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 Friday. Being on the list doesn't mean the drug is unsafe, only that 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 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 medicine a patient was taking.
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Presumably, many of the investigations that FDA will now announce will not find any new problem with the drug in question.
“The risk is that people will read more into this than what it is, which is a statement that an evaluation is under way,” said Paul Seligman of the agency's Center for Drug Evaluation and Research. He added he hoped patients would not stop taking a medicine simply because they saw it on the list.
Another official, Gerald Dal Pan, said that 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,'” he said.
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.