Zocor is a prescription drug that treats high cholesterol. It falls into a category of drugs known as statins. Zocor is used to lower “bad,” or LDL cholesterol levels in a patient’s body. Furthermore, it is supposed to simultaneously increase “good,” or HDL cholesterol levels.
Zocor is prescribed to people who currently have diabetes or coronary heart disease, as well as those who are at risk of developing these health problems. Zocor is designed to help lower the risk of heart attack, stroke, and other heart related complications that can result from high cholesterol.
Zocor is manufactured by Merck. Zocor was approved by the FDA in 1991, and it was first made available to patients in the US in 1992. By 1995, the drug had been prescribed to over 1 million Americans and 2.1 million patients in the rest of the world.
How Statins Work
Statins are drugs which lower cholesterol by blocking its production. Since first being approved by the F.D.A. in 1987, statins have become a central component in fighting heart disease risk. They are used in cases when exercise and proper diet alone do not sufficiently lower a person’s cholesterol.
As a statin, Zocor decreases cholesterol by inhibiting cholesterol production before it begins. The liver produces 70 percent of all cholesterol in the body. It does this by converting mevalonic acid into cholesterol. Zocor blocks production of the enzyme which creates mevalonic acid. Less mevalonic acid is produced and as a result the liver creates less cholesterol.
Common Zocor Side Effects
Patients and doctors are warned not to use high dosages of Zocor. The U.S. Food and Drug Administration (FDA) defines a high dosage of Zocor as 80 milligrams. Patients who have taken Zocor at 80 milligrams per day, for at least one year, without any Zocor side effects are allowed to continue to do so. However, their risk for Zocor side effects is substantially larger.
Typical side effects related to taking Zocor include:
- Abdominal pain
- Memory loss
- Joint pain
- Muscle cramping
Severe Zocor Side Effects
Use of Zocor can lead to a variety of serious health risks. While rare, serious allergic reactions can occur when taking Zocor. Patients are urged to seek medical attention if they exhibit signs of rash, dizziness, itching, swelling, difficulty with swallowing, or troubled breathing after taking Zocor.
Other severe Zocor side effects involve health conditions such as:
- Cholestatic hepatitis, or cholangiolitic hepatitis, which occurs when the liver’s bile secretion glands are blocked
- Hepatic cirrhosis, or permanent damage, cell death, and scar tissue formations within the liver
- Myositis, or inflammation of skeletal muscles
- Myopathy, when muscle fibers are not functioning properly
- Rhabdomyolysis, or the disintegration of muscle fibers into the bloodstream that clogs the kidneys
- Kidney failure
FDA Zocor Regulations
Zocor has undergone numerous safety updates by the U.S. Food and Drug Administration (FDA). In June of 2011, the FDA first changed their regulations regarding high-dosage Zocor patients taking doses of 80 milligrams. The FDA warned that the high dosage of Zocor was linked to an increased risk of muscle injury.
In March of 2012, the FDA changed safety regulations again. The FDA warned of elevated blood sugar levels as a result of taking statins. The heightened blood sugar levels caused by Zocor and other statins increased the risk of type 2 diabetes. The FDA also noted reports of memory loss, confusion, and liver injury as a result of statin prescription use.
Combining Zocor with Other Prescriptions
Zocor side effects are most severe in patients taking combined medications. Combining Zocor with other prescriptions increases a patient’s risk of myopathy and rhabdomyolysis. Both myopathy and rhabdomyolysis involve the weakening of muscle fibers. Myopathy is characterized by pain and unexplained muscle weakness. Rhabdomyolysis occurs when the patient’s muscle fibers break down into the blood stream, clogging the kidneys. If rhabdomyolysis is left untreated, it can lead to kidney failure and death.
Zocor in Pregnant and Breastfeeding Women
Zocor also interferes with certain preexisting health conditions. Adults with existing liver complications should not take Zocor. Women who are pregnant, may become pregnant, or are breastfeeding should avoid all statins, such as Zocor. Women taking Zocor during pregnancy are more likely to have a child who suffers from serious birth defects. In addition, mothers who are breastfeeding should not take Zocor because it may disrupt the baby’s lipid metabolism.
