Adverse Event Reporting—New FDA Report Puts Things in Perspective

Research published in the October 2008 issue of Pediatrics says that some of free prescription drug samples being distributed to pediatric patients may be unsafe. The researchers found that one in twenty American children received free drug samples in 2004—and that the most frequently distributed samples were unsafe to children. Four of the 15 most commonly distributed samples in 2004 were identified by the FDA to have significant new safety concerns.

Worse, more than half of U.S. drug safety studies never see the light of day, according to the journal PLoS Medicine; the researchers claim this amounts to scientific misconduct. Only 43% of the safety and efficacy findings used by the FDA to approve drugs is published in scientific journals. In 2007 there were 482,154 adverse events reported to the FDA for prescription drugs. How many of these adverse events could be avoided if the FDA, the prescribing physician, and the consumer had a clear picture of the drug’s risks as well as benefits?
On the other hand, the FDA has lowered its official 2008 estimate from 960 down to 856. Since most adverse events are reported by people taking prescription and over-the-counter drugs, the relative safety of dietary supplements contrasts sharply with the safety of prescription drugs.
According to a new survey conducted by Ipsos Public Affairs for the Council for Responsible Nutrition, a full 51% of supplement users indicated that current economic concerns will likely not change their supplement purchasing habits. Studies show that dietary supplement use can save billions of dollars in healthcare costs.
In fact, 72% of U.S. physicians use dietary supplements themselves, according to the Healthcare Professionals (HCP) Impact Study from the Council for Responsible Nutrition.
And 79% of American practitioners recommend supplements to their patients. Bone health, overall health and wellness, joint health and mobility, heart health, and maintaining healthy cholesterol are the top five conditions for which supplements are recommended. The AAHF website will help you find a physician knowledgeable in nutritional medicine.
If you are concerned about the lack of perspective in the marketplace regarding the risks of dietary supplements vs. the risks of prescription drugs, learn more about AAHF’s efforts to reform the FDA.