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FDA Approves Many Drugs That Increase Heart and Stroke Risk, Expert Says

Case Western Reserve physician calls on agency to address hidden risk

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.

Robert P. Blankfield, MD, MS, a clinical professor of family medicine, has issued this call to the FDA in an editorial published online in the Journal of Cardiovascular Pharmacology and Therapeutics.

The editorial notes that several medications passed 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 increase blood pressure. Other medications approved by the FDA, including some antidepressants as well as medications used to treat attention deficit hyperactivity disorder (ADHD), also raise blood pressure but remain on the market despite inadequate safety data, Blankfield says.

At issue is the apparent disconnect between what patients and physicians might consider a “clinically significant” risk and the standards that some FDA reviewers apply when evaluating the safety of new therapeutics. When it comes to medications that affect blood pressure, a few FDA reviewers classify “clinically significant” blood pressure spikes only as those that increase systolic blood pressure (SBP) by 20 mm Hg or diastolic blood pressure (DBP) by 10 to 15 mm Hg.

Increases in SBP of more than 2 mm Hg or increases in DBP of more than 1 mm Hg increase the risk of heart attack by 10% and stroke by 7% in middle-aged adults, according to an epidemiologic study published in The Lancet in 2002. Younger individuals have less risk. For example, studies published in 2011 in JAMA and the New England Journal of Medicine indicate that ADHD medications are safe when used by young adults. While different populations differ in terms of cardiovascular risk, Blankfield believes one point should draw broad agreement: unless one is a healthy, young adult, clinicians and patients should have adequate cardiovascular safety data before they make prescription decisions.

“It is unwise to allow medications that predictably increase risk to be marketed without adequate safety data,” Blankfield said. “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 increase blood pressure, advocates a three-step solution. First, the FDA needs to establish specific guidelines regarding the degree of blood pressure elevation that constitutes a risk for different populations, such as young adults, middle-aged adults, older adults, and individuals with diabetes or hypertension). 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.

“This would allow physicians and patients to make informed decisions about medications,” Blankfield said. “Physicians and the general public may assume that if a drug is approved by the FDA, it is safe. Yet even modest elevations in blood pressure increase the risk of heart attacks and strokes.”

Source: Case Western Reserve School of Medicine; May 27, 2014.

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