Drug Injury Watch

Hydroxycut Weight-Loss Products Are Recalled Due To Cases Of Serious Liver Injury

Reports Made To The FDA Have Involved Hepatitis, Liver Failure, Liver Transplant, And Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 1, 2009 the FDA warned people to stop using Hydroxycut products -- made by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- due to the fact that some Hydroxycut products are associated with a number of serious liver injuries. Furthermore, the manufacturer, Iovate, has agreed to immediately recall Hydroxycut products from the U.S. market.

The list of Hydroxycut products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

The FDA's reasoning for this May 2009 recall of Hydroxycut products can be found in a Health Hazard Evaluation Board document entitled "The Problem: Liver toxicity following consumption of dietary supplement, Hydroxycut".  From the Conclusion section of this Health Hazard Evaluation document:

Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity. First, many of the subjects described in the adverse event reports to CAERS, in the peer-reviewed literature, and in the case series described by hepatologists reported no history of liver disease or risk factors for liver disease (e.g., alcohol consumption, previous viral infection, hereditary factors, etc.) prior to experiencing liver injury following the ingestion of Hydroxycut. Second, in many subjects, thorough diagnostic evaluations performed in multiple settings ruled out a number of known causes of liver disease, including viral hepatitis, autoimmune diseases, and metabolic/inherited disorders. Third, prompt resolution of liver disease occurred in a number of patients following cessation of Hydroxycut ingestion.

In a Consumer Advisory, "FDA Warns Consumers Not to Use Dietary Supplements Labeled Hydroxycut because of the Potential Risk of Severe Liver Injury", the FDA provides the following medical information:

Consumers who use a Hydroxycut dietary supplement and who experience signs of illness associated with liver disease should immediately consult their health care provider. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, and loss of appetite.  FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis (a type of muscle damage that can lead to other dangerous problems, such as kidney failure), and cardiovascular problems, ranging in severity from irregular heart beat to a heart attack.  [bold in original]

The FDA -- as opposed to Iovate, the manufacturer of Hydroxycut products --has issued a "Dear Doctor" letter to healthcare providers in the U.S.

In addition, the FDA has put on its web site a Consumer Questions and Answers document regarding this Hydroxycut recall.

In closing, the FDA has stated that it will continue to investigate the relationship between the use of Hydroxycut dietary supplements and liver injury.

If you are aware of any case of liver damage caused by the use of Hydroxycut products, please consider sharing that information with us by submitting a Comment, below.

P.S.  North of FDA-land, Health Canada says it will continue to monitor adverse reaction reports associated with Hydroxycut products, and will provide Canadians with any new safety information. 

From "Health Canada Reviewing Hydroxycut Products in light of U.S. Advisory":

Health Canada has received 17 domestic adverse reaction (AR) reports associated with Hydroxycut products in Canada. These adverse reactions relate to the cardiovascular, respiratory, gastrointestinal, and neurological systems. None of the adverse reactions reported in Canada relate to liver injury.

It will be interesting to see if Health Canada follows the lead of our FDA and issue a Hydroxycut recall in Canada.  (5/4/09)

P.S.  On May 7, 2009 the FDA announced that Iovate Health Sciences USA, Inc. has provided Universal Product Codes (UPCs) for its products that were part of the May 1 Hydroxycut recall.  (5/8/09)

Debate Over Whether Zetia And Vytorin Are, In Fact, Effective Overshadows The Side Effects Of These Drugs

Ezetimibe Component Of These Drugs Is Associated With Liver Failure, Acute Pancreatitis, Rhabdomyolysis, and Thrombocytopenia

(Posted by Tom Lamb at DrugInjuryWatch.com)

Ezetimibe is used alone (i.e., Zetia) or in combination with other antilipemic agents such as a statin or fenofibrate.  In some instances, ezetimibe is in fixed combination with simvastatin (i.e., Vytorin).

Zetia and Vytorin are prescribed as an adjunct to dietary therapy in the treatment of primary hypercholesterolemia and mixed dyslipidemia, as well as homozygous familial hypercholesterolemia and/or homozygous familial sitosterolemia.  As is relatively well-known by now, however, the efficacy of Zetia and Vytorin was called into question when the results of the ENHANCE clinical study were finally released in January 2008 by Merck and Schering-Plough.

