FDA approves new generic version of powerful painkiller Actiq

posted on:
March 3, 2010


The Food and Drug Administration (FDA) has granted approval to drug maker Coviden for a generic version of the painkiller Actiq (fentanyl citrate), made by Cephalon. Coviden plans to start selling six different doses of the drug, a powerful painkiller prescribed to cancer patients who have become tolerant to opioids. Barr Pharmaceuticals also makes a generic version of Actiq.

Actiq is given as a lollipop lozenge, a method of delivery more easily tolerated by cancer patients. While the FDA-approved use of fentanyl citrate is strictly limited to cancer patients already under pain management, the drug’s off-label use for the treatment of headaches and backaches has become alarmingly popular. Fentanyl citrate is a powerful painkiller. No dosage is safe for patients who have not already become tolerant to opioids, and as a result, it has been linked to fatal respiratory complications. To date, 127 deaths and 91 incidents of severe side effects have been associated with use of Actiq.

Cephalon’s Fentora, a similar but much more powerful version of Actiq, was also found to have an off-label use of as much as 90 percent.

Doctors have the authority to prescribe prescription drugs for “off-label” use; however, drug companies are not allowed to promote uses that are not approved by the FDA. After a study identified the high off-label use of Actiq and Fentora, the FDA’s Office of Criminal Investigations and the U.S. Attorney General launched an investigation into Cephalon’s marketing practices.  That investigation is ongoing.

Source: Associated Press 

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