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bendectin the information provided on this www.bendectin.com site provides generally accepted medical and scientific conclusions regarding the history of bendectin. the information provided is solely for educational purposes and is not intended to favor any one party's interpretation, opinion or position regarding the practice of medicine, the science or any other issue that may or may not have been controversial over the years. information contained on this site is not meant to replace the independent advice of any healthcare practitioner and anyone having medical questions should speak with their physician to determine the best course of action for their unique circumstances. [read the full disclaimer] home bendectin history bendectin: the genesis bendectin was developed in the mid-1950s by the wm. s. merrell company of cincinnati, ohio, from pharmaceutical ingredients that had been individually marketed for many years. it was indicated specifically for nausea and vomiting of pregnancy. the product was approved by the fda in 1956. 1 the original drug formulation contained three ingredients: doxylamine succinate (an antihistamine), which has antinauseant and antiemetic properties, pyridoxine hydrochloride (vitamin b 6 ) and dicyclomine hydrochloride (an antispasmodic). 2 in 1975, the efficacy of each ingredient of multi-ingredient medications marketed between 1938 and 1962 had to be re-evaluated to ascertain that the drugs meet the efficacy requirement contained in the amended food, drug, and cosmetic act. consequently bendectin was submitted to this retrospective review - known as the desi process (drug effectiveness study implementation) - which was conducted by the national academy of sciences and the fda). 17 following an 8-way study, bendectin was reformulated in 1976 to contain only the two active ingredients (doxylamine, pyridoxine) that demonstrated efficacy to treat nvp. therefore the third ingredient, (dicyclomine, for which no benefits were observed), was removed from the original formulation. 3 bendectin became the leading treatment for nausea and vomiting of pregnancy (nvp) in the usa and in many other parts of the world under different trade names: as debendox in the uk and australia, as lenotan in germany and switzerland as well as in other countries of europe, south america and africa. the product maintained its status as the only antinauseant and antiemetic for nvp through 27 years and was used by more than 33 million pregnant women worldwide. in the 1980 annual national ambulatory medical care survey (namcs), bendectin accounted for 82 percent of 584,452 antiemetic prescriptions used to treat nvp in the u.s. 2 the delayed-release combination of doxylamine and pyridoxine is currently available in canada under the brand name of diclectin®, where it is manufactured by duchesnay inc.. 4 the canadian family-owned company has continued studying the safety and effectiveness aspects of the doxylamine-pyridoxine combination through surveillance programs and studies, including child neurodevelopment outcomes. 32 back to top bendectin: the litigation bendectin's legal saga started in the usa in the late 1970s with the first allegations regarding possible teratogenicity with bendectin. the first case that received wide publicity was the mekdeci case, which alleged that bendectin resulted in a birth defect called poland syndrome (a deficit in the pectoralis muscle) was filed in 1977. 1 some studies had emerged in the late 1970s and early 1980s, which associated bendectin to some specific malformations. 5,6,7,8 following an article published in the national enquirer (1979) 9 which stated that bendectin could cause birth defects, many women wanted to abort their pregnancies. following this article, the fda issued a fda talk paper on bendectin, which was helpful to physicians and patients by stating that "the current physicians labelling for the drug reflects the fda's evaluation that there is no adequate evidence linking bendectin with an increased risk of birth defects." 10 a series of lawsuits involving the safety of bendectin in pregnancy followed throughout the 1980s, which again attracted widespread media and public attention. 3 a number of large epidemiological studies, many of which were reviewed in a 1983 article 11 and in two meta-analyses 12,15 have exonerated bendectin and found no measurable teratogenic effect. in september 1980, the fda convened a panel of independent experts to review the available scientific information and address the confusion and concern caused by the court cases involving bendectin. the committee concluded that the existing data did not show an association between bendectin and human birth defects. 13 subsequently, the fda and other regulatory agencies (canada, uk, germany, switzerland) continued to monitor the scientific evidence on bendectin. 13 although the fda panel concluded that there were no association between bendectin and birth defects 13 , and despite that no known association between the use of bendectin and birth defects was established in any of the legal cases, merrell dow pharmaceuticals ceased production of bendectin worldwide in 1983, as their soaring legal and liability insurance costs eclipsed sales. 14 the drug remained approved by the fda and continues to be used in canada under the trade name diclectin®. in addition to the fda, other national health agencies responsible for drug safety (canada, uk, australia, germany and switzerland) had reviewed the scientific evidence on bendectin safety and had issued public statements indicating that the evidence did not demonstrate a connection between the use of bendectin during pregnancy and birth defects. subsequent to the 1980 fda panel meeting, the fda continued to monitor the scientific evidence of bendectin. in 1989, the cases in the us federal court system (750 separate cases with 1,100 claimants) were consolidated by the judicial panel on multidistrict litigation into one action (mdl-486) with merrell dow as the defendant in the federal court in cincinnati, ohio. following unsuccessful settlement discussions, the case went to the jury which ruled in the company's favor. the verdict was upheld on two appeals. 16 in spite of the lack of scientific evidence showing that bendectin could be teratogenic, a number of other cases followed. 1 in the late 1980s, following scientific fraud complaints against dr. william griffith mcbride, he was convicted of scientific fraud and ultimately struck in 1993 from the australian register of medical practitioners for deliberately falsifying data. 17 dr. mcbride is the australian obstetrician and gynaecologist who took the stand in the 1980s as an expert witness in several highly publicized u.s. cases and raised doubt about the safety of bendectin based on the “debendox experiment” he claimed to have performed but which later was proven to be false. 17 the seminal u.s. supreme court case involving bendectin is daubert v. merrell dow, 509 u.s. 579 (1993) . 18 daubert established a standard for admissibility of scientific testimony in courts of law in the u.s. in that case, plaintiffs alleged that bendectin - which had been manufactured by merrell dow pharmaceuticals, inc. - caused limb reduction birth defects. plaintiffs' experts, through what was ultimately deemed to be "junk science", failed to present any study in support of plaintiffs' theory that bendectin could cause malformations in human fetuses. 18 dr. mcbride had been on of the plaintiffs' expert witnesses. 19 the daubert decision is known well by lawyers and legal scholars, because it became a landmark case and it changed the standards for determining the admissibility of expert testimony and scientific evidence in the u.s. federal court civil system cases. 18 back to top bendectin: following discontinuation two separate meta-analyses were published by einarson et al in 1988 12 and by mckeigue et al in1994 15 , which included over 200,000 pregnanci

