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Epilepsy Newfoundland and Labrador
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| Drug Alert Notices | |
Neurontin (Gabapentin) and Potential Suicide Risk
The Food and Drug Administration has begun a preliminary inquiry into whether epilepsy drugs might increase the risk of suicidal behaviour in some patients.
Prompted in part by an attorney's claims against the leading anti-convulsant, Neurontin, the FDA last month asked makers of all epilepsy medicines to reanalyse studies of the drugs to see if there's any evidence of increased suicide risk.
"I don't think we have any suspicion yet that these drugs actually do that," cautioned FDA drug policy chief Dr. Robert Temple.
It's the same type of analysis the FDA ordered last year for antidepressants amid controversy over their use by children and teenagers; those drugs ultimately were linked to an increase in suicidal thoughts and actions in a small fraction of young patients, about two to three per cent.
In addition to use by millions of people with epilepsy, anti-seizure drugs are widely used to treat illnesses such as bipolar disorder as well as pain and other conditions. Some epilepsy drugs have FDA approval for other uses, while others are prescribed "off-label."
There are reports of suicides among anti-convulsant users, Temple said. But without a close examination of research studies, it is impossible to tell whether a drug played a role or the disease itself was to blame, he explained.
But "we are taking this matter very seriously," Dr. Russell Katz, FDA's chief of neurologic drugs, wrote New York attorney Andrew Finkelstein last week.
Finkelstein last summer filed a petition with the FDA asking that a black-box warning - the FDA's toughest - about suicide be placed on Neurontin's label. In the petition, Finkelstein cited 25 reports of suicides among Neurontin users from the FDA's own database.
The FDA still is investigating the petition. Last month, Finkelstein sent the agency 258 reports he had collected of suicides by people apparently taking Neurontin. Finkelstein has filed 72 lawsuits against Neurontin manufacturer Pfizer Inc. Finkelstein also produced a 1992 FDA review of Neurontin that called depression a potential rare side-effect.
Pfizer will comply with the FDA's request to reanalyse its studies, but patient data already submitted to the agency "shows no link between Neurontin and suicidal thoughts or behaviour," said spokesman Paul Fitzhenry.
Neurontin is approved for particularly hard-to-control epilepsy, a serious condition. The FDA gave Pfizer and manufacturers of all other epilepsy drugs six months to review their databases and report back to the agency.
The whole category of epilepsy drugs "is potentially very important" in treating other serious illnesses, "and we thought we ought to know this," Temple said.
The Associated Press, April 21, 2005
Disclaimer
The materials contained on the Epilepsy Newfoundland and Labrador website are to provide general information about epilepsy to the public. The information presented is not intended as medical or legal advice. Epilepsy Newfoundland and Labrador, its employees, board members, medical advisors, volunteers, agents and sponsors do not assume responsibility for inaccuracies or omissions or for the consequences from the use of the information obtained over this site or any links accessed through this site. Epilepsy Newfoundland and Labrador is not liable for any outcome or damages resulting from information in either a direct or indirect form. We recognize that each individual's experience of epilepsy is different. Consult your physician and/or neurologist with any questions you have.
People with epilepsy should never discontinue anti-epileptic medications or make changes in activities unless specifically advised to do so by an attending physician.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.
