Quarterly Drug Safety Reports Inform Consumers of Potential Drug Risks

All too often we hear belatedly that a popular prescription drug has been taken off the market because it was found to have dangerous side effects. Ideally, drug testing should be thorough enough that there will be no surprises after a pharmaceutical product is okayed for doctors to prescribe to consumers… but that hasn’t been the case and perhaps never will be. Even large-scale studies can’t anticipate results when used in the broader population and over a longer period of time. In an attempt to provide information to consumers on early-stage safety investigations, the FDA has now started posting a quarterly online report listing drugs that are under investigation because adverse event reports have been filed. The goal is to provide an alert to potential safety issues as they emerge, so consumers can have informed discussions with their healthcare provider about whether or not to take a particular drug.

“These reports are valuable and important,” says Larry D. Sasich, PharmD, an assistant professor of pharmacy practice at the Lake Erie College of Osteopathic Medicine (LECOM). He acknowledged that pharmacists and physicians have historically come up short when it comes to communicating drug risk information to patients — it makes sense, therefore, for the FDA to make such information available directly to consumers, not only to increase awareness, but also to disseminate news of potential safety problems faster.

The online report is taken from the FDA’s Adverse Event Reporting System (AERS), a database that contains adverse drug reports from pharmaceutical manufacturers, healthcare professionals and patients. These include a variety of problems, ranging from fairly minor (such as skin rashes) to those that are potentially life-threatening. Twenty drugs with potential safety issues were listed in the first report, which was published in September 2008 — for example, natalizumab (Tysabri), a drug used for people with multiple sclerosis, is being investigated for a possible link to skin cancer.

Drugs listed in this report aren’t necessarily definitively dangerous — inclusion means only that the FDA has identified a potential safety issue and is examining the drug more closely. It’s up to us to make our own decisions about whether or not to stop taking a drug that appears on the list, dependent upon the risk identified and the severity of the condition for which it’s being taken, says Dr. Sasich, who notes “these reports are a credible source of information that consumers should check before they have new prescriptions filled.”

Also, it is smart to check periodically to see whether a drug you’re already on (particularly if it is relatively new to market) has recently been listed — but be aware that what’s listed is only as good as the information provided to the FDA. We already know that only a small percentage of problems ever get reported… and those are the only ones that will make it to the Web site. Be especially careful if your doctor is prescribing a drug for off-label use. Note: If a drug you are taking is on the list, it’s a sign the safety information ought to be taken seriously indeed and discussed with your doctor.

Here’s how to find drug information on the FDA Web site and access the quarterly report:

  1. Go to www.fda.gov/cder/drugsafety.htm.
  2. Under “Latest Safety Information,” click on “Quarterly Reports on Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)” to see the most recent quarterly report. For the time being at least, you’ll need to look through all the posted reports to see whether a particular drug appears on any of them — each quarterly report identifies only those drugs for which new safety information or potential signs of serious risks have been identified through AERS during the previous quarter.
  3. To learn more about a drug listed in the report, go back to “Latest Safety Information.” Click on “Index to Drug-Specific Information.” Here you will find public health advisories, medication guides (information written specifically for patients that must be distributed by pharmacists for certain drugs with serious public health concerns) and other patient information.