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drug_recall neurontinThere are only two FDA-approved uses for the drug Neurontin (Gabapentin) in the United States. The anticonvulsant drug has been approved for the treatment of seizures commonly associated with epilepsy, as well as the treatment of nerve pain most often experienced after a shingles attack.
While FDA approval has only been granted for these two uses, many doctors have prescribed the medication to treat a variety of other conditions, including tremors, restless leg syndrome and hot flashes associated with menopause.
Because of its association with the nerve pain that accompanies the shingles virus, Neurontin has also been used to treat chronic neuropathic pain and other chronic pain syndromes. These can include endocrine diseases and diabetic peripheral neuropathy, the intensely painful condition that affects many diabetics. It has also been successful in treating tardive dyskinesia, a neurological syndrome caused by long-term use of neuroleptic drugs prescribed for psychiatric, gastrointestinal and neurological disorders.
Neurontin has also grown in popularity as a treatment for a number of mood disorders ranging from anxiety to bipolar disorder. Several clinical studies have found that people with depressed, manic and mixed states that do not respond to other medications have benefited from Neurontin.
Although the drug has been successful in treating a variety of psychiatric illnesses, Neurontin has still not been approved to treat these conditions because of the risk of serious side effects. Side effects in people taking Neurontin for mental disorders include serious psychiatric reactions, such as mania, paranoia, sexual side effects and suicidal thoughts.
In May 2004, Pfizer, the manufacturers of Neurontin, paid $430 million after pleading guilty to marketing the drug for unapproved illnesses. The lawsuit claims that the company illegally promoted Neurontin for 11 "off-label" medical conditions, including migraines, back pain and drug and alcohol withdrawal seizures, along with other conditions previously mentioned. Under federal laws, drug manufacturers are only allowed to market drugs for the purpose for which they are intended. Doctors, on the other hand, do not have to abide by FDA regulations and can prescribe medications for a variety of "off-label" uses.
The FDA has requested 14 drugmakers to check their study data to see if use of epilepsy drugs results in suicidal behavior or thoughts, giving the drugmakers six months to respond.
Sales of anti-seizure drugs in the U.S. during 2004 were th...
Just weeks after Pfizer and its Warner-Lambert Co. unit were penalized $430 million in federal and state courts for selling Neurontin for purposes that have not yet been FDA approved, the company is again under fire for fraudulent marketing practices. ...
The world''s largest drug manufacturer, Pfizer, Inc., agreed to pay at least $400 million in order to settle civil charges regarding kickbacks to encourage doctors to prescribe the anti-epileptic drug Neurontin for other purposes.
The se...