FDA Extends Black-Box Warning to All Antipsychotics

New studies and label warnings about the risks of all antipsychotics have not made clinical decisions any easier for physicians, patients, and caregivers.

Three years after the Food and Drug Administration (FDA) instituted a black-box warning for all second-generation antipsychotic (SGA) medications about increased risk of death in elderly dementia patients, a similar warning is being added to the labels of first-generation antipsychotics (FGAs) such as haloperidol and perphenazine.

The FDA announced its decision in mid-June after reviewing two epidemiological studies, both conducted in Canada, that were published in 2007. The two studies found mortality rates in elderly patients taking FGAs to be comparable to or higher than the rates in patients taking SGAs.

In a study by Sebastian Schneeweiss, M.D., and colleagues, the mortality hazard ratio in the FGA-treated elderly patients was 1.47 times that of SGA-treated patients within 180 days after starting the antipsychotic prescription. Included in this study were more than 37,000 people in British Columbia aged 65 and older who were started on antipsychotic medications. About one-third of these patients received FGA prescriptions, and the rest were given the newer SGAs. The study was published in the February 2007 Canadian Medical Association Journal.

READ MORE @ PSYCHIATRIC NEWS

Politics In The Suicide Black Box Decision For Bipolar, Epilepsy Meds

As some of you know, yesterday the FDA's psychopharmacology advisory committee declined to approve the FDA's recommendation that a black box warning be added to 11 anti-seizure drugs used to treat bipolar disorder and epilepsy. I've not seen a lot of press on the decision yet, so the committee's reasoning is not clear to me, but you can glean a bit from this early piece by the Dow Jones News Service:

"Panel members raised concerns about the unintended consequences of adding a black-box warnings to epilepsy [drugs], saying such a move would make doctors wary of prescribing the drugs.

"Panel member Sean Hennessy, a doctor, said he thinks there should be an additional warning on epilepsy drug labels, but added the FDA's analysis shows suicidal risks are 'modest.'

"'To me (the data) says there ought to be a warning, but given what we know about the effects on prescribing, I don't know if they rise to the level of a black box,' Hennessy said.

"GlaxoSmithKline Plc's (GSK) Jack Modell, vice president of clinical development, said his company believes additional warnings should be included on the label. An FDA analysis showed that Glaxo's epilepsy drug Lamictal had a higher increased risk of suicidal behavior and suicidal thoughts than other drugs."

READ MORE @ FURIOUS SEASONS (PHILIP DAWDY)