FDA approves many drugs that up heart and stroke risk
Washington: US Food and Drug Administration (FDA) is under fire after it approved many drugs that predictably increase heart and stroke risk.
The editorial by Robert P. Blankfield, MD, MS, a clinical professor of family medicine, notes that several medications survived FDA scrutiny, only to be pulled from the market after reports of increased heart attacks and strokes related to use of the drugs.
These include rofecoxib (Vioxx), valdecoxib (Bextra), and sibutramine (Meridia). What these drugs have in common is that they raise blood pressure. Other medications approved by the FDA, including some antidepressant medications as well as medications used to treat attention deficit hyperactivity disorder, also raise blood pressure but remain on the market despite inadequate safety data.
Blankfield said that it is unwise to allow medications that predictably increase risk to be marketed without adequate safety data, adding that risk should be quantified, and the product label should accurately communicate the risk.
The editorial was published online in the Journal of Cardiovascular Pharmacology and Therapeutics.