Tuesday, June 24, 2008

MEDICINE: FDA Expands Anti-Psychotic Drug Warning

(published and archived at www.thebulletin.us)

The U.S. Food and Drug Administration (FDA) will soon be increasing the number of prescription anti-psychotic drugs to carry a special warning label.

The label will warn against side effects, particularly for those over 65 based on recent studies suggesting the elderly are susceptible.

Several older or "conventional" antipsychotic medications used to treat behavioral and dementia-related problems are scheduled to join other newer drugs in carrying a "black box" warning.

The FDA's Web site lists Navane, Haldol and Moban among 11 conventional drugs affected by the new regulations.

Pharmaceutical manufacturers will have 30 days to submit either the wording for the new labels or a reason to dispute the FDA's labeling requirement. After that point, the FDA will have authority to enforce the legal requirement.

Although antipsychotic drugs are not approved to treat dementia, and are primarily utilized for schizophrenia, studies found that patients with dementia who take these drugs can exhibit violent behavior.

The decision whether or not to prescribe these medications is and will remain up to the prescribing doctor on a case-by-case basis.

Symptoms of dementia range from forgetfulness and diminished memory to an inability to recognize familiar objects, sounds or people.

In 2005, the FDA first announced requirements for black box warnings for the newer, or "atypical" antipsychotic drugs. These drugs with existing warning labels include Abilify, Clozaril, Risperdal, Seroquel and Zyprexa. These drugs tend to cause a lower incidence of side effects, such as involuntary tics and parkinsonism. Parkinsonism is the display of symptoms similar to, but not necessarily symptomatic of Parkinson's disease, including tremors slow movement, impaired speech or muscle stiffness.

In a news conference on Monday, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said that the warning is intended to help doctors and families understand and balance the risks and benefits of anti-psychotic medication.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Dr. Laughren.

In the two studies on which the box warnings are now based, researchers found patients taking the older drugs had a 4.5 percent risk of death, versus a 2.6 percent risk for those taking a placebo.

Dr. Laughren speculated however, that as the patients in the studies were elderly and many were already ill, its findings might be biased.

©The Evening Bulletin 2008

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