For some recent developments concerning the ENHANCE study controversy as well as the related issue of whether Zetia and Vytorin are effective treatments, we refer you to these two leading sources of information:

"Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)", which was issued by the FDA on January 25, 2008; and,

"Merck and Schering-Plough Respond To Issues Raised About ENHANCE Clinical Trial", a January 25, 2008 press release that these two drug companies managed to get out in advance of the FDA alerting the public about its Early Communication item concerning Zetia and Vytorin later that day.  This press release includes a link to an an ENHANCE Chronology (PDF format) prepared by Merck and/or Schering-Plough which is seemingly intended to reinforce the claims made in their press release.

Moving to the drug-safety aspect, there have been reports of Zetia and Vytorin causing some serious side effects, such as:

• drug-induced hepatitis;
• liver failure;
• acute pancreatitis;
• rhabdomyolysis; and,
• thrombocytopenia.

On February 6, 2008 we received The Annals Online Articles Ahead of Print Alert about a new article concerning a Vytorin adverse drug reaction report that was published online by The Annals of Pharmacotherapy before this article's scheduled publication in its March edition.  The Abstract for "Ezetimibe-Associated Immune Thrombocytopenia", this March 2008 medical journal article about Vytorin, provides these basic facts:

• OBJECTIVE: To describe a case of immune thrombocytopenia associated with treatment with ezetimibe, a cholesterol absorption inhibitor.
• CASE SUMMARY: A 72-year-old man presented with severe thrombocytopenia (platelets 3 x 103/µL) and "wet purpura" 4 weeks after being started on daily therapy using a combination of ezetimibe 10 mg/simvastatin 20 mg. Platelet counts normalized after administration of ezetimibe/ simvastatin was stopped. Nine months later, the patient was restarted on simvastatin because of uncorrected dyslipidemia. Platelet counts remained within the normal range following that rechallenge.
• DISCUSSION: Registry data revealed the possibility of ezetimibe-induced thrombocytopenia, but, as of December 3, 2007, no other case reports on this interaction had been published. This case illustrates the probable occurrence of ezetimibe-induced thrombocytopenia. Platelet counts dropped significantly when ezetimibe therapy was initiated, then resolved upon discontinuation of therapy. Other causes of thrombocytopenia were ruled out, and rechallenge with simvastatin further supports the presence of a causal relationship between thrombocytopenia and ezetimibe....
• CONCLUSIONS: Ezetimibe-associated thrombocytopenia cannot be ruled out in the patient reported here. Clinicians should be aware of this adverse event.

We will continue to watch for drug-injury reports concerning Vytorin as well as Zetia in the medical journals, and letting you know what we find, here.

Zocor-Amiodarone Drug Interaction Causes Rhabdomyolysis; Fifth Such Case Reported

Causation Theory: Zocor Is Metabolized By Same Enzyme Which Is Being Inhibited By Amiodarone

On March 14, 2006 The Annals of Pharmacotherapy published online an article about what the authors described as "the fifth reported instance, as of February 15, 2006, of a severe interaction between simvastatin and amiodarone."  Simvastatin in sold by Merck under the trade name Zocor.  Amiodarone is sold by Wyeth as Cordarone, and by Upsher-Smith as Pacerone; several companies sell a generic version of amiodarone, also.

This latest case report involves a 72-year-old white man who started taking amiodarone (200 mg/day) on July 10, 2004, and on August 13 started taking Zocor (80 mg/day) while continuing the amiodarone. The patient was hospitalized on September 21, 2004 after complaining of thigh weakness and achiness; he also reported having dark urine for 7 days.

At the time of his hospital admission, the patient's relevant lab results were as follows:

• creatine kinase (CK) 19,620 U/L (reference range 60-224);
• blood urea nitrogen 50 mg/dL;
• creatinine 2.6 mg/dL;
• aspartate aminotransferase (AST) 912 U/L (30-60);
• alanine aminotransferase (ALT) 748 U/L (30-60);
• urine myoglobin 71,100 µg/L (<50); and,
• serum myoglobin 13,877 µg/L (<110).

