The research team analyzed data from more than two million American, British and Canadian patients who had taken high-potency statins, a class of medications designed to lower cholesterol by reducing levels of low-density lipoprotein (LDL), which is a major contributor to coronary artery disease. Cholesterol medication is one of the biggest sellers in the United States, with combined sales in excess of $14.5 billion in 2008 alone.

The study looked at patients who took the medication for the first time between January 1, 1997 and April 30, 2008. Researchers compared the rates of kidney-related hospitalizations.

Of the two million, 4,691 patients were admitted to the hospital for non-chronic kidney problems. An additional 1,896 patients were hospitalized for chronic kidney injury. Researchers found that patients on Crestor, Lipitor or Zocor were more likely to be hospitalized than those who did not take the drugs.

Serious Zocor side effects supported by other studies

Previous medical research has shown that around 1 in 10,000 statin users have developed a muscle condition known as rhabdomyolysis, a rare condition that releases potentially-fatal myoglobin into the bloodstream.

In 2011, in response to negative publicity surrounding Zocor side effects, the FDA placed dosage restrictions on the drug, limiting patients to two daily doses of 40mg. The restriction was designed to deal with the reported risk of myopathy and rhabdomyolysis.

On February 28, 2012, the FDA issued a safety communication informing physicians and patients of changes to the labeling on all cholesterol drugs. The changes give patients more information regarding the safe use of statins. These include routine monitoring of liver enzymes. However, the FDA “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

On March 1, 2012, The FDA issued another safety communication stating that drugs for HIV patients and hep C patients, could, when combined with Zocor, increase the risk of muscle injury.

Litigation sparked by Zocor side effects

Statins like Zocor, Lipitor and Crestor have all been subject to allegations of a link between reductase inhibitors and rhabdomyolysis. Anyone who has been affected by health complications resulting from statins may qualify for a Zocor lawsuit. A qualified Zocor lawyer can help establish liability, and hold the manufacturers responsible for failing to warn consumers about drug risks. A successful lawsuit can help patients recover compensation for lost wages, medical expenses, pain and suffering, and other losses.

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In the years since its launch, the drug has been linked with serious Zocor side effects like muscle weakness and pain, muscle wasting, and kidney failure. Though there has been no Zocor recall, the FDA has issued warnings along the way to protect the most susceptible populations.

Early FDA warnings concerning Zocor side effects

As early as 2008, the FDA warned physicians and patients about unique Zocor side effects. On August 8 of that year, the agency notified the public about the risk of “a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone.”

Amiodarone is prescribed for patients who have heart rhythm problems, or “arrhythmia.” Since these issues often exist together with high cholesterol levels, many patients were taking both medications. The FDA warned that the risk of muscle injury was dose-related. In other words, the higher the dose of Zocor, the higher the risk of side effects. Reports of rhabdomyolysis were more likely with Zocor doses of 20 mg or more.

FDA issues another warning concerning Zocor dosage

On March 29, 2010, the FDA issued another warning—this time about muscle injury related to Zocor use alone. The agency focused on the highest dose of the drug, 80 mg. Patients taking this dose could have a greater risk of developing muscle injury, including rhabdomyolysis, the FDA stated. They advised healthcare professionals to consider the potential risks before prescribing this dose.

Rhabdomyolysis is a condition in which damaged muscle tissue breaks down quickly, with waste products flooding the bloodstream. As the kidneys struggle to clean the blood of this waste, they can become overloaded, leading to kidney failure. Symptoms may include muscle pain and weakness, painful or bruised areas of the body, digestive issues like nausea and vomiting, general feelings of malaise, fever, and dark-colored urine. Following this warning, many injured patients filed Zocor lawsuits to recover damages.

FDA cautions of risk of stroke associated with Zocor

On May 26, 2011, the FDA issued a statement on the AIM-HIGH trial, which studied the effects of raising HDL “good” cholesterol and lowering LDL “bad” cholesterol in patients with a history of cardiovascular disease. All participants in the trial were given Zocor at 40 mg per day, and then randomly assigned to receive either extended-release niacin or a placebo.

The trial was stopped early because of a lack of observed benefits. In addition, according to the FDA, “A small, unexplained, increase in the rate of ischemic stroke was noted in the simvastatin plus extended-release niacin group compared to the simvastatin group alone.”

FDA limits use of 80 mg dose, but no Zocor recall

On June 8, 2011, the FDA recommended that doctors “sharply curtail” the use of the highest 80 mg dose of Zocor because of risk of Zocor side effects like muscle injury. They stated that only patients who had already been taking this dose for a year or more should continue taking it.

“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” said Eric Colman, M.D., deputy director of FDA’s Division of Metabolism and Endocrinology Products. For patients experiencing inadequate results from the 40 mg dose, the FDA recommended doctors choose a different statin rather than raise the Zocor dose.

The agency required revised drug labels to include the new restrictions. They also noted that older age and female gender increased the risk of muscle injury, and advised doctors of dangerous drug interactions with specific other medications.

FDA warns of potential liver damage

On February 28, 2012, the FDA issued a safety communication notifying physicians and patients of label changes to all cholesterol-lowering drugs, including Zocor.

