Zocor lawyers at Pintas & Mullins report that a class action lawsuit has recently been filed in Louisiana against Zocor manufacturer Merck Pharmaceuticals. Injured plaintiffs are arguing that Merck failed to warn about the risks of serious and life-threatening muscle and kidney damage.
The FDA approved Zocor, which is the brand-name for the generic simvastatin, in 1991 as a cholesterol-lowering statin. Most recently, on January 24, 2013, Health Canada released an informational update for all cholesterol-lowering drugs. The agency now requires these drugs to include on their label that the drugs may increase blood sugar levels and slightly increase the risk of diabetes. The increased risk of diabetes is, for the most part, only evident in those already at risk for the illness, such as those with high glucose levels.
Zocor use has been linked to numerous severe adverse side effects involving the muscles and kidneys. A lawsuit was filed in October 2012 by a man who took Zocor for three years, between 2007 and 2010, and consequently developed serious muscle damage, weakness, and pain. It wasn’t until 2008, more than 17 years after Zocor was approved, that the FDA released warnings about the drug to patients and physicians.
The 2008 warnings included the increased risk of developing a rare muscle condition called rhabdomyolysis, when Zocor is taken with amiodarone – a drug to treat heart rhythm problems. This condition is the most serious type of muscle disease, and can lead to kidney failure or damage, and even death. Heart rhythm problems often manifest in conjunction with high cholesterol levels, so this finding was not insignificant. The FDA also informed the public that the risk of a developing a muscle disorder increased with higher doses of Zocor, which is offered in 5, 10, 20, 40, and 80 mg tablets. Reports of muscle conditions were more likely in patients taking 20 mg doses or higher.
Two years later, the FDA released another public warning, focusing on the 80 mg Zocor doses. The warning informed patients that they may develop rhabdomyolysis even if they were not taking a heart medication as well. Rhabdomyolysis causes muscles to rapidly break down, releasing muscle tissue into the blood stream that must be cleaned by the kidneys. When this happens too quickly or too often, the kidneys become overburdened, and can ultimately shut down. Symptoms of this condition include vomiting, muscle pain and weakness, bruising, and dark-colored urine.
In 2011, the FDA began a study to examine the effects of 40 mg Zocor on patients with cardiovascular disease. The study, however, was cut short, when researchers failed to observe any benefits, instead observing an increased rate of stroke. After this, the FDA urged doctors to sharply curtail Zocor prescriptions, particularly 80 mg doses.
Merck is currently in the midst of an enormous trial for a new cholesterol drug called Vytorin. This drug combines Zocor with Zetia, another cholesterol medication. Many pharmaceutical analysis and experts are projecting Vytorin to fail, pointing to studies comparing Zocor and Vytorin, which found that Vytorin showed an increased risk of heart attacks and other heart problems. Many believe that both drugs are simply ineffective, and as a result, sales of Vytorin have already plummeted.
Cholesterol drugs in general have been under intense scrutiny in the last three months. In November 2012, Ranbaxy Pharmaceuticals’ drug Lipitor was recalled because some lots were contaminated with particles of glass. Ranbaxy has a history of similar manufacturing glitches – in 2008, the FDA banned Ranbaxy, which is based in India, from importing dozens of drugs into the US. This ban was the result of numerous manufacturing problems and reports of forged data submitted to the FDA.
Zocor lawyers at Pintas & Mullins are currently reviewing cholesterol drug cases nationwide. Patients are urged to keep up to date with reports concerning Zocor, and we will continue to release reports and updates as soon as they are available.