The Food and Drug Administration Center for Drug Evaluation and Research has created a new website that lists prescription drugs that are under investigation for potential safety issues. This list is made available on the FDA website to both physicians and the public. This is the first time the public has had access to knowledge about which drugs are under investigation by the FDA. The list will be updated quarterly to reflect new information and findings.
Twenty pharmaceuticals were included in the first list which was published on August 29, 2008. The list includes drugs such as heparin, a blood-thinner that has been known to cause severe anaphylactic reactions, as well as children’s medicines that have had confusion regarding dosing instructions. The drugs on the list are not being recalled, they are just under investigation and further action will be taken if they are found to be dangerous.
Making the List
The list was made following a drug safety bill passed by congress in 2007, which instructed the FDA to post listings of drugs under investigation on a quarterly basis. The list is constructed based on biweekly reviews of the Adverse Event Reporting System (AERS). The AERS provides updates of potential drug problems reported by physicians and hospitals.
Drugs that are listed will be based on reports from hospitals, physicians, and patients. They will only be listed after reviewers at the FDA determine that the drug requires further investigation. Drugs under investigation pose a potential safety issue, but have not yet been proven to be the cause of any problems.
While this list provides a positive step, there are still many unanswered questions. The list is extremely vague and does not provide any information about the severity of the problem or the number of people affected. Currently, there is no way for the public to receive updates about the status of medications past the quarterly reports. There is also no indication of whether drugs that are found to be safe will be removed from the list.
If you find that a medication you are taking is one the list, do not stop taking it. If a physician has prescribed a specific drug, there is a reason. Many of the medications on the list are dangerous if they are stopped suddenly and without physician supervision. Make an appointment to discuss your concerns with your physician and continue taking the medication until told otherwise.