The changes provide patients with more information for the safe use of statins, including the need for routine monitoring of liver enzymes (to rule out liver damage), and information about reports of increased blood sugar levels associated with statins. No Zocor recall was issued, however, because the “FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

The most recent FDA warning occurred on March 1, 2012. The FDA issued a safety communication stating that drugs for HIV patients and hepatitis C patients, when combined with statins like Zocor, could increase the risk for muscle injury. They concluded that the use of simvastatin with these types of drugs was contraindicated.

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A recent study suggests some statins possess anti-cancer properties. Presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2012, the study found a slight reduction in cancer risk among women taking statins compared to a control group not using the drug. The results showed women with inflammatory breast cancer had longer periods where the disease was stable if they had a history of using statins.

However, there was no suggestion that using statins decreased the risk of developing breast cancer. Lead investigator Pinkal Desai looked at 154,587 postmenopausal women. Statin users and non-users were diagnosed with breast cancer at an equal yearly rate of 0.42%.

Keeping breast cancer at bay

TexasUniversity’s Naoto T. Ueno reviewed the records of 725 women diagnosed with and treated for stage III breast cancer between 1995 and 2011. The research showed women who did not take statins had an average of 1.76 years of disease-free survival (DFS). Women who took lipophilic statins – including Zocor – averaged 2.47 years of DFS. However, the report noted that statin use “did not extend overall survival in a statistically measurable way”.

Serious side effects of Zocor

However, there are a number of adverse side effects associated with taking Zocor. Among the more common are headaches, joint pain, constipation, indigestion, mild rash, insomnia and cold symptoms.

Some of the more serious side effects of Zocor may indicate that patients have had an allergic reaction, These include:

• Muscle pain, tenderness or weakness
• Fever
• Painful urination
• Discolored urination
• Swelling and weight gain
• Nausea, jaundice

Rhabdomyolysis: a potentially fatal condition

Some of the above complications may suggest rhabdomyolysis, a rare, potentially fatal condition. It occurs when tissues begin to break down, releasing muscle proteins into the bloodstream. In 2011, the FDA issued a warning about the link between Zocor and rhabdomyolysis, specifically referring to high dosage prescriptions of 80 mg and more.

Side effects spark many to file a Zocor lawsuit

Statins similar to Zocor have already been subject to complaints alleging a link between reductase inhibitors and the onset of rhabdomyolysis. Anyone who has been affected by complications arising from simvastatin may qualify for a Zocor lawsuit.

A  Zocor muscle injury lawyer can help establish liability in a legal claim and hold the manufacturers responsible for failure to warn and selling a potentially defective drug. Successful litigation can help a patient recover compensation for lost wages, medical expenses, pain and suffering, and other losses.

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Zocor lawsuits allege adverse health events

Simvastatin functions by reducing the amount of low-density lipoprotein (LDL), or bad cholesterol, in the blood. Vytorin and Zetia are two of Merck’s top-selling medications, with annual sales exceeding $4 billion last year. The drug manufacturer is hoping that positive results from the IMROVE-IT study will spark improved sales, after doubts over the medication’s efficacy and safety have been questioned.

The FDA currently cautions both health care providers and consumers to report side effects of Zocor, Vytorin or Zetia to the agency’s MedWatch Adverse Event Reporting program.

FDA warns of Zocor side effects

In June 2011, the FDA issued a warning about the dangerous side effects of Zocor, alerting consumers to the increased risk of muscle injuries among patients taking doses of 80mg. The agency stated that this maximum dosage was not recommended for new patients. The safety communication also linked Zocor with rhabdomyolysis – a severe type of myopathy where muscle fibers break down, sometimes leading to kidney failure and even death. Incidences of this condition increase greatly when Zocor is taken with antifungal drugs (such as itraconazole and ketoconazole), as well as HIV protease inhibitors, the antidepressant nefazodone, and cyclosporine.

Zocor lawyer can help patients seek legal recourse

After the FDA warning was issued, patients around the country learned of the risk of hazardous side effects from simvastatin, and some have already contacted a Zocor lawyer to discuss their legal options. To date, Zocor lawsuits have not been centralized in multidistrict litigation (MDL) or a class action suit, although this is a possibility for the near future.

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What is rhabdomyolysis?

With the use of Zocor, a possible side effect is that a person’s tissues begin to break down and release muscle proteins into the bloodstream. As these proteins build up, they can clog the kidney, causing kidney failure and, eventually, rhabdomyolysis. Rhabdomyolysis is a rare condition that can be fatal if left untreated. Fortunately, evidence suggests that discontinuation of Zocor may reverse muscular breakdown and also rhabdomyolysis. Nevertheless, this condition is very dangerous.

Symptoms of Zocor muscle injury

Muscle breakdown, which is a precursor to rhabdomyolysis, can begin with dark colored urine, muscle weakness, and muscle pain. As muscle breakdown progresses toward rhabdomyolysis, patients may experience nausea, tenderness, fever, and other symptoms. In 2001, after more than 50 deaths linking Baycol (a statin drug similar to Zocor) and rhabdomyolysis were reported to the FDA, the FDA recalled the drug. Similar allegations have been reported to the FDA regarding Zocor and other statins as well, including Crestor and Lipitor.

