High-dose statin temporarily withdrawn
Marketing and distribution of the 800µg dose of cerivastatin
(Lipobay) has been suspended in the United Kingdom. The drug’s manufacturer,
Bayer, says that the move is temporary and that its licence remains active.
In addition to the suspension, Bayer has changed
the summary of product characteristics for all doses of Lipobay to indicate
that the combination of cerivastatin and gemfibrozil is now contraindicated.
The previous labelling included a warning of increased risk of serious
muscle toxicity when the two drugs were given in combination.
A spokeswoman for Bayer told The Journal
that pharmacists receiving prescriptions for cerivastain 800µg, or for
multiple doses of other strengths of cerivastatin totalling more than
400µg, should contact the prescriber. Patients currently receiving doses
of 800µg would be advised to reduce the dose to 400µg, despite the fact
that the licence for the 800µg dose had not been withdrawn.
In a letter to health care professionals dated 27
June, Bayer says that the risk of muscle toxicity with statins is thought
to be related to plasma concentration.
Discussions between Bayer and the Medicines Control
Agency occurred following a “small increase” in adverse events with the
800µg doses reported in the United States. However, the spokeswoman for
Bayer pointed out that the incidence of off-label use of cerivastatin,
including starting therapy at the 800µg dose rather than titrating the
dose up, and concomitant use with gemfibrozil, was much higher in the
US.
Bayer is to conduct further assessments of higher
doses of cerivastatin at the request of the MCA.
Back to Top
|
