Pharmaceutical

FDA considers selling Rx meds for chronic diseases available OTC

Prescription drugs for high cholesterol, high blood pressure or diabetes may soon be available over the counter if a new proposal by the Food and Drug Administration (FDA) is approved. The federal agency hopes making drugs for common chronic diseases readily available to the public will ensure that people take them as needed.

The FDA says people who are not willing to take certain medications as prescribed for many chronic illnesses put themselves at risk for more serious health problems and ultimately put a strain on the country’s health care system. For example, untreated high blood pressure puts people at risk for heart disease and stroke. High blood pressure cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention.

The problem with making these prescription drugs available over-the-counter is that patients will need to have a good understanding of their illness and know exactly how and when to use the drugs. These drugs are often taken for months or years at a time, and patients will also need to be aware of side effects that may develop over time. Some of these side effects can be deadly.

For example, the FDA recently issued a warning for the diabetes drug Actos after studies showed long-term use put users at risk for bladder cancer. And, just last week, the FDA alerted the public that commonly used cholesterol-lowering statins were linked to an increased risk for diabetes and memory loss.

The FDA has rejected numerous over-the-counter drug applications for cholesterol-lowering statins over the years because there has been no way for consumers to determine their lipid levels without going to a doctor or clinic. The agency assured that the over-the-counter discussion is in the early stages and no formal decisions on the matter are expected any time soon.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

Sources:
Reuters
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