The U.S. Food and Drug Administration (FDA) has issued an "untitled" letter to Mayne Pharma regarding promotional materials for its oral contraceptive Nextstellis, stating that the company made misleading claims about the product's safety profile compared to other hormonal contraceptives.
According to the FDA's Office of Prescription Drug Promotion (OPDP), a professional slide deck for Nextstellis, which contains drospirenone and estetrol, inappropriately suggested the product is safer than other estrogen-containing contraceptives while simultaneously understating its risks.
FDA Cites Specific Misleading Claims
In the letter dated April 28, regulators specifically highlighted how Mayne's promotional materials created "a misleading impression about the risks a patient may experience as a result of using Nextstellis in comparison to other estrogen-containing CHCs [combined hormonal contraceptives]."
The agency took particular issue with claims suggesting the estetrol component in Nextstellis offers superior safety compared to estrogens in other contraceptives. Additionally, the FDA noted that Mayne "misleadingly minimizes the risk of breast cancer" associated with the product, despite Nextstellis being explicitly contraindicated in patients with current or historical breast cancer diagnoses.
This regulatory action represents the first "untitled" letter issued by the OPDP since the agency underwent reductions-in-force, signaling continued vigilance in monitoring pharmaceutical promotional materials despite reduced staffing.
Nextstellis Safety Profile and Warnings
Nextstellis received FDA approval in April 2021 with a boxed warning—the agency's strongest safety alert—regarding increased risks of serious cardiovascular events, particularly in women who smoke cigarettes while using combined hormonal contraceptives.
The product carries several significant contraindications, including:
- Patients at high risk of arterial or venous thrombotic diseases
- Current diagnosis or history of breast cancer
- Other hormonally-sensitive malignancies
The FDA's action emphasizes that despite being a newer formulation, Nextstellis shares many of the same serious risk considerations as other hormonal contraceptives on the market.
Implications Amid Corporate Changes
The regulatory citation comes at a significant time for Mayne Pharma, as the Australia-based women's health company is currently working to finalize a buyout deal with Cosette Pharmaceuticals.
Healthcare providers are reminded to consider the full safety profile of all contraceptive options when counseling patients, and to rely on FDA-approved labeling rather than promotional materials when evaluating comparative safety claims between different contraceptive products.
Regulatory Expectations for Promotional Materials
The FDA consistently monitors pharmaceutical promotional materials to ensure they present balanced information about both benefits and risks. This action against Mayne Pharma reinforces the agency's position that promotional materials must:
- Accurately represent a product's safety profile
- Avoid unsubstantiated comparative safety claims
- Clearly communicate all relevant contraindications and warnings
- Present risk information with appropriate prominence
Companies that receive untitled letters are expected to respond with corrective actions to address the cited violations and prevent similar issues in future promotional materials.
