Pravachol adverse effects by Ray Sahelian, M.D.
January 25 2016

Pravachol, also known as the generic pravastatin, is a statin drug used together with diet, weight-loss and exercise to reduce the amount of cholesterol and other fatty substances in the blood. Pravachol is in a class of medications called HMG-CoA reductase inhibitors (statins). Pravachol works by slowing the production of cholesterol in the body.

Adverse reactions
Circ Cardiovasc Qual Outcomes. 2013. Comparative tolerability and harms of individual statins: a study-level network meta-analysis of 246 955 participants from 135 randomized, controlled trials. Our objective was to estimate the comparative harms of individual statins using both placebo-controlled and active-comparator trials. We systematically reviewed randomized trials evaluating different statins in participants with and without cardiovascular disease. We performed random-effects pairwise and network meta-analyses to quantify the relative harms of individual statins. We included 55 two-armed placebo-controlled and 80 two- or multiarmed active-comparator trials including 246,955 individuals. According to pairwise meta-analyses, individual statins were not different than control in terms of myalgia, creatine kinase elevation, cancer, and discontinuations because of adverse events. Statins as a class resulted in significantly higher odds of diabetes mellitus (odds ratio, 1.09; 95% confidence interval, 1.02-1.16) and transaminase elevations (odds ratio, 1.51; 95% confidence interval, 1.24-1.84) compared with control. When individual statins were compared in network meta-analyses, there were numerous statistically detectable differences, favoring simvastatin and Pravachol. According to dose-level comparisons, individual statins resulted in higher odds of discontinuations with higher doses of atorvastatin and rosuvastatin. Similarly, higher doses of atorvasatin, fluvastatin, lovastatin, and simvastatin were associated with higher odds of transaminase elevations. Simvastatin at its highest doses was associated with creatine kinase elevations (odds ratio, 4.14; 95% credible interval, 1.08-16.24). Meta-regression analyses adjusting for study-level age at baseline, low-density lipoprotein cholesterol level, and publication year did not explain heterogeneity. There was no detectable inconsistency in the network. :As a class, adverse events associated with statin therapy are not common. Statins are not associated with cancer risk but do result in a higher odds of diabetes mellitus. Among individual statins, simvastatin and Pravachol seem safer and more tolerable than other statins.

CNS Drugs. 2014. Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management. Statins, or 3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors, such as lovastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, rosuvastatin and pitavastatin, may cause neuropsychiatric reactions. They include behavioural alterations (severe irritability, homicidal impulses, threats to others, road rage, depression and violence, paranoia, alienation, antisocial behaviour); cognitive and memory impairments; sleep disturbance (frequent awakenings, shorter sleep duration, early morning awakenings, nightmares, sleepwalking, night terrors); and sexual dysfunction (impotence and decreased libido). Studies designed to investigate specific neuropsychiatric endpoints have yielded conflicting results. Several mechanisms, mainly related to inhibition of cholesterol biosynthesis, have been proposed to explain the detrimental effects of statins on the central nervous system. Approaches to prevent and manage such adverse effects may include drug discontinuation and introduction of dietary restrictions; maintenance of statin treatment for some weeks with close patient monitoring; switching to a different statin; dose reduction; and use of ω-3 fatty acids or coenzyme Q10 supplements. The available information suggests that neuropsychiatric effects associated with statins are rare events that likely occur in sensitive patients.

Int J Surg Case Rep. 2015. Pravastatin-induced rhabdomyolysis and purpura fulminans in a patient with chronic renal failure. Rhabdomyolysis associated with the use of pravastatin has been demonstrated to be a rare but potentially life-threatening adverse effect of statins. Here, we report a rare case of rhabdomyolysis and purpura fulminans in a patient who had used pravastatin and developed chronic renal failure (CRF) necessitating the initiation of dialysis. We present the case of an 86-year-old man with chronic kidney disease (CKD) treated with dialysis who was admitted with back pain. He was prescribed and took pravastatin for almost 3 years to treat hyperlipidemia. We report an rare case of pravastatin-induced rhabdomyolysis and purpura fulminans with DIC in a patient with CRF.

Q. I seem to be fine with Passion RX until I take my cholesterol medicine - Pravachol. Then the side effects set in such as flush (red) face, hot heart, etc.
I even waited a day after to take the Pravachol, but still same results. Do you make a cholesterol medicine that would reduce cholesterol, yet, be safe to take with Passion RX?
   A. Sometimes unexpected side effects occur when drugs are combined with herbal products. you may consider taking a look at cholesterol page and discuss with your doctor natural options to Pravachol use. Also, sometimes reducing the dosage of the Passion Rx could make a difference, perhaps you could take 2/3 or half of the amount you are now taking, or taking the Passion Rx less frequently.