Merck Redesigns Zocor Label after FDA Study
Merck, the manufacturer of Zocor, drug name Simvastatin, announced it would be redesigning the label of its blockbuster drug. The redesign comes on the heels of a seven year study that found that patients who took the higher dose of Zocor were at a higher risk of developing rhabdomyolysis, a disease that causes muscle fibers to break down and release myoglobin, a protein that damages the kidneys.
Symptoms of rhabdomyolysis include muscle cramps, muscle tenderness and stiffness, pain, and spasms. The disease usually occurs in patients over the age of 65 or in those patients who have renal impairment or uncontrolled hypothyroidism.
Sales of the drug have been high in recent years, especially because the generic Simvastatin is available at a relatively low cost compared to some other statins currently on the market. An estimated 1.2 million Americans are currently taking the 80 milligram dose of Simvastatin, the highest dose sold legally in the United States.
Despite its low cost, researchers urge that patients should talk with their doctors about switching to a newer generation statin, like Crestor, which has had a greater success rate with reducing cholesterol levels, without the harsh side effects.
Before muscle deterioration and damage became a worry to researchers, some worried that statins caused nerve damage.
In 2002, Dr. David Gaist, MD, a researcher from Denmark, found that patients taking statins were at a nearly 16 times increased risk of developing neuropathy, compared to patients not taking statins. And those taking statins for two or more years were at a 26 times higher risk for developing neuropathy. Gaist concluded that the larger the dose given to the patient, the higher the risk that the patient would develop nerve damage.
Although the study conducted by the FDA did not reveal a link between Simvastatin and neuropathy, Dr. Gaist was on the right track with his research and the dangers posed by an increased dosage. Ultimately, Dr. Gaist’s report shows that the concern about the effects of Simvastatin on the human body was well-founded, even before the FDA saw fit to study the drug’s effects.
If you or a loved one has suffered from rhabdomyolysis while taking Simvastatin, call Van Wey Law today.