Upon admission, the Zocor and amiodarone were discontinued.  The patient was ultimately diagnosed with rhabdomyolysis, renal failure, and possibly hepatotoxicity.  After appropriate treatment, the patient recovered over the course of the next couple of weeks.

The authors of this drug-drug interaction case report in The Annals of Pharmacotherapy arrived at these conclusions:

1. "An objective causal assessment suggests that rhabdomyolysis, renal failure, and possibly hepatotoxicity were probably related to an amiodarone-simvastatin [i.e., Zocor] interaction."
2. "[Zocor] is metabolized primarily by CYP3A4, and amiodarone is a recognized inhibitor of this enzyme. This may, therefore, account for the presumed drug interaction."

The authors pointed out that this patient had pre-existing diabetes mellitus, hyperlipidemia, and hypertension, as well as mild azotemia.  They did not, however, believe that these pre-existing medical conditions were substantial contributing causes as concerned the drug-induced rhabdomyolysis.

(Posted by: Tom Lamb)

Crestor: Full-court Press on CBS News Reporter Sharyl Attkisson

Numerous Doctors Lined-Up to Sing Praises of Crestor for CBS News Report

There is an insightful article published in the July/August 2005 edition of the Columbia Journalism Review (CJR), Bitter Pill: How the press helps push prescription drugs, sometimes with deadly consequences, by Trudy Lieberman, a contributing editor to CJR.

In relevant part, this 2005 CJR article by Ms. Lieberman reveals the lengths to which a drug company might go to promote their prescription medicines.  In one part of the article, Ms. Lieberman discloses that AstraZeneca's promotional efforts for Crestor (rosuvastatin) -- a cholesterol-lowering agent and member of the statin class of drugs -- had included an apparent attempt to influence an investigative report being prepared by CBS News correspondent Sharyl Attkisson.

The AstraZeneca conduct which is covered in this 2005 CJR article occurred when CBS News and Ms. Attkisson were preparing a story in the latter part of 2004 about Crestor.  At that time, as some may recall, there were allegations by the consumer advocacy group Public Citizen and an FDA researcher named David Graham, and various others, about whether Crestor was an unsafe drug in comparison to other cholesterol medications in the statin-drug class -- namely Lipitor (atorvastatin), Zocor (simvastatin), Mevacor (lovastatin), Lescol and Lescol XL (fluvastatin), and Pravachol (pravastatin).

Some more background may be needed to put this conduct by AstraZeneca in context.  During his November 2004 congressional testimony, the FDA's David Graham had identified Crestor as one of the five prescription drugs whose safety profile should be "looked at quite seriously." On another front, Public Citizen, the advocacy group, had petitioned the FDA to remove Crestor from the U.S. market on the grounds that Crestor had a unacceptable rate of causing rhabdomyolysis (severe muscle breakdown / toxicity) and kidney failure in some patients. Needless to say, AstraZeneca, the maker of Crestor, probably felt under some pressure given these developments.  Perhaps to fight back, AstraZeneca launched a public relations campaign which included full-page ads in major newspapers, boasting that "the FDA has confidence in the safety and efficacy of Crestor".  This aspect of the PR campaign backfired, however, as the FDA soon thereafter publicly chastised AstraZeneca for making such a claim -- for the simple reason that AstraZeneca's claim about FDA confidence in Crestor was false from the agency's perspective.

We pick up, here, with the relevant part of Ms. Lieberman's article, Bitter Pill:

