As doctors continue to seek alternative treatments for uterine fibroids, following concerns over the cancer risks linked to power morcellation treatments, one drug that looked hopeful, Esmya, has run into concerns that it could cause liver damage.
On February 9, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) called for patients in Europe to avoid the drug for the time being, while they investigate concerns over the link between Esmya and liver damage. The warning comes as the drug, which is available in Europe, is seeking regulatory approval in the U.S. by the Food and Drug Administration (FDA).
In its press release, PRAC indicated that it is currently reviewing the risks and benefits of Esmya, an Allergan drug designed to treat uterine fibroids, following a number of reports of serious liver injury and liver failure, including the need for liver transplant. PRAC recommended no new patients start Esmya treatment until their review is complete, and called for women taking the drug to have liver functions checked at least once a month during the treatment and 2 to 4 weeks after treatment ends.
The drug was approved in the EU in 2012, as a treatment for moderate to severe symptoms caused by uterine fibroids. It is typically used up to three months before uterine fibroid removal surgery.
The drug first hit the European market just before controversy exploded over the risks of uterine fibroid removal procedures involving power morcellators, which had become increasingly popular over the past decade as a means of providing minimally invasive hysterectomies for removal uterine fibroids.
Power morcellators allow surgeons to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen, reducing the risk of surgical complications and recovery time. However, the procedures have been largely abandoned due to the risk that morcellators may spread undiagnosed cancer cells contained in the uterus, rapidly upstaging aggressive cancers like leiomyosarcoma.
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer risk, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
Since those warnings were issued by federal regulators in April 2014, the medical community has largely abandoned the use of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
Johnson & Johnson has faced dozens of hysterectomy morcellation lawsuits brought on behalf of women who suffered upstaged uterine cancer after a laparoscopic procedure, and wrongful death claims by family members who had died of such cancers, alleging that the device was defective and unreasonably dangerous. While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about morcellator risks.
Allergan officials have said that they do not believe the PRAC review, which began in December and is still underway, will have a significant effect on the drug’s approval here in the U.S.