FDA blocks self-diagnosis over-the-counter statin Mevacor
pharmafile | January 20, 2005 | News story | Medical Communications |Â Â Â
Merck and Johnson & Johnson's application to sell the statin Mevacor (lovastatin) has failed to gain approval from an FDA committee, and is unlikely to gain final clearance.
The FDA panel voted 20-3 against allowing OTC sales of the statin, citing concerns over the patient's ability to make an informed decision on whether the product is suitable for them. The proposal would have seen Mevacor sold on pharmacy shelves in 20mg doses without medical guidance or advice – something which the panel considered to be an unacceptable risk.
Dr Frank Davidoff, editor emeritus of Annals of Internal Medicines, said: "There have been times in my career when I thought the statins ought to be in drinking water but at this point, making them available over-the-counter would be a massive, uncontrolled experiment."
Mevacor's safety and efficacy profile is among the best of the statins but many panel members took the view that patients self-diagnosing and buying the drug off the shelf without guidance from a health professional would not be a positive step.
The panel voiced concerns over the switch after studies that simulated over-the-counter sales indicated that 90% of people who took Mevacor didn't meet the requirements of the label. Worries were also expressed regarding pregnant women taking the statin, with the possibility of inadvertent damage to the foetus cited as a major concern.
The companies argued that making Mevacor more easily available would help millions of Americans at moderate risk of heart disease, who needed to lower cholesterol levels, but were not already taking effective medication, being treated effectively.
Johnson & Johnson MSD's Zocor Heart-Pro (simvastatin) became the world's first statin to be made available without a prescription in June 2004 when it was approved in the UK.
The FDA committee members said they would have voted for non-prescription status had it come with the pharmacist-controlled sale approach being pioneered in the UK.
