The basis for the agreed revisions to the prescribing labeling for Crestor, which strengthen points contained in the original labeling, include modifications to dosage instruction; recent clinical trial information regarding special populations; and information regarding post-marketing safety experience with the medicine.
The approval signifies that the FDA has declared the drug’s muscular wasting side-effects to be no greater than those of rival products.
Consistent with other drug labeling in the statin class, jaundice has been added as a very rare event and, as with other statins, reports of rhabdomyolysis with Crestor are rare, but higher at the highest marketed dose (40mg).
Initial instructions regarding usage of the 40mg dose, which comprises 4% of total Crestor sales in the US, were made more explicit by strongly instructing that physicians reserve this dose only for those patients who have not achieved their LDL-C or ‘bad’ cholesterol goal with the 20mg dose.