Hope is faith holding out its hand in the dark.  -George Iles

Tuesday, June 9, 2009

Fibromyalgia Drug Warnings

FDA warns of suicide risk for 3 fibro drugs and 20 other medications

In December 2008, the Federal Food and Drug Administration (FDA) ordered the manufacturers of nearly two dozen medications to add new warnings about an increased risk of suicidal thoughts and behaviors to the drugs’ packaging.

At least three of those medications, pregabalin (Lyrica), gabapentin (Neurontin) and clonazepam (Klonopin), are used to treat fibromyalgia.

The new warnings were ordered after regulators reviewed 199 clinical trials of 11 anti-epileptic drugs and found that those taking these medications had almost twice the risk of suicidal behaviors compared with patients who took placebos. The increased risk translated to one additional case of suicidal thoughts or behavior for every 500 patients on these drugs.

Here is the complete list of drugs that carry the new warning:

Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)

Clonazepam (Klonopin)

Clorazepate (Tranxene)

Divalproex sodium (Depakote, Depakote ER)

Ethosuximide (Zarontin)

Ethotoin (Peganone)

Felbamate (Felbatol)

Gabapentin (Neurontin)

Lamotrigine (Lamictal)

Lacosamide (Vimpat)

Levetiracetam (Keppra)

Mephenytoin (Mesantoin)

Methosuximide (Celontin)

Oxcarbazepine (Trileptal)

Phenytoin (Dilantin)

Pregabalin (Lyrica)

Primidone (Mysoline)

Rufinamide (Banzel)

Tiagabine (Gabitril)

Topiramate (Topamax)

Trimethadione (Tridione)

Valproic Acid (Depakene, Stavzor Extended Release Tablets)

Zonisamide (Zonegran)

If you or a family member take one of these medications, it’s important to be vigilant for signs of suicidality and seek help immediately if you suspect problems.

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