In this new post out today in Science daily, doctors point out that the FDA is placing Americans at undue risk by approving drugs that carry risk even doctors wouldn’t approve of. Cases where drugs like like Vioox, Bextra, and Meridia were responsible for killing tens of thousands of Americans highlight how an agency charged with protecting Americans, is having issues carrying out this agenda.
“The agency charged to protect patients from dangerous drug side effects needs to be far more vigilant when it comes to medications that affect blood pressure.
The editorial 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.
“It is unwise to allow medications that predictably increase risk to be marketed without adequate safety data,” said Blankfield, also a family physician at University Hospitals Berea Health Center. “Risk should be quantified, and the product label should accurately communicate the risk.”
Blankfield, who has published other editorials recommending that the FDA require safety data for drugs that raise blood pressure, advocates a three-step solution. First, the FDA needs to establish specific guidelines regarding what degree of blood pressure elevation constitutes a risk for different populations (i.e. young adults, middle aged adults, older adults, diabetics, hypertensives, etc.). Then the agency should require pharmaceutical companies to provide cardiovascular safety data on medications that increase blood pressure. Finally, the agency should require pharmaceutical companies to post relevant data and/or warnings on medication labels.