Interstitial Cystitis Association
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Recent FDA Warnings
Anti-seizure Meds Increase Suicide Risk and Now Requiring Warning Labels Anti-seizure medicines are used by people with IC as well as those with fibromyalgia and other nerve-related pain conditions.  Recently, following an analysis and review of 11 of these medicines, the Food and Drug Administration (FDA) alerted physicians about the heightened risks of suicidal tendencies that has been found with these medicines and informed them that warning labels will be required on anti-seizure drugs.

The labeling applies to more than 20 medications used to control seizures, psychiatric disorders, and nerve pain.  The warning cautions doctors that there is increased "risk of suicidal thoughts or behavior in patients taking these drugs for any indication."

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, the FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Read entire FDA report here.

New Labeling Required for OTC Pain and Fever Medicines
The FDA is now requiring makers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks associated with these popular drugs used by many, including people with IC.  These risks include internal bleeding and liver damage.

The FDA is directing that labeling be revised for acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).  Acetaminophen, sold as brand names such as Tylenol, increases risk of severe liver damage.  NSAIDs, including aspirin, ibuprofen, naproxen, and ketoprofen, and sold as brand names such as Aleve and Motrin, increase risk of stomach bleeding.  These are two classes of commonly used drugs that are effective in reducing fevers and relieving minor aches and pain.  They are also commonly combined with other medicines, including pain medicines such as hydrocodone (Vicodin).

Read entire FDA report here.


Posted May 28, 2009