Crestor

There have been no recalls and black box warnings for the use of Crestor.

Other Warnings

The FDA has released a public advisory stating that usage of 40 mg of Crestor along with other statin drugs can be responsible for serious muscle damage also called rhabdomylosis.

It was believed that the use of statins contributed to amyotrophic lateral sclerosis (ALS) though after a detailed analysis, the FDA determined that the use of statins does not cause amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. This analysis was conducted by the FDA based on reports received from patients who were using statins and were also suffering from ALS.

The labeling of Crestor has also been revised based on a pharmacokinetic study involving Caucasian groups and Asian patients. The study discovered that the drug levels were increased in Asian patients.

Patients who are already suffering from diabetes, heart failure and hypertension are more prone to kidney failure when taking Crestor.

Crestor treatment should be discontinued if the creatinine kinase levels increase substantially or if a patient is diagnosed with a muscular disease in which the muscle fibers do not function properly (myopathy).

Liver enzyme tests should be conducted on patients before initiating Crestor treatment and 12 weeks after the conclusion of treatment to find out if there is any increase in the levels of serum transaminases.

It is believed that when Crestor is used along with activity-reducing steroids such as spironolactone, cimetidine and Ketoconazole, it may cause a disturbance in the adrenal reserve or reduce basal plasma cortisol concentration, though this theory has not been proven.

During a Crestor clinical study it was discovered that blood in the urine (hematuria) and excess protein in the urine (proteinuria) was found in patients taking 40 mg/day of Crestor. Doctors should consider lowering dosages for patients who are diagnosed with hematuria or proteinuria during their urinalysis.