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Domain Name: BENDECTIN.COM
Registry Domain ID: 1740712204_DOMAIN_COM-VRSN
Registrar WHOIS Server: whois.rebel.ca
Registrar URL: http://www.rebel.ca
Updated Date: 2018-06-06T14:10:38Z
Creation Date: 2012-08-25T18:39:41Z
Registry Expiry Date: 2018-08-25T18:39:41Z
Registrar: Rebel.ca Corp.
Registrar IANA ID: 735
Registrar Abuse Contact Email: [email protected]
Registrar Abuse Contact Phone: 1-866-620-7111
Domain Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited
Domain Status: clientUpdateProhibited https://icann.org/epp#clientUpdateProhibited
Name Server: NS10.DNSMADEEASY.COM
Name Server: NS11.DNSMADEEASY.COM
Name Server: NS12.DNSMADEEASY.COM
Name Server: NS13.DNSMADEEASY.COM
Name Server: NS14.DNSMADEEASY.COM
Name Server: NS15.DNSMADEEASY.COM
DNSSEC: unsigned
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  REGISTRAR Rebel.ca Corp.

SERVERS

  SERVER com.whois-servers.net

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DOMAIN

  NAME bendectin.com

  CHANGED 2018-06-06

  CREATED 2012-08-25

STATUS
clientTransferProhibited https://icann.org/epp#clientTransferProhibited
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NSERVER

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  NS14.DNSMADEEASY.COM 208.80.127.4

  NS15.DNSMADEEASY.COM 208.94.149.4

  REGISTERED yes

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