Product News and Recalls

Former FDA official says agency hid evidence of Stevens-Johnson Syndrome

In an interview with Truthout, a U.S. Food and Drug Administration drug reviewer described an atmosphere in which professionals tasked with evaluating the safety of drugs are pressured to look the other way when they see a problem. Failing to do so, he said, often brings about official retaliation from the agency.

Ronald Kavanagh B.S.Pharm., Pharm.D, Ph.D., is quoted as saying: “FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling.”

Kavanagh said he finds that indifferent attitude toward public safety particularly alarming when it involves medications meant for children.

He cites a case from 2006, when a medical reviewer found several cases of what he thought might be Stevens-Johnson Syndrome (SJS) in children who took Provigil or modafinil – a stimulant from Cephalon meant to treat ADHD.

SJS and the related condition toxic epidermal necrolysis (TEN) are life-threatening skin conditions where one’s entire body can become covered in rashes and blisters. Patients must often be treated in burn units.

Kavanagh said the diseases are incredibly painful and kill 10 and 40 percent respectively of the people who develop them.

The reviewer believed he was going to be overruled and asked Kavanagh for help, and they were able to get an advisory committee meeting in which he presented data backing up his claims of a correlation between the drugs and the condition.

He said Cephalon opposed him, with one company doctor trying to downplay SJS by saying a child was hospitalized, but was not in the “burn unit.”

And though the advisory committee eventually voted 12-1 against approving the drug, Cephalon improperly marketed it for 18 months as the FDA remained quiet about the issue of SJS in children. Kavanagh said he later found internal documents indicating that FDA officials were aware of the risks, but withheld them from the advisory committee.

If you or a loved one have suffered from SJS, you should consult with a Stevens-Johnson Syndrome attorney at Lopez McHugh to evaluate whether you have a claim.

See the story here:

http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety