Crestor is not as safe, study shows
April 2, 2006 16:20

Lead author, Richard Karas, analyzed 145 rosuvastatin assocaited adverse reactions during Crestor's first year and found it was much more likely to cause rhabdomyolysis, proteinuria, or kidney failure than other statins. Dr. Karas urges health care providers... (Read Crestor Article)

Will AstraZeneca's Crestor go the way of Baycol? Will it be removed from the market because of unique risks of muscle disease? 5 years ago, Baycol was removed for these same problems that now are appearing to be related to Crestor -- Rhabdbomyolysis. Like Baycol, Crestor is a statin. Statins block certain enzymes the body uses to make cholesterol. But this drug is listed as a DO NOT USE drug by http://www.worstdrugs.com.

The latest claims come as the drug industry struggles to clean up its image after a string of safety controversies that have sent its reputation to record lows. Public Citizen has been among the industry's most persistent critics, and recently turned its fire on Crestor, a cholesterol medicine from the UK's AstraZeneca which it claimed was unsafe.

Crestor, a cholesterol-lowering drug from the same company, fell under scrutiny for potential side effects. By the end of the year, all this heat was battering pharmaceutical company valuations and misting future prospects for drug stocks. http://www.businessweek.com/magazine/content/05_02/b3915433.htm

5/31/05: A pre-published article in Circulation last week reported that the cholesterol-lowering drug Crestor has been associated with a much greater frequency of reports to the U.S. Food and Drug Administration that other statin drugs (eg, Lipitor, Zocor, Pravachol). Unfortunately, the article did not offer any solutions, nor has the FDA. Jay S. Cohen M.D., a nationally recognized expert on medication side effects, has been writing and speaking about the increased risks with Crestor since the drug was first approved. Dr. Cohen believes that many of the problems with Crestor can be prevented with simple measures that the FDA must undertake to ensure patients' safety.

The study seemed to challenge a recent decision by the Food and Drug Administration to keep Crestor on the market. But it also showed that over all, these kinds of drugs, known as statins, were safe. Even the risks of serious problems with Crestor, which is manufactured by AstraZeneca, are very low, said the authors of the study, one of the largest reviews of the nationwide use of statin drugs. Officials of the American Heart Association, which published the findings online in its journal, Circulation, at www.circulationaha.org, said in a news conference that patients should continue taking any statin, including Crestor, until they could consult their doctor. Dr. Alice K. Jacobs, president of the heart association and a cardiologist at Boston University, said statins had been used safely for 20 years.

May 27, 2005 Wonder Drugs and Their Side Effects

It's been an up and down month for statins, a class of widely touted "wonder drugs" that have already sprinted to the top of the best-seller list based on their ability to lower cholesterol and thus reduce the risk of heart disease. Now preliminary studies suggest that they may be effective against an array of cancers as well, though that is far from proved.

The hitch is lingering safety concerns, highlighted by a recent study showing that the most powerful drug in the class had a much higher rate of serious adverse reports than did its competitors.

The statins are undeniably good at lowering cholesterol, and studies published early this year showed that they were also effective in reducing levels of a protein involved in inflammation, a separate risk factor in heart disease. Because inflammation appears to be at the root of many diseases, The Harvard Health Letter recently suggested that statins may eventually be used to treat conditions like Alzheimer's, multiple sclerosis and rheumatoid arthritis. Studies published or presented this month suggested that statins may reduce the risks of cancers affecting the colon, breast and other organs. Rigorous controlled trials are clearly needed.

Six statins are currently available, and they are known by a variety of brand names: atorvastatin (Lipitor*), fluvastatin (Lesco[dagger]), lovastatin (Mevacor,[double dagger] Altoprev), pravastatin (Pravachol||), rosuvastatin (Crestor), and simvastatin (Zocor[double dagger]). Although these drugs have been very successful in managing the cardiovascular health of many patients, there are also potential adverse effects that have been identified. The most common adverse effects reported include muscle pain or weakness that can progress to rhabdomyolysis and mortality.5 If detected early, statin-related symptoms are reversible after withdrawal of the statin.6,7 Early identification of these potentially serious adverse effects makes the information in this update critical for physical therapists, because they frequently screen patients with musculoskeletal complaints.

Tokyo (JCNN) - On April 27, AstraZeneca K.K. and Shionogi (TSE: 4507) announced that they have put on sale Crestor Tablet 2.5mg and Crestor Tablet 5mg, cholesterol-lowering agents used in the treatment of hypercholesterolemia, across Japan.

Crestor (rosuvastatin calcium) is a HMC-CoA reductase inhibitor that effectively reduces LDL cholesterol and elevate HDL cholesterol.

Based on the ICH E2E guideline on Pharmacovigilance Planning, the two companies will exclusively deliver the agents to specific medical institutions and promptly conduct post-marketing surveillance studies.