History
The combination of doxylamine and vitamin B6 was first introduced to the US market as Bendectin in 1956. At that time, Bendectin was a 3 ingredients prescription medication. The third one, (dicyclomine- a Pregnancy Category B antispasmodic, was omitted from the formulation starting in 1976 due to its lack of efficacy. Bendectin (doxylamine/vitamine B6) 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 celebrity 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.
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.
The FDA, in 1999, published a statement in the Federal Register that summarized their opinion regarding the safety of pyridxine/doxylamine during pregnancy: “The FDA has determined that the drug product Bendectin, a tablet composed of pyridoxine hydrochloride 10 mg, and doxylamine succinate 10 mg, for the prevention of nausea during pregnancy was not withdrawn from sale for reasons of safety or effectiveness”
On Monday April 8th, 2013 the FDA approved the return of Bendectin under the new trademark name of Diclegis. The medication will be produced by Duchesnay Inc. The Canadian based manufacturer has made a generic version, Dicletin, for many years. Per media reports the medication will be available for sale in the U.S. market in late May 2013.
Read more about this topic: Pyridoxine/doxylamine
Famous quotes containing the word history:
“There is nothing truer than myth: history, in its attempt to “realize” myth, distorts it, stops halfway; when history claims to have “succeeded” this is nothing but humbug and mystification. Everything we dream is “realizable.” Reality does not have to be: it is simply what it is.”
—Eugène Ionesco (b. 1912)
“It takes a great deal of history to produce a little literature.”
—Henry James (1843–1916)
“History has neither the venerableness of antiquity, nor the freshness of the modern. It does as if it would go to the beginning of things, which natural history might with reason assume to do; but consider the Universal History, and then tell us,—when did burdock and plantain sprout first?”
—Henry David Thoreau (1817–1862)