FDA Panel Recommends Against Epilepsy Drug Black Box Warning
Published: July 14th, 2008 • Comments: 5
The U.S. Food and Drug Administration (FDA) convened an advisory panel last week to evaluate the risk of suicide associated with epilepsy drugs, and to make recommendations about what regulatory actions should be taken to protect consumers. Although FDA officials indicated they believe a “black box” warning should be placed on the drugs, the independent panel recommended against such a strong warning at a hearing on July 10, 2008.
FDA advisory panels consist of external medical experts who are brought together by the agency to provide advice and recommendations. Although the FDA is not bound by the recommendations of their advisor panels, they usually do follow their advice.
The panel was convened after an FDA analysis released in January 2008 identified an increased risk of suicidal thoughts and behavior among users of the epileptic drugs. Data revealed that the anti-seizure medications increased the risk from .22% to .43%, which implies an additional 2 suicides could occur for every 1,000 people taking the drugs.
According to government estimates, nearly 2.7 million Americans suffer from epilepsy, which is a neurological disorder characterized by chronic unprovoked seizures. In 2007, anti-seizure drugs generated sales of over $10 billion, making them the fifth best-selling class of drugs in the United States. GlaxoSmithKline’s Lamictal, Pfizer’s Lyrica and Abbott’s Depakote are some of the top sellers.
The FDA advisory panel did find that the epilepsy drugs carry an increased suicide risk, but did not believe a “black box” warning is necessary. A “black box” warning is the strongest available warning that can be placed on a prescription medication, and it is prominently featured with a black border to draw attention to the seriousness of the risk.
The panel concluded that the risk of suicide was relatively low and there was not enough evidence to justify the use of the FDA’s toughest warning. They suggested that a “black box” warning could scare consumers into not taking their medication, which has been shown to be effective in treating epilepsy. It could also cause doctors to be reluctant in prescribing the drugs.
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[...] Related PagesTopamax LawsuitsFDA Panel Recommends Against Epilepsy Drug Black Box Warning [...]
Pingback by Epilepsy Drug Suicide Warnings Added by FDA : AboutLawsuits.com on 17 December 2008:
[...] FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication. However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warning was not appropriate. [...]
Comment by Elizabeth on 26 October 2009:
I have deep concerns regarding the use of Topamax and young people. My son has Asperger’s Disorder and was put on Topamax because of severe migraines that would trigger mild seizures. With in a very short time my son became very dark, and depressed. He had decided to commit suicide one night and it wasn’t until we were at the crisis unit dealing with this that we found out that a child with Asperger’s should never be on this drug because these kids are such global thinkers it was only a matter of time that it became too much for him and tried to take his life. He is not off the meds and getting councling. PLEASE BE VERY CAREFUL, this drug is DANGEROUS!
Comment by richard on 23 November 2009:
7-1-06 my wife mother of 3 girls ended her on life . did topamax have any thing to do with this ?
Comment by Joshua on 24 November 2009:
I was placed on Topamax in 2006 for migraines that were triggering seizures. I was taking 100mg twice a day for two years, During that time I attempted to take my own life 5 times, twice with a gun that misfired. My life was ruined. The High School I was attending (in 2007, I was a senior) sent me to a mental institution, and instead of letting me return to classes immediately, “suspended” me for unconfirmed alleged rumors that I was sent off because of threats to shoot up the school.
I now suffer with bipolar-like problems that affect my day-to-day life and memory. Is their anything that can be done for me?