The New Straits Times, August 19, 2001
By Professor Dzulkifli Abdul Razak
Last Week, a cholesterol-lowering brand named Lipobay was banned nationwide following a similar move worldwide (NST, Aug 10). The decision to stop using the medication for the treatment of hyperlipidemia resulted from the disclosure from the US Food and Drug Administration (FDA) that 31 deaths were linked to the use of the drug in the US, under a different name, Baycol. It refers to the same active ingredient, cerivastatin.
The company Bayer announced the voluntary withdrawal of all dosages of the drug due to increasing reports of side effects involving muscular weakness (rhabdomyolysis). Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream.
Reportedly symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting.
The pain may involve specific groups of muscles of may be generalised throughout the body. Most frequently, the involved muscle groups are the calves and lower back. However, some patients report no symptoms of muscle injury. In rare cases the injury is so severe that patients develop renal failure and other organ failure, which can be fatal.
Fatal rhabdomyolysis associated with the drug use have been reported most frequently when used at higher doses (at the 0.8mg dose), or when used in elderly patients.
More so, when used in combination with another lipid lowering active ingredient, gemfibrozil (brand name, Lopid). In fact, 12 of the 31 FDA death reports involved concomitant gemfibrozil use.
Patients taking the drug and experiencing muscle pain or are also taking gemfibrozil should discontinue taking it immediately and consult their physician. There are five other statins available and may be considered as alternatives to Lipobay/Baycol, namely: lovastatin (brand name, Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor).
The banned drug, cerivastatin, belongs to a group commonly referred to as "statins". Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the sysnthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Lipobay/Baycol have been reported significantly more frequently than for other approved statins, especially involving gemfibrozil.
According to Bayer despite its advisory placed on product prescribing information sheet against co-prescription with gemfibrozil, and issuance of letters to healthcare professionals warning against concurrent use of these two drugs, it continued to receive reports of rhabdomyolysis when gemfibrozil is prescribed as a co-medication.
If this allegation is true it is most disturbing to note that there are those not concerned at all about safety of their patients in co-prescribing such potent medicines.
This resulting phenomenon generally known as "drug-drug interactions" is an unwarranted and avoidable risk that needs professional attention. This is especially when more than one drugs are used at any one time, indeed a very common practice in the Malaysian healthcare scene.
Recommended website: http://www.fda.gov/cder/drug/infopage/baycol/baycol-qa.htm.
