European Union regulators have changed the prescribing rules for Crestor, a cholesterol-lowering drug made by AstraZeneca, following reports of several cases of life-threatening side effects linked to Crestor worldwide.
The changes concern the recommend initial 10 mg dose of Crestor and a restriction on the highest dose of 40 mg, said the Dutch Medicines Evaluation Board in a statement posted on its web site.
All patients must start on the initial 10 mg dose of Crestor once daily, moved to 20 mg if considered necessary after a 4 week trial of 10 mg, 40 mg dose should be prescribed under specialist supervision and should only be considered for patients with severe hypercholesterolaemia who do not have specific risk factors” for muscle toxicity, EU regulators said.
These precautions were prompted by a concern about reports of rhabdomyolysis with Crestor. Rhabdomyolysis is severe muscle toxicity leading to kidney damage. In consultation with the Regulatory Authorities of the EU Member States, AstraZeneca has sent a letter to all doctors and pharmacists to inform them about the changes, EU regulators said.
Crestor is the most potent member of a class of cholesterol-lowering drugs commonly referred to as �statins.� Muscle toxicity is a recognized, side effect, leading in rare cases to rhabdomyolysis, which is potentially life-threatening.
Where cases of rhabdomyolysis have been reported in association with the use of Crestor, the majority have involved patients who received higher than the recommended dose of Crestor or had pre-disposing factors for muscle toxicity, EU regulators said.
AstraZeneca officials reaffirmed that: “CRESTOR is a safe and effective treatment for elevated cholesterol,” in a statement posted on its web site.
(via Dutch Medicines Evaluation Board)
3 responses so far ↓
Andrew Grandin // Jun 24, 2004 at 2:32 pm
I can understand the frustration with the people that contract rhabdomyolysis with the use of Crestor. But it also has been shown to be a helpful tool for the the MD’s and DO’s of the world. The statistics show that Crestor has more benefit than risks asociated with it. I think that even with the potential for dangerous side effects that Crestor still should be allowed to continue being Rxed.
Genny // Jun 26, 2004 at 6:55 am
I took 5mg Crestor for 2 weeks. My body ached all over and I began to experience problems with my kidneys. My doctor told me how potent Crestor is. I discontinued use immediately when symptoms appeared.
Janet Mundle // Jun 28, 2004 at 7:23 am
I have been taking 40mg of crestor per day for 4 weeks. Since taking this medication I have had the following reactions: Rash, swollen face, painful eyes, pain in my right lower abdomen, Burning sensation all over my body. This I reported to my Primary care Physician. I have stopped taking the medication, but I am wondering If crestor capable of damaging any of my internal organs within a 4 week period.
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