Zocor F.D.A. Safety Alert
In 1998, the F.D.A. approved an 80-milligram, high-dosage version of Zocor. However, in 2010, the FDA issued a safety warning about 80-milligram Zocor. By 2011, Zocor and generic Zocor had been taken by over 2.1 million Americans.
Also in 2011, the F.D.A. released new safety restrictions after Zocor was proven to cause myopathy. The restrictions stated that no new patients should be given the 80-milligram version of Zocor. They also recommended that individuals already taking this high dosage should only continue if they had been taking it for over a year without any muscle pain.
Zocor Myopathy & Rhabdomyolysis
Zocor was developed in 1991 to treat cholesterol. It belongs to an anti-cholesterol group called statins. These medications are designed to reduce the patient’s levels of low-density lipoprotein (LDL) cholesterol. By lowering levels of LDL cholesterol, Zocor helps to reduce the risk of heart attack, stroke, and cardiovascular death in patients.
While Zocor has helped a number of patients lower their LDL cholesterol levels, the drug has also caused severe side effects. Patients have reported debilitating muscular diseases. These include myopathy and rhabdomyolysis, which can cause kidney failure and death if left untreated. A number of other Zocor side effects have been reported, such as memory loss, liver damage, and type 2 diabetes.
A number of patients have reported the onset of Zocor myopathy. Zocor myopathy is most common in patients taking the highest dosage of 80 milligrams per day. Myopathy is a muscular condition during which the patient’s muscles fail to function properly. As a result, the patient experiences muscular weakness. In Greek, the term myopathy translates to “muscle suffering.”
Patients who believe they may suffer Zocor myopathy should seek immediate emergency medical attention. Severe Zocor myopathy symptoms may be present in patients who experience difficulty swallowing, slurred speech, sudden weakness in one side of the body, or difficulty raising the foot and toes.
Other Zocor myopathy symptoms may include:
- Stiffness or rigidity
- Swelling and inflammation
- Tetany, or spasms
- Atrophy, or wasting
In severe cases, myopathy can develop into Zocor rhabdomyolysis. During Zocor rhabdomyolysis, the patient’s muscle tissue begins to break down rapidly. In healthy patients, muscle breakdown in normal levels does not pose serious health risks. When muscle breakdown occurs, the muscles produce byproducts such as myoglobin. These byproducts are then filtered out of the bloodstream by the patient’s kidneys.
In normal levels, these muscular byproducts do not cause harm to the kidneys. However, high levels of myoglobin and other muscular byproducts can cause harm. During Zocor rhabdomyolysis, the excessive byproduct levels cause kidney damage. If Zocor rhabdomyolysis progresses and fails to receive proper treatment, the patient may experience kidney failure and death.
Patients with Zocor rhabdomyolysis may experience:
- Dark or reddish urine
- Decreased urine production
- Myalgia, or muscle aching and stiffness
- Tenderness and weakness in affected muscles
- Nausea or vomiting
- Malaise, or general feelings of illness
Diagnosis and Treatment
It is essential to diagnose cases of Zocor myopathy and rhabdomyolysis. With proper and immediate medical treatment, patients may experience full recovery. Medical professionals can conduct a series of tests to determine if a patient is at-risk for damage from these conditions. Testing may be used to determine levels of specific enzymes and proteins in the blood. Testing of blood myoglobin, or serum myoglobin, may be conducted to determine if the patient has high levels of myoglobin. This may indicate excessive muscle breakdown that can lead to kidney damage.
Depending on the severity of the patient’s Zocor myopathy and rhabdomyolysis, the patient may need to be carefully monitored in a hospital’s intensive care unit. Intravenous (IV) fluids may be administered to prevent dehydration and kidney failure. The patient typically requires ongoing treatment to maintain adequate urine production. In the event that kidney failure occurs, the patient will undergo dialysis treatment to filter the blood.
Many claims have been filed by personal injury attorneys and citizens’ watch groups on behalf of patients who were prescribed Zocor. Aggrieved parties believe that Merck did not provide adequate information about the risks involved with Zocor. They believe that Merck knew about the serious side effects that Zocor could bring on and did not effectively warn consumers. Additionally, claimants feel that the makers of Zocor failed to do adequate research into the causes of Zocor’s side effects.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.