Pravastatin is a prescription drug that lowers levels of blood cholesterol and other lipid compounds, such as triglycerides and low density lipoproteins, also called LDL cholesterol. Pravastatin was developed by Bristol Myers Squibb and marketed under the brand-name, Pravachol. The Food and Drug Administration approved Pravachol in 1991, and the revised product label in 2007. Today, pravastatin is a generic prescription drug. Despite its effectiveness, pravastatin has many side effects.
Coronary Heart Disease
Landmark research conducted by S.E. Nissen, a cardiologist at the Cleveland Clinic, and published in the "Journal of the American Medical Association" in 2004, demonstrated that patients treated with pravastatin have progression of coronary atherosclerosis.
Impaired Liver Function
According to the product label, Pravastatin is associated with biochemical abnormalities in liver function that is marked by over three times the normal levels or four times pretreatment level of enzymes called transaminases. Patients taking pravastatin do not usually have symptoms of these elevated enzymes, however this condition can lead to liver toxicity and liver failure. Patients with liver disease should be closely monitored during pravastatin therapy.
Skeletal Muscle Breaakdown and Kidney Failure
Pravastatin increases levels creatine phosphokinase, an enzyme that breaks down skeletal muscle fibers, says information found on the product label. This causes a condition called rhabdomyolysis that is characterized by weakness, aches and pain in skeletal muscle throughout the body. The broken muscle fibers enter the bloodstream and can cause acute kidney failure.
Endocrine and Sexual Function
Pravastatin can reduce gonadal steroid hormone production. The product label reports that testosterone production decreased after 16 weeks of pravastatin therapy in 21 males. Less than one percent of patients in double blind placebo controlled studies reported sexual dysfunction.
Vision
Pravastatin can cause vision problems associated with the lens of the eyes. According to the product label, 15 percent of patients can experience a worsening of eyesight, including blurry vision, after one year of treatment with pravastatin.
Other Side Effects
Several types of side effects from pravastatin have been reported by more than 2 percent of patients in clinical trials, according to the product label. Pravastatin can cause gastrointestinal side effects that include indigestion, heartburn, nausea, vomiting, gas and constipation. Pravastatin can cause angina pectoris, a cardiovascular condition characterized by severe chest pain and discomfort that occurs when the heart does not receive a sufficient supply of blood. The drug can also cause fatigue, dizziness, headaches, skin rash and muscle cramps.
The product label says that post marketing studies of pravastatin have reported alterations in taste, impairment of movement, inflammation of the liver and kidneys, discoloration of skin, dryness of hair and nails and abnormalities of the thyroid gland.
The MedlinePlus website says that pravastatin can cause uncommon side effects that include fever, yellowing of the skin or eyes, pain in the upper right part of the stomach, unusual bleeding or bruising, loss of appetite, flu-like symptoms, hives, itching, difficulty breathing, difficulty swallowing, hoarseness and swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs. MayoClinic.com reports strange side effects from pravstatin that include dark colored urine, burning urination, ear congestion, double vision and feeling fearful and sad.
References
- Bristol Myers Squibb: Pravachol Prescribing Information
- Food and Drug Administration: Pravachol Label and Approval History
- "JAMA"; Effect of Lipid-Lowering Therapy on Progression of Coronary Atherosclerosis; Nissen, S.E.; Mar 3 2004
- American Society of Health-System Pharmacists: Pravastatin
- MayoClinic.com: Pravastatin



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