Crestor lawyer: "Crestor safety in Doubt. Crestor: Lawyers begin to put AstraZeneca in sight."
December 9, 2004 13:38

Lawyers are beginning to pursue Crestor cases with the same agressiveness as Vioxx.

The scandal widens as the analysis of the behaviors of pharmaceutical manufacturers becomes more acute.

Some research suggests that Crestor carries greater risk of serious side effects than other statins, Michael Miller, director of the Center for Preventive Cardiology at the University of Maryland, said current knowledge does not warrant taking most patients off the drug. He will continue to monitor patients carefully and won't prescribe Crestor to those at high risk for the most serious side effects. Thus, the allowance of Crestor on the market, despite side effects that Public Citizen director Sidney Wolfe describes as a "unique toxicity that distinguishes this drug from the other statins," is a tragedy waiting to happen.

More Cases of Muscle Deterioration, Kidney Failure Reported

WASHINGTON, D.C. The U.S. Food and Drug Administration (FDA) had evidence before approving the cholesterol drug Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration), yet the agency approved it anyway, erroneously believing that this toxicity was limited to an 80 milligram dose that was not ultimately approved, Dr. Sidney Wolfe, director of Public Citizen?s Health Research Group, writes in this weeks issue of The Lancet (June 26).

Crestor is a new prescription medicine for people with high cholesterol. Crestor was introduced to the market in August, 2003.

Over one million patients have been treated with this drug, with over two million prescriptions have been written. Since its approval, patients developed kidney failure or muscle damage, and have died.

Did you know that Crestor side effects were known BEFORE it was approved?

Its true. Crestor was approved by the Food and Drug Administration approval in August 2003, after a delay because of safety concerns. Safety concerns into muscle wasting syndrome. During FDA studies seven cases of the potentially fatal, muscle-destroying condition rhabdomyolysis occurred.

What did the studies show about Crestor side effects?

www.healthyscepticism.org (Peter Mansfield>
www.statinawareness.com (Dianne Scarbrough)
www.westonaprice.org (Sally Fallon)
www.THINCS.org (The International Network of Cholesterol Skeptics)
jacohen@ucsd.org (JayCohen MD, author OVERDOSE)
JoeGraedon@aol.com (Peoples Pharmacy)
KilmerMcCully@med.va.gov (Kilmer McCully MD, author THE HOMOCYSTEINE REVOLUTION AND THE HEART REVOLUTION)
langsjoen@compuserve.com (Peter Lansjoen MD, authority, Coenzyme Q10)
ravnskov@tele2.se (Uffe Ravnskov MD, author THE CHOLESTEROL MYTHS) statinstudy@ucsd.edu (Beatrice Golomb MD, director UCSD statin study)
stress124@optonline.net (Paul Rosch MD, president, the American Institute of Stress)

Background

Cholesterol is a waxy substance used by the body in small quantities to make essential tissues. In larger quantities the excess cholesterol is used to make the blockages which form in our arteries: atherosclerotic plaque. Excess cholesterol gets into the body in two ways: some people get their extra cholesterol from a diet rich in animal fats, some people get their extra cholesterol because their bodies simply make too much cholesterol.

No matter how we get the extra cholesterol, it is one of the major causes of the blockages in our arteries that cause heart attacks, strokes and poor circulation. Your likelihood of developing these problems depends on how high your cholesterol level is. Many studies have now shown that lowering your cholesterol level will help to prevent these complications of atherosclerosis. Whether you lower your cholesterol by diet, exercise or drug therapy, this effort will help to prevent future heart attacks, strokes and poor circulation.

There are many ways to measure the cholesterol levels in our blood. Previously, total cholesterol was the most common measure. Now cholesterol is divided into good and bad portions based on the direction that they carry fats. LDL or ?bad cholesterol? carries fats to the artery wall. HDL or ?good cholesterol? carries fats away from the artery wall. Many recent studies have confirmed that the ratios of these types of cholesterol is a better predictor of heart disease than total cholesterol alone.

