Health Care Issues - Monday, October 13, 2008 10:27 - 0 Comments

FDA post list of potential problem drugs

The government has started posting a list of prescription drugs under investigation for potential safety problems. This is an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications and the potential issue for each. However, the list provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question the usefulness of the list. Food and Drug Administration officials are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

Drugs will be placed on the list based on reports the FDA receives regularly from hospitals, doctors and patients. The list is not just a reflection of raw data, but more like what a police officer would call “probable cause.” Officials say a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look. Dr. Paul Seligman, who is responsible for the FDA’s safety communications, observed:

Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list.

Consumer advocates called the listing a positive step, but said it needs to be fleshed out. It appears that the effectiveness of the lists will depend on how much detailed information is contained along with the drug name. Also, it would be helpful to know how many reports on a drug have been received and how many people died or were severely injured or damaged. Nor is it clear how drugs suspected of a problem will be removed from the list if later found safe.

The names of products and potential signals of serious risks/new safety information that were identified for these products during the period January – March 2008 can be found in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA emphasizes that the listing of a drug and a potential safety issue on this Web site doesn’t mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. The FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate. If you want the names of drugs on the list go to the FDA Web Site (www.FDA.gov).

Source: Associated Press