- In addition to use by millions of people with epilepsy,
anti-seizure drugs are becoming widely used to treat psychiatric illnesses
such as bipolar disorder -- also called manic depression -- as well as
pain and other conditions. Some epilepsy drugs have FDA approval for various
other uses, while others are prescribed "off-label."
-
- The Food and Drug Administration has begun a preliminary
inquiry into whether epilepsy drugs might increase the risk of suicidal
behavior in some patients, particularly those who use them for psychiatric
illnesses instead of seizure prevention.
-
- Prompted in part by an attorney's claims against the
leading anticonvulsant, Neurontin, the FDA last month asked makers of all
epilepsy medicines to reanalyze research studies done with the drugs to
see if there is any evidence of increased suicide risk.
-
- "I don't think we have any suspicion yet that these
drugs actually do that," cautioned Dr. Robert Temple, FDA's drug policy
chief.
-
- It's the same type of analysis that the FDA last year
ordered for antidepressants amid controversy over their use by children
and teenagers -- and ultimately those drugs were linked to an increase
in suicidal thoughts and actions in 2 percent to 3 percent of young patients.
-
- In addition to use by millions of people with epilepsy,
anti-seizure drugs are becoming widely used to treat psychiatric illnesses
such as bipolar disorder -- also called manic depression -- as well as
pain and other conditions. Some epilepsy drugs have FDA approval for various
other uses, while others are prescribed "off-label."
-
- There are reports of suicides among anti-convulsant users,
most of them bipolar patients, 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, noting that between 10
and 20 percent of bipolar patients commit suicide.
-
- 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, a development first reported by The Boston
Globe.
-
- 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 FDA's own database Latest News about
database.
-
- FDA still is investigating the petition. So last month,
Finkelstein sent the agency 258 reports he had collected of suicides by
people apparently taking Neurontin. Finkelstein, who in fall 2003 aired
a brief national television ad searching for such cases, has filed 72 lawsuits
against Neurontin manufacturer Pfizer Inc. Latest News about Pfizer
-
- Finkelstein also produced a 1992 FDA review of Neurontin
that called depression a potential rare side effect.
-
- Pfizer will comply with FDA's request to reanalyze its
studies, but patient data already submitted to the agency "shows no
link between Neurontin and suicidal thoughts or behavior," said spokesman
Paul Fitzhenry.
-
- Neurontin is approved to particularly hard-to-control
epilepsy, a very 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.
-
- © 2005 Associated Press. © 2005 Sci-Tech Today.
-
- http://www.sci-tech-today.com/story.xhtml?story_id=33309
|