CBS's Attkisson thought Crestor's troubles added up to a good story. While AstraZeneca was weighing her request for an on-camera interview, Attkisson began to receive unsolicited offers for interviews from doctors with financial ties to AstraZeneca. In one e-mail, a doctor from Rush University Medical Center in Chicago told Attkisson he had conducted numerous studies on Crestor and urged her to take him up on his offer "to ensure ALL the information about this important class of medication gets out to the public, and not just a selective interpretation of data." A second doctor, a nephrologist from the Cleveland Clinic Foundation, wrote to Attkisson that the accusations made by Public Citizen about Crestor's safety were false, saying it was "imperative" that her story "be both factual and accurate." AstraZeneca sent Attkisson examples of other press stories quoting doctors making positive statements about Crestor. Attkisson told the company she didn't need help finding independent experts. At that point, she says, AstraZeneca got pushy. "We got lobbied so hard on this story by doctors, two outside p.r. firms, AstraZeneca, and one crisis-management firm," she says. "They worked me and pushed me and contacted the executive producer and the president of the news division. But my bosses were generally supportive." Her Crestor story, when it finally aired in mid-December 2004, featured an AstraZeneca vice president but none of the doctors who had e-mailed Attkisson.

To date, the FDA has not seen it necessary to remove Crestor from the U.S. market.  In March 2005, the FDA did ask AstraZeneca to place stronger warning language on the package insert label for Crestor to inform doctors and patients that the use of Crestor may increase the risk of developing rhabdomyolysis.

(Posted by: Tom Lamb)

Health Canada Advisory About Statins and Rhabdomyolysis Side Effect

July 2005 Statin Advisory Provides Patients With Important Safety Information

On July 12, 2005 Health Canada issued an advisory about rhabdomyolysis being a serious side effect of all cholesterol-lowering drugs known as statins. Specifically, the statin class of drugs includes these prescription drugs:

• Crestor (rosuvastatin) 
• Lipitor (atorvastatin)
• Zocor (simvastatin)
• Mevacor (lovastatin)
• Lescol and Lescol XL (fluvastatin)
• Pravachol (pravastatin)

This Health Canada advisory states that cases of rhabdomyolysis associated with the use of the statin drugs have been reported in Canada and worldwide.

The Health Canada advisory pointed out that some patients who are candidates for statin use may have pre-existing medical conditions which might cause them to have a greater risk of developing rhabdomyolysis as well as lesser muscle-related problems. In that regard, this July 2005 statin advisory from Health Canada provides the following specific guidance for patients.

Before taking a statin, patients should tell their doctor or pharmacist if they:

-are pregnant, intend to become pregnant, are breast-feeding or intend to breast-feed;
-have thyroid problems;
-regularly drink three or more alcoholic drinks daily;
-are taking other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate) or niacin;
-are taking other medications, including prescription, non-prescription and natural health products, as drug interactions are possible;
-have a family history of muscular disorders;
-had any past problems with the muscles (pain, tenderness), after using a statin;
-have kidney or liver problems;
-have diabetes;
-have undergone surgery or other tissue injury;
-do excessive physical exercise.

Patients are advised to contact their physician promptly if they experience any of the following while on statin therapy:

-muscle pain they cannot explain;
-muscle tenderness or muscle weakness;
-generalized weakness, especially if they do not feel well (i.e. fever or fatigue);
-brownish or discoloured urine.

Patients should continue to take their medication as prescribed and should contact their physician if they have any concerns.

Previously, Health Canada had requested that the drug companies responsible for the sale of these statin drugs in Canada put on the package insert label a rhabdomyolysis warning as well as a description of the initial symptoms related to a possible incident of rhabdomyolysis.  This July 2005 statin advisory informs the public that the requested safety information updates to the statin drug warning labels is now completed.

(Posted by: Tom Lamb)

Drug-induced Rhabdomyolysis and Acute Renal Failure (ARF) Cases On Increase

Rhabdomyolysis is Result of Skeletal Muscle Injury Caused by Drugs (and Other Things)

The number of drug-induced rhabdomyolysis adverse event reports submitted to the FDA is rising, seemingly due to the introduction to market of more and increasingly potent prescription drugs in recent years.

The actual total number of cases of drug-induced rhabdomyolysis is difficult to ascertain, largely because most adverse drug events go unreported to the FDA MedWatch program, which monitors drug safety issues.

Rhabdomyolysis is also caused by these various conditions:

• muscle trauma (for instance, from vigorous exercise, crush injuries, battering, or seizures),
• inadequate blood perfusion,
• heat stroke,
• electrolyte imbalance,
• hereditary enzyme deficiencies, infections,
• myotoxic drugs, such as cocaine and alcohol. 

