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09 Aug 2001:
Suspension of product licence of Lipobay® (cerivastatin)

The statins, a specific class of cholesterol lowering drugs are associated with a risk of rhabdomyolysis, which is a form of severe muscle adverse reaction to the drug. However, the incidence of rhabdomyolysis is reported to be rare.

Current scientific information suggests that one of the statins, cerivastatin (Lipobay®) is associated with a higher incidence of rhabdomyolysis, about 10 times that of the other statins. Fatal reports of rhabdomyolysis with cerivastatin occurred most frequently at higher doses, when used in the elderly, and particularly, when used in combination with gemfibrozil, a non-statin lipid lowering agent. The HSA has suspended sales and marketing of this product on 9 August 2001.

The statins that are currently registered in Singapore are atorvastatin (Lipitor®), lovastatin, fluvastatin (Lescol®), pravastatin (Pravachol®), simvastatin (Zocor®). Our local Adverse Drug Reaction reporting programme also confirms that the incidence of rhabdomyolysis is very rare for the other statins compared to cerivastatin. This rare adverse effect of the statins is a known side effect and the necessary information is already provided with the product so that physicians are aware of it and know how to manage the use with respect to this side effect.

As a precautionary measure, the HSA advises patients who are taking any of the above statins and who experience muscle aches involving their calves, back, or their entire body accompanied by weakness, fever and nausea to consult their doctors. We would like to assure the public that the HSA is monitoring the situation very closely and is in touch with the other regulatory agencies and the relevant pharmaceutical companies. We will take the necessary action to protect public health and safety when the need arises.


Last updated on 02 Jul 2010 16:54:27
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