Serious Side Effects Monitoring of New Medications Should Improve

UnitedHealth Care Inc., one of the nation’s largest health maintenance organizations in the U.S., has announced a new drug-safety monitoring tool which should provide more timely notice of potential safety problems involving drugs newly approved by the FDA.

Each year he FDA currently receives about 400,000 reports of possible adverse reactions to drugs by means of voluntary reports from doctors and patients to its MedWatch reporting program.  It is estimated, however, that only ten percent of serious side effects are reported to MedWatch.  Put otherwise, there could be as many as four million cases of adverse drug events in the U.S. annually.

The drug-safety tool being developed by UnitedHealth will be in the form of a drug registry that will use the insurer’s large patient database to find potential associations between certain drugs and serious side effects.  Up too this point in time, the FDA and medical researchers have only used such patient databases to conduct retrospective, i.e., "look-back", studies which are initiated after there is enough evidence of a potential safety problem associated with a prescription drug to cause general concern.  In contrast, UnitedHealth intends to provide real-time drug-safety information by continually monitoring those drugs that have been approved by the FDA since 2004.  Accordingly, it is hoped that unsafe drugs can be identified, and removed from the market, more quickly.

Recent examples of delay in safety-based drug withdrawals include:

• Bextra: approved in 2001, withdrawn in 2005, due to increased risks of heart attacks, ischemic strokes, and serious skin reactions such as Stevens Johnson Syndrome;
• Vioxx: approved in 1999, withdrawn in 2004, due to various cardiovascular problems in patients taking higher doses; and,
• Baycol: approved in 1997, withdrawn in 2001, due to rhabdomyolysis.

Recently, the FDA has been in discussions with large health maintenance organizations like UnitedHealth and Kaiser Permanente about making use of their adverse drug effects claim information for this purpose.  The acting director of the FDA’s Center for Drug Evaluation and Research, Steven Galson, was quoted in the Wall Street Journal as stating " The kind of data available from these databases represents an evolution in drug-safety information."

(Posted by: Tom Lamb)