2005;330:396. Psychiatry Res. Simvastatin has been shown to both significantly lower testosterone [70] and worsen sleep problems on average [43]. Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. 2015;584:30813. Article Potential mechanisms are reviewed, including hypothesized mechanisms related to oxidative stress and bioenergetics. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. Paradoxical rage reactions during psychotropic medication. For example, Steegmans and colleagues10 found that plasma serotonin concentrations are lower in untreated men with persistently low serum cholesterol concentrations (4 to 5 mmol/L or less) than in a reference group. PubMed Lower serum high-density lipoprotein cholesterol (HDL-C) in major depression and in depressed men with serious suicidal attempts: relationship with immune-inflammatory markers. 1996;153:8434. Neuromuscul Disord. 2007;30:195201. Blutalkohol. Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series. Am J Psychiatry. Genetic risk factors associated with lipid-lowering drug-induced myopathies. Concentrations of pravastatin and lovastatin in cerebrospinal fluid in healthy subjects. Behavioral/mood findings often accompanied muscle, cognitive, or other better recognized statin adverse effects [3941]. J Clin Lipidol. Psychiatric adverse drug reactions (ADRs) have been reported with statin use, but the literature regarding statin-associated mood/behavioral changes remains limited. RCT meta-analysis in the statin era did not support an increase in violent death on average (indeed the point estimate was lower, though not significantly) [35]. Often, these marginalized groups are unable to receive basic health care, including maternity care. 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108905.htm. 1. 5. Rev Neurol (Paris). Genetic predisposition to statin myopathy. Popular statins include atorvastatin ( Lipitor ), rosuvastatin (Crestor), and simvastatin (Zocor). Drug Saf - Case Rep 3, 1 (2016). Golomb BA, Tenkanen L, Alikoski T, Niskanen T, Manninen V, Huttunen M, et al. All patients experienced other recognized statin adverse effects while on the drug. Pharmacotherapy. More than 2 patches at a time may be cumbersome for patients: Estradiol valerate IM a <20mg IM q 2 wk: 20mg IM . The latency profile is consistent with that for other statin ADRs that share common mechanisms [40, 41], and bear RCT support [39, 59, 61, 62]. Following 8 months of treatment on atorvastatin and over 2 years on statins, with persistent adverse personality change, he discontinued treatment due to the changes in personality and memory By 1 week after discontinuation, he noted significantly reduced irritability and temper (and a "mellower" personality), as well as a resolution of his . CNS cholesterol levels are abnormally low in many people with mood disorders. Br J Clin Pharmacol. Nederlands Tijdschrift voor Geneeskunde. New approaches to postmarketing surveillance. Drugs and medications with behavioral concerns include alcohol (best recognized) [1], but also varenicline [24], loratadine [5], mefloquine [6], tramadol [7, 8], isotretinoin [9], tricyclics [10], benzodiazepines [11, 12], and selective serotonin reuptake inhibitors (SSRIs) [1316], among others [17]. It is thought that Viagra . Mitochondrial dysfunction has a documented connection to a range of psychiatric problems [8287], and may also contribute to behavioral change with statin-induced oxidative damage. They tested 1016 healthy men and women for 6 months in a randomized, double-blind, placebo-controlled trial using 20 mg of the more lipophilic sim-vastatin, 40 mg of the hydrophilic pravastatin, or placebo. Destee A, Martin JJ, Muller JP, Scholte HR, Verier A, Largilliere C, et al. Part of Springer Nature. Sarchiapone M, Camardese G, Roy A, et al. Napumpujte ho antioxidantmi a vitamnmi! CAS Lipid Screening in Childhood and Adolescence for Detection of Familial Hypercholesterolemia: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Fattal O, Link J, Quinn K, Cohen BH, Franco K. Psychiatric comorbidity in 36 adults with mitochondrial cytopathies. J Neurochem. PubMed Central Encephalopathy with lactic acidosis and cerebral infarction. Poster presented at: International Society on Brain and Behaviour: 2nd International Congress on Brain and Behaviour; November 17-20, 2005; Thessalo-niki, Greece. (1) Simvastatin 80mg was followed in 5days by irritability/depression culminating in suicide in a man in his 40s (Naranjo criteria: possible causality). Fisher S, Bryant SG. In 2004, we published a case series of 6 patients who were referred or self-referred with irritability and short temper on statin cholesterol-lowering drugs, Golomb said. headache, hypotension, bradycardia, rebound HTN/tachycardia, palpitations, facial flushing, sublingual burning, dizziness, weakness, faintness, nasal congestion, GI bleeding, edema Nitroglycerin precautions Monitor BP for hypotension Nitroglycerin Interactions 1987;48:3856. 