Vioxx withdrawn because of cardiovascular concerns
Merck Sharp & Dohme has announced the immediate voluntary withdrawal
of Vioxx (rofecoxib). The decision is a result of concerns raised in the APPROVe (adenomatous polyp prevention in Vioxx) study, which found an increased risk of heart attack and stroke after 18 months of treatment.
All strengths and formulations of the cyclo-oxygenase-2 selective inhibitor
are being withdrawn on a worldwide basis. Stocks will also be recalled
from wholesalers and all clinical trials are being stopped. Limited stocks
for compassionate use remain available in the short term.
“We are taking this action because we believe it best serves the
interest of patients,” said Raymond Gilmartin, chairman, president
and chief executive officer of MSD’s parent company Merck & Co
Inc. “Although
we believe it would have been possible to continue to market Vioxx with
a licence that would incorporate these new data, given the availability
of alternative therapies, and the questions raised by the data, we concluded
that a voluntary withdrawal is the responsible course to take.”
David Pruce, director of practice and
quality improvement, Royal Pharmaceutical Society, said: “Pharmacists
approached by
patients taking Vioxx should advise that they consult their doctor. Patients
wanting to stop taking Vioxx before visiting their doctor should be offered
advice on alternative painkillers. Because Vioxx is often prescribed
for patients at higher risk of developing serious gastrointestinal side
effects caution should be taken before recommending an over-the-counter
preparation containing non-steroidal anti-inflammatory drugs.”
First authorised in 1999, Vioxx is used by an estimated 400,000 patients
in the UK. It is indicated for osteoarthritis, rheumatoid arthritis and
short-term pain relief. The summary of product characteristics and patient
information leaflets highlight the need for caution in high risk patients,
after trials suggested the possibility of additional thrombotic risk.
A major study in 2000 demonstrated an increased risk of cardiovascular
events with Vioxx compared with naproxen, but other studies have not
shown an increased risk compared with placebo or other NSAIDs.
The APPROVe trial studied the effect of three years of treatment with
Vioxx on the recurrence of neoplastic polyps of the large bowel in 2,600
patients with a history of
colorectal adenoma. After 18 months of treatment, patients taking Vioxx
showed a higher rate of confirmed serious thrombotic events compared
with placebo (6 versus 3 per 400 patient years).
Gordon Duff, chairman of the Committee on Safety of Medicines, said that
the data are specific to rofecoxib and cannot be generalised to other
COX-2 inhibitors. |
The
Pharmaceutical Journal
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