GSK reprimanded over "shocking error" in Omjjara info

A complaint against GSK accusing it of a major breach of the pharma industry's code of practice on prescribing information has been upheld after a review by the Prescription Medicines Code of Practice Authority (PMCPA).

The case was in relation to wording about the use of hormonal contraceptives in the prescribing information for Omjjara (momelotinib) – a medicine to treat enlarged spleen in myelofibrosis patients – which was reported by an uncontactable individual who said they were a health professional.

Specifically, the complaint refers to a "shocking error" in the information for the product, which is unsafe for use in pregnancy, and gave misleading advice – namely that "women using oral hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of Omjjara."

That prompted the complainant to comment that "common sense and reasoning suggests any non-oral hormone contraception will raise the same concern" and to "query the ability of GSK to accurately produce prescribing information and […] whether sufficient checks have been made to these items prior to release."

GSK said it had withdrawn the prescribing information as a precaution but, after a review, said it disagreed with the allegations, which it said referred to text on a promotional website called GSKPro aimed only at UK healthcare professionals.

The statement was in line with a requirement to include a "succinct" statement about adverse reaction risks, it contended, adding that the offending statement was a direct lift from the approved summary of product characteristics (SmPC) for Omjjara.

The PMCPA partially accepted that response, but upheld the complaint on the grounds that different sections of the SmPC describe the use of contraceptives in different ways – namely "oral hormonal contraceptives" and "systemically acting hormonal contraceptives."

Its panel said there was an "important difference" between these terms as the phrase oral hormonal contraceptives does not cover other hormonal contraceptives, such as an intrauterine device, injection, or implant.

"Given that Omjjara was a black triangle medicinal product subject to additional monitoring, which was contraindicated in pregnancy as it may cause foetal harm, and that important safety information with respect to preventing pregnancy had been presented in a misleading manner, the panel considered that GSK had brought discredit upon and reduced confidence in the pharmaceutical industry," according to the PMCPA.