topamax) on overweight subjects. In the study, researchers randomly assigned overweight adults with two or more additional risk factors (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to take a placebo or either a high or low dose of phentermine with topiramate.

Each subject was put on a diet and exercise plan to be followed while taking the drugs. After about a year, the placebo group lost an average of three pounds. But those who had taken the medicine combination had much more – those who had taken the smaller dosage lost an average of 18 pounds, while those who had taken the higher dosage lost more than 22 pounds. The medication was not without its side effects, though. The most common were dry mouth, paraesthesia (tingling or numbness of the skin), constipation, insomnia, dizziness, and dysguesia (distorted sense of taste). Subjects also reported instances of anxiety and depression. Despite this, the report concluded that the weight loss benefits were worth the risks of the drug.

The American Law Partners is imploring anyone who has taken Topamax and suffered any severe adverse side effects, including harm to a newborn child.

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