Monday, March 12, 2007

Seroquel and Zyprexa: Off Label Use Rampant?

Seroquel prescriptions for off-label use are growing. According to a recent report in Bloomberg,

Prescriptions for Seroquel and Zyprexa, generated more than fourteen billion dollars in total sales last year. According to doctors, the drugs have been prescribed to patients with Alzheimer's disease as well as to teenagers with emotional conditions.

Nearly half of Seroquel prescriptions last year were allegedly for disorders for which AstraZeneca has yet to gain regulatory approval. It is, however, legal for doctors to administer drugs for certain unapproved medical conditions. Companies are prohibited from marketing products to doctors for uses not yet cleared by the U.S. Food and Drug Administration in Washington or by regulators in other countries.

Consequences for off-label scripts? Half a dozen states have filed suit against Eli Lilly, claiming in those lawsuit papers that the drugmaker (and others) failed to disclose the risks of side effects caused by the drug and promoted their use to treat conditions for which they were not approved.

For more, go here.