The Food and Drug Administration recently eliminated the fetal toxicity risk-mitigation requirement for three pulmonary hypertension medications. FDA removed the Risk Evaluation and Mitigation Strategies requirement for ambrisentan, macitentan and the macitentan-tadalafil combination tablet.
The FDA retained its black box warning for those drugs because they remain toxic to fetuses and embryos. The FDA believes the label alone is sufficient to convey the risk without a dedicated risk-mitigation program.
However, the FDA’s risk-mitigation requirements for bosentan remains in place. Bosentan, like macitentan and tadalafil, is an endothelin receptor antagonist, which prevents blood vessels from narrowing and carries the same fetal risks. FDA hasn’t explained why it eliminated REMS requirements for three endothelin-blocking PH therapies but not the fourth. FDA has removed the requirement for endothelin blockers for other conditions.
Pharmacies and PH health care professionals likely will continue to require pregnancy tests before refilling prescriptions because of the fetal toxicity risks.
The FDA announcement doesn’t affect risk-mitigation requirements for PH drugs that could cause liver toxicity.
If you have questions about safety risks and risk mitigation requirements related to your PH therapy, talk to your care team or specialty pharmacy.
Email us to reach PHA’s treatment access program or call 301-565-3004, ext. 758.
