Sacramento Head Start Alumni Association

Should the US allow statins OTC?

Oct 12, 2004

DIFFERENT HOUSES HAVE DIFFERENT RULES

When my children complain about something that their friends are permitted to do but that I do not allow them to do, my response is "different houses have different rules." So, too, with England's decision to move a cholesterol-lowering statin drug from a prescription-only to over-the-counter (OTC) status. First up: Simvastatin (Zocor), at a daily dose of 10 mg (half the standard prescription dosage).

While the US Food and Drug Administration (FDA) turned down applications for OTC statins in the 1990s, their approval abroad has spurred pharmaceutical companies to renew efforts for OTC approval here in the US. But is this a good idea? With the many risks associated with taking statins, are they really something that you should self-prescribe? Or is this a self-serving move on the part of greedy drug manufacturers?

SIDE EFFECTS NOT UNCOMMON

To get some answers, I spoke with Jay S. Cohen, MD, associate professor (voluntary) of family and preventive medicine at the University of California in San Diego. Dr. Cohen is author of What You Must Know About Statin Drugs and Their Natural Alternatives (Square One) and Over Dose: The Case Against the Drug Companies (Tarcher).

He told me that side effects of statins are not as uncommon as the pharmaceutical companies would have you think. While manufacturers claim that side effects impact only 1% to 2% of statin takers, the data shows that about 15% to 30% of statin users get muscle pain, joint pain, abdominal discomfort or cognitive or memory problems. The higher the dose, the worse the side effects. In some cases, these effects can be so severe that they are disabling, yet it often is not clear that they are due to statins, says Dr. Cohen.

Although lower doses are safer, he warns that side effects still can occur. Moreover, making statins available OTC would significantly increase the number of people who take them, while decreasing medical monitoring for side effects.

THE CASE FOR STATINS

Statins already are best-selling drugs, netting their manufacturers billions of dollars in annual profits. Yet pharmaceutical companies contend that fewer than half of all Americans who could benefit from taking statins do so. They say that making these drugs available OTC will provide greater access and protect more Americans with mild to moderately elevated cholesterol levels from developing heart disease.

Critics counter that economics motivate pharmaceutical manufacturers to make statins available OTC. With patents on several statins expiring in the next few years, OTC sales could keep the billions rolling into their coffers.

Many experts also remain unconvinced that everyone with mildly elevated cholesterol needs to take a pill to lower it. Dr. Cohen recommends first trying dietary changes, such as eating less saturated fat and more fresh fruits and vegetables.

OTC SAFETY CONCERNS

According to Dr. Cohen, most OTC medications have an immediate, measurable effect. For example, an aspirin alleviates headache pain... an antihistamine controls sneezing and itchy, watery eyes. Statins are different. They work by lowering the level of cholesterol in your body -- an effect that you cannot see or monitor without a blood test.

Dr. Cohen is concerned that OTC access will encourage people to take statins without paying sufficient attention to side effects, such as muscle aches or joint pain. Even more serious are potentially life-threatening liver injury and toxicity -- which like cholesterol levels cannot be seen and must be monitored with blood tests.

If you're not medically trained, it's easy to overlook the significance of side effects, observes Dr. Cohen. For example, if a person experiences joint pain, he/she may not associate it with statins at all and may begin taking anti-inflammatory medications. This can lead to a cascade of even more damaging side effects, since anti-inflammatories such as ibuprofen are associated with an increased risk of gastrointestinal bleeding and liver damage.

DOSAGE MATTERS

The one-size-fits-all dosage of the OTC preparation is another cause for concern. The standard starting doses of statins are often double the amount that people need, says Dr. Cohen. The higher the dosage, the greater the risk for side effects... however, you may need larger doses to sufficiently lower your LDL (the so-called "bad" cholesterol), which requires a doctor's involvement and can't be accomplished by simply taking the OTC product.

Dr. Cohen adds that most people (even doctors) are unaware that lower dosages are sometimes sufficient:

Zocor Daily Dosage Average Reduction in LDL
Standard initial prescription dosage 20 mg 38%
Standard OTC dosage in England 10 mg 30%
An effective lower dosage for many people 5 mg 26%

Source: Chart adapted from What You Must Know About Statin Drugs and Their Natural Alternatives, by Jay S. Cohen, MD (Square One).

LIFESTYLE CHANGES ARE KEY

Many people with mildly to moderately elevated cholesterol levels don't even need statins, emphasizes Dr. Cohen. He notes that these drugs are very effective in lowering cholesterol in people with heart disease or at high risk of developing it -- but most people do not fit in this category.

Will statins become available OTC in the US? Only time will tell. In the meantime, keep in mind that these are serious drugs with potentially serious side effects. Use them only if you really need them, under the supervision of your health-care provider. And before you turn to statins, consider simple solutions such as healthier eating, more regular exercise, maintaining a proper weight and refraining from smoking.