Product News and Recalls

Start-up companies provide better access to FDA drug/device side-effect database

Two new start-up companies now allow users to search the Food and Drug Administration’s drug and device databases to see side-effects and malfunctions experienced by others. For years, the FDA has accepted reports from patients, doctors, and manufacturers, and stored detailed information as part of its effort to monitor the thousands of drugs and medical devices in use across the country. While the data are available on its web site, a user is required to download dozens of large files and load them into specialized database software to make any use of them.

As reported by the Wall Street Journal yesterday, these new services provide streamlined and simplified access to the “FDA’s often impenetrable database.” The first start-up company, AdverseEvents Inc., allows users to search either for a drug or a specific symptom, and may be useful for patients or doctors to research a particular symptom or drug. If others are experiencing the same symptom and all are on the same drug, then it suggests that the drug might be part of the cause.

For example, the page for Yaz indicates that “pulmonary embolism” is one if the three most-reported side-effects. Conversely, a search for “pulmonary embolism” shows that the FDA has received over 5,000 reports of people who believe Yaz or Yasmin might have caused a pulmonary embolism.

The second start-up company, Clarimed LLC, focuses on 130,000 medical devices, which are also tracked by the FDA. To date, over 6 million reports have been logged regarding medical devices.

Although these services will be valuable to patients, the Wall Street Journal notes some important limitations:

Still, the FDA’s data have other limitations that some critics say make it potentially misleading. For one, there is no way to determine whether a side effect is due to a drug or a coincidence. (Device malfunctions are even trickier, since operator error or surgical skill can affect how they perform.) For another, the reporting doesn’t necessarily mirror the true incidence of problems. New drugs tend to generate more reports than older ones, and a negative news story about a drug or device can prompt a sudden spike in reported problems. Expectations matter, too. Chemotherapy drugs that cause severe side effects get far fewer reports than drugs for, say, heartburn.

The full Wall Street Journal Article can be found here (subscription required).