Takeda Pharmaceutical was sanctioned by Japan's Ministry of Health, Labor and Welfare (MHLW) for using exaggerated marketing materials to promote hypertension medicine Blopress and was issued a business improvement order with which it will comply, according to a June 12 press release from the company.
The case referred to advertisements on the CASE-J investigator-led clinical study that MHLW said used exaggerated phrases in describing the results of a comparison of Blopress (candesartan) and amlodipine. MHLW said the ads were a violation of the Pharmaceuticals and Medical Devices Law.
The company said changes were already afoot as a response.
"Takeda has already introduced enhanced review and management structures for controlling promotional materials to prevent similar incidents, in response to the changing social environment and regulations in Japan," according to a press release on the company's website. "The company takes this order to improve business operation by the MHLW very seriously, and will continuously enforce necessary preventive measures."
The study, conducted between September 2001 and December 2005, involved nearly 5,000 Japanese hypertensive patients and did not show a statistically significant difference in the cardiovascular primary endpoint.
- here's the Takeda release