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fed-up Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Feb-04-08 12:57 PM
Original message
drugs DOUBLE risk of SUICIDE/Suicidal thoughts-story buried in business section
last Friday-why buried in the business section, because how it will affect profits is all that matters, not that people are dying from the cure

I posted this on Saturday, and am posting again in the hopes that more people read it and tell friends/family members.

from my previous post

and I just stopped lamictal for bipolar last wednesday as I got a very painful, hard, swollen lymph node, sore throat and fever within 9 days of starting the med (which indicates a hypersensitivity to anti-convulsants and can be fatal, but physician's assistant claims I must just have a virus-no bloodwork, no nothing, just "clinical judgement"), does it matter if I am hypersensitive, yes as it is genetic, if I had Cheney's insurance I would have had blood work done, now I just get to sweat out the next 3-6 months and hope that I stopped the drug in time) and yes, there were increased thoughts of suicide

how dare they not require these companies to do thorough studies and to publish ALL of the results
http://www.nytimes.com/2008/02/01/us/01suicide.html
F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications
By GARDINER HARRIS and BENEDICT CAREY
Published: February 1, 2008
Drugs for epilepsy, bipolar illness and mood problems double the risks of suicidal thoughts and behavior, and patients taking them should be watched for sudden behavioral changes, drug regulators have said.

The increased risks, while double in relative terms, are small. The Food and Drug Administration undertook a combined analysis of 199 clinical trials with 43,892 patients and found 4 suicides and 105 reports of suicidal symptoms among the 27,863 patients who were given the drugs compared to no suicides and 35 reports of suicidal symptoms among the 16,029 patients treated with placebos.

Taken together, the risk of suicidal thoughts and behavior was 0.43 percent for those on drug therapy and 0.22 percent for those given placebos.

These medications are primarily used to help epileptics control seizures and to calm the surges in energy and mood that, along with bouts of depression, characterize bipolar disorder. The drugs, which include
Depakote, Lamictal, Topamax, Keppra, Lyrica and Neurontin, are sometimes prescribed for chronic pain and headaches, as well.
Doctors said Thursday that the increased risk did not outweigh the benefits of the drugs.

http://www.medscape.com/viewarticle/569595

Antiepileptic Drugs Linked to Increased Risk for Suicidality
..snip
Results were generally consistent among the 11 drugs studied, and the relative risk (RR) vs placebo was higher in patients receiving treatment for epilepsy (RR = 3.6) than for selected psychiatric illnesses (RR = 1.6) or other conditions (eg, migraine and neuropathic pain; RR = 2.0).
AEDs included in the analysis included carbamazepine (Carbatrol, Shire US, Inc; Equetro, Validus Pharmaceuticals; and Tegretol/Tegretol XR, Novartis Pharmaceuticals Corp), felbamate (Felbatol, MedPoint Pharmaceuticals), gabapentin (Neurontin, Pfizer, Inc), lamotrigine (Lamictal, GlaxoSmithKline), levetiracetam (Keppra, UCB, Inc), oxcarbazepine (Trileptal, Novartis), pregabalin (Lyrica, Pfizer); tiagabine (Gabitril, Cephalon, Inc), topiramate (Topamax, Ortho-McNeil Pharmaceutical, Inc), valproate (Depakote/Depakote ER, Depakene, and Depacon, Abbott Laboratories), and zonisamide (Zonegran, Eisai, Inc, under license from Dainippon Pharmaceutical Company Ltd). Some of these medications are also marketed in generic form.

The FDA notes that the increased risk for suicidality is likely to apply to all AEDs and anticipates broad application of class labeling changes, which will be discussed at an upcoming advisory committee meeting.

In the interim, all patients currently taking or beginning therapy with antiepileptic drugs should be closely monitored for notable behavioral changes that could indicate the emergence or worsening of suicidal thoughts, behavior, or depression. Symptoms such as anxiety, agitation, hostility, mania, or hypomania may be precursors to emerging suicidality, the FDA said.
..snip
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/01/BUJDUPV97.DTL&hw=lamictal&sn=001&sc=1000
Doctors warned about epilepsy drugs' risks
Bernadette Tansey, Chronicle Staff Writer
Friday, February 1, 2008
The risk of suicide or other suicidal behavior doubles for patients taking any one of 11 drugs prescribed to millions of people for epilepsy, pain, psychiatric illnesses and other disorders, the Food and Drug Administration said in an alert to physicians Thursday..The FDA's action could very well saves lives and might also cost the industry money. That's because the alert may affect sales for all manufacturers of the drugs. It might also increase the legal woes of Pfizer Inc., which faces hundreds of lawsuits claiming its drug Neurontin caused suicides and suicide attempts.
Drug regulators reviewed data from 199 clinical trials on anti-epilepsy medications, including Pfizer's drugs Neurontin and Lyrica, Topamax from Ortho-MacNeil Pharmaceutical, and Abbott Laboratories' Depakote. While the risk of suicide-related events was low for those on the drugs, the FDA found it significantly higher than for those on a placebo.
Such symptoms can arise as quickly as a week after a patient starts on one of the drugs, and can persist for six months or longer, the agency said.
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HiFructosePronSyrup Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Feb-04-08 01:02 PM
Response to Original message
1. Weird, those are meaningful numbers?
4 suicides per 27,863 would be expected. And I'd think 0.43% and 0.22% would be within a margin of error.

:shrug:
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fed-up Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Feb-04-08 01:07 PM
Response to Reply #1
2. "the FDA found it significantly higher than for those on a placebo." nt
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HiFructosePronSyrup Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Feb-04-08 01:08 PM
Response to Reply #2
3. Yeah, but why?
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