Cerivastatin (withdrawal from sale)

10 August 2001
  • Cerivastatin sodium is being withdrawn from sale worldwide by its sponsor, Bayer.
  • Cerivastatin is one of the statin class of drugs taken to lower cholesterol.
  • Reporting of adverse reactions to cerivastatin in a number of countries has highlighted two problems with cerivastatin.
  • The use of the combination of cerivastatin and another cholesterol lowering drug, gemfibrozil, has caused severe damage to muscle in some patients. The damage can be in the form of rhabdomyolysis where there is breakdown of muscle cells and release of myoglobin which in turn can lead to kidney damage.
  • Severe muscle damage has also been reported following use of cerivastatin alone. Generally this has been related to use of doses higher than those recommended in Australia but there have been some cases reported with the recommended Australian doses.
  • Similar severe effects on muscle are recognised as a rare adverse effect of other statins but evidence has been accumulating that they are more common with cerivastatin.
  • The national committee responsible for monitoring the safety of medicines in Australia - Adverse Drug Reactions Advisory Committee - has been monitoring the safety of cerivastatin closely. In the February 2001 Australian Adverse Drug Reactions Bulletin, ADRAC published an article about cerivastatin muscle effects and highlighted that cerivastatin and gemfibrozil should not be used together.
  • More recently, the Therapeutic Goods Administration has required the sponsor company in Australia to include prominent warnings in the product information documents for cerivastatin and to write to doctors and pharmacists about the danger of use in combination with gemfibrozil. In addition, the TGA has been liaising actively with other regulatory agencies around the world.
  • There have been 141 Australian reports of suspected adverse reactions to cerivastatin since it was registered in Australia, of which just over half (73 reports) included descriptions of unwanted effects on muscle. Twenty five reports described rhabdomyolysis - sixteen of these patients were also taking gemfibrozil. None of the Australian reports described a fatal outcome of the reaction. Fourteen of the reports explicitly stated that the patient had recovered. For the other reports the patient had either not yet recovered at the time of reporting or the outcome was not stated in the report.
  • The sponsor companies in Australia will today commence a recall of stocks of cerivastatin from pharmacies and will write to doctors.
  • The following advice is given to patients taking cerivastatin:
    • There are no short term unwanted effects of stopping cerivastatin.
    • Patients taking cerivastatin who have muscle aches and pains should stop taking cerivastatin immediately and arrange to see their doctor.
    • All other patients taking cerivastatin should stop taking cerivastatin immediately and arrange to have a discussion with their doctor within the next week about changing to alternative therapy.

Drugs involved:

Cerivastatin brand names in Australia: Lipobay; Kazak 200; Kazak 300; Kazak 400.

Gemfibrozil brand names in Australia: Lopid; Ausgem; Chem mart Gemfibrozil; Gemfibrozil-BC; Gemhexal; GenRx Gemfibrozil; healthsense gemfibrozil; Jezil; Lipazil 600 mg; Terry White Chemists gemfibrozil.

Contact for media at Bayer Australia: K Impey 02 9391 6077.