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FDA Has Posted Drug-Safety List
Posted on Oct 27, 2008
Recently, the U.S. Food and Drug Administration (FDA) began posting a list of prescription drugs under investigation for potential safety problems, as a way to better inform doctors and patients.
The first posted list is a compilation of 20 medications and the potential risk for each. The potential signals of serious risks/new safety information that was identified for each medication occurred during the period January 2008 to March 2008 in the Adverse Event Reporting System (AERS) database. The FDA has made it a point to mention that even though a drug appears on the list, does not mean the FDA has concluded that the drug has the listed risk. It simply means that the FDA has identified a potential safety issue and that there has not been an established causal relationship between the drug and the listed risk.
Some examples of the drugs posted on the website include Desflurane (Suprane), which has the potential risk of cardiac arrest and Arginine Hydrochloride Injection (R-Gene 10), which carries a possible risk of pediatric overdose due to labeling/packaging confusion.
On the FDA’s website, it states that the agency may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy or gathering additional data to better characterize the risk, if the FDA determines that the drug has the associated risk.
The list does not give any indication as to how widespread or serious the problems might be, which has led some consumer advocates to question its effectiveness. Some industry experts are concerned that skittish patients might stop taking their prescription medication if they see it on the list.
FDA officials said that they are trying to walk a fine line in being more open to the public while at the same time, minimizing needless scares. Patients are encouraged to contact their health care providers if they have concerns about a listed medication.
Read More About FDA Has Posted Drug-Safety List...
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