2007;69:9324. Beatrice A. Golomb. A. Vladutiu GD, Tabone E. Mitochondrial disease in patients with exercise intolerance. Barnes M, Houston D, Worsnop CJ, Neill AM, Mykytyn IJ, Kay A, et al. These drugs are widely prescribed and most prominently include statins (3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors), which held the place of best-selling class of prescription drugs in the world and include the best-selling prescription drug in history [2124]. van Riemsdijk MM, Sturkenboom MC, Pepplinkhuizen L, Stricker BH. An analysis of 324 e-mails of individuals taking statins who reported adverse effects found about 30% reported mood changes (depression, anxiety, irritability), she said. Nitrostat sublingual tablets are used to treat a type of chest pain called angina. Golomb BA, Tenkanen L, Alikoski T, et al. A total of 12 subjects and/or their family members (if the subject was deceased) who reportedly experienced mood and behavioral changes while receiving one or more statin, as identified by the subject and/or by family members, contacted our study group and provided survey information. Cite this article. Deaths due to accidents and violence in two recent trials of cholesterol-lowering drugs. 2007;6:7. A significantly greater number of individuals taking simvastatin reported sleep problems than those taking either pravastatin or the placebo, Golomb said in her report at the American Heart Association meeting in 2007.14 Those who reported much worse sleep while taking study medication also showed a significant adverse change in ag-gression scores, she added. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love Many . A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . Am J Psychiatry. It also lead to an elevation of CK (creatine kinase) which is a muscle enzyme. Francesca Notarangelo M, Marziliano N, Antonietta Demola M, Pigazzani F, Guidorossi A, Angelica Merlini P, et al. Isoprostane 8-epi-PGF2alpha is frequently increased in patients with muscle pain and/or CK-elevation after HMG-Co-enzyme-A-reductase inhibitor therapy. Important drug warningUltram (tramadol). Shrivastava and colleagues1 explored the effect of chronic cholesterol depletion induced by mevastatin on the function and dynamics of the human serotonin-1A receptors stably expressed in animal cells. Google Scholar. Suzuki T, Koizumi J, Shiraishi H, Ofuku K, Sasaki M, Hori T, et al. Lozano P, Henrikson NB, Dunn J, Morrison CC, Nguyen M, Blasi PR, Anderson ML, Whitlock E. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Aug. Report No. In some cases, proximal mood or behavioral changes arising with cholesterol-lowering agents led to the addition of psychiatric medications, and a role for these psychotropic medications in behavioral sequelae cannot be excluded. 1993;42:4556. 2007;101:56676. 1996;33:8493. Sarchiapone and colleagues,11 among others, have hypothesized that low cholesterol levels indirectly lead to reduced brain serotonin because of the requirement of adequate cholesterol in nerve cell membranes to maintain the functional integrity of serotonin receptors, Lake added. Compliance with Ethical Standards Funding The ADR database and survey from which these findings were drawn was funded by a Robert Wood Johnson Generalist Physician Faculty Scholar Award to Dr. Golomb. Individuals who take statins to lower their cholesterol sometimes display symptoms of irritability, anxiety, and depression; these symptoms are reported by their family members, caregivers, and coworkers. Simvastatin but not pravastatin affects sleep: findings from the UCSD Statin Study. Second, the fractional risk change itself may be greater in a behaviorally vulnerable subset (effect modification): illustrating this point, the odds ratios risk of psychiatric events with mefloquine use was reported to be 3.8 among those without a psychiatric history, versus apparently double that (8.0) in those with a psychiatric history [6]. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. 1978;135:1178. Clin Exp Allergy. 2013;127:AP072. Oh J, Ban MR, Miskie BA, Pollex RL, Hegele RA. 1998;128:47887. Severe irritability associated with statin cholesterol-lowering drugs. Circulation. 