The study of adverse reports has its limitations in post-marketing surveillance.
Madison, WI (PRWEB) September 3, 2008
In 2004, the FDA sponsored a study on occurrences of rhabdomyolysis, a sometimes deadly side effect of cholesterol-lowering statins, generally believed to be rare after the withdrawal of cerivastatin. The FDA study looked at patients using statins for a period of one year, with results showing that only 0.44 in 10,000 patients will develop this sometimes life-threatening condition.
The creators of eHealthMe.com, a new free public research tool for prescription drug and interaction information, have taken another look at the study.
"The FDA study may show that rhabdomyolysis is a rare condition in overall statin patients," says Johnson Chen, Co-Founder of eHealthMe.com. "However, what that study doesn't do is look specifically at the risk of the condition in the many patients already known to be susceptible to statin side effects. We analyzed a more extensive data set concentrating on the frequency of rhabdomyolysis in only those patients who had been known to experience side effects from statins usage, in an effort to provide better information to help those patients most at-risk make better decisions in their choice of healthcare."
- Side effect occurrences varied greatly between individual statins. Of seven statins analyzed, rates of rhabdomyolysis and myopathy accounted for 3.29% to 7.76% of all side effects in patients who experienced one or more adverse reactions.
- Evaluation of the adverse reports indirectly suggests the rate of rhabdomyolysis may be significantly higher than the previous FDA study estimated, because many statin patients are elderly or have impaired kidney function, thus being more likely to experience the statin side effects.
- New kinds of information about statins should be made available to patients and professionals to aid them in making healthcare decisions. This should include information, such as that provided by eHealthMe.com, to help the public understand that they may have an increased risk of developing a specific side effect to a drug if they are already susceptible to the condition.
- Further investigation may be needed into actual rates of occurrence of rhabdomyolysis in statin patients.
"The study of adverse reports has its limitations in post-marketing surveillance." says Chen. "However, it contributes to the overall evaluation of medications by accounting for 'real-life use' of drugs. It also allows for long-term, broader monitoring to increase the chances of discovering rare adverse events."
eHealthMe.com is the first resource to make adverse report analysis available to members of the public, offering patients and medical professionals drug risk information not previously available with free and easy access. Now anyone can search the eHealthMe database to review risks and benefits of any medication before they are prescribed or taken.
- The analysis is exclusively funded by an independent company, HealthLat, which owns and runs eHealthMe.com.
- This analysis does not consider dosage of each drug, or drugs co-used (no evaluation of drug interactions with statins).
eHealthMe.com was publicly launched in July 2008 by Madison, Wisconsin-based HealthLat, a leader in Healthcare 2.0. HealthLat launched eHealthMe.com as a means of offering members of the public multi-dimensional drug outcome and drug interaction information based on data analyzed by more than 2 million reports from the FDA and other sources from 1977 to present. The company's mission is to help professionals and consumers make better educated decisions regarding prescription-related risks by making drug information more easily accessible. Basic services of eHealthMe.com are free and anonymous, and the company also offers fee-based enhanced features.
For more information about eHealthMe or the free online tool available to check drug interactions and side effect information, please visit eHealthMe.com.
Co-Founder - eHealthMe.com