Negative evidence continues to mount against the adverse side effects
caused by drugs. While various drug classes have taken their rightful
place under the microscope, a new class has been positioned for
inspection: epilepsy drugs.
The Food and Drug Administration (FDA) has begun an investigation
into whether epilepsy drugs increase a patient's risk of suicide,
especially those who use the drugs for purposes other than seizure
prevention. That's because, in addition to being used by millions
of people for epilepsy, anti-seizure drugs are largely used to treat
psychiatric illnesses such as bipolar disorder -- also known as
manic depression -- as well as pain and other conditions.
It's the same kind of analysis the agency mandated when they examined
suicide risks associated with young children and teens taking antidepressants.
Prompted by Claims Against Neurontin
The FDA asked makers of all epilepsy medicines to reanalyze research
studies conducted on the drugs to determine if any evidence of increased
suicide risks surfaced. This move was prompted in part by one New
York attorney's claims against the leading epilepsy drug, Neurontin
-- approved for particularly hard-to-control epilepsy, a very serious
condition.
Specifically, the attorney:
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Filed a petition asking the FDA to place a black-box warning
on Neurontin -- citing 25 reports of suicides from the agency's
own database. (The petition is still under FDA investigation.)
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Sent the FDA 258 reports of suicides blamed on Neurontin.
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Aired a brief national television ad searching for such cases
and has filed 72 lawsuits against Pfizer, the manufacturer of
Neurontin.
In light of the potential suicidal side effects evoked by taking
these drugs, the FDA has given Pfizer (and other manufacturers of
all other epilepsy drugs) six months to review their databases and
report back to them.
MSNBC
April 21, 2005
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