Fibromyalgia Treatments' Label May Not Carry FDA's Highest Warning of Suicide Risk
After reporting a few months ago that it may force makers of 11 anti-seizure drugs, including the fibromyalgia treatments Lyrica (pregabalin) and Neurontin (gabapentin), to carry a prominent suicide-risk label, an FDA panel now says the risk doesn't appear great enough for that type of labeling. The Wall Street Journal reports that decision could be an $8-billion boon to the companies that make those medications.
Instead of the highly visible warning for patients, the panel recommends sending a medication guide to doctors explaining the suicide risk linked to these drugs.
Just over a year ago, Lyrica became the first drug to be FDA approved as a fibromyalgia treatment. Doctors frequently prescribe Neurontin, Lyrica's predecesor, in part because it's far less expensive. Neurontin, however, carries a greater risk of general side effects. The other anti-seizure drugs linked to a heightened suicide risk are:
- Carbatrol, Equetro, Tegretol, Tegretol XR (carbamazepine)
- Felbatol (felbamate)
- Lamictal (lamtrigine)
- Keppra (levetiracetam)
- Trileptal (oxcarbazepine)
- Gabitril (tiagabine)
- Topamax (topiramate)
- Depakote, Depakote ER, Depakene, Depacon (valproate)
- Zonegran (zonisamide)
Even if the risk is small, it's still there. If you're taking any of these drugs, both you and those closest to you should know they do put you at risk for suicidal thoughts and behaviors. Please keep this list of resources on hand in case of an emergency.
Resources:
- Suicide Crisis Hotlines (US): 1-800-784-2433 or 1-800-273-8255
- Warning Signs of Suicide
- How to Help a Suicidal Person
- FDA Information for Healthcare Professionals
- About.com's Fibromyalgia & ME/CFS Forum
Comments
I have been taking Lyrica for a year now with no thought of suicide. I am also on Zoloft to treat my depression. Lyrica is safe, if taken as directed. Of course, as with any medication, there are certain risks. One can’t tell how it may effect an individual until it’s taken.
I understand that all drugs have side affects
But as a person that has Fibro along with other pain reasons.Any help some times is better than ne help. I think you should do a study on how many people have comment suicide with any help.????? Can you anwer that one. ?
I couldn’t take Lyrica. I wasn’t even depressed before going on it. I became “seriously” depressed, to the point of giving up. If you take it and start getting depressed, get off of it immediately.
Bottom line, there will be lawsuits over Lyrica before too long. Mark my words. This is April 2009 – so let’s just see within a year’s time. This medication should have never been approved for Fibromyalgia. It’s all about profits with no regard for safety. It was announced just this week that some research studies were faked and forged. These doctors and researchers deserve to have this stuff shoved down their throats so they can experience the debilitating, stultifying side effects… many of which I had to experience the three months I took it. Kidney dysfunction and thyroid malfunction are side effects that are not disclosed by the company, and these are just two of the long, long list of problems people are suffering while taking this poison, trying to seek relief from chronic pain. I had vision problems to the point of running off the road and almost wrecking. I gained 60 pounds within three months – when I’ve always been very trim & petite. Sitting like a zombie, unable to concentrate, staggering, stumbling, falling, unable to even wear socks & shoes because I was so swollen… because every ounce of fluid I took in, I was retaining… I have two pages of side effects from Lyrica. People who are seeking help with fibromyalgia so they can keep working and be functional are finding themselves unable to function at all – and are not only losing their jobs, they’re having car accidents and suffering falls because they cannot even walk straight. This substance should be pulled off the market. There should be a full investigation into how the studies were performed, how it was approved – and how much money the pharma company has poured into its ad campaign to make it look oh-so warm, fuzzy and inviting to people who say they have fibromyalgia. Fibromyalgia is very real, but most people who say they have it could see improvement if they stopped drinking sodas & coffee all the time, ate right, did some light exercise and tried to lose some weight. A PCP or IC physician cannot accurately diagnose fibromyalgia. It can only be reliably diagnosed by a rheumatologist. Depression should be ruled out because the symptoms overlap and mirror one another so closely. Nevertheless, LYRICA is NOT the answer. Lyrica is a bane – not a blessing. Before you begin taking this medication, read people’s comments and do not rely on the company’s slick marketing. And if you are taking it and are suffering any side effects, visit the FDA’s MedWatch website and report your experiences to help make it safer for others. The few people who have said they’ve seen relief is just too isolated and rare for this medication to be considered effective enough to continue marketing it for fibromyalgia treatment. It is not worth the risks. There are just too many acute and long-term risks. My kidneys still give me problems – and I still have hypothyroidism. I’ll always have to take Synthroid. Don’t take Lyrica!