Bendectin

Bendectin

Combination of
Pyridoxine	Vitamin B6
Doxylamine	H1 antagonist
Clinical data
Pregnancy cat.	?
Legal status	Withdrawn (US)
Routes	Oral
Identifiers
CAS number	99007-20-2
ATC code	?
PubChem	CID 163685
ChemSpider	10750 Y
Y(what is this?)  (verify)

Bendectin (known as Debendox in the UK and Diclectin in Canada) is a combination of pyridoxine (vitamin B₆) and doxylamine prescribed to treat nausea and vomiting of pregnancy or morning sickness.

History

In 1956, when the drug was introduced it also contained dicyclomine, a Pregnancy Category B antispasmodic that was later omitted. Bendectin was voluntarily removed from the market in 1983 by its manufacturer, Merrell Dow Pharmaceuticals, following numerous lawsuits alleging that it caused birth defects, although an FDA panel concluded that no association between Bendectin and birth defects had been demonstrated.^[1] In litigation, Bendectin was supposed to cause all kinds of fetal malformations and problems including limb and other musculoskeletal deformities, facial and brain damage, defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems, blood disorders and cancer.^[1] The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals (1993). These suits were led by plaintiff attorney Melvin Belli.^[2] The star witness for the case against Bendectin, William McBride, was later found to have falsified research on teratogenic effects of the drug, and was struck off the medical register in Australia.^[3][4]

Current status

The drug continues to be used in Canada (as Diclectin), and in Europe under the same name, and no subsequent epidemiological studies have found any teratogenic effect.^[5] The two ingredients of the drug are a vitamin (essential also during pregnancy) and a Pregnancy Category A drug, each available over the counter to pregnant patients in the US. An extensive review of the evidence submitted in legal proceedings regarding Bendectin has been summarized and found no evidence that the drug in clinical use was linked to birth defects.^[6]

Aftermath

The Bendectin case had a number of consequences aside from removing a medication that alleviated morning sickness in pregnant women - not a trivial matter as severe forms of hyperemesis gravidarum can be life-threatening. It has been claimed that subsequent to the Bendectin experience drug companies stayed away from developing medications for pregnant patients.^[7] As a result only two medications (oxytocin, cervidil) were approved between 1962 and 2010 for obstetrical indications by the FDA.^[7]

From a legal perspective, the case through Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) set a new standard for admitting expert testimony in federal courts in lieu of the Frye standard.

See also

• Daubert v. Merrell Dow Pharmaceuticals
• Daubert standard

References

1. ^ ^{a b} Jane E. Brody (1983-06-19). "Shadow of Doubt Wipes Out Bendectin". New York Times. http://query.nytimes.com/gst/fullpage.html?sec=health&res=9A02E6DC123BF93AA25755C0A965948260. 
2. ^ Korcok M (November 1980). "The Bendectin debate". Canadian Medical Association Journal 123 (9): 922–8. PMC 1704894. PMID 7437993. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1704894. 
3. ^ Thalidomide hero found guilty of scientific fraud — Article published in "New Scientist" on 27 February 1991
4. ^ Thalidomide doctor guilty of medical fraud — Article published in "The Independent" on 20 February 1993
5. ^ Kutcher JS, Engle A, Firth J, Lamm SH (February 2003). "Bendectin and birth defects. II: Ecological analyses". Birth Defects Research 67 (2): 88–97. doi:10.1002/bdra.10034. PMID 12769504. 
6. ^ Brent RL. "Bendectin: Review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen". Reproductive Toxicology, Vol. 9, No. 4, pp. 337-349, 1995. http://www.voteview.com/Bendectin_Tortogen_Litigen.pdf. 
7. ^ ^{a b} Wing DA, Powers B, Hickok D (April 2010). "U.S. Food and Drug Administration Drug Approval: Slow Advances in Obstetric Care in the United States". Obstetrics & Gynecology 115 (4): 825–33. doi:10.1097/AOG.0b013e3181d53843. PMID 20308845. 

External links

Bendectin from www.birthdefects.org

• http://www.birthdefects.org/research/bendectin_1.php on side effects listed worldwide
• http://www.birthdefects.org/research/bendectin_2.php
• http://www.birthdefects.org/research/bendectin_jop.php
• The History of Bendectin, from www.babyzone.com.