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FDA Issues Warning Regarding Zocor

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Silver Spring, MD: The US Food and Drug Administration (FDA) issued a warning about the potential for an increased risk of muscle injury when patients use 80 mg of Zocor (simvastatin). The muscle injury, known as myopathy, is a side effect of all statins; however, the warning highlights the increased risk of developing this injury when patients use higher doses of Zocor. The warning includes an increased risk of rhabdomyolysis, a serious form of myopathy that can lead to kidney damage, kidney failure and death.

"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available," said Eric Colman, M.D., Deputy Director of FDA's Division of Metabolism and Endocrinology Products (DMEP). "It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy."

Simvastatin is sold as the brand name Zocor and is also sold in combination medications. When sold in combination with ezetimibe, the medication is called Vytorin. When sold in combination with niacin, the medication is called Simcor.

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LEGAL ARTICLES AND INTERVIEWS

Zocor and Simvastatin Hit with New FDA Restrictions
Zocor and Simvastatin Hit with New FDA Restrictions
June 9, 2011
Thirteen years after high-dose Zocor was approved by the US Food and Drug Administration (FDA) as a drug whose benefits outweighed its risks, the health regulator has slapped new restrictions on the drug over concern for the onset of myopathy. READ MORE

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My father Gary H. Pettus passed away May 28 2012 from heart failure, he had peripheral neuropathy and was being prescribed 500 mg daily of Levaquin prior to his passing. My father was on numerous medications that I have seen on the bad drug list such as Levaquin, Zofran , Plavix, Zocor, Prevastatin, Prevachol, Cilostazol, and may others like Neurontin, Norvasc, Lovenox, Nitroglycerin, Lyrica, Ambien Oxycotin and even Phentanal patches. He was also misdiagnosed for diabetes and treated for over two years for that. My father originally had went in to Swedish Medical because he was having nerve pain in his leg from an accident years prior which left his liver scared. They had also put an IVC filter in at that time. Swedish Medical Seattle gave him a nerve blocker which helped for a while but when it wore off he went in for a second one and they nicked him somehow and he started to hemorrhage but they couldn't find where it had started so they induced him into a coma which lasted thirteen days. They then discovered he was 90% blocked in his right leg so they did a lower extremity aortic bypass where they put in an artificial vein to try to increase blood flow but his body rejected it and infection set in. So they ended up doing another surgery later to put in a live vein which did restore some blood flow to his leg but this resulted in nerve damage that bothered him constantly. He then started having heart palpitations and chest pain frequently so he went to UCLA at the recommendation of a friend that had a heart replacement done there. UCLA did a Dye test and discovered Swedish Medical had used veins not arteries in his aortic surgery. So UCLA put in a stent. I know he never had any heart related problems before all this happened and all the medication and I watched him deteriorating in such a short period of five years time. I have his paperwork from the two hospitals and his medical ID number and I would like to find some justice and closure.

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