Bendectin
Encyclopedia
Bendectin is a combination of pyridoxine
(vitamin B6
) and doxylamine
prescribed to treat nausea
and vomiting
of pregnancy or morning sickness
.
, 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. 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. The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals
(1993). These suits were led by plaintiff attorney Melvin Belli
. 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.
can be life-threatening. It has been claimed that subsequent to the Bendectin experience drug companies stayed away from developing medications for pregnant patients. As a result only two medications (oxytocin
, cervidil) were approved between 1962 and 2010 for obstetrical indications by the FDA.
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
.
Pyridoxine
Pyridoxine is one of the compounds that can be called vitamin B6, along with pyridoxal and pyridoxamine. It differs from pyridoxamine by the substituent at the '4' position. It is often used as 'pyridoxine hydrochloride'.-Chemistry:...
(vitamin B6
Vitamin B6
Vitamin B6 is a water-soluble vitamin and is part of the vitamin B complex group. Several forms of the vitamin are known, but pyridoxal phosphate is the active form and is a cofactor in many reactions of amino acid metabolism, including transamination, deamination, and decarboxylation...
) and doxylamine
Doxylamine
Doxylamine is one of the many sedating antihistamines used by itself as a short-term sedative, and in combination with other drugs as a night-time cold and allergy relief drug...
prescribed to treat nausea
Nausea
Nausea , is a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit. It often, but not always, precedes vomiting...
and vomiting
Vomiting
Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose...
of pregnancy or morning sickness
Morning sickness
Morning sickness, also called nausea gravidarum, nausea, vomiting of pregnancy , or pregnancy sickness is a condition that affects more than half of all pregnant women. Related to increased oestrogen levels, a similar form of nausea is also seen in some women who use hormonal contraception or...
.
History
In 1956, when the drug was introduced it also contained dicyclomineDicyclomine
Dicyclomine, also known as dicycloverine, is an anticholinergic that blocks muscarinic receptors. Dicycloverine was first synthesized in the United States circa 1947.- Clinical uses :...
, a Pregnancy Category
Pregnancy category
The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast...
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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
panel concluded that no association between Bendectin and birth defects had been demonstrated. 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. The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals
Daubert v. Merrell Dow Pharmaceuticals
Daubert v. Merrell Dow Pharmaceuticals, is a United States Supreme Court case determining the standard for admitting expert testimony in federal courts...
(1993). These suits were led by plaintiff attorney Melvin Belli
Melvin Belli
Melvin Mouron Belli was a prominent American lawyer known as "The King of Torts" and by detractors as 'Melvin Bellicose'. He had many celebrity clients, including Zsa Zsa Gabor, Errol Flynn, Chuck Berry, Muhammad Ali, Sirhan Sirhan, the Rolling Stones, Jim Bakker and Tammy Faye Bakker, Martha...
. 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.
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. 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.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 gravidarumHyperemesis gravidarum
Hyperemesis gravidarum is a severe form of morning sickness, with "unrelenting, excessive pregnancy-related nausea and/or vomiting that prevents adequate intake of food and fluids." Hyperemesis is considered a rare complication of pregnancy but, because nausea and vomiting during pregnancy exist...
can be life-threatening. It has been claimed that subsequent to the Bendectin experience drug companies stayed away from developing medications for pregnant patients. As a result only two medications (oxytocin
Oxytocin
Oxytocin is a mammalian hormone that acts primarily as a neuromodulator in the brain.Oxytocin is best known for its roles in sexual reproduction, in particular during and after childbirth...
, cervidil) were approved between 1962 and 2010 for obstetrical indications by the FDA.
From a legal perspective, the case through Daubert v. Merrell Dow Pharmaceuticals
Daubert v. Merrell Dow Pharmaceuticals
Daubert v. Merrell Dow Pharmaceuticals, is a United States Supreme Court case determining the standard for admitting expert testimony in federal courts...
, 509 U.S. 579 (1993) set a new standard for admitting expert testimony in federal courts in lieu of the Frye standard
Frye Standard
The Frye standard, Frye test, or general acceptance test is a test to determine the admissibility of scientific evidence. It provides that expert opinion based on a scientific technique is admissible only where the technique is generally accepted as reliable in the relevant scientific community. In...
.
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.