New drugs have unexpected consequences

Nearly a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval, according to a study published Tuesday.

CHICAGO — Almost one-third of new drugs approved by US regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications, a new analysis found. To identify factors that might enhance patient safety and regulatory surveillance efforts, the Yale-led team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017.

Biologics, psychiatric therapeutics and those receiving accelerated approval and near-regulatory deadline approval were statistically significantly associated with higher rates of events, the study found.

While President Trump has made it clear he believes slow FDA approval is hurting patients by keeping potentially life-saving drugs off the market, others worry that by accelerating drug reviews, the FDA risks approving potentially risky treatments.

He said that both the FDA and Merck, the maker of Vioxx, had failed their duty to safeguard public health by not examining Vioxx for potential cardiovascular problems, which forced the drug's withdrawal in 2004.

The Trump administration has pressured the FDA to approve drugs faster. The agency said it would review the study findings but declined to comment further. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less, making it hard to detect safety issues that might be identified once more patients use the drug over a longer time period. Developing a system to manage safety warnings or recalls; providing care to patients using unsafe drugs; and returning drugs to manufacturers and replacing them with alternatives come with significant costs, healthcare experts said. Whats the appropriate level of safety concerns to have identified only once the product is out of the gate?” said Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. The withdrawn drugs and the reason: Bextra, an anti-inflammatory medicine, heart problems; Raptiva, a psoriasis drug, rare nervous system illness; and Zelnorm, a bowel illness drug, heart problems. Safety communications, which are issued when new, serious risks are identified, were issued for 59 drugs, including drugs for migraine, erectile dysfunction and diabetes. Good next steps would be to dig into the most serious safety problems, determine whether the FDA could have flagged them sooner and examine how they might have been missed, he says.

Alexander commended the researchers, saying their study “underscores the importance of surveillance” after a drug has been launched. "Nothing could be further from the truth". We learn tremendous amounts about a product only once its on the market and only after use among a broad population.”.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

  • Joanne Flowers