FDA approves many drugs that predictably increase heart and stroke risk

His argument centers on a recurring pattern seen in several drugs that were initially approved, but later withdrawn after evidence linked them to increased cardiovascular harm.

Examples discussed in the editorial include Vioxx, Bextra, and Meridia—all of which were removed from the market following safety concerns related in part to heart attacks, stroke risk, or cardiovascular complications.

Blankfield notes that these medications shared a common effect: raising blood pressure.

His broader concern is that other approved medications—including certain antidepressants and medications used to treat Attention Deficit Hyperactivity Disorder—can also raise blood pressure, while long-term cardiovascular risk data may remain limited for some patient groups.

The editorial also highlights debate around what qualifies as a “clinically significant” increase in blood pressure.

According to Blankfield, some regulatory evaluations have historically focused on larger blood pressure increases when assessing concern thresholds. He argues this may underestimate the impact of smaller elevations that, while modest in the short term, may still contribute to measurable cardiovascular risk over time—particularly in adults already at elevated risk.

Research published in The Lancet has previously associated even relatively small increases in blood pressure with higher rates of heart attack and stroke across populations, particularly among middle-aged and older adults.

At the same time, cardiovascular risk is not identical across all age groups.

Blankfield acknowledges that younger adults—especially otherwise healthy individuals—may face lower short-term risk from medications that modestly raise blood pressure. Studies involving ADHD medications in younger populations, for example, have generally shown reassuring safety findings in many cases.

His argument is therefore not that such medications should automatically be removed from use.

Rather, he argues that patients and physicians need clearer cardiovascular safety data to make informed prescribing decisions based on age, health history, and existing risk factors.

The editorial proposes three main steps:

– clearer FDA guidance defining what level of blood pressure increase represents meaningful risk in different populations
– stronger requirements for pharmaceutical companies to provide cardiovascular safety data for medications known to elevate blood pressure
– clearer labeling so physicians and patients can better understand those risks during treatment decisions

The broader issue raised is one of informed consent and transparency.

Blankfield argues that many patients assume FDA approval automatically means a medication’s long-term risks are fully understood. His position is that when blood pressure elevation is predictable, that risk should be clearly measured, openly communicated, and factored into prescribing decisions—especially for people with existing hypertension, diabetes, cardiovascular disease, or other risk factors.

At the center of the editorial is a public health question with broad relevance: how much evidence should be required before medications that raise blood pressure are considered adequately safe for widespread use—and how clearly should that risk be communicated to the people taking them?