FDA Mandates Black Box Warning On Older Antipsychotics

The FDA is trying out its new teeth.

The agency was given the authority to mandate drug warnings by the Amendments Act of 2007. Previously the FDA could only request the manufacturer comply.

In the first demonstration of its new authority, the Food and Drug Administration is ordering makers of older antipsychotics, such as thorazine and prolixin, to carry a new black box warning alerting physicians of their dangers.

The drugs are sometimes used to treat seniors with dementia and behavioral problems, although not approved for that use.

Manufacturers will receive letters mandating them to update their labels with the black box or stronger labels, warning about an increase in the risk of death among elderly given the drugs.

The class of drugs targeted are the so-called conventional antipsychotics, and also include Navane (Pfizer), and Moban (Endo Pharmaceuticals). 

The newer class of drugs, atypical antipsychotics, such as Zyprexa (Eli Lilly & Co.) and Risperdal (Johnson & Johnson), already received the stronger warning labels in 2005, alerting the public about the potential for heart attack and pneumonia when given to the  elderly with dementia.

Observational studies show the conventional antipsychotics carry the same risk as atypical antipsychotics.

Seniors in nursing homes with dementia sometimes exhibit psychotic symptoms such as agitation, delusions and hallucinations. They can be aggressive and violent. The antipsychotics are used to quell those symptoms.

Convention and atypical antipsychotics work by blocking the dopamine action in the brain.

In an interview with reporters, Dr. Thomas Laughren of the FDA’s Division of Psychiatry Products said that when the agency looked at data involving atypical antipsychotics, it found that after 10 weeks, nearly half of the patients with dementia died, compared to 2.6 percent on a placebo.

The patients, in their 80s were already sickened by cancer or infections.

A study by Canadian researchers, published last month, found that the elderly with dementia were more than three times likely to die when given atypical antipsychotics, when compared to those who had been given no drug therapy.

The black box warning doesn’t mean doctors cannot prescribe the conventional antipsychotics to those sickened by dementia.

"What we want to do is make them aware of this risk. This is something we hope they would discuss with the families and caregivers so they can understand that there are risks to using these drugs,” says Laughren to the Washington Post. #