Nonprescription Heart Medicine: Too Risky?
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LEXINGTON, Ky. (March 3, 2008) − Cholesterol-lowering drugs similar to those
available over-the-counter in Great Britain shouldn't be available without a prescription and
supervision in the U.S., a University of Kentucky cardiologist says.
In a reader’s comment published in the March 1 issue of the American Journal of Cardiology, UK Gill Heart Institute cardiologist and University of Kentucky College of Medicine professor Thomas F. Whayne Jr. says that patients who take statins should be followed closely by a physician, who would be more likely to recognize the onset of rare but potentially dangerous side effects related to the breakdown of muscle tissue.
"For the ideal, conscientious patient who maintains a regular physician-patient relationship, OTC statins would likely be safe," Whayne notes. "However, the average patient has poor medication adherence." He cites a study in which only about 36 percent of patients followed the prescribed dosing of their blood pressure medicine.
"The elderly fare even worse and are more susceptible to problems" related to side-effects from statins and are less likely to take them correctly, Whayne says. "OTC statin availability to patients at high risk for adherence problems has the potential for significant harm that may remain undetected until appropriate management may be too late."
Statins are available in the United Kingdom without a prescription as simvastatin in 10 mg doses for all men over 55 years old, regardless of their risk for a heart attack, and for men over 45 and women over 55 if they have certain risk factors, such as family history of heart disease. The drug is kept behind the counter, and customers are required to consult with a pharmacist before buying statins.
In a 2007 article in the American Journal of Cardiology, another physician suggested that patients at risk for heart attack could benefit from easier access to statins (which lower "bad" cholesterol and raise levels of "good" cholesterol) using lovastatin 20 mg as the over-the-counter statin. An FDA advisory committee voted down a similar proposal in 2005 and again in 2007.
In a reader’s comment published in the March 1 issue of the American Journal of Cardiology, UK Gill Heart Institute cardiologist and University of Kentucky College of Medicine professor Thomas F. Whayne Jr. says that patients who take statins should be followed closely by a physician, who would be more likely to recognize the onset of rare but potentially dangerous side effects related to the breakdown of muscle tissue.
"For the ideal, conscientious patient who maintains a regular physician-patient relationship, OTC statins would likely be safe," Whayne notes. "However, the average patient has poor medication adherence." He cites a study in which only about 36 percent of patients followed the prescribed dosing of their blood pressure medicine.
"The elderly fare even worse and are more susceptible to problems" related to side-effects from statins and are less likely to take them correctly, Whayne says. "OTC statin availability to patients at high risk for adherence problems has the potential for significant harm that may remain undetected until appropriate management may be too late."
Statins are available in the United Kingdom without a prescription as simvastatin in 10 mg doses for all men over 55 years old, regardless of their risk for a heart attack, and for men over 45 and women over 55 if they have certain risk factors, such as family history of heart disease. The drug is kept behind the counter, and customers are required to consult with a pharmacist before buying statins.
In a 2007 article in the American Journal of Cardiology, another physician suggested that patients at risk for heart attack could benefit from easier access to statins (which lower "bad" cholesterol and raise levels of "good" cholesterol) using lovastatin 20 mg as the over-the-counter statin. An FDA advisory committee voted down a similar proposal in 2005 and again in 2007.