Significantly, about 10% to 40% of patients diagnosed with rhabdomyolysis (or rhabdo, for short) go on to develop acute renal failure (ARF).  Some patients may need dialysis, and the condition can be fatal.

(Posted by: Tom Lamb)

Crestor Side Effects: Reports to FDA MedWatch Analyzed by Tufts Doctors

Crestor-Rhabdomyolysis Link: New Study May Support Allegations by Public Citizen Group

Rhabdomyolysis, proteinuria, nephropathy, and kidney or renal failure are serious side effects which apparently occur more often with the use of Crestor (rosuvastatin) than with other leading cholesterol drugs known as statins.  Moreover, when serious side effects did occur, they tended to be within the first three months of Crestor use and not necessarily associated with higher dosages of Crestor. This analysis comes from a new study done by researchers affiliated with Tufts University School of Medicine and the Tufts-New England Medical Center.  The new analysis supports the mounting concern about the relative safety of Crestor at the range of dosage levels commonly prescribed to patients in the U.S. Intererstingly, this analysis seems to challenge a recent U.S. Food and Drug Administration decision related to the Crestor's safety, and certainly runs contrary to recent safety claims by AstraZeneca, the manufacturer of Crestor.

In March 2005, the FDA had contended Crestor's side effect risks were no greater than the other statins available for use in the U.S., and it rejected consumer efforts to have Crestor pulled from the market. Instead, the FDA ordered AstraZeneca to put a stronger warning on the Crestor label, which now states that Crestor could cause serious muscle problems and kidney damage, especially among Asians.

The lead researcher for this new study is Richard Karas, director of the preventive cardiology at Tufts-New England Medical Center in Boston.  The Tufts study was published May 24, 2005 on an expedited basis by the American Heart Association's journal Circulation by making it available online before the print version was available.  An abstract of this new Crestor study can be viewed by use of this link:

http://circ.ahajournals.org/cgi/content/abstract/CIRCULATIONAHA.105.555482v1?&searchid=1116892479272_18705&usestrictdates=yes&journalcode=circulationaha&ct

For this Crestor study, the Tufts researchers analyzed adverse event reports (AERs) regarding alleged Crestor serious side effects which had been sent to the FDA MedWatch program for the first year that Crestor was available for use in the U.S.  The primary analysis examined MedWatch reports concerning Crestor AERs of rhabdomyolysis, proteinuria, nephropaty, and renal or kidney failure.  Secondary analyses by the Tufts researchers examined ohter categories of Crestor AERs, including adverse events with serious outcomes, liver toxicity, and muscle toxicity such as myopathy without rhabdomyolysis.  In turn, this FDA data was compared to those MedWatch reports of serious side effects made by doctors and patients to the FDA during the same time period for three other statins: Lipitor (atorvastatin), Zocor (simvastatin), and Pravachol (pravastatin).  Comparison was also made to adverse events reported to the FDA for the first year of marketing of Baycol (cerivastatin), a statin which was recalled in August 2001 due to an unacceptable high-incidence rate of rhabdomyolysis among patients taking Baycol.

The year after Crestor came on the market in October 2003, more than 5 million prescriptions were filled for the drug.  An estimated 20 million Americans are believed to be taking drugs called statins, which researchers say are still the best drugs for lowering high cholesterol and reducing the risk of heart disease and stroke.

An expert and the study's authors agree there were practical, real-world limitations to the new Tufts study.  On one side, there is the possible underreporting of Crestor side effects. On the other side, some theorized that the removal of Baycol from the market likely heightened public awareness of safety concerns involving statins, resulting in an increased reporting rate.  This situation was summed up by Benjamin Ansell, co-director of the cholesterol treatment program at UCLA medical center in Los Angeles.  He acknowledged that is there a general tendency to underreport prescription drug side effects to the FDA; however, there is also a tendency to overreport when controversial prescription drug, like Crestor, has gotten a lot of media attention.