More sophisticated measures sub-fractions of the good and bad cholesterols are now available. Although they are not yet commonly available, studies now show that they may be even better predictors of atherosclerosis. Most adults should have their cholesterol measured every five years. Those who have suffered atherosclerotic problems like heart attack or stroke and those with diabetes require more strict

Current recommendations treat those who already have blocked arteries or diabetes differently than those who do not have these problems. People without these problems are advised to maintain their total cholesterol less than 200, their bad cholesterol (LDL) less than 160 mg% and their good cholesterol (HDL) greater than 40 mg%. Patients who are diabetic or already have blocked arteries are treated more aggressively. These patients are advised to keep their bad cholesterol (LDL) less than 100 mg%.

A good diet and exercise program are the first step in any cholesterol lowering program. Many patients will require drug therapy as well in order to reach the goals stated above.

There are three components to a cholesterol lowering diet:

• decreased calories,
• decreased fat consumption, and
• decreased cholesterol consumption.

A good exercise program will not only condition your cardiovascular system and help you reach your ideal body weight, but it will also lower your cholesterol level. Patients with heart disease should ask their doctor how much exercise will be acceptable for them. Others should aim for 45 minutes of aerobic exercise daily. Walking, jogging, swimming and bicycling are all forms of aerobic exercise.

From: http://www.impostertrial.com/patient.htm

RHABDOMYOLYSIS BACKGROUND

Bayer?s voluntary withdrawal of cerivastatin (Baycol) from the U.S. market in August, 2001 has prompted questions about the safety of all hydroxymethylglutaryl-coenzyme A reducatase inhibitors (statins). Interest in rhabdomyolysis, the most serious statin toxicity, has also increased.

While the terminology used to describe muscle toxicity has been imprecise and sometimes inconsistent, the ACC/AHA/NHLBI CLINICAL ADVISORY ON STATINS has chosen to standardize the terms as follows:

Cholesterol lowering therapy with HMGCoA reductase inhibitors (statins) convincingly reduces death and myocardial infarction among patients with coronary heart disease Application of the National Cholesterol Education Program?s ATP III guidelines could lead to as many as 36 million patients receiving this therapy in the United States.

The remarkable success and proliferation of statin therapy is largely due to the absence of significant toxicity occurring in more than 50,000 patients included in randomized controlled trials of statins over the last 16 years. Myopathy? defined as unexplained muscle pain or weakness accompanied by a CK greater than 10 times normal, occurred in only one case per 10,000 person years among subjects randomized to statin treatment in the 4S and Heart Protection Study trials. An identical incidence has been calculated when statins are used in the community at large. Despite this very low incidence of serious muscle toxicity, many patients in these trials have had minor muscle complaints. However, these minor muscle complaints occur with the same frequency among patients randomized to placebo. Consequently, it is generally believed that patients whose CK levels remain normal are not having a reaction to these drugs, despite complaints of muscle symptoms. Nonetheless, both minor and major muscle toxicities related to statin therapy are not well understood and have been poorly studied. The recent withdrawal of cerivastatin from the market has highlighted both our ignorance and the need for post-marketing surveillance of these therapies. Several lines of evidence suggest that there are common minor myopathic toxicities in addition to the rare rhabdomyolytic reactions to these drugs.

McKelvie PA, Dennett X. Myopathy Associated with HMG-CoA Reductase Inhibitors (Statins: A Series of 10 Patients and Review of the Literature. J Clin Neuromusc Dis 2002;3:143-148.

Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis [letter]. N Engl J Med 2002; 346:539-540.

Chang JT, Green L, Parks M, Staffa J. Clinical characteristics of U.S. cases of rhabdomyolysis associated with statin use [abstract].

Paul S. Phillips, MD, Richard H. Haas, MD, Sergei Bannykh, MD, PhD, Stephanie Hathaway, RN, Nancy L. Gray, RN, Bruce J. Kimura, MD, Georgirene D. Vladutiu, PhD, John D.F. England, MD and the Scripps Mercy Clinical Research Center. Statin Associated Myopathy with Normal Creatine Kinase. Ann Int Med 2002;137:581-585.

Richard Haas, Bruce Barshop, Sergei Bannykh, Darius Amjadi, UCSD Medical Center, Paul Phillips, Scripps-Mercy Hospital Statin associated myopathy is associated with lipid accumulation and 3-methylglutaconic excretion[abstract]. Presented at Society for Inherited Metabolic Disease meeting in Asilomar, CA 3-4-02.

