The Controversy of Gabapentin

Gabapentin (Neurontin) was specifically designed to control seizures in epilepsy, treat neuropathic pain after shingles, hot flashes and restless leg syndrome. Neuropathic pain comes from lesions or disorders of the somatosensory system. Let’s simplify this. The somatosensory systems are the nerves (sensors) that process touch and temperature. You touch a hot stove and your hand jerks back. The sensors (nerves) registered heat and told your brain to jerk your arm back away from the heat.  Typical types of pain are burning or coldness, pins and needles sensations, numbness and constant itching.

Gabapentin comes with side effects such as dizziness, drowsiness, weight gain, dry mouth, vomiting, diarrhea and swelling of the extremities. Swelling of the extremities means that your arms and legs increase in size. The worst side effect detected is an increase in suicide or suicidal thoughts. The FDA had to get involved by issuing a black label warning on the drug for a higher risk of suicidal tendencies.

Where is the Controversy?

The controversy lies in what is called off-label use. When a drug is studied and registered with the FDA, it is approved for a certain use such as high blood pressure or migraines. Doctors sometimes will try that drug on other patients who have similar symptoms or diseases that are difficult to treat in the hopes that it might be a more effective treatment. This is called off-label use. Pharmaceutical companies can get approval for other uses but have to restart all the clinical trials based on that new treatment option. This gets expensive but ensures that the drug will work when compared to a placebo.

Gabapentin Promotion

Gabapentin was used by doctors and psychiatrists for bipolar disorder, migraines, and normal neuropathic pain. Doctors were encouraged to use Gabapentin for the above symptoms. The problem was that Pfizer (Warner Lambert) never did a comparison study to determine if Gabapentin did really work for other diseases other than epilepsy. All their marketing material promoted Gabapentin for bipolar disorders without there being true facts. Since doctors don’t have the time to research all the data, they trust that the marketing of the drug is accurate. The promotions included marketing materials, advisory boards, consultant meetings, etc. This was a violation of FDA guidelines for promotion of pharmaceutical drugs. If you didn’t test it, it is not true. So it makes you wonder if profit was placed ahead of safety. 

Pfizer Sued

Pfizer who currently owns Gabapentin was taken to court concerning the increase in suicide attempts for patients using it for bipolar disease. This risk was determined after the fines imposed by the FDA. Studies were done to verify the effectiveness of Gabapentin against a placebo for treatment of bipolar disease. Guess what they found? It wasn’t effective at all and there was an increased risk of suicidal tendencies. Had they performed this study earlier, they could have saved themselves a lot of heartache and money. Has your doctor ever prescribed a medication to be used off-label?