Will Statins Become OTC Drugs in the U.S.?

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Will Statins Become OTC Drugs in the U.S.?

 

Drug company Merck is seeking approval from the FDA to sell their

cholesterol drug Mevacor over the counter. The attempt marks the

company's second try at selling their drug without a prescription.

 

As it stands, only allergy pills and stomach acid remedies have made

the switch from prescription to over-the-counter status. The

difference is that cholesterol-lowering drugs, unlike the other two

categories, are geared toward a chronic condition that has no symptoms.

 

This is one reason why doctors who believe over-the-counter drugs

should be used for short-term conditions that patients can diagnose

themselves are highly skeptical of the potential switch.

 

Further, cholesterol drugs, which make up the top-selling category of

drugs in the United States (they brought in $14 billion in sales in

2003), are known to raise the risk of liver, kidney and muscle problems.

 

Previously, the FDA recommended against allowing Mevacor to be sold

without a prescription, saying they needed more information about

whether consumers would use the drug in the right manner. Since then,

Merck reportedly conducted a study showing that consumers are able to

make the correct decisions regarding the drug.

 

If Mevacor is granted over-the-counter status:

 

* Merck has prepared in-store materials to educate consumers on

whether or not they should take the drug

* Consumers would need a blood test to identify their cholesterol

level

* Consumers would need to learn the risk factors for heart disease

* The drug would be marketed to people with at least one risk

factor for heart disease and a " bad " LDL cholesterol level in the 130

to 170 range

* The drug, in a 20-milligram dose, would cost about $1 a day

 

Bristol-Myers Squibb also intends to seek over-the-counter status for

its cholesterol drug Pravachol.

 

USA Today December 28, 2004

 

Dr. Mercola's Comment:

 

Back in 2003, there was talk in the business press that drugmakers

Bristol Myers-Squibb and Merck would file separate requests with the

FDA to sell their statin drugs, Pravachol and Mevacor respectively,

over the counter (OTC). That intention has finally become a reality,

with Merck's application being considered, for a second time, by an

FDA advisory committee and Bristol Myers-Squibb announcing it will

seek the same status for Pravachol.

 

British regulators approved another statin drug, Zocor, for OTC status

in August 2004.

 

If you noticed, there was only ONE major concern voiced in the piece:

The one expert who smartly pointed out such deregulation is a bad idea

because OTC drugs are meant to treat short-term conditions, and high

cholesterol " has none of those things. "

 

I couldn't agree more with that comment, but the problem is much more

complex than that.

 

Folks, the bottom line is that statin drugs are truly dangerous--I

find it hard to believe that many would take them if they knew the

" secrets " of how to truly optimize their cholesterol and, at the same

time, improve their health and reduce their risk of cancer.

 

In fact, there are only a very small handful of people who I would

recommend them to--far less than one in 100. Nearly everyone can

normalize their cholesterol levels by eliminating grains and sugars,

exercising and retooling your diet based on your body's unique

metabolic type.

 

 

There are only a handful of people with genetic issues who I feel

benefit from taking statin drugs, and their cholesterol levels are

typically 350 or higher.

 

Related Articles:

 

High Cholesterol Drug Mevacor Approved for Kids -- But Don't Be Fooled

 

The Truth About Crestor: Is Crestor Dangerous And, if so, Why?

 

Crestor and Other Statins: Are They Really Worth the Risk?

 

Statins, Calcium a Deadly Mix

 

Cholesterol Drugs: How Expensive Is Too Expensive?

 

Cholesterol Drugs Actually Cause Heart Disease