ASTRAZENECA ISSUES WARNING LETTER TO BRITISH PHYSICIANS REGARDING OFF-LABEL CRESTOR USEMay 18, 2004 | www.pharmexec.com
AstraZeneca Plc issued a warning letter to British physicians regarding off-label prescribing of its statin Crestor (rosuvastatin), Reuters reported.
After discovering four cases of rhabdomyolysis a muscle toxicity condition that can lead to kidney damage among high-dose Crestor users, the company cautioned physicians to adhere to indications on the label and not begin patients on high doses of the drug.
AstraZeneca advised that patients be administered 10 mg doses of Crestor initially and be increased to 20 mg or 40 mg doses only as required.
The rate of adverse events from Crestor use was similar to the side effect profile observed in other competing statins. The four cases of rhabdomyolysis occurred after patients were initiated on a high Crestor dose, according to AstraZeneca spokeswoman Kirsty Walker.