FDA warns Exeltis over misleading advertising of Slynd birth control pill

FDA warns Exeltis over misleading advertising for Slynd birth control pill, citing omission of side effect information.

The Food and Drug Administration (FDA) has taken a firm stance against misleading advertising practices by issuing a warning to Exeltis, the manufacturer of the progesterone-only birth control pill, Slynd. The FDA's letter, dated August 11, rebukes Exeltis for a sponsored social media post that conveyed inaccurate claims about the safety and effectiveness of Slynd.

FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. (AP)

Based in Florham Park, New Jersey, Exeltis has drawn the FDA's ire for failing to provide information about possible side effects associated with the drug. The FDA underscored that omitting essential side effect information creates a distorted perception of Slynd's benefits and safety. The FDA letter stated, "These violations are concerning from a public health perspective because the promotional communication fails to include any risk information, which creates a misleading impression about the expected benefits and safety of Slynd."

The FDA's communication highlighted potential side effects associated with Slynd usage, including acne, abnormal uterine bleeding, headaches, breast pain, weight gain, menstrual pain, nausea, vaginal bleeding, decreased libido, breast tenderness, and irregular menstruation. Additionally, the FDA pointed out that Slynd is not approved for individuals with specific medical conditions such as kidney impairment, adrenal insufficiency, liver tumors, and a history of certain cancers.

The prescribing information for Slynd further underscores potential risks, including increased blood potassium levels, bone loss, thromboembolic disorders, liver disease, cervical cancer, ectopic pregnancy, and depression. The letter stressed the significance of disclosing these risks to consumers, emphasizing that omitting such vital information misrepresents the drug's safety profile.

Exeltis was granted 15 working days from the date of the FDA's letter to respond. The FDA also requested that Exeltis submit any other communications that fail to disclose risks and side effects. Furthermore, the FDA urged Exeltis to provide a plan for discontinuing misleading advertising practices and "ceasing distribution of Slynd" if needed.