FDA issues warning linking Zocor to rhabdomyolysis

In 2011, the FDA issued a consumer warning regarding rhabdomyolysis and its link to Zocor. The FDA warning related specifically to high dosages of Zocor (80 mg) and its generic equivalent, simvastatin. Additionally, the FDA warned consumers of other side effects, including liver damage, muscle injuries, and diabetes.

Zocor lawsuit compensation

Consumers who have been injured by either Zocor or simvastatin are advised to contact a Zocor lawyer to see if they eligible to file litigation to hold the drug manufacturer liable for monetary compensation. A Zocor lawsuit can help recover damages for pain and suffering, medical expenses, and even wrongful death.

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Zocor lawsuit

Rosenberg’s Zocor lawyer names as the defendants Merck & Co. as well as Lupin Pharmaceuticals, Teva Pharmaceuticals, Dr. Reddy’s Laboratories and Ranbaxy Laboratories, all companies that were involved in the manufacturing or distribution of the drug.

In 2010, the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) study linked Zocor, also known by its generic name Simvastian, to Zocor muscle injury, including a potentially life-threatening condition known as rhabdomyolysis. The study showed that the side effects were more likely to occur at doses of 80 milligrams, and the FDA used this information to require a warning label change for Zocor.

Defendant failed to warn of adverse side effects

The plaintiff in this case claims that he took Zocor as prescribed by his physician from July 2007 through February 2010.  He further alleges that his muscle damage and weakness are direct result of ingesting the medication. The side effects, he claims, have caused him to suffer physical injuries, pain and suffering, loss of enjoyment of life, lost wages and a host of other damages. In the Zocor lawsuit, Rosenberg asserts that Merck & Co. had a responsibility to warn patients of the possibility of injury associated with the drug, but that the company failed to adequately do so.

Zocor muscle injury a common complaint

Rosenberg, like numerous other patients who took the statin drug and sustained muscle injuries, is holding drug manufacturer Merck & Co. liable. Symptoms of Zocor muscle injury generally include muscle pain and weakness, unexplained fatigue, joint pain, and inflammation. Patients who have suffered muscle injury or other serious side effects after taking the medication are encouraged to contact a Zocor lawyer.

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On October 29, the agency announced that it would limit doses of the cholesterol-regulating drug to 20 milligrams. High doses of the drug have been linked to a variety of muscle conditions, including myopathy and rhabdomyolysis. Rhabdomyolysis occurs when muscle fibers break down, a deterioration that releases the protein myoglobin into the bloodstream, causing injury to the kidneys. Most patients who experience the condition are over 65 years of age, or suffer from conditions such as renal impairment or hypothyroidism.

Dosing change to protect against Zocor muscle injury

This move in the U.K. follows the U.S. Food and Drug Administration’s lead, which limited the drug to 10 milligram doses until late last year, when it relaxed the limitation to 20 milligram doses. The FDA changed the dosing requirements because of high numbers of complaints of Zocor muscle injury. The cholesterol drug is one of Merck & Co.’s best selling drugs, bringing in $4.3 billion dollars in 2005, which was the year its patents expired.

Many people seek help from Zocor lawyer

Many people who have ingested the drugs at high doses and later experienced muscle injury have sought relief through lawsuits against Merck. There is a Zocor class action lawsuit currently pending; most of the plaintiffs in this case claim to have taken the drug in accordance with their doctor’s prescription, and allege that they could not have known the dangers associated with the drug because of negligence on Merck’s part. They have sought the assistance of a Zocor lawyer to assist them through the complex and often lengthy litigation.

Zocor lawsuit numbers increase after link between dosage and muscle problems

The FDA first approved the drug for distribution in the U.S. in 1998, but by 2010 the government organization issued a public safety communication noting the link between Zocor and a heightened risk of muscle injury. A study at the time showed that 11% of patients who took 80-milligram doses suffered muscle injuries, spawning a surge in the number of Zocor lawsuit claims against Merck.

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11% of patients may develop Zocor rhabdomyolysis

Zocor, or simvastatin, is a prescription cholesterol drug in the HMG-CoA reductase inhibitor drug class, also known as statins. Statins, including Zocor, reduce “bad cholesterol” (low-density lipoprotein, or LDL) while increasing “good cholesterol” (high-density lipoprotein, or HDL). While the FDA first approved Zocor in 1998, it wasn’t until 2010 that the agency acknowledged the link to muscle injury. After one study showed that 11% of patients on simvastatin (80 mg) developed Zocor rhabdomyolysis, the FDA in June 2011 issued an official warning regarding muscle injury. Furthermore, the FDA recommended that no new patients be prescribed the maximum (80 mg) dose.

