2008-09-06

The Food and Drug Administration 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.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

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.

Presumably, many of the investigations that the FDA will now announce will not find any new problem with the drug in question.
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"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.

"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.

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, 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 first quarterly report, covering Jan. 1 to March 31, listed 20 drugs. Four were being investigated for problems that already announced to the public: heparin and severe allergic reactions; the diagnostic "contrast agent" Definity and cardiopulmonary reactions; Cymbalta and urinary retention; and tumor necrosis factor inhibitors and cancer in children and young adults.

Some of the newly revealed investigations involve confusing names or packaging, not novel side effects. For example, FDA regulators are looking into problems caused when a cream with the trade name Carac used to treat precancerous skin conditions is confused with a cream called Kuric prescribed for fungal infections.

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