Did you know that serious side effects from prescription drugs kill over 100,000 Americans every year?
The number of deaths would be even greater without the FDA website, which communicates health warnings and risks. So the FDA website is central to saving thousands of lives annually, but it can do more.
Serious side effects (also called "adverse drug reactions" or "adverse drug events") are between the 4th and 6th leading cause of deaths in the United States. No drug is without risks, but the FDA depends heavily on reports of adverse drug reactions to issue warnings that can save lives.
Unfortunately for you and me, only a small fraction of serious reactions are reported to the FDA. Research suggests that once drugs are approved, FDA learns of less than 10% of serious reactions leading to hospitalization or death. This low level of reporting that save lives. And this is very real--51% of new drugs have serious, undetected adverse effects at the time of approval.
So, increasing the rate of reporting adverse drug reactions is central to drug safety.
Recent research suggests three easy ways to increase the rate of reporting:
Increase awareness of MedWatch, FDA's online reporting system. — Only a little more than half of doctors are aware of MedWatch, FDA's online drug reaction reporting system, and only 16% of adverse drug reactions are reported through MedWatch. This is despite FDA's wish to emphasize online reporting.
Improve the usability of MedWatch. — Of those doctors who do know about MedWatch, many consider it inconvenient (including my own rheumatologist), which discourages reporting.
FDA's web team can save lives by doing these things. The first two goals can be supported with simple changes to the FDA.gov homepage and the MedWatch homepage. Improving the usability of MedWatch requires usability and design effort, but it should be a priority for FDA.
A quick look at the FDA website suggests why there is little awareness of MedWatch; the only link to it is easily overlooked below the fold. However, placing a well-chosen graphic or button on the homepage could educate millions of doctors and patients about reporting adverse drugs reactions to FDA. In a study by FDA's own scientists, the authors found that publicity increases reporting of adverse drug reactions.
For example, graphic like the one to the right might serve this purpose.
If FDA wishes to use its website to improve public health, then increasing the use and awareness of MedWatch ought to be a key goal and metric of success.
I'm not sure who else should be aware of my experience besides Salley Hansen, the manufacturer of Lip Inflation Extreme. However, my lips were burned by this product after two applications in the same day. they turned purple/black and were painful for two weeks. They also peeled for over two weeks. Seven dollars for a beauty product resulted in over two weeks of pain and suffering, literally. I want to make sure that people are aware of this incident so that will use with caution.
Thanks for the opportunity to share.