Topamax, also known as topiramate, was originally approved by the Food & Drug Administration (FDA) for the treatment of seizures in epileptic patients. However, it is often prescribed “off-label” for weight loss, chronic pain, headaches, alcoholism, bulimia, and psychiatric conditions. Off-label use of medications is controversial, but not illegal. A drug company is only permitted to market its drugs for uses that are part of the warning label and for indications for which the FDA has approved the drug after reviewing available safety data. Many pharmaceutical manufacturers, however, have faced civil and criminal penalties over the last decade for also promoting their drugs for uses for which they have not been approved by the FDA and for which they have failed to provide adequate safety information. Many physicians are unaware of the lack of safety data to support a number of off-label uses of medications, which has resulted in harm to patients.
Recently, Topamax has been linked to birth defects in children. Continue reading
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