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. Statin adverse effects: a review of the literature and evidence for a mitochondrial mechanism. Psychosom Med. Food and Drug Administration. Atherosclerosis. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Vasodilators are medications that open (dilate) blood vessels. Neurosci Lett. 2004;97:22935. 2008;40:28195. Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series. Repova K, Aziriova S, Krajcirovicova K, Simko F. Med Res Rev. Lower serum high-density lipoprotein cholesterol (HDL-C) in major depression and in depressed men with serious suicidal attempts: relationship with immune-inflammatory markers. Fisher S, Bryant SG. 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 . Dis Nerv Syst. For those in whom rechallenge was possible, symptoms recurred. 2023 Springer Nature Switzerland AG. Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, et al. (8) Simvastatin 10 mg was followed (time-course not recalled) by depression, aggression/irritability culminating in suicide in a man in his 60s (possible causality). (However, in the latter, there is no gauge of severity; and physical problems can themselves contribute to some level of psychic distress). Demonstration of an association among dietary cholesterol, central serotonergic activity, and social behavior in monkeys. 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]. ADRs had implications for marriages, careers, and safety of self and others. Dr. Cham is now employed by the Department of Obstetrics and Gynecology, Columbia New York Presbyterian. Psychiatric disturbance in mitochondrial encephalomyopathy. Reported problems included violent ideation, irritability, depression, and suicide. Some patients who take statins complain of GI distress and many other adverse effects, Lake said. Statin-associated myopathy with normal creatine kinase levels. -. Ann Med. However, a profound change in state while receiving a drug, particularly with dechallengerechallenge support, strengthens the case for causality. Of note, there was no evidence of more patients with these characteristics in the cholesterol-lowering group, but the excess of events emphasized these patients. CNS Drugs. Varenicline (marketed as Chantix) information. Stewart JT. Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults. 2023;1411:459-486. doi: 10.1007/978-981-19-7376-5_20. 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 Article Participants (and/or proxies) self-referred with behavioral and/or mood changes in apparent association with statins completed a survey eliciting cholesterol-lowering drug history, character and impact of behavioral/mood effect, time-course of onset and recovery in relation to drug use/modification, co-occurrence of recognized statin-associated ADRs, and factors relevant to ADR causality determination. Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management. 2015;584:30813. 2010;44:13891394. Disclaimer. My doctors at Johnson Space Center in Houston had given me Lipitor, 10 . A. This study has the limitations inherent to all case series: data are observational, which constrains causal inference. HEALTH New Viagra: Can Cholesterol-Lowering Statins Beat Erectile Dysfunction? Rev Neurol (Paris). Typical effects in men (particularly in men who were both younger and less aggressive at baseline) were toward reduced aggression [69], with older age and female sex shifting the distribution. sharing sensitive information, make sure youre on a federal Before Int J Risk Safety Med. The leading statin drugs include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev), pravastatin (Pravachol), rosuvastatin calcium (Crestor), and simvastatin (Zocor). 2007;6:7. Relative exclusion may affect detection of risk in two ways. Psychopharmacology (Berl). CAS (12 cases are included; for those interested in knowledge of other cases of this kind, a 13th case, involving a physician with behavioral changes while receiving statins and leading to professional review, is planned for inclusion in a separate manuscript on statin adverse effects in physicians). Drug Saf. One possible exception was a man with bipolar disorder; however, he had manifested years of stability and good control since initiation of lithium until statin initiation, which resulted in loss of psychiatric stability persisting for the years he was receiving statins until his death. Destee A, Martin JJ, Muller JP, Scholte HR, Verier A, Largilliere C, et al. DeepBiomarker: Identifying Important Lab Tests from Electronic Medical Records for the Prediction of Suicide-Related Events among PTSD Patients. Eur J Pain. Correspondence to 1997;99:S7506. (11) Atorvastatin 20mg and then simvastatin 20mg were followed in 2weeks by aggression/irritability in a man in his 50s (definite causality). 2009 Jul;13(34):1-74, 75-118. doi: 10.3310/hta13340. Ann Pharmacother. 1999;29(Suppl 3):2406 (discussion 750). Effects of statins on energy and fatigue with exertion: results from a randomized controlled trial. First, the same fractional (relative) risk change will lead to a greater number affected, and more power to show a change, in those at higher risk (a doubling of nothing is still nothing) [68]. However, patient self-reports of ADRs can be a valuable and reliable tool [96100], andif heededmay hasten recognition of important ADRs [101]; such benefits have led to standardized implementation of patient reporting for EU-based pharmacovigilance databases [102]. (12) Lovastatin, rosuvastatin, atorvastatin, and simvastatin at varying doses were followed as quickly as 1 day by aggression, irritability, and violent ideation in a man in his 40s (definite causality). Kasliwal R, Wilton LV, Shakir SA. (9) Simvastatin 20mg then atorvastatin 10mg were followed (time-course not provided) by irritability/aggression in a man in his 60s (definite causality). It could, according to Lake. Ahmad Z. Statin intolerance. 