FDA Kicks Off Project To Announce Drugs Under Review for Safety Issues
On Friday, FDA officials said the agency will begin publishing quarterly a list of drugs being investigated for potential safety risks, the Washington Post reports.
The list, available on the FDA Web site, names the drug and the nature of the related "adverse event" but does not address the severity or the number of such events reported. Appearing on the list does not mean a drug has been found to be unsafe, according to the Post.
The new policy is required under legislation passed last year.
Only drugs submitted to the agency's Adverse Events Reporting System will be included on the list. AERS received 482,154 unsolicited reports of potential drug reactions last year but the "vast majority were false alarms," the Post reports.
The agency also investigates drugs based on data from clinical trials and other studies, but such drugs will not appear on the list.
Gerald Dal Pan, an FDA official, said the agency's "post-market surveillance" system will not change but the agency will alter the timing and extent to which the public is informed regarding potential drug safety risks. He said, "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" (Brown, Washington Post, 9/6).
Although the list is intended to provide consumers and health care professionals with advance information on FDA investigations, many experts -- including some inside the agency -- have raised concerns that the system could harm patients by causing unneeded alarm.
The agency is aware of the possibility "that people will stop taking a drug inappropriately" because it appears on the list, Paul Seligman, FDA associate director of safety policy, said (Favole, Wall Street Journal, 9/6).
According to the AP/Sentinel, "Consumer advocates called the listing a positive step, but said it needs to be fleshed out."
Thomas Moore, a senior scientist at the Institute for Safe Medication Practices, said, "It's a good thing to get started, but it needs to have much more detail if it's to have significant safety value. A table with just a few words of description is quite limited" (Alonso-Zaldivar, AP/Orlando Sentinel, 9/6).
Drugmakers said that they support the new policy but noted that the information is being given to patients without necessary context and questioned its value.
AstraZeneca spokesperson Tony Jewell said, "It is very, very important that patients and their physicians understand the benefits and risks of the drug. To speak about one without the other could have an impact on patient perception of their medications" (Wall Street Journal, 9/6).
Pharmaceutical Research and Manufacturers of America expressed similar concerns about the potential for the list to alarm patients unnecessarily.
Janet Woodcock, director of 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" (AP/Orlando Sentinel, 9/6).
FDA officials said they have not decided how they will inform the public when a drug is found to carry no safety risk (Washington Post, 9/6).
The first list, published Friday, names 20 drugs and includes a "wide array" of drug types and numerous adverse reactions, the Wall Street Journal reports.
FDA previously had announced safety investigations for some of the drugs listed, but for other treatments on the list it is the first time their safety has been questioned publicly (Wall Street Journal, 9/6).
The drugs heparin, for its link to severe allergic reactions, and Cymbalta, for its connection with urinary retention, were included in the list, among others.
According to the Post, some of the drugs included in the list were added because of investigations into confusing names or packaging, including similar-sounding treatment names (Washington Post, 9/6).