US FDA to list names of drugs under investigation

The US Food and Drug Administration (FDA) took customer concern a step further by publishing for the first time, a list of drugs that are on the market and being used by consumers but are under review for potential safety issues.

From now on, the FDA will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

This listing is part of the FDA Amendments Act, signed into law one year ago. FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

Dr Janet Woodcock, direct of the FDA's Center for Drug Evaluation and Research said, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

The agency's Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

"The risk is that people will read more into this than what it is, which is a statement that an evaluation is underway," said Paul Seligman of the agency's Center for Drug Evaluation and Research. He added that he hopes patients will not stop taking a medication simply because they saw it on the list.

Another official, Gerald Dal Pan, said that the FDA's "post-market surveillance" system is not changing, only the timing and extent to which the public is informed. However, he did express some concerns.

"I think the public has told us in recent years that 'we want to know what you are working on.' We are telling the public at pretty much the earliest stage what we are working on," he said.

A drug is evaluated for safety in many ways in the long process leading to the FDA's decision to approve or reject it for sale. Nevertheless, rare side effects and interactions sometimes are not recognized until after a drug is on the market and taken by many more people - and people with more health problems - than those in pre-market studies.

In the last decade, the painkiller drug Vioxx was found to increase the risk of heart attack and stroke; the diabetes drug Avandia to increase the risk of congestive heart failure; and numerous anti-epilepsy drugs to increase the risk of suicide. In each case, the hazard was not fully recognized until years after the drug was approved. (See: Merck agrees to settle Vioxx claims for $4.85 billion)

The quarterly list, which can be found on the FDA Web site, will name only drugs being reviewed because of reports to the AERS program. The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list.

When the FDA finds that a drug has newly recognized hazards, it can add warnings to the official directions for the drug's use ("the label"), send warning letters to physicians, and require patients taking the drug to be monitored closely, or take the medication off the market. FDA officials said yesterday that they had not yet decided how to inform the public when an investigation exonerates a drug.

The present list contains 20 drugs along with the potential safety issue of each drug. It includes a wide array of drugs, from Eli Lilly & Co.'s anti- depressant Cymbalta to Purdue Pharma LP's powerful painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated.

The FDA has already sent out warnings on a handful of the drugs on the list. For instance, the report lists TNF blockers - such as Johnson & Johnson's Remicade - as being potentially associated with cancer in children. The FDA said in June it was investigating the possible link.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp. PLC's multiple sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking the drug, but the FDA hasn't previously said it was investigating the drug for this side effect.