A law in Ohio requiring doctors to follow outdated FDA protocols for medication abortion led to patients requiring more medical interventions and experiencing more side effects. Photo by pim pic/Shutterstock
WASHINGTON, Aug. 30 (UPI) -- A law requiring doctors in Ohio to follow outdated FDA recommendations for use of medication abortion resulted in patients experiencing more side effects and requiring more care, according to a recent study.
After doctors were required to follow outdated dosing protocols from the U.S. Food and Drug Administration on use of mifepristone, which is combined with the drug misoprostol for medication abortion, women were found to require additional interventions, according to researchers at the University of California San Francisco.
Mifepristone, also known as RU-486, is combined with misoprostol to cause abortion, and is successful about 95 percent of the time.
In 2011, Ohio, and several other states, started requiring abortion providers to follow a protocol that had been approved by the FDA when Mifepristone was approved for use in 2000.
While following FDA guidelines is generally advisable, recommended doses of the drug at the time of the change in law were based on studies from the 1990s. In the intervening two decades, lower doses were found to be effective while causing fewer side effects.
International standards had shifted with studies that had been conducted after approval of the drug, and most doctors also had shifted to the lower dose -- a not-uncommon off-label use of a drug -- because it worked better for patients.
The FDA updated its label for the drug in March 2016, allowing doctors in Ohio to prescribe lower doses of the drug, though researchers at UCSF say the damage had already been done for many women.
"Ohio's departure from international standards for medication abortion was not associated with improved abortion outcomes," Dr. Ushma Upadhyay, a researcher at UCSF, said in a press release. "Instead, women actually required more medical interventions, had to make more visits, suffered more side effects and incurred greater costs following implementation."
For the study, published in the journal PLOS Medicine, researchers analyzed chart data for 2,783 women who obtained medication abortion between 2010 and 2014 at four Ohio clinics for complications, success rates and side effects.
The researchers found women having medication abortion were three times as likely to need more medical interventions to complete their abortion compared to women before Ohio changed the law, with significantly more women experiencing side effects such as nausea and vomiting as a result of the higher doses of the drug.
While the FDA has changed its recommendation, should research or medical practice reveal additional improvements to recommended use of the drug before the agency again revises its labeling, UCSF researchers say women in Ohio are unlikely to receive state-of-the-art treatment.
"Although the FDA updated the medication abortion protocol in March 2016 to match the evidence, this protocol may also become outdated in the future, and health providers in Ohio will be required to provide care based on legislation, rather than the most up-to-date research and evidence-based practice," researchers write in the study.