F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications

[fed-up]

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 a starting the med (which indicates a hypersensitivity to anti-convulsants and can be fatal), 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?ref=us

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.

[TZ]

1. Actually they ARE required to realease ALL their data to the FDA

And it takes the FDA quite a considerable amount of time to go through that data. Problem is, clinical trials aren't usually large enough to document ALL POSSIBLE side effects. In stage Four of clinical trials the FDA monitors problems like this and will give warnings about the drug.
FYI, after marketing I imagine you can get all the clinical trial data through the FDA and freedom of information act.
Anyone who doesn't understand that these drug makers MUST turn over ALL data good and bad is blowing smoke out of their ass and doesn't know a thing about the FDA or how it works
What you are seeing is what the FDA is SUPPOSED TO DO!!

[godai]

3. Not really...

Companies need to submit to FDA all data necessary for approval and that leads to interpretation. Not all test data is submitted. Phase IV trials are not required for all approved drugs, so don't depend on that as a safety valve.

You're right that clinical trials are not large enough to pick up all adverse reactions. An event occurring once in 10,000 people will not show up in a clinical trials with only 1,000 patients.

One other point, drugs tend to be dosed high, particularly in the US. Companies want to be sure of effectiveness and this leads to higher doses being tested. Lower doses would be safer.

I have 30 years experience with FDA, so I have some background on this topic.

[demnan]

2. I gave you an R

This is important information. I sincerely hope that you have loved ones close at hand right now that know your situation with the meds. Please tell someone who can keep a very close watch on you. I say this with love for a fellow human being and because I lost a cousin to suicide.

Recently I had to go back on anti-depressants because of my own problems, and I needed to take my own advice. Fortunately I have a dear friend who will probably call me every day this week to check up.

[Kindigger]

4. Neuropathic pain

I've been on Neurontin and Lamictal, but didn't notice any improvement. The Dr. recently gave me Lyrica starting at 50mg per day, and increasing to 400 in a week! I took 50mg for three days, and felt like ripping someone's face off. The rest of it went down the toilet.