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OTC Statins? Crestor or Lipitor Without an Rx?

Many cardiologists think that more people should be taking statins to lower cholesterol. Should OTC statins like Crestor get FDA approval?
OTC Statins? Crestor or Lipitor Without an Rx?
Statins, Statin pills and a warning sign,

Many years ago, a prominent cardiologist suggested on our public radio show that statins ought to be put in the water supply. His statement was likely tongue in cheek, but some physicians probably did believe that statins, like fluoride, should just be added to municipal water systems. That idea never got off the ground, but now there seems to be a growing movement to allow OTC statins such as Crestor (rosuvastatin) or Lipitor (atorvastatin).

The Effort to Allow OTC Statins: Lipitor Sank Without a Trace:

Pfizer once dominated the statin marketplace. That was because Lipitor was a money-making machine. At its peak in 2006, this statin was bringing in almost $13 billion annually.

That was before generic atorvastatin came along and let the air out of the balloon. At the end of 2011 the cash cow known as Lipitor started producing a lot less green.

Then Pfizer came up with an idea to resurrect the brand. An OTC version of Lipitor might regain some of that lost revenue.

Pfizer had reason to be optimistic. Think back to the acid-suppressing drugs called proton pump inhibitors (PPIs). When Prilosec (omeprazole) lost its patent, the manufacturer took the brand over the counter. Now, you can also buy Prevacid OTC (lansoprazole) and Nexium 24HR (esomeprazole) without a prescription.

OTC Lipitor?

The company started a study in 2013 to determine whether patients could manage their own cholesterol treatment. To do so, they needed to be able to take Lipitor, monitor their own blood cholesterol and seek medical advice when appropriate.

An article in Forbes (July 29, 2015) describes the motivation: 

“Pfizer believed that the dozens of clinical trials involving tens of thousands of patients dosed for multiple years demonstrated sufficient efficacy and safety to justify such a conversion to OTC status. But Pfizer was also banking on the possibility that having the only statin available OTC would rejuvenate sales that were being eroded by low-cost generic versions of Lipitor (atorvastatin) entering the marketplace.”

The OOPS of OTC Statins:

The 1300-patient trial was a failure. Patients were not able to meet the goals of the study and Pfizer abandoned its plan for OTC statins in the form of Lipitor.

Dr. Steve Nissen, one of the country’s leading cardiologists, applauded this decision:

“It’s hard enough for me to teach young physicians in training who to administer statins to, let alone to try to do that for the general public…Self-treatment of something as serious as a lipid disorder is not an appropriate course of action.”

The Resurrection of OTC Statins:

Fast forward six years. Dr. Nissen appears to have modified his thinking. He is the lead author of an article titled, “Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy” (Journal of the American College of Cardiology, Sept. 14, 2021). This is a report on a web application designed to help people determine if they would benefit from rosuvastatin (Crestor).

Dr. Nissen and his colleagues introduce their study this way:

“Administration of statins to reduce low-density lipoprotein cholesterol (LDL-C) plays a pivotal role in public health efforts to improve cardiovascular outcomes in primary and secondary prevention populations. However, studies demonstrate that only about one-half of patients eligible to receive statins are actually treated. Barriers to effective treatment are complex but include reluctance of patients to seek regular medical care and lack of access to health care resources in some communities. Recognition of the problem of undertreatment with statins has resulted in efforts to make these drugs available without a prescription.”

The OTC Statins Study:

After people answered online questions, they got one of three responses: “OK to use,” “not right for you,” or “ask a doctor.” In the other part of the study, clinicians evaluated whether or not people would benefit from the drug. Then the investigators compared whether the responses coincided.

In the overwhelming majority of cases, the recommendations did agree. That is the basis on which Dr. Nissen and his eminent co-authors are suggesting that online access to nonprescription statin therapy is desirable.

The Results:

Dr. Nissen and his co-authors report:

“Expanded access to statin could have a significant positive public health impact given the benefits of these drugs in primary prevention and the observation that as many as one-half of patients who are guideline-eligible for statin therapy are not treated. To expand access to statins, several attempts to provide OTC availability of these drugs have been undertaken, but all failed to achieve regulatory approval due to the inability to demonstrate that consumers could appropriately self-select for treatment. In the current study, a novel strategy using a Web application for self-selection was highly successful with >95% concordance for the primary endpoint that compared results obtained by participants and an independent clinician assessment.”

On the other hand, 92 percent of the volunteers did not need statins. The questions produced the response inappropriate (“not right for you”). Given that finding, it isn’t clear that offering statins without a prescription would achieve the authors’ stated goal of getting the 50 percent of people who could benefit from statins to take the pills.

What About Statin Side Effects?

Sadly, over-the-counter medications carry inadequate side effect warnings. NSAIDs like ibuprofen or naproxen can cause stomach ulcers, raise blood pressure and increase the risk for heart attacks. Irregular heart rhythms (A-fib) and kidney damage are other complications. And that’s just for openers. Here is a link to an article That describes some of the risks of NSAIDs. 

Really Bad News About Ibuprofen, Naproxen and Other NSAIDs
People in pain do NOT want to hear bad news about ibuprofen, naproxen or other NSAIDs. To take such drugs safely, people must know the risks!

Acid-suppressing drugs (proton-pump inhibitors like esomeprazole, lansoprazole and omeprazole) can change gut bacteria. They may also increase the risk for kidney damage, fractures and pneumonia. Here is a link to learn more about the potential complications of PPIs.

OTC Statins and Side Effects:

Do consumers read and understand drug labels, especially if they don’t reveal some of the more serious adverse reactions?

Dr. Nissen and his colleagues acknowledge that many consumers do not:

“Studies suggest that the majority of consumers do not read the drug facts labels for OTC products prior to initiating treatment or during actual use. Additionally, while the drug facts label was designed to help consumers use OTC drugs appropriately, many struggle to correctly apply the instructions.”

On the other hand, statins can also trigger significant adverse reactions. They include elevations in blood sugar, diabetes, muscle pain and weakness, joint pain, nerve pain, digestive distress, cataracts, cognitive impairment and liver enzyme changes. You can read more at this link:

What Are the Most Common Statin Side Effects?
Some physicians would like you to believe that statins do not cause side effects. We offer a different perspective on common statin side effects.

Risks and Benefits of OTC Statins:

If people will be taking OTC statins without a prescription, we hope that they will become as well informed about the risks as the benefits. Judging from the labels on other OTC drugs, I’m not holding my breath.

Please share your own experience with statins in the comment section below. Do you think statins should become available without a prescription? We would like your perspective. You may also find our eGuide to Cholesterol Control & Heart Health of interest. Here is a link to our Health eGuides

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
  • Nissen, S.E., et al, "Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy," Journal of the American College of Cardiology, Sept. 14, 2021, doi: 10.1016/j.jacc.2021.06.048
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