Pfizer reprimanded over Celebrex promotion
Pfizer has been reprimanded for using promotional material that implied there were no concerns about the cardiovascular safety profile of Celebrex (celecoxib). The company has also been asked to correct prescribing information relating to Dynastat (parecoxib).
Following a complaint from Merck Sharp & Dohme, manufacturer of the
now withdrawn rofecoxib (Vioxx), the Prescription Medicines Code of Practice
Authority ruled that Pfizer had breached the code of practice for the
promotion of medicines. The case, which also resulted in Pfizer being
reported to the Association of the British Pharmaceutical Industry board
of management, is recorded in the PMCPA’s quarterly report.
MSD alleged that material used by Pfizer distinguished between the cardiovascular
safety of celecoxib and rofecoxib and promoted celecoxib as a safer option
in patients at risk of cardiovascular disease.
The PMCPA agreed that Pfizer made unqualified claims and had implied
that celecoxib was an appropriate treatment for patients with arthritis
who might have cardiovascular risk factors. It also considered that health
professionals reading the material would assume that the safety profile
of celecoxib was comparable to placebo and that patient safety could
be compromised.
Because of the seriousness of the case, the PMCPA reported Pfizer to
the Code of Practice Appeal Board, which, in turn, reported the matter
to the ABPI board of management. The ABPI board decided that Pfizer should
be publicly reprimanded.
In a separate matter, the Medicines and Healthcare products Regulatory
Agency has asked Pfizer to issue a correction relating to an advertisement
for parecoxib that was distributed across Europe, including the UK.
The advertisement failed to carry warnings about congestive heart failure
and postoperative pain following coronary artery bypass grafting, two
new contraindications for use of parecoxib. |
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