Phillips P, Haas R, Barshop B, et al. Utility of Abnormal 3-Methylglutaconic Aciduria (3MGA) in Diagnosing Statin Associated Myopathy. Atheroscler Thromb Vasc Biol Online Journal 2002; 22:878.

Phillips P, Haas R, Bannykh S, et al. HMG-CoA reductase inhibitor associated myopathy with normal creatine phosphokinase. Drugs Affecting Lipid Metabolism (DALM) Symposium. NYC 9-8-01.

Joint American College of Cardiology, American Heart Association, National Heart Lung and Blood Institute Statins Advisory (June, 2002).

AstraZeneca halted development of the 80-milligram dose because of the safety problems, and Crestor is now only sold in 5-, 10-, 20-, and 40-milligram (mg) strengths. There are special restrictions on the distribution of Crestor 40-milligram strength, based on FDA Crestor guidelines prompted by known Crestor risk factors.

A press release from Sidney Wolfe, Health Research Director of Public Citizen said, Crestor is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after 'enough' people have been injured or killed, that Crestor will have to be pulled from the market." Dr. Wolfe went on to say, The FDA should never have approved Crestor in the face of such serious and potentially lethal adverse effects. The only way the agency can show it has concern for patient safety, and not industry wishes, is to pull Crestor from the market immediately."

The statin family are atorvastatin (brand-name Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor). The statin cerivastatin (Baycol), was removed from the market. Crestor is a statin drug.

AstraZeneca Plc was reprimanded by the U.S. Food and Drug Administration for underplaying risks linked to its Crestor cholesterol drug in an advertisement.

The FDA is under pressure from lawmakers and consumer groups who say it isn't doing enough to police the safety of medicines after they are approved, such as Merck & Co.'s withdrawn Vioxx painkiller. A company study found that patients taking Vioxx for 18 months or longer had twice the risk of heart attacks and strokes as those on a placebo.

`Misleading' Claim about Crestor: In its letter to AstraZeneca, the FDA stopped short of asking the company to publish corrections to the advertisement. The agency also didn't issue a formal warning letter, which can trigger slowdowns in new drug approvals and other consequences. That suggests the letter was intended to keep AstraZeneca from making similar claims in the future, said Ira Loss, who follows the FDA and regulatory issues for Washington Analysis. Bloomberg

The witch's magic mirror has one more negative to reveal, too. The FDA is going to review all COX-2 inhibitors and has asked doctors to limit prescribing Bextra and Celebrex to patients who cannot tolerate non-steroid painkillers such as ibuprofen (which, by the way, is linked to gastrointestinal bleeding in some patients).

Look out if you live in Japan. Bad drugs are on the way...

AstraZeneca said yesterday that the Japanese authorities were close to approving Crestor, its drug to treat high cholesterol. Final approval was conditional on the agreement of a post-marketing surveillance programme, and details of this were under negotiation.

The positive news follows a series of setbacks for the group, whose shares have fallen by 30 per cent since September. A week before Christmas it revealed that Iressa, its lung cancer drug, had failed to prolong life in clinical trials.

In September, the FDA refused to approve Exanta, AstraZeneca's blood thinning drug, which was intended to prevent strokes and blood clots.

Injured by Crestor? Contact a Lawyer at Monheit Law. Now!

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Crestor Wins Approval in Japan
December 29, 2004 09:45

By Graeme Evans, PA City Editor AstraZeneca announced a boost for one of its key drugs today after cholesterol-beating product Crestor received the support of Japanese authorities. Shares in Astra rose as investors expressed relief at some good news from the London-based company after a series of recent setbacks, including the emergence that Iressa did not boost the survival chances of lung cancer sufferers. http://business.scotsman.com/latest.cfm?id=3938395

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F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and Misleading'
December 30, 2004 09:25

NY TIMIES
AstraZeneca's recent full-page newspaper advertisements defending the safety of its cholesterol-lowering pill, Crestor, are "false and misleading," in part because serious concerns remain about the safety of the drug, federal drug regulators said Wednesday.

The advertisements stated that "the F.D.A. has confidence in the safety and efficacy of Crestor" and that the agency "as recently as last Friday publicly confirmed that Crestor is safe and effective." Neither is true, said a letter from the Food and Drug Administration to AstraZeneca.

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