The FDA approves medications that increase the risk of heart attack and stroke—drugs used to subdue pain, curb depression, treat ADHD, plus more kinds of drugs. The safety data of these drugs is hardly impressive, yet they remain on the market.
These drugs raise blood pressure, which in turn elevates risk of heart attack and stroke.
How are these drugs getting on the market? The FDA considers only the following as “clinically significant” blood pressure spikes: systolic BP raising by 20 mm Hg, or diastolic BP raising by 10-15 mm Hg.
However, an increase in systolic BP of just more than two mm Hg, or an increase in diastolic by only more than one mm Hg, raises risk of heart attack and stroke by 10 percent and seven percent, respectively, in middle-aged patients.
“It is unwise to allow medications that predictably increase risk to be marketed without adequate safety data,” says Robert P. Blankfield, MD, in a report (online Journal of Cardiovascular Pharmacology and Therapeutics).
Dr. Blankfield proposes some steps to resolve this issue. First, the FDA needs to lay down specific guidelines about what degree of blood pressure elevation poses a risk for various populations. Next, drug companies should be required to provide safety data about cardiovascular risks from drugs that spike blood pressure.
Finally, Big Pharma should be required to post warnings and/or relevant data on the medication labels. After all, people will assume that as long as a drug is on the market, it’s safe. Dr. Blankfield says that “even modest elevations in blood pressure increase the risk of heart attacks and strokes.”