Coalition of Scientists and Advocates call on FDA to Protect Women and Fetal Health

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


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.”

The petitions specifically challenge the claim that NOWS is “life-threatening.” According to the petitions this labeling is false and misleading, unsupported by medical and scientific evidence, and inconsistent with leading national and international expert opinion on opioid use and treatment during pregnancy. Dr. Robert Newman, a leading expert on addiction treatment explained, “there is no support for the claim that prolonged use results in a neonatal opioid withdrawal syndrome that is ‘life-threatening.'” Specifically addressing opioid substitution therapy, Dr. Newman added: “More than 40 years of research confirms that when babies show evidence of neonatal withdrawal, these symptoms can be readily treated, and there is no empirical evidence suggesting any long-term adverse consequences.” The petitions also urge the inclusion of appropriate, evidence-based treatment options for pregnant women using opioids, including opioid substitution therapy.

The FDA is charged with a crucial role in safeguarding the healthcare of the American public, yet despite NAPW’s urgent petitions, it announced on October 25, 2013, that the newly approved drug Zohydro ER will be the first ER/LA opioid analgesic to have the inaccurate labeling.

Kylee Sunderlin, Soros Justice Fellow at NAPW, explained “the proposed FDA changes would likely result in pregnant women being denied adequate pain treatment, discourage opioid-dependent pregnant women from seeking and being offered potentially life-saving methadone and related treatments, and will almost certainly result in an increase in unwarranted child welfare proceedings against pregnant women who receive such treatment.” Such predictions are well grounded. On October 18, 2013, the New Jersey Supreme Court announced that it would review a state appellate court decision holding that a pregnant woman’s participation in medically recommended and supervised methadone treatment constituted a form of civil child abuse.