Zocor muscle injury can be life threatening

Muscle injury is most common during the first 12 months of use (80 mg dose) or when taken with other drugs that increase simvastatin levels. Patients who are genetically predisposed to simvastatin-related muscle injury are also at risk. The most common types of muscle injury include:

• Myopathy: A muscle disease that can cause weakness, pain, tenderness, and wasting. The most common form is called myalgia, and entails mild to sever muscle pain that worsens with activity. This condition may signal the beginning of muscle breakdown.
• Rhabdomyolysis: This is a rare and very severe form of muscle disease. A patient with rhabdomyolysis will experience rapid muscle breakdown. The substances released from deteriorating muscles can damage the kidneys, causing kidney failure, compartment syndrome, and/or disseminated intravascular coagulation (DIC).
• Autoimmune necrotizing myopathy: This form of muscle injury is very serious, as it is an autoimmune disease and will not improve even after a patient discontinues use of Zocor.

Injured patients file Zocor lawsuits

Around the country, people injured by Zocor, and especially those who have experienced related muscle injury, have begun filing Zocor lawsuits. As the FDA warning was issued only a year ago, lawsuits currently proceed on an individual basis, but it is possible that they will be consolidated into multidistrict litigation (MDL) or a class action in the future. Currently, the best course of action for patients suffering muscle injury or other side effects is to contact a Zocor lawyer.

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Working with her Zocor lawyer, she filed suit in the U.S. District Court, Western District of Louisiana, seeking relief based on a variety of claims including several product liability and unfair trade practices laws, negligent misrepresentation and negligent infliction of emotional distress.

Zocor lawyer encounters procedural complications

The plaintiff and her Zocor lawyer have encountered a number of complications throughout the litigation process, which is indicative of what patients must undergo in order to receive compensation for their often severe and debilitating injuries. After first working to remedy a situation in which they incorrectly sued Ranbaxy Pharmaceuticals as Ranbaxy Laboratories, Inc., the judge overseeing the case has granted a motion to strike some information from the complaint.

A judge will typically grant a Federal Rules of Civil Procedure 12(F) motion to strike when a party has pleaded an insufficient defense or any redundant, immaterial, impertinent or scandalous matter.

The plaintiff in this case asserts that she took Zocor or its generic equivalent, simvastin for cholesterol regulation from approximately August 2001 to January 2012. During that time, she suffered physical injuries, including Zocor muscle injury and kidney damage. She claims that the drugs have caused her serious consequences, including pain and suffering, loss of enjoyment of life, lost wages and earning capacity, medical expenses and emotional distress.

FDA label change after study shows Zocor muscle injury risk

Though the FDA first approved the drug for distribution in the U.S. in 1998, it was in just 2010 that the FDA issued a press release concerning the link between Zocor and muscle injury, including rhabdomyolysis. A study showed that 11% of patients who took the drug at an 80-milligram dosage developed rhabdomyolysis, prompting the FDA to issue a label change to the drug.

Zocor lawsuits may require expert plaintiff attorneys

Such procedural complications are why it is essential to work with a Zocor attorney that has experience working in complex claims, particularly when it comes to class action claims such as the one at hand. In this Zocor case, which was originally filed on June 1, 2012, the plaintiff will likely continue to endure more procedural hiccups as the case goes on.

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Pneumonia Prevention and Zocor Side Effects

Early research conducted by Israeli scientists looked at 18,000 patients who were given rosuvastatin, a drug similar to Zocor, were 17 percent less likely to be diagnosed with pneumonia over a number of years. The study appeared to support previous research that showed individuals on statins who were diagnosed with serious infections like pneumonia were less likely to die from the condition.

However, another study conducted at the University of Michigan and reported in the American Journal of Medicine suggested that those initial findings were not as strong as first thought. When scientists factored in additional variables from the observational study, such as vaccinations and pneumonia severity, the correlation between statin use and lower pneumonia risk was much smaller.

Researchers concluded the evidence for prescribing statins as a means of preventing pneumonia was inadequate. In addition, risk of other side effects, such as Zocor muscle injury, should be taken into account when considering statin use as well.

A third study, conducted by researchers at the University of Texas, found that statin use may actually increase the incidence of pneumonia in some populations. After examining the medical records of 68,000 people, researchers determined that statin use could be a significant risk factor in a pneumonia diagnosis. Even when other factors, such as age, gender and condition frequency, were taken into account, the risk remained higher in statin users.

Zocor Muscle Injury

Conflicting research like this in a period of a few months suggests additional studies need to be done before a definite link between statin use and pneumonia. Clinical studies that include randomized trials are necessary to determine a true cause and effect between statin use and a pneumonia diagnosis. In the meantime, those considering statins need to know about the risk of side effects, including muscle injury, which can become serious and even life threatening in some patients.

Zocor muscle injury, also known as myopathy, is a serious concern for Zocor users. Symptoms of muscle injury include fatigue, joint pain and muscle weakness. If left unchecked, Zocor myopathy can develop into a more serious condition known as rhabdomyolysis, which can result in kidney failure and even death.

More than one injured user of the drug has contacted a Zocor lawyer to determine if they are eligible to seek compensation through litigation..

