GSK reprimanded over misleading contraceptive guidance for Omjjara

UK – GlaxoSmithKline (GSK) has been formally reprimanded by the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for providing misleading information regarding contraceptive use in the prescribing details of its drug Omjjara (momelotinib), used to treat myelofibrosis. ​

The PMCPA found that the prescribing information suggested that only women using oral hormonal contraceptives needed to add a barrier method during treatment and for at least one week after the last dose of Omjjara.

This guidance failed to address other forms of hormonal contraception, such as injections or implants, potentially leaving some patients at risk. ​

An anonymous healthcare professional raised the concern, describing the omission as a “shocking error” and questioning GSK’s ability to produce accurate prescribing information. ​

In response, GSK withdrew the prescribing information from its professional website as a precaution.

However, the company maintained that the information was consistent with the approved summary of product characteristics (SmPC) for Omjjara. ​

The PMCPA’s review concluded that the inconsistent terminology between “oral hormonal contraceptives” and “systemically acting hormonal contraceptives” in different sections of the SmPC led to confusion.

Given that Omjjara is contraindicated in pregnancy due to potential fetal harm, the panel determined that GSK’s guidance was misleading and failed to uphold high standards, thereby reducing confidence in the pharmaceutical industry. ​

GSK has acknowledged the PMCPA’s findings and emphasized its commitment to adhering to industry codes and regulations. ​

For more details, refer to the PMCPA’s official case report: AUTH/3810/8/23 – Complainant v GSK.