US regulators could bring more common drugs over the counter

Posted: Published on March 8th, 2012

This post was added by Dr P. Richardson

Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators.

In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March.

The goal is to ensure people take drugs as needed, while still understanding safety issues.

Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States.

About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention.

The FDA said about a third of those with high blood pressure stop taking their medication.

The problem with making these drugs available without a prescription is that many require patients to understand complex aspects of their disease, or exactly when to take a drug to ensure safe use.

A typical over-the-counter drug generally treats short-term conditions with easily recognized symptoms such as a headache or runny nose, and comes with only a factbox or pamphlet.

But taking cholesterol-lowering drugs called statins requires knowledge about a person's elevated or abnormal levels of fat in the blood, known as lipids.

"We've had several applications already to switch statins to over the counter, and they have failed because consumers can't determine their lipid status," Janet Woodcock, head of the FDA's drugs center, told reporters on Wednesday.

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US regulators could bring more common drugs over the counter

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