FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation

ROCKVILLE, MD — January 31, 2008 — FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.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, 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 the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

SOURCE: US Food and Drug Administration

I had the pleasure of dining with 3 CVID patients in Savannah last week. We talked up a storm. It is always enlightening to meet patients and share stories. Gini Lea, Mandy and Jen made me feel like I talk in slow speed being from the north. We had lots of fun and lots of laughs.

Gini Lea is an honors biology teacher. She has remarkable strength and intelligence. She has fought many health battles, including loss of hair, only to keep bouncing back like the everready bunny. Whenever she was younger, she was on treatment, then stopped, then started again. She finally entered a clinical trial for Vivaglobin, and has been doing Sub Q ever since.

Mandy is the mother of 2 boys, 9 months and 5 years old. Mandy has been sick since she was around 6 years old. She was in and out of hospitals about once a month as a child. She started IV’s when she was 8 yrs old. She is very excited that she finally started Sub Q about 5 weeks ago and claims “I love it, I would never go back”. She happily admits that she no longer has that last week before the IV when she always got sick. Now that she is doing Sub Q with Vivaglobin, she “just wants to get up and GO”!

Jennifer has a 7 yr old daughter. Jen was diagnosed at 3 yrs of age. She started with IM shots, and began IV when she was 7. She has battled pneumonia so many times, that she had to have a lobectomy a few years ago from multiple bacterial infections. She currently does monthly IVig, but is considering switching to Sub Q.

The lovely ladies from Savannah are pictured from left to right:

Jen, Mandy, Gini Lea and the gremlin peeking from behind is me.

I keep running into patients and physicians who are not registered with the IDF.  I’m always very surprised whenever I learn about it.

Why?? If you are not registered how do they know you are out there?

If they do not know you are there- how can they help you?

By registering with the IDF you  are able to add your name as a PIDD patient, which helps with education, advocacy, research and lobbying in DC for better health care.

You will also learn about local chapter meetings coming up in your area.

Please, as a New Year resolution, make the time to get registered.

Here is the link to contact them:

http://primaryimmune.org/contact.asp  or

800-296-4433