(Reuters) -British pharmaceutical giant GSK has not met required ethical and regulatory standards in the marketing and prescription information for its Omjjara drug, an industry self-regulatory body said on Tuesday. Omjjara is used to treat symptoms such as an enlarged spleen in adults with myelofibrosis – a rare bone marrow blood cancer – and moderate […]
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GSK in breach for misleading prescription information on Omjjara, industry body says
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(Reuters) -British pharmaceutical giant GSK has not met required ethical and regulatory standards in the marketing and prescription information for its Omjjara drug, an industry self-regulatory body said on Tuesday.
Omjjara is used to treat symptoms such as an enlarged spleen in adults with myelofibrosis – a rare bone marrow blood cancer – and moderate to severe anaemia.
The prescribing information provided for the drug misled women using hormonal contraceptives about the necessity for extra precautions to prevent pregnancy, the Prescription Medicines Code of Practice Authority (PMCPA) said.
“We take adherence to industry codes and regulations very seriously,” a GSK spokesperson said.
(Reporting by Chandini Monnappa in Bengaluru; Editing by Mrigank Dhaniwala, Nivedita Bhattacharjee and Shounak Dasgupta)