Congenital abnormalities in baby born to mother using lovastatin

This study was published in the Lancet 1992 Jun 6;339(8806):1416-7

Study title and authors:
Congenital abnormalities (VATER) in baby born to mother using lovastatin.

Ghidini A, Sicherer S, Willner J.

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/1350826

This paper reports the case of an infant born with many malformations after the mother used a statin during pregnancy.

(i) A woman was treated for five weeks with lovastatin, starting approximately six weeks from her last menstrual period.
(ii) The statin was discontinued when her pregnancy was diagnosed at 11 weeks' gestation.
(iii) A female infant was delivered by cesarean section at 39 weeks' gestation. The infant had a constellation of malformations termed the VATER association (vertebral anomalies, anus not developed properly, an abnormal connection between the oesophagus and the trachea with part of the oesophagus missing, and kidney, forearm and wrist abnormalities).
(iv) Her anomalies included a deformed chest, spinal deformity, absent left thumb, foreshortened left forearm, shortened left elbow, fusion of the ribs on the left, anomalies in the spine, deformed left forearm, and a narrow lower oesophagus.

Simvastatin has deleterious effects on human first trimester placental cells

This study was published in Human Reproduction 2005 Oct;20(10):2866-72

Study title and authors:
Simvastatin has deleterious effects on human first trimester placental explants.

Kenis I, Tartakover-Matalon S, Cherepnin N, Drucker L, Fishman A, Pomeranz M, Lishner M.
Oncogenetic Laboratory, Department of Internal Medicine A, Sapir Medical Center, Kfar-Saba, Israel.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/15958395

A group led by Dr Irina Kenis explored the effects of statins on the placenta. The study compared cultured human first trimester placental cells exposed to small doses of simvastatin with cells not exposed to simvastatin.

The study found:
(a) Compared with unexposed cells, simvastatin sharply inhibited the migration of extravillous trophoblast cells. (The migration of extravillous trophoblast cells into the uterus is a vital stage in the establishment of pregnancy).
(b) Compared with unexposed cells, simvastatin inhibited the formation of trophoblast cells.
(c) Compared with unexposed cells, simvastatin led to more cell death in the trophoblast cells.
(d) Progesterone levels were significantly reduced in the simvastatin-treated cells in comparison with unexposed cells. (Progesterone keeps the placenta functioning properly and the uterine lining healthy and thick).
(e) Human chorionic gonadotropin levels were reduced in the simvastatin-treated cells in comparison with unexposed cells. (Human chorionic gonadotropin is a hormone produced during pregnancy and should almost double every 48 hours in the beginning of a pregnancy. Human chorionic gonadotropin levels that do not rise appropriately may indicate a problem with the pregnancy).

Dr Kenis concludes: "Simvastatin adversely affects human first trimester trophoblast. These effects may contribute to failure of the implantation process and be deleterious to the growth potential of the placenta".

Statins increase the risk of birth defects, miscarriage and premature birth

This study was published in the British Journal of Obstetrics and Gynaecology 2012 Nov 30

 

Study title and authors:

Pregnancy outcome following maternal exposure to statins: a multicentre prospective study.

Winterfeld U, Allignol A, Panchaud A, Rothuizen L, Merlob P, Cuppers-Maarschalkerweerd B, Vial T, Stephens S, Clementi M, De Santis M, Pistelli A, Berlin M, Eleftheriou G, Maňáková E, Buclin T.

STIS and Division of Clinical Pharmacology, University Hospital, Lausanne, Switzerland.

 

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/23194157

The objective of the study was to investigate the risk associated with exposure to statins during pregnancy. The study collected observations from 249 statin-exposed pregnancies and 249 women not taking statins.

The study found:
(a) The statin-exposed women had a 50% increased risk of having a child with a major birth defect compared to the women not taking statins.
(b) The statin-exposed women had a 36% increased risk of having a miscarriage compared to the women not taking statins.
(c) The statin-exposed women had a 110% increased risk of having a premature birth compared to the women not taking statins.

The data from the study shows that statins increase the risk of birth defects, miscarriage and premature birth.

