In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored.

FDA told Baxter in the latest letter that it is “very concerned by your continued violative promotion of your products.” The agency requested that Baxter cease dissemination of the Araplast brochure and respond in writing about how it intends to bring its promotional material in line with the Federal Food, Drug, and Cosmetic Act.

Baxter reports that it has since sent a letter of response to FDA and put its promotional material for Araplast on hold. In a statement issued Aug. 31, the company said it “has confidence in the strength of its promotional review policies and procedures and a history of collaborating with FDA. [Baxter] will continue to work with FDA to ensure the company is in compliance with all relevant rules and regulations.”

Of the 199 trials, 66 (33%) had at least one suicidal behavior or ideation event (source: FDA)

Makers of antiepileptic are now required to include a warning that the drugs could boost thoughts of suicide, according to an FDA statement released yesterday. Drugmakers also must create a risk mitigation strategy for each drug and handout a pamphlet to patients spelling out the potential adverse reactions.

“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,” stated Russell Katz, director of the division of neurology products at CDER, in a release. “Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

In clinical trials, four patients committed suicide as opposed to none taking the placebo. However, the committee chose not to upgrade the labeling to a stronger boxed warning, instead recommending that the labeling be followed with increased education.

Below is a list of the drugs mandated to add the new warnings:
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.