The elderly and teenagers in the United States increasingly are being given a class of anti-psychotic drugs for uses not cleared by regulators.
By Shannon Pettypiece and Etain Lavelle March 9 (Bloomberg) -- The elderly and teenagers in the United States increasingly are being given a class of anti-psychotic drugs for uses not cleared by regulators.
Prescriptions for off-label, or unapproved, applications of the medicines are helping to propel sales for AstraZeneca Plc, Johnson & Johnson, and Bristol-Myers Squibb Co., market research data show. The practice has caught the attention of Representative Henry Waxman, a California Democrat, who is probing whether drugmakers promote unapproved usage.
The treatments, including AstraZeneca's Seroquel and Eli Lilly & Co.'s Zyprexa, generated $14.7 billion in sales in 2006, 20 percent more than the previous year, based on data compiled by Bloomberg. Doctors are prescribing the drugs to patients with Alzheimer's disease and adolescents with mental-health illnesses, though there is little evidence the pills are safe and effective for these ills, some researchers say.
``The off-label uses have driven a lot of growth,'' said Kate Hohenberg, an analyst with market research firm Decision Resources Inc. in Waltham, Massachusetts. ``Physicians who treat these diseases are desperately looking for something.''
It is legal for doctors to administer drugs for unapproved medical conditions. Companies aren't allowed to market products to doctors for uses not yet cleared by the U.S. Food and Drug Administration in Washington or by regulators in other countries.
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