October 4, 2012

Simvastatin FDA Warning and Recall: The Story

Filed under: muscle pain — robertprice @ 4:15 pm

Simvastatin. A statin-class drug used to decrease a person’s “low-density lipoprotein cholesterol,” or what we call bad cholesterol.

Simvastatin was approved in 1991 as a single-ingredient generic medicine. It was branded as Zocor. It comes in various dosages, with the 80mg dose prescribed to more than 2 million people.

The Food and Drug Administration (FDA), however, issued simvastatin warnings after a broad and wide-ranging review of information from clinical trials and data.

All data came from the FDA’s Adverse Event Reporting System. The system is one of the agency’s most important tools for tracking the safety of medicines after they have hit the market.

Simvastatin Muscle Pain

All statin drugs carry the risk of what’s called myopathy. In essence, this means weakness in the muscles.

However, those taking the 80mg dose of simvastatin, which is the highest approved medicinal dosage, have been found to be at greater risk of the disease. And this is especially true during the first year of treatment.

The muscle damage is often caused by the drug’s interaction with other medicines. Plus, some people are just genetically predisposed to this kind of muscle damage disease.

Even worse, a rare form of the disease, called rhabdomyolysis (rab-dough-my-all-iss-iss), can cause kidney failure and even death.

These findings caused the FDA to issue a recommendation: sharply limit the use of the 80mg simvastatin dose.

Note: there is no complete simvastatin recall from the market. But, the strict restrictions mean that no more patients will start on 80mg of simvastatin.

The only people allowed to continue using the 80mg dose are patients who have taken simvastatin for at least 12 months and have not shown any signs of ill effect or muscle toxicity.

Also, patients taking the 40mg dose who still fail to meet their cholesterol goal are not to be given the higher 80 mg dosage. Instead, they would be advised to choose a different statin drug completely.

Simvastatin Side Effects

Aside from myopathy and rhabdomyolysis, the drug can also cause several side effects, ranging from the relatively mild to the life threatening ones:

  • Muscle pain
  • Joint pain
  • Nausea
  • Dizziness
  • Constipation and other gastrointestinal problems
  • Liver damage brought about by increased liver enzymes. This is a serious side effect that must be addressed immediately.

There have also been some findings on simvastatin weight gain.

The root of this is sleep problems that can be set off by the drug crossing into the brain, unique to simvastatin. The resulting sleep disturbance can greatly affect the quality of a patient’s life and may have negative consequences, such as resistance to insulin and increase in weight.

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December 7, 2009

Strange Cases in Medicine Proteus Syndrome


This week’s strange case in medicine is Proteus Syndrome. Proteus Syndrome results in the overgrowth of skin and irregular bone development that is often followed by the growth of tumors over the body. The condition is extremely rare, with only about 120 people living with the condition.

Proteus Syndrome is described as a progressive condition, meaning that when a child is born with the condition it may not be apparent right away. However, as time moves on deformities begin to become fairly obvious. Although not all cases of Proteus Syndrome are diagnosed, as not all irregular growths are severe.

Unfortunately, skin, bone, and tumor growth can begin at any age. Also, the risk of an early death increase dramatically for those diagnosed with Proteus Syndrome. Many individuals suffering from Proteus Syndrome are more likely to develop deep vein thrombosis and pulmonary embolism due to the malformations of the blood vessels. Furthermore, carrying around all the extra weight, caused by the condition, can be hazardous in itself. Arthritis and muscle pain are common for those with Proteus Syndrome, although other, more fatal outcomes are possible.

The cause of the condition is still undetermined. Without a cause for the condition it becomes very hard to treat the condition. As of today there is still no cure. Those that suffer from severe problems due to their enlarged limbs may require amputations.

CanDrugstore.com, a Canadian Internet-based pharmacy intermediary (license #BC X23), offers low cost, long-term prescription drugs. A professionally registered pharmacist fills all Canadian prescriptions. A certified member of the Canadian International Pharmacy Association, CanDrugstore.com is ranked as one of the best Canadian pharmacies online by PharmacyChecker.com. For more information on how to order your drugs from Canada safely and securely call 1-866-444-6376 or visit http://www.candrugstore.com/– a trusted and reliable Canadian online pharmacy since 2002.Read more: “CanDrugStore” – http://www.candrugstore.com/blog/#ixzz0EaSkHrOA&A;

CanDrugstore.com, a Canadian Internet-based pharmacy intermediary (license #BC X23), offers low cost, long-term prescription drugs. A professionally registered pharmacist fills all Canadian prescriptions. A certified member of the Canadian International Pharmacy Association, CanDrugstore.com is ranked as one of the best Canadian pharmacies online by PharmacyChecker.com. For more information on how to order your drugs from Canada safely and securely call 1-866-444-6376 or visit http://www.candrugstore.com/- a trusted and reliable Canadian online pharmacy since 2002.