JEDDAH, 17 October 2004 — The newly introduced anti-cholesterol drug Crestor, which is seeking final approval from the Ministry of Health, has not caused any cases of rhabdomylosis — a breakdown of muscle fibers which releases proteins that can severely harm the kidney — in Saudi Arabia.
In a written statement to Arab News, Dr. Naim Ahmad, the medical manager for Astra Zeneca — the company manufacturing and marketing the drug — and leader of the trials in the Kingdom, said: “It is impossible to hide any such cases. There is not a single case of rhabdomylosis reported from the clinical trial conducted on Crestor in Saudi Arabia, where 210 patients have taken part.”
Following up in a later phone call, he said that if there were, he would take “full responsibility.”
Dr. Ahmad continued by pointing out that “it has been one year since the launch of Crestor in the United States and around three years in Europe (and the) FDA Adverse Event Reporting System continues to show that the safety profile of Crestor remains in line with any other statin.”
“The drug,” he emphasized, “is now approved in 64 countries worldwide and has reached 10 million prescriptions and (is) taken by three million patients. The post-marketing surveillance data confirms the safety of Crestor is not different from any other statin.”
The drug is widely prescribed in the US after approval by the FDA, albeit at a much reduced dosage level than originally.
Dr. Ahmad was at pains to point out that physician education was an important part of prescribing drugs and that adherence to manufacturers and regulatory authorities’ guidelines was essential and that lifestyle and diet should be taken into consideration before prescription.
Asked if it was unusual that no cases of rhabdomylosis had occurred during the field trials in the Kingdom, Dr. Ahmad said the genetic make-up of individuals varied from country to country and that this possibly accounted for it.
The manufacturers of the drug are, said Dr. Ahmad, “fully confident” in the safety profile of the drug.
“The ongoing safety surveillance has not raised any new safety issues and the safety profile remains similar to that seen with all other marketed statins.”
