Report Says FDA’s Expedited Drug Approval Process May Have Put Public in Danger

FL FDA Defective Drug ApprovalA recent report in the Journal of the American Medical Association (JAMA) is calling into question whether the U.S. Food and Drug Administration’s (FDA) expedited drug approval process is doing more harm than good.

The JAMA report stated that medicines are getting onto the market without proper safety analysis and that is compromising prescription drug safety. The authors, two well-known drug safety experts, cited three drugs in particular that have exposed patients to unforeseen risks. They are: Caprelsa, a drug that treats advanced thyroid cancer; Gilenya, a medication used to prevent multiple sclerosis relapse; and Pradaxa, an anticoagulant used for stroke prevention.

The MS drug, Gilenya has been associated with adverse effects on heart rate, while the JAMA report noted that Caprelsa, “was sufficiently toxic that overall survival (was) not different from that achieved with a placebo.”

Pradaxa, in particular, has been in the news because it has been linked to uncontrolled bleeding that has led to severe injuries and death in patients. When it was approved, Pradaxa was seen as an easier-to-use alternative to the decades-old anticoagulant warfarin. Unlike warfarin, there is not an antidote that can be administered during Pradaxa bleeding emergencies.

Janet Woodcock, director of the FDA’s center for drug evaluation, said that the public and medical groups have been urging the agency to move more quickly on drug approvals and stressed that “where there are unmet medical needs, the public has told us they are willing to accept greater risks.”

Profit should never trump safety. If you or a loved one has suffered serious side effects from a medicine and you believe the manufacturer is to blame, contact the Hialeah pharmaceutical litigation lawyers at Farah & Farah. We can investigate your case and discuss your legal options. Call us at (800) 533-3555 for a free and confidential consultation.