FDA Adds Safety Warnings to Cholesterol Statin Drugs

FDA Adds Safety Warnings to Cholesterol Statin Drugs | Pintas & Mullins Law Firm

Dangerous drug lawyers at Pintas & Mullins Law Firm report that the FDA recently added new safety warnings for statin drugs, including the increased risks of developing Type II diabetes and adverse brain-related effects. Statins are cholesterol-reducing medications, applying to popular medications like Crestor, Lipitor, Mevacor, Vytorin, and Zocor.

Additionally, a class-action lawsuit was recently filed in Louisiana against Zocor manufacturer Merck Pharmaceuticals, alleging the company failed to warn patients about the risk of life-threatening kidney and muscle damage. Zocor is the brand-name for the generic simvastatin, which was approved in 1991 as a cholesterol-lowering statin. In 2008, the FDA released warnings about Zocor informing consumers about the risk of developing a rare muscle condition called rhabdomyolysis, when taken with Amiodarone, a heart rhythm medication.

In 2010, the FDA warned the public that patients may develop rhabdomyolysis even if they were not taking a heart drug. This condition is the most serious form of muscle disease, causing muscles to break down, releasing tissue into the blood stream and overburdening kidneys. The kidneys can subsequently shut down, which can ultimately lead to death.

Merck is also currently in the midst of mounting litigation surrounding Vytorin, which is a combination of Zocor and Zetia. Numerous studies show that Vytorin is linked to an increased risk of heart attacks and other cardiovascular problems. Several experts assert that they believe these drugs are not just dangerous, but ineffective as well.

In January 2013, Health Canada released a similar safety update for cholesterol-lowering drugs, requiring statin manufacturers to add the potential of increased blood sugar levels (and therefore, increased risk of diabetes) on labels.

The new warnings are based on recent adverse event reports and clinical trial findings, which found that statins may increase incidents of memory loss and confusion, along with the increase of blood sugar levels. Additionally, the development of Type II diabetes further increases the risk of heart disease.

Mevacor was asked to change its labels specifically because it can interact with other drugs and put patients at risk for muscle pain and weakness. The FDA warned that the medication should not be taken in conjunction with certain antibiotics, anti-fungal medications, or protease inhibitors, which are used in HIV treatment.

The FDA stated that statins should be taken only with care and knowledge of their side effects. The president of the American Heart Associated affirmed that patients who need to lower their cholesterol should always channel their energy into lifestyle changes first and foremost, only trying drug treatment as a secondary therapy.

Late in 2012, particles of glass were reportedly found in generic Lipitor medications, leading to a nation-wide recall. The generic, Atorvastatin, is manufactured by Ranbaxy Pharmaceuticals, which has an illustrious history of manufacturing defects, most recently recalling many of its products due to mispackaging. The company is based in India, and, in 2008, the FDA banned the importation of dozens of Ranbaxy products because of an array of manufacturing problems and forged documents. The ban was lifted in 2012. To date, Ranbaxy makes up about 40% of the U.S. Lipitor market, and about 1 million prescriptions are sold each week. 

The new labels as mandated by the FDA are not located on the bottle, but inside the package inserts. Other products affected by these new safety warnings include Prevachol, Livalo, Lescol, and Altoprev. Early clinical trials indicate that there is a possibility of liver damage associated with statin use as well. Due to this discovery, the FDA now recommends that liver enzyme tests be performed before any statin treatment is initiated.

Statin lawyers at Pintas & Mullins Law Firm urge patients on medication for high cholesterol to keep watch of any possible signs and symptoms of liver damage, diabetes, cognitive dysfunctions, and muscle damage. If you or a loved one was seriously injured by a statin medication, you have important legal rights, and may be entitled to compensation through a lawsuit against the manufacturer.