Drugs with Potential for Patient Injuries Revealed

By: Gerri L. Elder

The FDA has announced that it has compiled a quarterly table of drugs that have been identified as having potential safety issues and has posted this information on its Web site.

The listing of potentially dangerous drugs is part of the agency's new mandate to pay closer attention to drug safety and is actually required by the FDA Amendments Act, according to a report by Pharmalot.

The first list that has been posted on the FDA's website includes 20 drugs with potential safety issues that were identified during the first quarter of 2008. Included on this list are Cymbalta, Tykerb, Heparin, Revlimid, Tysabri, OxyContin, Dilantin and Seroquel.

A drug's inclusion on the list does not mean that the drug actually has the risk associated with it on the list. However, it does indicate the potential for the identified risk.

If the FDA determines that the drug and the potential risk are associated, further action may be taken. The potential risks that the FDA has identified with these drugs range from overdoses due to packaging confusion to cancers in children and young adults.

The FDA list is based on drug issues that come into the FDA reporting system known as AERS, or Adverse Events Reporting System, and includes drugs that are being evaluated for potential safety issues. Drugs included on the list have a greater than expected number of reported adverse events, some adverse event that has not previously been known about or associated with the drug, or something already known about the drug that requires further refinement of FDA knowledge.

Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA's Center for Drug Evaluation and Research, has stressed that the list does not include all of the drugs with post-marketing safety issues that the FDA knows about. Paul Seligman, associate director of safety policy and communication, added that the review of drugs by the FDA is not a new thing. However, what is new is the effort being made now to alert the public about the potential of injuries at such an early stage in the research.

Another factor that contributes to the potential for injuries, illnesses or death resulting from prescription drug use is drug mix-ups due to similar drug pronunciations and spellings. More than 1.5 million Americans are injured by medication errors each year and one-fourth of these injuries can be attributed to drug name confusion.

The Associated Press reported that a major study by the U.S. Pharmacopeia, which helps set drug standards and promote patient safety, has shown that almost 1,500 commonly prescribed drugs have names so similar to at least one other medication that they have already caused problems.

The group has recently launched an Internet-based tool to allow consumers and doctors to easily check to see if they are taking or prescribing any of the drugs with problematic names that have been flagged. A patient-oriented Web site, iGuard.org, is also being developed that will send patients e-mail alerts about drug name confusion.

The FDA is also stepping up to help stop the confusion over drug names. Approximately one-third of all proposed drug names are already rejected by the FDA because they are too similar to existing drugs. To further protect against drug name confusion, the FDA is also preparing a pilot program that will shift more responsibility for drug mix-ups to the manufacturers.