In the wake of this new Crestor safety report being published, the consumer advocacy group Public Citizen announced it would try, again, to get the drug off the market.  "This will be further reason to take the drug off the market," said Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen.  A March 2005 letter by Public Citizen to the FDA regarding Public Citizen's allegation that Crestor has higher rates of rhabdomyolysis compared to other statins can be viewed here:

http://www.citizen.org/publications/release.cfm?ID=7370

• Read more about the Crestor safety controversy

http://www.drug-injury.com/druginjurycom/2005/05/crestor_safety_.html

http://www.druginjurylaw.com/Crestor-information.html

(Posted by: Tom Lamb)

Crestor Label Changes from March 2005 Not Posted on FDA MedWatch Site Until May 2005

Crestor Package Insert Label Changes Include Rhabdomyolysis Risk

In March 2005 the FDA and AstraZeneca reached agreement about making certain changes to the package insert label for the pharmaceutical company's cholesterol-lowering drug Crestor (rosuvastatin).  Specifically, the following sections were changed:  Warnings; Precautions; and, Adverse Reactions. 

On May 13, 2005, the FDA posted on its MedWatch web site their summary of these Crestor label changes, which reads as follows:

In clinical trials, the incidence of myopathy and rhabdomyolysis increased at doses of rosuvastatin above the recommended dosage range (5 to 40 mg). In postmarketing experience, effects on skeletal muscle, e.g. uncomplicated myalgia, myopathy and, rarely, rhabdomyolysis have been reported in patients treated with HMG-CoA reductase inhibitors including rosuvastatin. As with other HMG-CoA reductase inhibitors, reports of rhabdomyolysis with rosuvastatin are rare, but higher at the highest marketed dose (40 mg). Factors that may predispose patients to myopathy with HMG-CoA reductase inhibitors include advanced age (≥65 years), hypothyroidism, and renal insufficiency.

Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as, renal impairment, advanced age, and inadequately treated hypothyroidism.

The 40 mg dose of rosuvastatin is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of rosuvastatin once daily.

Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).

More details about this safety-related label change can be found in the "FDA Public Health Advisory on Crestor (rosuvastatin)" document which was issued on March 2, 2005.  That document can viewed by use of this link:

http://www.fda.gov/cder/drug/advisory/crestor_3_2005.htm

• Read more about Crestor safety issues

http://www.druginjurylaw.com/Crestor-information.html

(Posted by: Tom Lamb)

Rhabdomyolysis Risk for Statin Users Increased By Drinking Grapefruit Juice

Risk is Most Significant for Patients on Cholesterol-lowering Zocor

There is an increased risk of developing rhabdomyolysis, a potentially life-threatening muscle disorder, for patients taking statins when they drink grapefruit juice.  This problem occurs because grapefruit contains a chemical that inactivates a liver enzyme involved in drug metabolism, and regular consumption of grapefruit juice can lead to excessively high levels of the medicine in the blood.  The risk of developing rhabdomyolysis due to this drug-food interaction of a statin and grapefruit juice is greatest with cholesterol-lowering Zocor, according to the British Medicines and Healthcare Products Regulatory Agency.

More generally, the muscle toxicity condition called rhabdomyolysis is a recognized adverse reaction for patients taking high doses of any statin drug.  Simply put, with rhabdomyolysis a person's muscle fibers break down and are released into the blood circulation system, thereafter potentially damaging the kidneys.

During the past year or so, the risk of rhabdomyolysis due to the use of Crestor -- which is the most potent of all anti-cholesterol drugs -- has been the subject of a relatively high-profile debate between the consumer advocacy group Public Citizen and AstraZeneca, the manufacturer of Crestor.  A March 2005 letter by Public Citizen to the FDA regarding Public Citizen's allegation that Crestor has higher rates of rhabdomyolysis compared to other statins can be viewed here:

http://www.citizen.org/publications/release.cfm?ID=7370

The use of cholesterol-lowering statin medications among persons aged 45 and older more than tripled during recent years.  A statin was prescribed 40.5 physician visits per 100 population in 2001 to 2002, compared to 12.3 physician visits per 100 population in 1995 to 1996.  This trend is expected to continue due to new cholesterol treatment guidelines.

(Posted by: Tom Lamb)