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Statins some of the world’s bestselling drugs

Statins, a poplar drug class prescribed to lower blood cholesterol levels, are some of the world’s bestselling drugs. In fact, Lipitor (atorvastatin) is the world’s bestselling drug in history, at $130 billion in cumulative sales. And in 2012, simvastatin, the generic version of Zocor, was the #2 prescription drug in the United States. Additional statin drugs include Advicor (lovastatin/niacin extended-release), Altoprev (lovastatin extended-release), Crestor (rosuvastatin), Lescol (fluvastatin), Livalo (pitavastatin), Mevacor (lovastatin), Pravachol (pravastatin), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

Zocor lawyer: Diabetic statin-users exhibit highest cataract risk

A study published in the August 2012 issue of Optometry and Vision Science revealed that the use of statins may increase the risk of age-related cataracts. The study examined 6,400 University of Waterloo (Canada) patients throughout 2007 and 2008, and considered both statin medications and diabetes type 2 as risk factors for the development of cataracts. Researchers concluded that patients with diabetes exhibited an 82% increased risk, while statin users showed a 57% increase. Notably, diabetic patients on statins demonstrated the highest and fastest increase in risk of cataract development.

Side effects lead to Zocor lawsuit complaints

Diabetes and cataracts are not the only side effects associated with Zocor. In June 2011 the FDA issued a warning against muscle injury, including rhabdomyolysis, in patients taking the maximum dosage of Zocor (80mg). At that time, the FDA also recommended that doctors not prescribe the maximum dose to new patients. Zocor has also been linked to gastrointestinal conditions, including nausea, diarrhea, constipation, dyspepsia, and related pains. Psychological side effects include paranoia, depression, nightmares, and suicidal thoughts, while other risks include cranial nerve dysfunction, vertigo, hepatic failure, light hypersensitivity, and memory loss.

Many patients affected by simvastatin side effects have chosen to contact a Zocor lawyer to explore their legal options. For some, an individual Zocor lawsuit is appropriate, while others may be better served by joining the Zocor class action lawsuit in the U.S. District Court for the Eastern District of Louisiana.

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For patients taking Zocor or other statin drugs, grapefruit juice may cause a greater risk of side effects, including Zocor muscle injury. Injured patients should seek immediate medical attention. If you have suffered severe or life-altering side effects, you may be eligible to join the ranks of Zocor lawsuits seeking compensation for injuries and other damages.

Grapefruit juice increases risk of Zocor muscle injury

For many prescription medications, and a handful of over-the-counter drugs, an enzyme in the small intestine known as CYP3A4 aids in drug metabolization. However, certain substances contained in grapefruit juice may actually block CYP3A4, therefore increasing absorption of medication ingredients. When this occurs, instead of metabolizing and ridding the body of excess medication, the body absorbs more of the drug than it should. This causes a greater risk of side effects.

In July 2012, Public Citizen updated its list of drugs that have poor interaction with grapefruit juice. Zocor was included on the list, as were other popular medications, including Benadryl, Celexa, Coumadin, Haldol, Lipitor, Multaq, Paxil, Prilosec, Propulsid, Prozac, Seroquel, Serzone, Tegretol, Valium, Viagra, Viracept, Zoloft, Zocor, and others.

Patients should limit or eliminate juice from their diet

Statin drugs, including Zocor (simvastatin), are one of the major drug classes that should not mix with grapefruit juice. Grapefruit juice increases absorption of drugs like Zocor, which is designed to lower cholesterol. And the interactions are not limited to immediate cause and effect: experts recommend that patients taking Zocor limit or eliminate their consumption of grapefruit juice during the duration of their treatment. Markedly, even drinking the juice several hours after taking the medication can increase a patient’s risk of developing Zocor side effects.

Patients file Zocor lawsuits after experiencing serious side effects

Zocor side effects can be severe and life threatening. One of the most dangerous risks is that of Zocor muscle injury, which includes conditions known as myopathy, rhabdomyolysis and autoimmune necrotizing myopathy. Notably, autoimmune necrotizing myopathy is a permanent effect of Zocor muscle injury and will not dissipate even after discontinuing use of the cholesterol medication. Many affected patients have chosen to file Zocor lawsuits in order to seek compensation for medical costs, pain and suffering, and other damages.

It is unclear whether these results extend to Zocor, Lipitor and other statins. In addition to diabetes, the list of Zocor side effects encompasses liver damage, rhabdomyolysis, and Zocor muscle injury. An experienced Zocor lawyer is best qualified to evaluate each complaint on a case-by-case basis.

Statin side effects assessed in JUPITER, a pharmaceutical-funded study

The published analysis was designed to, “address the balance of vascular benefits and diabetes hazard of statin use.” To do so, researchers analyzed information from the JUPITER study, a randomized, double-blind trial of 17,603 men and women. Study participants had no history of diabetes or cardiovascular disease, and were assigned either a placebo or rosuvastatin 20mg (Crestor) for up to five years. The primary endpoints for each participant included stroke, myocardial infarction, or cardiovascular death, while secondary endpoints extended to venous thromboembolism, incident physician-reported diabetes, and all-cause mortality.

