November 13, 2013, CONTACT: Anais Duran, ADURAN@RABENGROUP.COM

COALITION OF SCIENTISTS AND ADVOCATES CALL ON FDA TO PROTECT WOMEN AND FETAL HEALTH

National Advocates for Pregnant Women (NAPW) along with a coalition of researchers and advocates filed a Citizen Petition as well as a Petition for Stay of Action to the Food and Drug Administration (FDA) calling on the agency to refrain from implementing new labeling changes that are medically inaccurate and dangerous to maternal and fetal health.

On September 10, 2013, the FDA announced labeling changes for extended-release/long-acting (ER/LA) opioid analgesics. Opioid analgesics are a class of drugs used to alleviate moderate to severe pain-from the management of cancer-related pain to labor pain. One of the label changes would require a boxed warning-the strongest warning required by the FDA and one that indicates significant risks associated with a drug-stating: “For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome [NOWS]. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.” Continue reading →