2002;2:2534. Some individuals taking statins report problems with anxiety and depression, but far more report problems with irritability and changes in personality, Golomb told Psychiatric Times. 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. No evidence for an association between serum cholesterol and the course of depression and suicidality. Naranjo presumptive ADR causality criteria were assessed. Steegmans PH, Fekkes D, Hoes AW, et al. Pharmacotherapy. Genetic risk factors associated with lipid-lowering drug-induced myopathies. "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . Lake and Golomb point out that lowering cholesterol levels reduces morbidity and mortality from heart disease. and transmitted securely. Behavioral consequences of lipid-lowering medications have been reported for non-statin treatments, including fibrates [20] (implicated in case 5), with support extending to meta-analyses of RCTs showing significantly increased violent death [28, 33, 34]. 2002. http://www.imshealth.com/public/structure/dispcontent/1,2779,1343-1343-144004,00.html. Currently, Golomb and her team are preparing another case series involving 12 individuals who experienced problems with irritability, anxiety, or depression during statin therapy. Br J Clin Pharmacol. Cholesterol and violence: Is there a connection? Golomb BA, Kane T, Dimsdale JE. Research findings dating back to the 1990s show that serum cholesterol level, especially the HDL fraction, is significantly lower in many patients with major depressive disorder than in matched non-depressed individuals and that clinical improvement following antidepressant therapy is often associated with normalization of serum total cholesterol to higher levels.2-5 But more recent studies have failed to replicate these findings.6-8. 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. 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. Stenver DI. Oh J, Ban MR, Miskie BA, Pollex RL, Hegele RA. Address mental health issues possibly related to the use of certain cholesterol-lowering drugs. Below, check out the tour dates, as well as a weird tour . Accessed June 2001. A total of 75% of cases were accompanied by other symptoms with a confirmed relation to statin use, including muscle symptoms [41, 5360], cognitive problems [40, 6163], and dermatologic reactions [39]. Pinkofsky HB, Woodward RA, Reeves RR. Physiogenomic association of statin-related myalgia to serotonin receptors. Results: In each case the personality disruption, once evident, was sustained until statin use was discontinued; and resolved promptly with drug cessation. 1990;48:1027. Sinzinger H, Lupattelli G, Chehne F. Increased lipid peroxidation in a patient with CK-elevation and muscle pain during statin therapy. Sublingual NTG becomes effective within two to five minutes and its effects last 15 to 30 minutes. -, Moore TJ, Glenmullen J, Furberg CD. Lochhead JJ, McCaffrey G, Quigley CE, Finch J, DeMarco KM, Nametz N, et al. Concentrations of pravastatin and lovastatin in cerebrospinal fluid in healthy subjects. Eight met presumptive criteria for probable or definite causality; others had additional factors not considered in Naranjo criteria that bear on casual likelihood. Postmarketing surveillance: accuracy of patient drug attribution judgments. Mefloquine increases the risk of serious psychiatric events during travel abroad: a nationwide case-control study in the Netherlands. Clin Neuropharmacol. Improvement in sleep apnoea associated with switch from simvastatin to pravastatin. Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Findings from some human clinical trials, however, raise questions about the hypothesis. Well, first I want to congratulate you for taking care of your body and being so healthy at 79 years of age. (5) Fenofibrate+rosuvastatin (unknown dose), later combined with atorvastatin were followed in 1month by aggression/irritability in a male in his 30s (probable causality). The explanation accords with our finding that behavioral adverse effects commonly co-occur with better known statin adverse effects, for which a relation to oxidative stress and mitochondrial dysfunction has been elucidated [39]. 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]. Summary. Berlin: Medical Radiology, Springer; 2009. p. 213. 2013;127:AP072. May be taken with or without food. Golomb BA, Tenkanen L, Alikoski T, Niskanen T, Manninen V, Huttunen M, et al. Several hypotheses have been advanced to explain the relationship between cholesterol, mood disorders, and violence, according to Lake. Repo-Tiihonen E, Halonen P, Tiihonen J, Virkkunen M. Total serum cholesterol level, violent criminal offences, suicidal behavior, mortality and the appearance of conduct disorder in Finnish male criminal offenders with antisocial personality disorder. Whether this is important for central effects of the kinds described is unknown, since peripheral effects can have central consequencesand since prooxidant effects of statins, which are linked to the occurrence of statin adverse effects [92], also raise bloodbrain barrier penetrability [93, 94]. Triggs WJ, Roe CR, Rhead WJ, Hanson SK, Lin SN, Willmore LJ. The site is secure. Fisher S, Bryant SG, Kent TA, Davis JE. Botti RE, Triscari J, Pan HY, Zayat J. 2005;161:6919. First, they stop the production of cholesterol in your body. Medawar C, Herxheimer A. Psychiatric adverse drug reactions (ADRs) have been reported with statin use, but the literature regarding statin-associated mood/behavioral changes remains limited. 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