Statins cause 28% increase in diabetes for high-risk patients

Diabetes is a dangerous and serious condition. It entails permanent lifestyle changes and can lead to painful injuries and death. For many, the benefits of a medication may never outweigh the risk of developing diabetes, but statistically speaking, the numbers favor statin drugs. For example, the JUPITER trial found that for high-risk individuals, statins were associated with a 39% reduction in primary endpoints and a 17% reduction in total mortality; by comparison, they caused a 28% increase in diabetes. For trial participants without any risk factors for diabetes, statins were found to reduce primary endpoints by 52%, death by 22%, and to have no increase in diabetes risk.

Statins are associated with other side effects as well as increased risk of diabetes

In addition to an elevated risk of diabetes, statin drugs are also associated with a range of other side effects. The FDA defines affected statin drugs as: Altoprev (lovastatin extended-release). Crestor (rosuvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Livalo (pitavastatin), Mevacor (lovastatin), Pravachol (pravastatin), and Zocor (simvastatin), as well as combination medications Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

For patients on simvastatin, one of the most serious dangers is Zocor muscle injury, including rhabdomyolysis. Additionally, the drug is associated with memory loss and liver injury. Patients suffering from any side effects should contact a Zocor lawyer for an evaluation of his or her claims.

This warning was one of many issued by the FDA over the years. Critics say the agency was slow to respond to the risk of injury with Zocor, however. Many patients who suffered from serious Zocor side effects like muscle injury, rhabdomyolysis, kidney failure, and heart disease, have hired a Zoloft lawyer and filed a lawsuit in an attempt to hold Merck liable for failing to warn of the risks.

FDA warns of Zocor muscle injury in 2008

In 2005, Zocor became Merck’s highest-grossing product reaching sales of $4.3 billion. In June 2006, the company’s patent expired and generic versions became available.

As early as 2008, however, the FDA began issuing warnings and public safety communications concerning Zocor. On August 8, 2008, they issued an alert notifying the public of a “rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone.” Amiodarone is a medication used to control a heart rhythm problem.

The agency added that the Zocor warning label had been adjusted to reflect this risk in 2002, but that reports of patients treated with both medications and suffering side effects were still coming in.

Zocor lawyer likely to refer to FDA 2010 warning

A lawyer representing a plaintiff in a Zocor lawsuit is likely to refer to the March 19, 2010 news release by the FDA. The agency furthered their 2008 warning by notifying the public and healthcare practitioners of the potential for Zocor to increase risk of muscle injury when taken at the 80 mg dose—even when taken alone.

“Rhabdomyolysis is the most serious form of myopathy,” the agency stated, “and can lead to severe kidney damage, kidney failure, and sometimes death.”

The agency followed up on June 8, 2011, with a warning advising physicians to “sharply curtail” their use of the 80 mg dose, and continue it only in patients who had been taking it for 12 months or longer with no ill effects.

Patients filing a Zocor lawsuit

On March 1, 2012, the FDA issued another drug safety communication, this time warning of concerning interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) and statins like Zocor. Taken together, the drugs may increase the risk for Zocor muscle injury, the warning noted.

Patients who have suffered severe muscle injury, rhabdomyolysis, or kidney failure may be eligible to file a lawsuit. A plaintiff’s Zocor lawyer is likely to claim that manufacturer Merck failed to warn about the risks in a timely manner, particularly those related to the highest dose of the medication (80 mg).

Patients who have suffered from this side effect have consulted a Zocor lawyer to determine if they are eligible to file a lawsuit.

Zocor muscle injury

Rhabdomyolysis is a condition in which a patient’s muscles are gradually broken down. The causes may vary, but typically involve some type of trauma or injury. A prolonged coma, genetic muscle diseases, some viruses and bacteria, over-intense exercising, and drug and alcohol intoxication can also lead to the condition.

Zocor rhabdomyolysis differs from standard muscle injury, however, in that it involves the release of proteins into the bloodstream. As the injury or other trauma breaks down the muscle tissues, they may release a protein called “myoglobin” and an enzyme called “creatine kinase” into the blood. The level of these components can be measured by a blood test, which can alert doctors to the presence of rhabdomyolysis, which is also called “muscle wasting.”

How can I tell if I have rhabdomyolysis?

Patients with rhabdomyolysis don’t always experience symptoms. Often, however, muscle aches and pain, stiffness, muscle weakness, muscle swelling, and brown or dark-colored urine signal the presence of rhabdomyolysis. These symptoms should be reported to a doctor right away.

Left untreated, Zocor rhabdomyolysis can result in kidney problems and eventual kidney failure. This is because the kidneys have to work harder to filter out the proteins and enzymes being released into the bloodstream by the injured muscles, and can become overwhelmed.

How is Zocor rhabdomyolysis treated?

Once a doctor has confirmed a diagnosis of rhabdomyolysis, the first step is to eliminate the cause of the condition. The first step for patients taking Zocor will likely be to discontinue the medication. Doctors may also get more fluids into the body through mouth or intravenously (IV). If caught early, this step will often completely reverse the condition.

In more severe cases, the patient may need to be hospitalized to monitor and manage kidney dysfunction. Long-term kidney damage may need to be treated with dialysis.

