Pfizer Rapped Over Zoloft Clams

The US Food and Drug Administration has sent an eight-page detailed letter to Pfizer chief executive William Steere, ordering the company to stop distributing sales brochures which the agency feels deal with unapproved, and possibly unsafe, uses of its selective serotonin reuptake inhibitor antidepressant Zoloft (sertraline). The letter cites the company for marketing the drug to treat premenstrual depression, chronic low-grade depression, obsessive-compulsive disorder and postpartum depression, all uses which have not been approved by the FDA.

The most serious offense, according to a report in the Wall Street Journal, is distributing a brochure that suggests Zoloft may be used for treating patients suffering depression after a heart attack. Pfizer's own safety database for the drug has suggested that in some cases it may cause chest pain, variations in blood pressure and rapid heartbeat. The FDA letter notes that "Pfizer's statements...raise significant safety concerns."

In its defence, Pfizer said that "neither Zoloft nor the other drugs in its class have been studied to any appreciable extent in [depressed heart attack] patients, yet it is important to treat their depression. Independent medical research has shown that depression can lead to an increased risk of death in patients who have recently had a heart attack."