GSK Faces Scrutiny Over Misleading Omjjara Prescription Information

On April 15, 2025, the Prescription Medicines Code of Practice Authority (PMCPA) determined that GlaxoSmithKline (GSK) breached ethical and regulatory standards concerning its drug Omjjara. The PMCPA found that the prescribing information for Omjjara was misleading, particularly for women using hormonal contraceptives, by failing to adequately communicate the need for additional pregnancy prevention measures. 

Omjjara is prescribed for adults with myelofibrosis, a rare bone marrow cancer, and for those suffering from moderate to severe anemia. The PMCPA’s findings highlight concerns about the accuracy of information provided to patients and healthcare professionals.

In response, a GSK spokesperson stated, “We take adherence to industry codes and regulations very seriously.”  This incident adds to GSK’s history of regulatory challenges, including a $3 billion settlement in 2012 over allegations of illegal marketing practices and failure to report safety data.