Women, Depression, Babies & Off-Label Prescriptions

One of every seven prescriptions for common drugs are for off-label uses lacking scientific support suggests a study. See www.fool.com/investing/dividends-income/2006/12/22/is-offlabel-offbase.aspx

Paxil is not approved for use in children, but doctors can prescribe drugs as they see fit and routinely recommend antidepressants for children suffering from depression and other psychological disorders.

Dr. Gleason, 53, is a Maryland psychiatrist. He was arrested and charged in connection with promoting a drug for purposes other than those approved by the federal government. At hundreds of speeches and seminars, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. www.nytimes.com/2006/07/22/business/22drugdoc.html?ex=1311220800&en=eeafd3a0752f4924&ei=5088&partner=rssnyt&emc=rss

Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug. A 2005 study showed major birth defects in babies born to women who took this antidepressant during the first three months they were pregnant. An article at www.nytimes.com discussed the study showing twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often evade the rules by funding seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.

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