Last Friday an FDA expert panel voted overwhelmingly against the over-the-counter sale of Merck's cholesterol lowering drug Mevacor (lovastatin). Mevacor is one of a number of drugs known as "statins" which are widely considered to be the most effective drugs for the treatment of high cholesterol. Statins work by inhibiting a liver enzyme used in the manufacture of cholesterol.
Other drugs classified as statins include, atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol) and simvastatin (Zocor). Statins are the most sold prescription drugs in the world.
A majority vote denied the request by Merck's request. The panel members expressed doubt that patients would be able to correctly evaluate their need for treatment.
Other concerns raised included
- People not taking the drug in the correct dose.
- The possibility of pregnant women using the drug.
- Negative side effects, such as muscle damage.
- No studies in pre-pubertal patients or patients younger than 10 years of age.
UK health authorities expect to increase the usage of statins in primary prevention, in order to reduce cholesterol levels in the UK population and ultimately reduce the country’s high incidence of heart disease, arguing that the move is in favour of improving patient choice and access to medicines.
Recently The European Society of Cardiology (ESC) stressed the importance of viewing statins appropriately within the global risk management environment.