A new 2007 federal law that requires the federal government disclose its investigations into adverse events regarding drugs. Now for the first time the FDA has released the list of drugs that are under investigation for adverse effects. All of the reports on the list come from the FDA’s early-warning system for drugs already on the market. This Adverse Event Reporting System (AERS) collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might — or might not — be related to a medication.
Just because a drug is on the list doesn’t mean it isn’t safe — or even that it caused the suspected problem. Nobody should stop taking a drug just because it’s on the list, the FDA says.
“If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation,” Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.
However, the list is just that-a list and not an exhaustive discussion of the potential problems concerning the drug. The list also doesn’t say anything about the severity of the problem or how widespread it may be. In some instances, the drug listed has already received adverse publicity such as the antipsychotic drug Seroquel. The blood thinner drug Heparin is also on the list. Heparin received quite a bit of adverse attention earlier this year due to contaminaton issues.