Epilepsy Drugs Must Carry Suicidal Warnings: FDA
5 CommentsBy Ed Silverman // December 16th, 2008 // 5:09 pm
The move, which comes nearly a year after the agency decided the drugs have a slightly higher risk for suice than a placebo, applies to 21 medications, including several such widely known pills as Pfizer’s Lyrica, Glaxo’s Lamictal and Johnson & Johnson’s Topamax.
However, the FDA stopped short of adding a Black Box warnings, which the agency staffers had proposed earlier this year (back story). An FDA advisory committee last July agreed that stiffer warnings were needed, but declined to recommend a Black Box (look here).
The FDA reviewed 199 clinical trials of 11 drugs which showed patients had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, according to the FDA (see statement).
Just A Thought
Oh, ya know, I had this long thing written and decided to scrap it. As I recall- the numbers for suicidal ideation would easily be outdone by a group of angst filled teenagers. I’ve already gone over the dangers of a placebo test and how it isn’t reasonable. I’ve gone over how Dilantin was omitted from this test- which is perfectly predictable considering the FDAs involvement in messing that drug up. I get to sit through another round of calls from my friends and family to find out if I would ever consider suicide. Another conversation with business people and those in the medical field who are on these drugs and fear losing their positions based on this type of decision. How difficult it is to qualify for SSDI when you have epilepsy and how the FED best make that easier to keep the thousands of epileptics from moving under the nearest bridge now that they’ve made it even harder to get a job. It was plenty hard already.
Here’s a suggestion for the FDA and for drug makers. Stop inventing ways to use epilepsy drugs to treat every effin conceivable illness for your own profit. Stop approving those drugs to be used for illnesses other than epilepsy so that we can be comfortable knowing that we know the risks and that we won’t be damaged by those who don’t.
Idiots telling people they may be suicidal like a parent telling a child that with his ADHD he isn’t expected to do as well as other children. There is no end to the stupidity in this world. But hey, I am on one of those drugs and I fully expect to be disabled.
Just A Thought
Two actually, I didn’t see Dilantin as it was lined up off kilter.
Tom
My sympathies to the woman with epilepsy, but the raw scars of several months dealing with my daughter whom the drug Lamictal made acutely suicidal and wrecked her hormonally. No knives in the house, constant wishes to smash out glass windows and score her veins, monthly ebbs and flows, outbreaks of strange menstrual problems, outbreaks of hot flashes and other inappropriate mid-life symptoms unexpected in a 38 year old. I am sorry the woman feels her epilepsy drugs have been muddied as pharma tacks other conditions on them, but those several months were among the longest of my life. Medwatch response? Contact Glaxo. Glaxo’s response: Fill out this little questionnaire. My response - my life continues to get shorter from dangerous, no warning, crappy psychotropic drugs. Merry Christmas to you, greedy Pharma.
Just A Thought
Tom,
They voted down the black box warning but added the suicidal ideation warning anyway. There is no difference in my opinion. If you read the study you will see how flimsy the evidence for epileptic suicidal ideation is. You can find it here:
http://www.pharmalot.com/2008/07/fda-wants-black-box-warnings-on-epilepsy-meds/
So sorry to hear about your daughter and the effect Lamictal has had on her and on your whole family. I do understand. I am not belittling your experience, but rather, wishing these drugs were not so over-prescribed. They are dangerous. I wouldn’t swallow them if to not swallow them would allow me to do anything but seize and sloth around in fear of the next seizure. Dilantin saved me from that horrible life- until it was changed by, what Pfizer claims, was the suggstion of the FDA.
“FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications”
~targets people with epilepsy specifically. Not those taking these drugs for other indicated and approved maladies.
It doesn’t say FDA Requires Warnings of Risks of Suicidal Thoughts and Behaviors for people taking medication for epilepsy, bipolar disorders, migraine headaches- and on and on and on and on.
“Antiepileptic Medications” points to epileptics alone in public opinion. We have a government agency making a statement that will lessen our attempt to life, liberty, and the pursuit of happiness- by adding to the stigma.
Insult to injury.
A. Mauceri
I am taking lyrica for lower leg and toe spazims. Is this aplicable for me. I wear a brace and have drop foot on left leg. Also diabetic.
Thank You