Despite increasing concerns in recent years about the potential side effects of Crestor, including a link to serious muscle injury and a risk of diabetes, the cholesterol drug was prescribed more than 23.7 million times over the past year, making Crestor the top selling drug in the United States.
According to a report by the research firm IMS Health, new prescriptions and refills for Crestor exceeded all other prescribed drugs in the United States between October 2012 and September 2013. Combined sales for the medication were estimated at $5.4 billion over the 12 month period.
Even though no other drug had as many prescriptions, Crestor ranked fifth in total sales, behind the more expensive medications Abilify, Nexium, Cymbalta and Humira.
Crestor (rosuvastatin) belongs to a family of drugs known as statins that are used to lower cholesterol. It was approved by the FDA in 2003 and has been aggressively marketed AstraZeneca, leading it to overtake other popular cholesterol drugs, such as Lipitor and Zocor.
Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs to an increased risk of diabetes, muscle injury and kidney damage.
In February 2012, the FDA announced it was requiring new diabetes warnings for Crestor and other similar statins, informing users that they may face an increased risk of changes to blood glucose levels.
All statins have also been found to carry a risk of muscle injury, known as myopathy. But some studies indicate that Crestor is the statin most strongly associated with the injuries. The most severe form of the muscle damage is rhabdomyolysis, which may lead to severe kidney damage, kidney failure and death.
All statins currently contain a warning that myopathy and rhabdomyolysis are rare possible side effects. The condition causes muscle fibers to begin to break down, releasing a protein called myoglobin which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis can include muscle cramps, tenderness, stiffness, pain, and spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.
Shortly after Crestor was introduced, the prominent consumer group Public Citizen filed a petition with the FDA calling for a Crestor recall, due to the potential risk of health problems associated with the medication and the availability of alternatives on the market. The FDA declined to remove Crestor from the market, and it has gone on to be used by millions of Americans.
In recent years, a growing number of former users have been considering potential Crestor lawsuits against AstraZeneca over the drug maker’s failure to adequately warn about the risk of side effects, including the risk of users developing diabetes. While information was added to the label in February 2012, many claims suggest that AstraZeneca knew or should have known about the risk of diabetes from Crestor side effects long before that time.
Momentum for the Crestor litigation has increased with the recent rise in Lipitor diabetes lawsuits, which raise similar allegations about the makers of the competing high-potetency statin.