Crestor Manufacturer Struggles in Face of Litigation, Patent Loss

Crestor lawyers at Pintas & Mullins Law Firm affirm that the drug’s manufacturer, AstraZeneca, is reporting profit drops of more than 35% due to loss of exclusivity and litigation surrounding its top-seller, Crestor. The popular statin drug is associated with an increased risk of liver and kidney injury, along with other life-threatening health effects.

Crestor, along with its stain counterparts (Zocor, Lipitor, Mevacor, and Vytorin), are cholesterol-lowering medications for patients with high LDL cholesterol at risk for heart attack, stroke, or heart disease. These are among the best-selling drugs in the United States, however, they are also extremely dangerous, particularly when taken in large doses or for a long period of time.

There has been much research in recent years confirming the link between statin use and the development of type 2 diabetes, which is one of the more severe side effects Crestor patients may experience. Prescribing statins to people with elevated blood sugar levels may push them into the diabetic range, even if the risk is relatively low. Experts are still trying to determine the exact cause of the diabetes link, although the increase risk has been reported to be as high as 12%.

There is also a risk of the drug negatively affecting liver and kidney function and causing rhabdomylosis, a rare disease that depletes muscle mass and strength. In fact, the FDA initially withheld Crestor approval because of concerns surrounding a similar medication that caused serious kidney and muscle side effects. It was ultimately approved in 2002, however, two years later, the non-profit organization Public Citizen requested that the FDA remove Crestor from American markets because of its severe side effects.

In response to the Public Citizen request, the FDA issued a Public Health Advisory in June 2004, warning patients of the increased risk of serious muscle toxicity, especially in the highest doses (40 mg). One year later, the federal agency issued another alert stating that many Crestor patients were experiencing serious muscle damage (rhabdomyolysis), and changed the medication’s labels to highlight these important risks. In February 2012 the drug’s labels again changed to reflect the increased risk of elevated blood sugar levels and consequent development type 2 diabetes.

The muscle breakdown caused by rhabdomyolysis releases muscle tissue into the blood stream and, in time, overburdens the kidneys. This can subsequently cause the kidneys to shut down, which may lead to death if left untreated for any amount of time.

The manufacturer of Vyotrin, a statin similar to Crestor, is also in the midst of serious litigation after numerous studies proved that it was linked to an increased risk of heart attacks and other adverse cardiovascular events. Compounding this is that several experts assert that they believe these statin drugs are not only dangerous, but largely ineffective as well.

Mevacor was also required to change its labels because it can negatively interact with other medications and put patients at risk for muscle problems. The FDA warned that Mevacor should not be taken with certain antibiotics, anti-fungal medications, or protease inhibitors, which are used to treat HIV/AIDS.

In a separate arena, AstraZeneca recently settled a long-running lawsuit involving Crestor’s patent, which will now be protected until 2016. This means that more and more Americans will be subjected to the dangerous side effects of the drug, many of them unknowingly. Crestor attorneys at Pintas & Mullins Law Firm remind the public that anyone taking a statin that develops diabetes, suffers a heart attack, or any type of organ damage may have a legal claim against the manufacturer. A Crestor lawsuit can help you pay for any medical bills, lost wages, and other related expenses.

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