Injured patients eligible for Zocor lawsuit

The FDA first warned about Zocor myopathy, or muscle injury, in 2009. They issued another warning in 2010, and then the dosage alert in 2011. That year, the agency reported they had received over 500 reports of rhabdomyolysis caused by cholesterol-lowering drugs, with Zocor causing the highest number of cases (123). Still, experts believe the condition is largely underreported.

Patients injured by Zocor rhabdomyolysis have often secured the advice of a Zocor lawyer, to hold manufacturer Merck & Co liable for failing to warn of the risks.

However, despite its widespread use, Zocor is not free of side effects, according to the FDA and several medical studies.  Due to significant numbers of complications associated with the use of the drug, as well as reports of adverse interactions with other medications, the FDA has issued several warnings to notify users of associated risks.

Zocor Muscle Injury Side Effects

Starting in 2002, the FDA began to issue warnings pertaining to Zocor, noting that some users had experienced liver damage and increased rates of myopathy, a type of Zocor muscle injury.  According to one study, nearly 1% of all patients who received 80 mg doses of the drug experienced some kind of muscle damage in conjunction with using the medication.

Additional Zocor side effects include rhabdomyolsis, cardiomyopathy and liver disease.  In the most extreme cases, patients develop rhabdomyolysis when  muscle cells break down and cause damage to the kidneys.  Zocor rhabdomyolsis is a treatable condition, but if left untreated can cause kidney failure.  People who experience Zocor cardiomyopathy may be at risk for arrythmia or sudden cardiac death.

Zocor FDA Warnings and Additional Studies

In 2009, the FDA issued a warning about simvastatin, the generic name for Zocor, and its link to myopathy.  The agency issued another warning in March 2010 as part of an ongoing investigation of Zocor and other statin medications.  In June 2011, the FDA issued yet another warning, noting that those most susceptible to the myopathy as a direct result of Zocor were those who were taking 80 milligram doses of the drug and had been taking such doses for less than one year.

When results of the SEARCH study (Study of Effectiveness of Additional Reductions in Cholesterol and Homocysteine) were released, the FDA ordered doctors to stop prescribing the 80 mg dose and required the drugmaker to update its warning label.

The most recent safety communication released by the FDA with regard to Zocor concerned still new side effects. On February 28, 2012, the FDA stated that the label would once again be updated to reflect risk of memory loss or related cognitive effects and type 2 diabetes as a result of increased blood sugar levels.

Filing a Zocor Lawsuit

Patients who have suffered Zocor muscle injury or any injury resulting from treatment with simvastatin may be eligible to receive compensation for their ordeal.  Zocor lawyers are offering complimentary consultations and can answer any question with regard to pending litigation.

Zocor side effects: muscle injury

Although this Zocor lawsuit cites kidney failure as the reason for filing the complaint, this type of side effect typically stems from Zocor muscle injury, known as myopathy. When the muscle injury progresses, muscle fibers actually break down in the body and release a substance known as myoglobin. This condition is known as rhabdomyolysis. When fiber particles travel to the kidneys, the result can be kidney damage and renal failure, as in the case of this plaintiff.

In 2011, the FDA issued a warning regarding Zocor, stating that higher 80 mg doses significantly increased the risk for muscle injury, and recommended that physicians stop prescribing the higher amounts to new patients. However, more than two million people in the U.S. had already been taking the higher dosage, leaving many of them vulnerable to the related Zocor side effects.

Zocor lawsuit claims plaintiff took drug for 10 years

The plaintiff claims she took Zocor for 10 years, until August, 2010. At that time, Woolens suffered from kidney failure, a condition she directly attributes to her Zocor use. The plaintiff’s Zocor lawyer allege that as a result of her diagnosis, the plaintiff will continue to suffer from pain, lost wages and earning capacity, embarrassment, and emotional distress. The plaintiff also continues to cope with ongoing medical bills and loss of enjoyment of life.

Woolens claims she was unaware of the risks of Zocor side effects when she began taking the drug to treat high cholesterol levels. The plaintiff accuses Zocor manufacturer Merck of “concealing” serious risks associated with their product, and continuing to market the drug despite knowledge that its use could lead to serious problems like myopathy and rhabdomyolysis.

In addition to listing Merck as a defendant, Woolens names other companies involved with the manufacturing and distribution of the drug. These companies include Lupin Pharmaceuticals, Teva Pharmaceuticals, Dr. Reddy’s Laboratories, and Ranbaxy Laboratories.

In June of 2011, the Food and Drug Administration (FDA) recommended restrictions on high (80mg) doses of the drug. This move was prompted by concerns over adverse Zocor side effects. In particular, the FDA sought to reduce the risk of severe muscle damage (myopathy) and a life-threatening consequence known as Zocor rhabdomyolysis.

Some patients who have experienced these dangerous side effects have filed Zocor lawsuits seeking compensation for their injuries.

Zocor rhabdomyolysis and renal failure

Statins have long been known to cause muscle pain and weakness. Some statins, however, appear to damage skeletal muscle cells to a greater degree. In severe cases of myopathy, damaged muscle cells can release a protein known as myoglobin into the bloodstream. Low levels of myoblobin are filtered and removed from the body by the kidneys. At high concentrations, however, myoglobin can overwhelm the kidneys’ capacity and cause kidney failure (also known as renal failure). This most severe and life-threatening form of myopathy is known as rhabdomyolysis.