Women should not be prescribed statins as they fail to provide any overall health benefit

This article was published in the British Medical Journal 2007 May 12; 334(7601): 983 Study title and author:

Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No

Malcolm Kendrick, general practitioner

24 Prestwick Close, Tytherington, Macclesfield, Cheshire SK10 2TH

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1867901/?tool=pubmed

Dr. Kendrick believes there is little or no evidence of health benefits for women taking statins.

 

He makes the following observations:

(a) To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women.

(b) The primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women.

(c) Women should not be prescribed statins. Not only do statins fail to provide any overall health benefit in women, they represent a massive financial drain on health services. This money could be diverted to treatments of proved value.

(d) Statins carry a substantial burden of side effects.

(e) Mass medicalisation is a dangerous road with many psychological and societal consequences.

(f) In the Scandinavian simvastatin survival study three more women died taking statins than the women who took the placebo.

(g) In the studies of primary prevention neither total mortality nor serious adverse events have been reduced.

(h) A meta-analysis published in the Lancet found that statins even failed to reduce coronary heart disease events in women.

(i) Another meta-analysis of statins in primary prevention suggested that overall mortality may actually be increased by 1% over 10 years (in both men and women).

(j) Data from 124,814 women in 19 studies and trials found that cholesterol levels had no impact on total death rates and heart disease.

(k) Studies have suggested that side effects from statins may be much more common than is recognised.

(l) One study found that 80% of athletes could not tolerate statins.

(m) Research by Golomb and McGraw found that doctors often dismiss most (probable) statin related events. Patients who met the criteria for definite or probable adverse events reported that their doctors tended to dismiss symptoms, deny specific statins adverse events, and failed to appreciate the effect of the adverse reaction on their quality of life.

(n) More evidence comes from the US Food and Drug Administration adverse event reporting system. Between November 1997 and May 2004 simvastatin was reported as a direct cause of 49,350 adverse events and 416 deaths.Adverse events are greatly under-reported, so the actual figures are likely to be much higher.

(o) Of further concern, as statins are increasingly prescribed to younger women, is the potential for birth defects, with severe neurological abnormalities reported. Spending millions on a treatment that has no proved benefit and may cause serious harm goes against the rationale of evidence based prescribing.

 

Women should not be prescribed statins as they fail to provide any overall health benefit.

Statin use during pregnancy could lead to birth defects and malformations

This post includes a synopsis of a paper published in Prescrire international 2006 Feb;15(81):18-9

Study title:

Statins: beware during pregnancy
No authors listed

Books:

 

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/16548110

This review of statins and pregnancy found:
(a) Central nervous system and limb defects have been reported in newborns exposed to statins in the uterus. Several case reports describe malformations that are very rare in the general population.
(b) Animal toxicity studies also suggest that statins cause malformations of an embryo or fetus.
(c) The data suggests that statins should be avoided during pregnancy and that pregnant women exposed to cholesterol-lowering drugs should be monitored very closely.

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Statin exposure causes birth abnormalities

This post includes a synopsis of a paper published in the New England Journal of Medicine 350, 1579-82 2004

Study title and authors:
Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure
Robin J. Edison, M.D., M.P.H. Maximilian Muenke, M.D.
National Institutes of Health Bethesda, MD 20892-1852

Books:

This paper can be accessed at: http://www.nejm.org/doi/pdf/10.1056/NEJM200404083501524

The paper reviewed 52 cases of first-trimester statin exposure reported to the Food and Drug Administration (FDA).

The review found:
(a) Among these cases, there were 20 reports of malformation, including 5 severe defects of the central nervous system (2 of which were holoprosencephaly) and 5 unilateral limb deficiencies.
(b) One patient had both of these malformations. The two simvastatin-exposed cases of limb deficiency were complex lower-limb anomalies including both long-bone shortening and aplasia or hypoplasia of the foot structures. The infant in one of these cases and a lovastatin-exposed infant also had rare forms of the VACTERL association (i.e., three or more of the following findings: vertebral, anal, cardiac, tracheal, esophageal, renal, and limb defects).
(c) It is thought that only a small proportion of statin adverse events are reported to the FDA.
(d) There would be no expected cases of most of the malformations listed in the paper; yet three rare anomalies are each observed twice.

Dr Edison concludes that these findings support the need for controlled studies evaluating the potential birth defects effects of statin drugs.
 

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