News & Resources

July 2, 2011. Category: Library Articles

Off–Label Use of Drugs

Many physicians are prescribing drugs for "off-label" uses - for conditions and symptoms other than the drug was designed to treat. The problem is that these drugs may not have been rigorously tested to ensure the safety for these "off-label" uses. Drug companies are forbidden to promote such uses of their product, but, based upon recent litigation and warning letters from the FDA, it is obvious that off-label promotion is occurring quite often in violation of federal law.

The diet drug combination "fen-phen" is perhaps the best example of rampant off-label use pharmaceuticals. These diet drugs were pulled from the market several years ago after being linked to serious heart valve damage and a fatal lung condition. Today, there is great controversy over Neurontin (an epilepsy drug), which is prescribed "off-label" more than 80% of the time. A company insider has filed a "whistleblower" lawsuit against Neurontin's manufacturer and consumers have also filed cases over the company's marketing practices and concerns about the safety and effectiveness of Neurontin, especially when used for "off-label" purposes. There are also concerns about Topamax, another seizure medication, which is being widely prescribed for weight loss. Topamax has been linked to glaucoma and vision loss.

If you have been injured due to one of these drugs or another drug prescribed for an off-label use, please contact Alley, Clark & Greiwe to consult regarding your potential medical malpractice or products liability claims.

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