Crestor

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Crestor

What’s Wrong With Crestor?

Consumer advocates demanded that the drug be recalled because of its associations with a grave muscle disorder. However, the drug remains on the market regardless of additional risks surfacing. AstraZeneca continues to stand by claims that the product is safe.

Patients and families filed lawsuits against AstraZeneca LP and AstraZeneca Pharmaceuticals, and distributor McKesson Corporation in California state court back in March 2012. Plaintiffs allege that the companies designed, manufactured, distributed and marketed the drug in spite knowledge of the drug’s dangers. They also allege that the possibility of sudden cardiac death is also associated with the medication.

In May 2012, a group of patients had filed a lawsuit against AstraZeneca. Allegations include drug associations with sudden cardiac death. A month later, another group also filed a lawsuit in California, with claims that the drug maker and its distributors marketed the drug with full knowledge of the adverse complications that can rise from the use of the drug.

AstraZeneca has encountered litigation with Watson Laboratories, Inc., (formerly known as Actavis, Inc.  and now known as Allergan), and EGIS Pharmaceuticals with regard to US patent infringement litigations.  Settlements have been made, including agreements of Watson and EGIS conceding that the patent is valid, and would be infringed by Watson’s rosuvastatin products.

Also included in the agreement is permission for Watson to market and begin selling its generic version and another rosuvastatin product on May 2, 2016, with AstraZeneca receiving a percentage of 39% from Watson’s net sales of the products until the conclusion of pediatric exclusivity on July 8, 2016.  All claims and counterclaims regarding the litigations will be dismissed in a consent judgment by the United States District Court for the District of Delaware.

Although reports and lawsuits regarding the grave side effects have been circling against its manufacturer, AzstraZeneca, the company still continues to gain profits from the drug due to the FDA’s refusal to recall and ban the statin.

Symptoms and Side Effects

The risk of serious side effects include memory loss, type 2 diabetes, muscle pain, liver damage and rhabdomyolysis – a rare muscle condition that can lead to kidney failure and death.

The most serious problems that patients contract include liver enzyme abnormalities, cardiomyopathy, and rhabdomylolysis with myoglobinuria and actute renal failure and mypopathy.

Controlled clinical studies gave 5,394 patients placebos and active-controlled drugs. Within about 15 weeks of treatment, 1.4% of the patients stopped using the drug because of injurious reactions. The most common of these reactions were myalgia, abdominal pain, and nausea.  In the same clinical trial, the most prevalent reports on drug reactions also include headaches, myalgia, abdominal pain, nausea and asthenia.

The most severe side effects have wide ranges that vary from problems in the areas of musculoskeletal, renal, hepatic, respiratory, nervous system, psychiatric, gastrointestinal, cardiovascular, endocrine, hematologic, genitourinary, and hypersensitivity, among others.

It was reported that in one of the clinical trials for the drug, patients with one risk factor for diabetes who used Crestor were 28% more likely to have type-2 diabetes progression as compared to those who took the placebo. The same trial also showed that even lower dosages of Crestor increase the risk for diabetes. This is not a surprising fact, as other statins have also been known to be linked with diabetes risks.

Continued use has also been linked to liver damage. Patients are advised to take liver enzyme tests before beginning treatments with the drug. Combining with other drugs that lower cholesterol (i.e. fibrates and niacin) increases risk for liver damage as well.

Rhabdomyolysis is the most severe side effect, which can result in death. This disease breaks down muscle fibers and can infiltrate the bloodstream, which damages the kidneys, leading to kidney failure and death.

Symptoms of liver problems involve tiredness or weakness, loss of appetite, upper abdomen pain, and dark-colored urine, as well as blood sugar level increase.  Symptoms of immune-mediated necrotizing myopathy include proximal muscle weakness and increased serum creatine kinase. These two symptoms can possibly continue to develop even after discontinued use of Crestor.

FDA Recalls, Warnings and Reports

The FDA has been forced to take action. The FDA released a public health advisory in 2004, with statements of increased risk of muscle damage for users, with an even greater increase in risk for Asians.

A petition representing 160,000 consumers was sent to the FDA in 2004 by Sidney Wolf, M.D. – director of Public Citizen, a nonprofit health advocacy group. The petition requested an urgent recall to avoid future cases of muscle and/or kidney damage in individuals wanting to take the drug. The health advocacy group compared dangers of Crestor with Cerivastatin, further affirming unfavorable events from trial data and post-market use.

The letter from Public Citizen addressed to the FDA noted that liabilities of rhabdomyolysis is 6.2 times higher in Crestor as compared to the combined rates of all other statins. Upon comparison of Crestor with the statin with the lowest rate of rhabdomyolysis, Crestor was found to have risks that were 21.8 times higher.

A year later, the FDA responded to this petition. They declared that the Crestor label must be updated, since the drug’s risks were not much greater than other statins in the market. Later that year, the same institution sent out alerts warning about muscle damage and emphasized elevated risk for doses of 40mg. Crestor can lead to kidney failure as well, as reported in the same alert. In response to the FDA actions, AstraZeneca added warning information to the packet insert of the drug. The newly revised label also recommended that Asians start with 5mg doses; according to studies, Asians have increased risks of muscle damage. However, the FDA has still denied Public Citizen petitions to ban Crestor from being sold in the market.

The FDA announced a label change to statin drugs in March 2012. Label changes were done to inform and alert patients using the drugs of the risk of adverse side effects and drug interactions. The institution also mentioned reports of muscle injury when statins are used with fibrates, niacin in high dosages, Ranexa or Colchicine. Rare but serious liver complications for statin users were also reported by the agency.

The FDA stated that Crestor is associated with low incidence rates of rhabdomyolysis. Different forms of kidney failure have also been seen and reported in patients that take the AstraZeneca drug.

In October 2012, the FDA announced that changes were made in the warning labels of Crestor. It then included alerts to patients of the risk of immune-mediated necrotizing myopathy – an autoimmune myopathy associated with use of statins.

It was in January 2014 when the FDA had issued a Consumer Health Information entitled “FDA Expands Advice on Statin Risks” further advising consumers and even healthcare professionals about dangers associated with statins, with no exception on Crestor.

Found in the Canadian Medical Association Journal, a published article reported that eight post-clinical trial cases of rhabdomyolysis were found. Some of these cases were reported to have been taking low dosages of Crestor, as low as 10mg.

There have also been reports of higher side effect risks for people who take the drug in higher doses. Germany, Norway and Spain have not approved the drug due to safety concerns.

Lawsuit funding is NO LONGER AVAILABLE on Crestor