NEWS - FDA warns that 11 drugs are linked to an increased risk of suicidal thoughts and behaviors

[Guest guest]

Suicidal-Thoughts Risk Is Linked

To Drugs Used to Treat Epilepsy

By JENNIFER CORBETT DOOREN

February 1, 2008

WASHINGTON -- The U.S. Food and Drug Administration warned patients

and health-care professionals Thursday about an increased risk of

suicidal thoughts and behaviors associated with 11 drugs used to treat

epilepsy and certain psychiatric disorders.

The FDA said in an alert posted on its Web site that it looked at

nearly 200 clinical studies involving the 11 drugs and found a

doubling of the risk of suicidal thinking or behavior. The drugs

include & 's Topamax, GlaxoKline PLC's Lamictal,

Pfizer Inc.'s Lyrica, and Novartis AG's Tegretol and Trileptal.

Topamax is also approved to treat migraines, and Lyrica is approved to

treat certain pain conditions from diabetes, shingles and

fibromyalgia.

In a statement, Pfizer said it hasn't identified any evidence an

increased risk of suicide-related events in Lyrica or Neurontin based

on a review of clinical studies and post-marketing reports.

GlaxoKline said they would work with the FDA to update Lamictal's

label if needed, and & said there is already a

discussion about suicide attempts in the Topamax label. Novartis

didn't immediately return requests for comment.

The FDA said patients receiving any of the 11 drugs had approximately

twice the risk of suicidal behavior or ideation, or 0.43%, compared to

0.22% of patients receiving placebo in studies involving about 44,000

patients. The agency said increased risk was observed as early as one

week after starting an anti-epileptic drug and continued through 24

weeks. (See the FDA's warning.)

The agency also said patients currently on the drugs or starting

treatment with the drugs " should be closely monitored for notable

changes in behavior that could indicate the emergence or worsening of

suicidal thoughts or behavior or depression. "

The FDA said it would be working with manufacturers of the

antiepileptic drugs to include the new information in product

labeling. The FDA also said it planned to discuss the data at an

upcoming advisory committee meeting.

The review looked at reports of suicidal behavior, which includes

completed suicides, suicide attempts and preparatory acts and suicidal

ideation or thinking about suicide that were seen in clinical studies

of the drugs. The analysis included a total of 43,892 patients ages

five and older with 27,863 in drug treatment groups and 16,029 in

placebo groups or groups receiving fake drugs.

The FDA said four patients who were taking one of the antiepileptic

drugs committed suicide compared to none of the patients in the

placebo group.

The FDA said because most trials included in the analysis didn't

extend beyond 24 weeks, the risk of suicidal thoughts or behavior that

point could not be reliably assessed.

The review of suicidality data was similar to an earlier analysis of

antidepressants, which resulted in the FDA's toughest black-box

warning being placed on those drugs in 2004 to warn about the risks of

suidical behaviors and thoughts.

http://online.wsj.com/article/SB120180739011432733.html?mod=googlenews_wsj

--

Not an MD

[Guest guest]

Thank you for this information ! Very interesting!

I took Topomax for migraines for quite awhile. It

helps many for weight loss too. I had trouble with

high dosages of Cymbalta prescribed for my FMS after

taking it for a couple of years. It began to cause

really low moods and really bad thoughts. We weaned

me off of it fairly quickly. It's scary what some of

these meds can do in regards to altering moods.

---

<Rheumatoid.Arthritis.Support@...> wrote:

> Suicidal-Thoughts Risk Is Linked

> To Drugs Used to Treat Epilepsy

> By JENNIFER CORBETT DOOREN

> February 1, 2008

>

>

> WASHINGTON -- The U.S. Food and Drug Administration

> warned patients

> and health-care professionals Thursday about an

> increased risk of

> suicidal thoughts and behaviors associated with 11

> drugs used to treat

> epilepsy and certain psychiatric disorders.

>

> The FDA said in an alert posted on its Web site that

> it looked at

> nearly 200 clinical studies involving the 11 drugs

> and found a

> doubling of the risk of suicidal thinking or

> behavior. The drugs

> include & 's Topamax, GlaxoKline

> PLC's Lamictal,

> Pfizer Inc.'s Lyrica, and Novartis AG's Tegretol and

> Trileptal.

> Topamax is also approved to treat migraines, and

> Lyrica is approved to

> treat certain pain conditions from diabetes,

> shingles and

> fibromyalgia.

>

> In a statement, Pfizer said it hasn't identified any

> evidence an

> increased risk of suicide-related events in Lyrica

> or Neurontin based

> on a review of clinical studies and post-marketing

> reports.

> GlaxoKline said they would work with the FDA to

> update Lamictal's

> label if needed, and & said there is

> already a

> discussion about suicide attempts in the Topamax

> label. Novartis

> didn't immediately return requests for comment.

>

> The FDA said patients receiving any of the 11 drugs

> had approximately

> twice the risk of suicidal behavior or ideation, or

> 0.43%, compared to

> 0.22% of patients receiving placebo in studies

> involving about 44,000

> patients. The agency said increased risk was

> observed as early as one

> week after starting an anti-epileptic drug and

> continued through 24

> weeks. (See the FDA's warning.)

>

> The agency also said patients currently on the drugs

> or starting

> treatment with the drugs " should be closely

> monitored for notable

> changes in behavior that could indicate the

> emergence or worsening of

> suicidal thoughts or behavior or depression. "

>

> The FDA said it would be working with manufacturers

> of the

> antiepileptic drugs to include the new information

> in product

> labeling. The FDA also said it planned to discuss

> the data at an

> upcoming advisory committee meeting.

>

> The review looked at reports of suicidal behavior,

> which includes

> completed suicides, suicide attempts and preparatory

> acts and suicidal

> ideation or thinking about suicide that were seen in

> clinical studies

> of the drugs. The analysis included a total of

> 43,892 patients ages

> five and older with 27,863 in drug treatment groups

> and 16,029 in

> placebo groups or groups receiving fake drugs.

>

> The FDA said four patients who were taking one of

> the antiepileptic

> drugs committed suicide compared to none of the

> patients in the

> placebo group.

>

> The FDA said because most trials included in the

> analysis didn't

> extend beyond 24 weeks, the risk of suicidal

> thoughts or behavior that

> point could not be reliably assessed.

>

> The review of suicidality data was similar to an

> earlier analysis of

> antidepressants, which resulted in the FDA's

> toughest black-box

> warning being placed on those drugs in 2004 to warn

> about the risks of

> suidical behaviors and thoughts.

>

>

>

http://online.wsj.com/article/SB120180739011432733.html?mod=googlenews_wsj

>

>

> --

>

> Not an MD

>

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