Merck is recalling all lots of the cholesterol drug Liptruzet, which is a combination of Lipitor and Zetia, due to packaging defects that could change the effectiveness of the medication.
The Liptruzet recall was announced by Merck on Tuesday, indicating that the action will remove the entire supply of the drug from all pharmacy shelves, less than a year after the combination cholesterol drug was introduced.
Manufacturing defects with the packaging may allow air and moisture to infiltrate the foil pouches that contain pills. This could lead to a decrease in effectiveness or a change in the characteristics of the pills. However, patients are not being asked to return already purchased pills and Merck indicates that it has received no adverse event reports associated with the recall. The drug maker indicates that the risk of adverse health effects are remote.
Liptruzet (ezetimibe and atorvastatin) is a combination of Zetia and Lipitor that is sold in 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets. It is prescribed to help patients lower and control cholesterol levels. It was first introduced to the U.S. market in May 2013 and is known outside of the U.S. and Canada as MSD. Neither of those products in their separate forms are affected by this recall.
Merck recommends that any patients who experience an adverse event they believe is linked to Litruzet should contact the FDA and file a report through the MedWatch adverse event reporting program.
Merck did not say when or if the drug would again be available.
Lipitor Diabetes Concerns
The recall comes amid increasing concern over the risk of diabetes from Lipitor and other statin-based cholesterol drugs.
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 potentially serious injuries, including muscle damage, kidney problems and diabetes.
Just days ago, a study published in the medical journal Diabetes, Obesity and Metabolism found that for every three patients who see decreased cardiovascular risk from using statins, one statin patient will be diagnosed with type 2 diabetes and said it is likely that a small number of diabetes cases are the direct result of taking statins like Lipitor.
In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, many critics have suggested that the warnings are not strong enough for certain medications.
Pfizer currently faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States, who allege that use of the medication as a preventative measure to prevent heart failure has caused them to develop diabetes, which carries a number of health risks, including an increased risk of heart disease. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information to avoid a negative impact on sales and growth of the blockbuster medication.
Later this month, a panel of federal judges are scheduled to hear oral arguments in a motion to centralize all product liability lawsuits over Lipitor filed in U.S. District Courts throughout the United States. Plaintiffs indicate that as Lipitor injury lawyers continue to review and file cases, thousands of complaints will likely be brought against Pfizer throughout the federal court system.