Statins go OTC in Britain

Over-the-counter (OTC) drugs are medications available to consumers without a prescription. Millions of consumers each year use these formulations for the treatment of self-diagnosed conditions without physician intervention, because doing so has been deemed safe by regulatory bodies, such as the U.S. Food and Drug Administration (FDA), U.K.’s Committee on Safety of Medicines, and others. More than 80 therapeutic categories have been approved as OTC drugs and range from drugs that fight acne to medications that treat fever, allergy to weight control drugs. While, there is little risk associated with the use of these medications, severe adverse effects can result because of either improper use or drug interactions.

The Committee on Safety of Medicines, an independent committee of experts, advise the British government on safety, quality, and efficacy of medicines. The Committee recently advised that Simvastatin 10mg should be made available as OTC, without the need of prescription. The switch to OTC is good news for people on prescription Simvastatin as they can now lower their cholesterol without regular visits to the doctor and at reduced cost. The low strength of Simvastatin has been considered safe, however, lack of proper patient education can result in number of harmful side effects.

Statins such as Simvastatin work to lower blood cholesterol levels by reducing cholesterol production within the liver. Statins block the liver enzyme hydroxy-methylglutaryl-coenzyme A reductase (HMG-CoA reductase), which is responsible for making cholesterol. Therefore, scientifically, statins are HMG-CoA reductase inhibitors. The benefits of statins include decreasing a patient’;s risk for congestive heart disease (CHD). It is estimated that approximately 14.8 million people use Stains worldwide and are credited for saving the lives of more than 16,000 -17,000 people per year. Moreover, in addition to cholesterol reduction, Statins have also been shown to reduce the risk of breast cancer. The low cost OTC statins are expected to extend benefits to more patients with risk of congestive heart disease.

The benefits of OTC Statins must be weighed against the potential side effects. Proper patient education is the key to success of OTC Statins. The patient might experience side effects, commonly termed as ‘;statin side effects’;, by taking higher than recommended dose. These side effects can include headache, nausea, vomiting, constipation, diarrhea, headache, rash, muscle pain, and weakness. Taking other commonly available OTC medications can treat these conditions. However, combination of OTC medication with Statin may result in dangerous drug interactions. A commonly encountered side effect with the usage of Statin and pain relieving medications is Rhabdomylysis, which can result in damage to muscles. Though these OTC pain medications are often considered benign, they might result in dangerous drug interactions when used with Statins.

In addition to the side effects, the patients may not be aware that diet and lifestyle can impact CHD risk. Even while taking OTC Statins, the patient may be exposed to CHD risk because of patient’;s diet and lifestyle.

Patient education is becoming crucial as prescription medications such as Simvastatin go OTC. The patient should be adequately educated and informed about the possible side effects and risks of the medications. Though OTC medications are deemed safe, lack of patient education can result in serious side effects.

Upcoming patent expirations in United States for Statins such as Zocor and Pravachol is expected to force companies to explore the opportunity of OTC Statins. While the switch allows companies to sustain their revenues, the FDA’;s efforts to reduce healthcare cost will also be complemented. However, this is not a lucrative option for Statins with long patent expiry such as Lipitor and Crestor.

As more prescription medicines go OTC in global markets, weighing benefits with possible side effects will become of utmost priority. Patient education is expected to remain a key strategy for the success of OTC products. Initiative of European countries such as United Kingdom to make Simvastatin available as OTC is expected to be a trial that will be carefully watched by the world.