In 2011, the FDA received 516 reports of rhabdomyolysis caused by statin drugs, with the highest number of cases (123) caused by Zocor. The second-most reported statin, Crestor, had only 73 cases.

Zocor side effects may be underreported

While public awareness of side effects like Zocor rhabdomyolysis have grown, both through media reports and high-profile Zocor lawsuits, many patient advocates are concerned that cases of myopathy are significantly underreported.

A recent study conducted at the University of California at San Diego found that only 29% of doctors responded with concern when patients taking statins reported muscle pain or weakness. Nearly half (49%) of doctors in the study rejected any link between statins and muscle pain, and 24% did not respond either way. This study, together with the growing number of Zocor lawsuits and recent FDA warning, may cause some in the medical community to be more vigilant about statins’ effect on muscle health.

The majority of Zocor lawsuits have involved claims related to muscle injury, including rhabdomyolysis, a condition of muscle wasting, and kidney failure, which can result when rhabdomyolysis goes untreated. A recent study published in the Journal of the American Medical Association has suggested that such side effects have been underreported, and the risk is greater than previously believed.

Now, a new study indicates that statins like Zocor may rob patients of energy, creating unusual muscle fatigue, particularly after exercise.

Varying reports of Zocor muscle injury

According to a study published in the Cleveland Clinic Journal of Medicine (June 2011), “There is little consensus on the definition of statin-induced myopathy [muscle weakness and soreness], and it is underdiagnosed.” According to the researchers, 25 percent of adults who start taking statins like Zocor stop taking them after 6 months, and up to 60 percent stop by two years.

“Patient and physician fears about myopathy remain a key issue for stopping,” the researchers write.

Studies show Zocor side effects may occur more often

All statins are not created the same, and the risk of Zocor muscle injury seems higher than the risk of similar side effects with other statins. A 2005 study, for example, called the PRIMO study, found that 18.2 percent of patients taking Zocor at the 40 – 80 mg dose experienced muscle injury, while only 5.1 percent of those taking Lescol (fluvastatin) did.

The FDA has recommended physicians not prescribe the 80 mg dose to new patients.

New research indicates risk of muscle fatigue

A study published online on June 11, 2012 (Archives of Internal Medicine) shows that taking statins like Zocor can increase their risk of suffering muscle fatigue during and after exercise. Researchers in France gave Lipitor (another statin) to rats for two weeks, while a control group received no medication. Then, some of the rats from both groups ran on treadmills until they were exhausted.

The rats on statins couldn’t run as far, and became exhausted much earlier than those not given statins. The medicated rats also had less stored glycogen (energy) in their muscles, and their cells showed signs of energy-producing dysfunction. In sum, the statins made running harder and more damaging.

As scientists continue to puzzle out the statin-related muscle injury problem, patients experiencing severe Zocor muscle injury and other Zocor side effects continue to file Zocor lawsuits, blaming manufacturer Merck for failing to warn of the risks.

Zocor side effects may include fatigue

Though anecdotal evidence has long suggested that statin users experience lower energy levels, new research provides the first scientific evidence to support those claims.

Dr. Golomb’s research team studied data from a previous study into 1,000 patients, both men and women. Study participants had been assigned to take Zocor (simvastatin), Pravachol (pravastatin), or a placebo. The patients recorded their energy levels at the start of research, and again after six months of statin or placebo use. The study’s findings suggest that approximately 15% of patients experienced reduced energy levels during exercise and in general. Women were the most affected, and 40% of the study’s female participants reported fatigue and low energy.

Zocor rhabdomyolysis a potentially fatal side effect

Fatigue is just the latest risk for possible addition to the list of side effects of Zocor. In June 2011, the Food and Drug Administration (FDA) informed the medical community and general public of the life-threatening risk of Zocor muscle injury. For those patients taking the maximum dose of Zocor (80 mg), or for those taking the statin for 12 or more months, the risk of myopathy (muscle injury) increases.

Myopathy has been linked to joint pain, muscle weakness, general fatigue, and inflammation. In its most severe form, myopathy can develop into Zocor rhabdomyolysis, which occurs when a patient’s muscles begin to break down, releasing myoglobin into the bloodstream. Myoglobin is damaging to the kidney, thus rhabdomyolysis can lead to kidney damage, kidney failure, and eventually, death.

Zocor lawsuits address detrimental effects on patient health

Zocor lawsuits address the question of side effects linked with Zocor – kidney failure, diabetes, and muscle injury among them – and if Dr. Golomb’s study conclusions are verified, fatigue may be added to the list of complaints.

Though fatigue in itself is not a fatal condition, a sedentary lifestyle can lead to a slew of life-threatening health risks. Dr. Golomb commented, “Lower energy is linked to less interest in activity… and fatigue with exertion is linked to less actual activity.”

Dr. Kausik Ray, a heart disease prevention researcher at St. George’s University of London and who did not participate in the study, emphasized that the “risks and benefits in absolute terms should be discussed on a case by case basis.”