FDA issues boxed warning for antipsychotics


WASHINGTON The Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of “conventional” antipsychotic drugs to make safety changes to prescribing labeling to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics.

In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, boxed warnings were added. The boxed warning will now be added the older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

“It is important that health care professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research. “The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia.”

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary.

The medications involved in this action are:

Conventional Antispychotic Drugs

  • GlaxoSmithKline’s Compazine
  • Ortho-McNeil’s Haldol
  • Watson’s Loxitane
  • Novartis’ Mellaril
  • Endo’s Moban
  • Pfizer’s Navane
  • Gate’s Orap
  • Bristol-Myers Squibb’s Prolixin
  • GSK’s Stelazine
  • GSK’s Thorazine
  • Schering’s Trilafon

Atypical Antipsychotics

  • BMS and Otsuka’s Abilify
  • Novartis’ Clozaril
  • Avanir’s FazaClo
  • Pfizer’s Geodon
  • Janssen’s Invega
  • Janssen’s Risperdal
  • AstraZeneca’s Seroquel
  • Eli Lilly’s Zyprexa
  • Eli Lilly’s Symbyax

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