Professor calls for more stringent guidelines to reduce adverse cardiovascular events
- Dr. Robert Blankenfield has published an article in the Journal of Cardiovascular Pharmacology and Therapeutics suggesting the FDA safety guidelines are insufficient.
- Blankenfield contents that many drugs, such as Vioxx (fofecoxib) and Bextra (valdecoxib) increase the risk of heart attack.
- Blakenfield cites a correlation between increased blood pressure (BP) and the use of certain antidepressants and drugs used for ADHD.
Dr. Robert Blankenfield, a professor of family medicine at Case Western Reserve, is concerned that the FDA’s drug safety guidelines are too lax when it comes to adverse cardiovascular events. The editorial will be published in print in the fall in the Journal of Cardiovascular Pharmacology and Therapeutics. (It was published early online for journal subscribers.) At issue is what is considered significant clinical risk. According to Dr. Blankenfield, FDA considers an increase in systolic BP of 20 mm Hg significant, just as it considers a 10- to 15-mm Hg diastolic BP increase significant. He considers those thresholds too high.
Dr. Blakenfield cites evidence to make his points. He points to a study published in the Lancet that shows the correlation between a 2 mm Hg increase in diastolic BP and a 10% increased risk of heart attack and a 7% increased risk of stroke in middle-aged adults.
- worldpharmanews.com FDA approves many drugs that predictably increase heart and stroke risk