FDA and Zocor: What the Former Had to Say About the Latter

Zocor, which once was the best selling cholesterol-lowering drug on the market, was manufactured by Merck in 1991 after the company received approval from FDA. With a sales figure of $ 4.3 billion in 2005, a generic version of the drug hit the market in  June of 2006.

As per FDA stats, more than 2 million patients were prescribed Zocor 80 mg dose in a span of just one year, which is 2010. After this when studies got conducted on the drug, a finding shocked every soul which recognized the drug. The news came when FDA declared the drug to cause increased risk of muscle damage, which if overlooked can turn fatal over time. FDA’s final say declared that the drug should not be administered to any new patient seeking for a medication that can lead to lowered cholesterol and also Zocor should not be prescribed in combination with some drugs that show interaction.

A recent report from FDA has clearly stated that Federal Drug Administration committee has put brakes on prescription of high dose of Zocor, statin class drug from Merck. It also said that if any new patient is advised it should not exceed the dose amount of 20 mg. This can be given to patients in high doses, only when they have been taking the drug for a year but without facing any muscle damage.

FDA’s warning against the risks associated with high dose of Zocor and its relation to causing muscle injury at a much increased rate was a genuine step taken to save any new patient from suffering. Another announcement from FDA said that Zocor is shown to interact with a number of drugs that include heart medications and antibiotics amongst others. After FDA’s announcement, Zocor, which was once the largest selling drug in US market has now seen an extreme downfall in its popularity and the sales curve too.

Another finding also threw light on a rare coincidence which said that people of Chinese descent are more prone to experience muscle damage when administered 80 mg dose of Zocor, in comparison to others.

As per FDA’s regulation, patient on the following medications should never take Zocor in any dose amount. These include ketoconazole, itraconazole, telithromycin, erythromycin, clarithromycin, nefazodone and HIV protease inhibitors (the list may include more names). Also, those taking medications like cyclosporine, gemfibrozil and danazol should not take Zocor in more than 10 mg doses.

FDA recommends all such people to discuss in detail about the medications and supplements they are taking before starting Zocor to help the healthcare experts know what good and what bad the drug can do and at what risk percentage.

As per a report published on 9th June, 2011, FDA has ordered to limit the higher doses of Zocor. The drug can be continued only in patients who have been taking the same for a year, but without any history of muscle toxicity, seen even once. Also, patients who do not get the desired results in lowering LDL levels should go in for alternative treatment. The new recommended drug should be such that should greatly reduce the incidence of any drug to drug interaction.

With new dosing restriction for higher doses, the labels for Zocor were reviewed after FDA’s announcement.

The final verdict was regarding restriction on high dose prescription and also to study the complete medical history of patient to avoid any drug-drug interaction. This also said that no new patient should be prescribed Zocor.

Getting educated about medicines, which can alter one’s life completely, is thus needed. Awareness regarding the effect medicines can do to a person’s life is inevitable. Similar is with Zocor, which with its own set of merits and demerits has created a ferocity among people, especially the one’ who have suffered the damage.