Navigation Links
FDA Adds Suicide Warning to Epilepsy Drugs
Date:12/16/2008

Says patients on antiepileptics need to be monitored for indications of mood changes

TUESDAY, Dec. 16 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday that it was adding a label warning on heightened suicide risk for users of antiepileptic drugs.

The move, which follows the advice last summer of an FDA advisory panel, stops short of slapping the strongest "black box" warning on this class of drugs, which includes widely used medications such as clonazepam (Klonopin), phenytoin (Dilantin) and topiramate (Topamax).

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

But, he added, "patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

The warning includes a heightened risk to users of "suicidal thoughts and behaviors (suicidality)," the agency announcement said.

The FDA is also requiring that manufacturers draw up Medication Guides handouts that outline the risks and can be given to patients and their families when the medications in question are prescribed.

Tuesday's move follows recommendations in July from a 20-member advisory panel that voted unanimously, with one abstention, to back the scientific findings on 11 antiepileptic drugs studied by the agency.

In late January of 2008, the FDA announced it was considering a black box warning after an agency review of 199 studies comparing the drugs, which are used by millions, to placebos. That review found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo.

The absolute risk amounted to about 1 added case of suicidal thoughts or behaviors for every 500 patients taking the antiepileptic drugs versus placebo. The mechanism linking antiepileptic drugs with potetial suicide risk remains unknown, the FDA said.

"We have concluded this was a real signal, and the signal applied to all drugs we studied," Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, told reporters in July.

"We propose that labels for all these antiepileptic drugs be changed to include a box warning, and patients should be given a medication guide describing these events with each prescription refill," he said.

The advisory panel appeared to agree with him -- up to a point. It voted in favor of sending a medication guide to doctors detailing the suicide risks, but not the boxed warning. A majority of panel members voted against adding the black box warning, saying the studies didn't show a high enough risk for suicidal behavior.

"The general view of the committee was concern that patients or physicians would not prescribe these drugs in certain circumstances where they should," Katz said.

One specialist said Tuesday that he remained skeptical of any strong link between antiepileptics and suicide.

Dr. Gholam Motamedi, director of clinical neurophysiology fellowship and epilepsy at Georgetown University Hospital in Washington, D.C., said it was "surprising to attribute suicide to the antiepileptic drugs per se, because a good number of these drugs are used in psychiatry for their positive effects on mood and depression. Nevertheless, this emphasizes the importance of screening for signs and symptoms of depression and suicidal tendencies in the epilepsy clinics."

He also pointed to studies that have shown that people with epilepsy tend to have a higher incidence of depression, which is tied to suicide.

"Therefore, this increased rate of suicide may tell us patients with epilepsy may have higher rate of suicide, but it doesn't mean it's 'caused' by the anti-seizure drugs," Motamedi said.

"The better warning would be, in my opinion, to be sensitive to depression of other psychiatric symptoms in epilepsy patients and refer them to psychiatrists," he added.

In addition to clonazepam, phenytoin and topiramate, the drugs covered by the new FDA-mandated labeling are: carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal); pregabalin (Lyrica); primidone (Mysoline); tiagabine (Gabitril); trimethadione (Tridione), and zonisamide (Zonegran). Some of these drugs are also available as generics.

According to the FDA, antiepileptic drugs are used to treat epilepsy, bipolar disorder, migraine headaches and other conditions.

More information

For more on epilepsy, visit the Epilepsy Foundation.



SOURCES: Dec. 16, 2008, news release, U.S. Food and Drug Administration; Gholam Motamedi, M.D., associate professor of neurology and director, clinical neurophysiology fellowship and epilepsy, Georgetown University Hospital, Washington, D.C; July 10, 2008, teleconference with Russell Katz, M.D., director, division of neurology products, Center for Drug Evaluation and Research, FDA, Rockville, Md.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. Jump in Youth Suicide Prompts National Childrens Charity KidsPeace to Issue Tips on Prevention, Warning Signs
3. Teen Suicides Up Sharply for First Time in Years
4. Newer antidepressants led to less, not more, teen suicides
5. SAVE Recognizes National Suicide Prevention Week
6. Assisted Suicide Proponents Seek to Expand With New 1-800 Suicide Consultations
7. Doctor-aided suicide: No slippery slope
8. Californians Against Assisted Suicide: Assisted Suicide Study From Biased Author is Questionable at Best
9. Assisted Suicide Wont Up Deaths for Vulnerable Groups: Study
10. Suicide Prevention Organization Launches New Website
11. Study reveals huffing household chemicals connected to teen suicide
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Adds Suicide Warning to Epilepsy Drugs
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: