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Sunday, October 6, 2013

Pravastatin (Statin Drug) Side Effects

Are you on a Statin Drug for cholesterol? Here is one I have NOT done a previous post on and wanted to list the side effects here. I sincerely now believe that cholesterol is not the cause of heart disease and therefore that statin drugs in general are of very little use in preventing heart attacks or changing the outcome of heart disease. YES, they have been proven to lower overall cholesterol and to lower (so called BAD LDL cholesterol) however they do NOT RAISE SO CALLED GOOD HDL CHOLESTEROL, so based on everything I have read concerning the "Unified Theory" of heart disease (vs.) the "Lipid Theory" set forth and practiced by modern medicine and Big Pharma, I do not see much value in a lifetime of taking statin drugs.

That is simply MY OPINION. Some of these side effects are darn right SERIOUS and life threatening. You decide for yourself, however I strongly suggest if you are on a STATIN DRUG..............ANY STATIN DRUG, you need to educate yourself on side effects. You also need to educate yourself concerning any proposed long term health benefits of a given drug (vs.) the possible side effects.

A CASE STUDY: see link:


Case 1. Acute cholestatic hepatitis attributed to pravastatin therapy.
[Modified from: Hartleb M, Rymarczyk G, Januszewski K. Acute cholestatic hepatitis associated with pravastatin. Am J Gastroenterol 1999; 94:1388-90. PubMed Citation]

A 57 year old man developed abdominal pain and nausea followed by fever and jaundice 6 weeks after starting pravastatin (20 mg daily) for long-standing hypercholesterolemia. He had a history of coronary artery disease and had been treated with beta blockers and various cholesterol lowering drugs including fenofibrate and simvastatin in the past. At the time of presentation he was taking only pravastatin and metoprolol, both of which were discontinued promptly. He denied alcohol use and had no risk factors for viral hepatitis. Physical examination showed jaundice and hepatic tenderness but no rash, fever or signs of chronic liver disease. Laboratory results showed a cholestatic pattern of serum enzyme elevations and hyperbilirubinemia (Table). Tests for hepatitis A, B and C were negative as were autoantibodies. Ultrasound and CT of the abdomen showed no evidence of biliary obstruction and ERCP was normal. A liver biopsy showed intrahepatic cholestasis compatible with drug-induced liver injury. He was treated with ursodiol (750 mg daily). Once pravastatin was stopped, symptoms and liver test abnormalities improved rapidly and were completely normal 7 weeks later.

Key Points

Medication:Pravastatin (20 mg daily)
Pattern:Mixed (R=2.8)
Severity:3+ (Jaundice, hospitalization)
Latency:6 Weeks
Recovery:~7 Weeks
Other medications:Metoprolol

Laboratory Values

Time After StartingTime After StoppingALT* (U/L)Alk P* (U/L)Bilirubin (mg/dL)Other
6 weeks042148213.6Admission
2 days26011.8
8 weeks2 weeks1513.7
9 weeks3 weeks2553.0Liver biopsy
10 weeks4 weeks2101.9Discharge
3 months7 weeks40Normal0.5Outpatient follow up
Normal Values<40<130<1.2

* Some values estimated from Figure 1.


The onset of injury within 2 months of starting pravastatin and resolution within 2 months of stopping is supportive evidence that this represented drug-induced liver disease due to pravastatin. All other causes of acute liver injury were satisfactorily excluded. Metoprolol had been used for a longer period and, like other beta-blockers, is a rare cause of drug induced liver injury. The pattern of serum enzyme elevations was considered “mixed” but the clinical presentation, symptoms and liver histology were more cholestatic.  This patient had previously tolerated simvastatin without obvious liver injury.  Cross susceptibility to cholestatic hepatitis from the statins is frequent but not invariable. 

In any event here are the side effects of PRAVASTATIN:


Pravastatin Side Effects

For the Consumer

Applies to pravastatin: oral tablet
Along with its needed effects, pravastatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking pravastatin:
More common
  • Difficulty with moving
  • muscle or bone pain
  • muscle stiffness
  • pain in the joints
  • pain, localized
Less common / MY INPUT: if you count these you will come up with THIRTY SIX LESS COMMON SIDE EFFECTS WITH VARIATIONS:
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chills
  • cough
  • dark-colored urine
  • diarrhea
  • difficult or labored breathing
  • ear congestion
  • fast or irregular heartbeat
  • fever
  • general feeling of discomfort or illness
  • headache
  • loss of appetite
  • muscle cramps or spasms
  • muscular tenderness, wasting, or weakness
  • nasal congestion
  • nausea
  • runny nose
  • shivering
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • tightness in the chest
  • trouble with sleeping
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Some side effects of pravastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
  • Stomach pain
Less common / Here is an additional 19 side effects/ Now the medical community will tell you that everyone does not get side effects (TRUE).........however SOMEBODY EXPERIENCED EVERY SINGLE ONE OF THESE IN ORDER FOR THEM TO MAKE THE LIST. In addition, most first time reporters of side effects unless they are life threatening are simply dismissed.
  • Acid or sour stomach
  • belching
  • bloated full feeling
  • blurred vision or other changes in vision
  • difficult or painful urination
  • difficulty having a bowel movement (stool)
  • dizziness
  • double vision
  • fear or nervousness
  • feeling sad or empty
  • increased urge to urinate during the night
  • irritability
  • loss of interest or pleasure
  • pain in the chest below the breastbone
  • passing gas
  • rash
  • stomach discomfort or upset
  • stuffy nose
  • tiredness
  • trouble concentrating

For Healthcare Professionals

Applies to pravastatin: oral tablet
Hepatic side effects of pravastatin have included elevated in liver function tests (1.3%). HMG-CoA reductase inhibitors have reported hepatic side effects of hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, and fulminant hepatic necrosis.
Persistent elevations in liver function tests three times normal values have been reported in up to 1.3% of patients in clinical trials. In one review of 1,142 patients, elevations in serum transaminases led to discontinuation of pravastatin in 1% of patients. Clinical monitoring of hepatic function is recommended and pravastatin should be discontinued in patients with persistent, significant elevations (three times normal) in liver function parameters.
HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

One case of myopathy and one of dermatomyositis associated with pravastatin have been reported in the literature.

Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured and if markedly elevated, pravastatin should be discontinued. The value of routine monitoring of creatine kinase is not known.

A case of asymptomatic pravastatin-induced rhabdomyolysis has been reported in a patient receiving the drug for 3 years. Following discontinuation of pravastatin, the patient's serum creatine kinase levels returned to normal after 3 weeks.
Musculoskeletal side effects of pravastatin have included elevations in creatine kinase, myopathy, and a case report of dermatomyositis. Musculoskeletal side effects reported with HMG-CoA reductase inhibitors have included rhabdomyolysis, arthralgia, and tendon rupture.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.
Gastrointestinal side effects of pravastatin have included nausea and vomiting (0.5% to 7.3%), diarrhea (2.0% to 6.2%), abdominal pain (0.3% to 5.4%), constipation, flatulence, and heartburn. Gastrointestinal side effects reported with HMG-CoA reductase inhibitors have included pancreatitis and anorexia.
Gastrointestinal side effects have been among the most common symptoms reported by patients on pravastatin. These symptoms tended to be mild and transient in nature and resolved with continued therapy.
Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with some HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.
Nervous system
Nervous system side effects of pravastatin have included headache (0.6% to 6.2%), dizziness, drowsiness, and weakness. Cranial nerve dysfunction, tremor, vertigo, fatigue, weight loss, memory loss, decline in cognitive function, paresthesias, peripheral neuropathy, and peripheral nerve palsy have been reported with HMG-CoA reductase inhibitors.
Renal side effects of HMG-CoA reductase inhibitors have included myoglobinuria and acute renal failure secondary to rhabdomyolysis.
Dermatologic side effects of pravastatin have included rash (0.9% to 4.0%) and a case report of bullous erythematous lesions. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, and alopecia have occurred with HMG-CoA reductase inhibitors.
Endocrine side effects of gynecomastia and thyroid function abnormalities have been reported. Endocrine side effects associated with other HMG-CoA reductase inhibitors have included hypospermia. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.
Hypersensitivity reactions have rarely occurred with HMG-CoA reductase inhibitors. Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, and dyspnea have been reported.
Immunologic side effects of HMG-CoA reductase inhibitors have included a lupus-like syndrome, positive ANA, elevated ESR, polymyalgia rheumatica, and vasculitis.
Ocular side effects of HMG-CoA reductase inhibitors have included progression of cataracts and ophthalmoplegia. There are no data associating pravastatin with lens opacities in humans.
Psychiatric side effects of pravastatin have included insomnia and other sleep disturbances. Other psychiatric side effects of HMG-CoA reductase inhibitors have included decreased libido, anxiety, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares.
Genitourinary side effects of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence and testicular pain.
Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient lead to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.
Oncologic side effects including hepatocellular carcinomas and malignant lymphomas have been associated with pravastatin in animal studies. Long-term clinical trials are needed to define the cancer risk in humans.

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