2023 Springer Nature Switzerland AG. The patients completed a survey, providing information on the character of behavioral effect, time-course of onset, and recovery and relevant factors.9 In each case, the personality disruption, once evident, was sustained until statin use was discontinued, and it resolved promptly with drug cessation. Varenicline (marketed as Chantix) information. We sought to elicit information germane to natural history and characteristics of central nervous system/behavioral changes in apparent connection with statin and/or cholesterol-lowering drug use, and delineate mechanisms that may bear on an association. 2011;82:30916. Several participants exhibited compelling on-off-on reproducibility of findings. In addition, the researchers found novel changes in receptor dynamics with chronic cholesterol depletion. PubMed Central 2009. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm. Golomb and associates12 also have extensively researched the issues of low cholesterol levels, serotonin, and violence. Mitochondrial myopathy. Fitoterapia. PubMed Dis Nerv Syst. Neurosci Lett. Sinzinger H, Lupattelli G, Chehne F, Oguogho A, Furberg CD. Zabel GE. 2011. http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm. These drugs may help stabilize the plaques on blood vessel walls and . 1994;11:30511. Present address: Department of Obstetrics and Gynecology, Columbia New York Presbyterian, New York, NY, 10032, USA, Department of Medicine, University of California, San Diego, 9500 Gilman Drive # 0995, La Jolla, CA, 92093-0995, USA, Stephanie Cham,Hayley J. Koslik&Beatrice A. Golomb, You can also search for this author in Thoughts and acts of aggression/violence toward others reported in association with varenicline. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Findings from some human clinical trials, however, raise questions about the hypothesis. The Benefits Outweigh the Risks of Treating Hypercholesterolemia: The Statin Dilemma. Lipid-lowering medication use and aggression scores in women: a report from the NHLBI-sponsored WISE study. Deisenhammer EA, Kramer-Reinstadler K, Liensberger D, et al. US top ten products by prescriptions. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behavior. Curr Opin Rheumatol. For others, statins appear to have triggered significant personality changes, transforming otherwise placid individuals into uncontrollable balls of rage, wrecking marriages and turning. Observationally, lower cholesterol has been linked to greater violence (including aggression, suicide, homicide, violence) in many studies, including prospective longitudinal studies [28, 29, 64, 65]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Relation of serum cholesterol, lipid, serotonin and tryptophan levels to severity of depression and to suicide attempts. FDA drug safety communication: new restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. 2008;17:18794. Repova K, Aziriova S, Krajcirovicova K, Simko F. Med Res Rev. 44 Citations 144 Altmetric Metrics Abstract Psychiatric adverse drug reactions (ADRs) have been reported with statin use, but the literature regarding statin-associated mood/behavioral changes remains limited. The tour begins on Aug. 3 in Sterling . 1990;301:30914. Bookshelf Accessed July 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPa NCI CPTC Antibody Characterization Program, Zabel GE. Relative exclusion may affect detection of risk in two ways. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. BMJ (Clinical Research Ed). CAS Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in N Engl J Med. For this medicine, the following should be considered: Allergies Accessibility Depressive symptoms and cholesterol-lowering drugs. Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series, https://doi.org/10.1007/s40800-015-0024-2, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm, http://www.fda.gov/downloads/Safety/MedWatch//UCM213265.pdf, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108905.htm, http://www.imshealth.com/public/structure/dispcontent/1,2779,1009-1009-110296,00.html, http://www.imshealth.com/public/structure/dispcontent/1,2779,1343-1343-144004,00.html, http://www.ims-global.com/insight/news_story/0403/news_story_040316.htm, http://www.imshealth.com/web/content/0,3148,64576068_63872702_70260998_83746585,00.html, http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm. 2001;322:115. 2000;108:53846. Vladutiu GD, Simmons Z, Isackson PJ, Tarnopolsky M, Peltier WL, Barboi AC, et al. -. Cases commonly involved more than one psychiatric element (Table2). doi: 10.1345/aph.1P172. The https:// ensures that you are connecting to the Some of our participants had underlying conditions (such as a psychiatric disorder) that can themselves lead to an adverse outcome; however, as above, the odds ratios for risk of psychiatric events due to a drug can be magnified in the presence of a psychiatric history [6]. Lowering cholesterol isn't the only benefit associated with statins. The Minimum Necessary: How Much Will You Need to Divulge to Insurers? In vivo and in vitro blood-brain barrier transport of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. Still, the relationship between serum cholesterol level and mood is complex, and research findings to date are inconsistent, he added. Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management. Side effects such as insomnia, drowsiness, dry mouth, nausea, and increased sweating may be more common with citalopram than escitalopram, a related drug. The modern spectrum of rhabdomyolysis: drug toxicity revealed by creatine kinase screening. Information on drug, drug dose, reported mood and behavioral effect, factors supporting a causal connection, other statin symptoms, family history of psychiatric problems associated with statin use, and presence of risk factors for statin adverse effects are listed in Table1. Psychosom Med. 2007;30(8):669-75. doi: 10.2165/00002018-200730080-00003. Part I: An Overview, Blue Light Blockers: A Behavior Therapy for Mania, Changing the Paradigms of How We Think About Depression, Blue Light, Depression, and Bipolar Disorder, Evolution of Pharmacological Treatments at the 2023 APA Annual Meeting, Multidisciplinary Program Improves Perinatal Depressive Symptoms, Expert Perspectives on the Unmet Needs in the Management of Major Depressive Disorder, Novel Delivery Systems Utilized in the Treatment of Adult ADHD, Expert Perspectives on the Clinical Management of Bipolar 1 Disorder, Tales From the Clinic: The Art of Psychiatry, Domestic Violence: Three Important Truths, Comprehensive Dictionary of Psychoanalysis. PMC For those in whom rechallenge was possible, symptoms recurred. Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. 1991;155(6656):970. Association of low serum total cholesterol with major depression and suicide. Maes M, Smith R, Christophe A, et al. Pharmacovigilance: when to report adverse reactions In: Thomsen HS, Webb JAW, editors. Varenicline (marketed as Chantix) information. Psychiatric histories, alcohol/substance use, and low conscientiousness are risk factors for lower compliance, so may lead to exclusion with compliance run-ins, but are also risk factors for adverse behaviors, so vulnerable individuals might be preferentially excluded [67]. Ruano G, Thompson PD, Windemuth A, Seip RL, Dande A, Sorokin A, et al. It has long been reported that total serum cholesterol levels are consistently lower in more severely depressed and more aggressive patients, said James Lake, MD, chair of the APAs Caucus on Complementary and Integrative Medicine, and visiting assistant professor of medicine at the Center for Integrative Medicine at the University of Arizona School of Medicine in Tucson. RCT patient selection may be one factor: excess violent deaths on pre-statin lipid drugs were preferentially evident in those with risk factors for violencee.g., alcohol, psychiatric history, and non-compliance [66]. A paper slated for the December issue of Drug Safety-Case Reports describes a dozen cases in which statin use was apparently linked to irritability, aggression, violent thoughts, and even suicide. (3) Atorvastatin 20mg was followed in ~1 month by depression and irritability/aggression in a male in his 50s (probable causality). Clin Pharmacol Ther. IMS Health. In four patients, re-challenge with statins occurred, and led to recrudescence of the problem. More lipophilic statins have better brain penetration [89, 90], though all statins have some ability to cross the bloodbrain barrier [91]. Summary. No evidence for an association between serum cholesterol and the course of depression and suicidality. 2003;23:87180. Careers. Drug Saf. In contrast to non-lipophilic statins, the more lipophilic statins readily penetrate the blood-brain barrier, where they inhibit HMG-CoA reductase and suppress several cytokines (including interferon-g, and interleukin [IL]-2 and IL-12), which results in lowering of tryptophan availability in the brain and decreased serotonin synthesis. These results have broad implications in light of recent reports of anxiety and depression in patients receiving long-term statin therapy. MeSH Kaplan JR, Shively CA, Fontenot MB, Morgan TM, Howell SM, Manuck SB, et al. Frequency of change is brand/product dependent. (4) Atorvastatin 10mg was followed in several months by aggression/irritability and depression culminating in suicide in a man in his 40s (possible causality). Commonly involved more than one psychiatric element ( Table2 ) with statins: epidemiology, pathophysiology, and... 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