April 10, 2013
FDA Approves Morning Sickness Pill 30 Years After Being Deemed Unsafe
redOrbit Staff & Wire Reports - Your Universe Online
A drug pulled from pharmacies three decades ago following accusations that it was responsible for causing birth defects has now become the only US Food and Drug Administration (FDA)-approved treatment for morning sickness, according to various media reports published Tuesday.
The medication is known as Diclegis, and according to MedPageToday Staff Writer Nancy Walsh it is a combination of vitamin B6 and an antihistamine. More specifically, it is “a delayed-release formulation of pyridoxine” and doxylamine, which is a common ingredient in over-the-counter sleep aids. Diclegis is “intended for use by women with persistent symptoms that have not responded to conservative management,” Walsh added.
Liz Neporent of ABC News, reported the pill was originally released in 1956 under the name Bendectin. It was prescribed to an estimated 33 million women worldwide, but over the years it became the target of hundreds of lawsuits from women claiming the medication had caused birth defects in their children. The original distributor of the drug, Merrell Dow, opted to discontinue sales of Benedctin in 1983.
Studies eventually concluded that the drug did not increase the baseline risk for birth defects, which the US Centers for Disease Control and Prevention (CDC) reports occurs in one in 33 babies, Neporent said.
Walsh added that the FDA published a notice in the Federal Register in 1999 stating that an internal review had found that the drug had not been withdrawn due to concerns over its safety or efficacy.
On Monday, the FDA cleared the way for Diclegis — a new version of the drug — to once again go on sale in the US. The drug, which is manufactured by Duchesnay USA, received the FDA's Pregnancy Category A status, which Neporent explains “is reserved for pharmaceuticals that have failed to show risk to the fetus during well-controlled human trials.” It is expected to become available sometime this June.
“Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle,” Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the FDA´s Center for Drug Evaluation and Research, said in a statement. “Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms.”
The drug was studied in 261 women at least 18 years old, each of whom had been pregnant for seven to 14 weeks and had been experiencing symptoms of morning sickness, including nausea and vomiting. Each was randomly assigned to receive two weeks of treatment with either Diclegis or a placebo, the FDA said. The women taking the newly-approved medication showed greater improvement in nausea and vomiting versus those taking placebo.
“Diclegis is taken daily. Tablets must be taken whole on an empty stomach,” the US health agency said. “The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime).”
“Nausea and vomiting due to pregnancy usually improve after the first trimester. Health care professionals should reassess their patients for continued need for Diclegis as pregnancy progresses,” they added. “Drowsiness or sleepiness, which can be severe, is the most common side effect reported by women taking Diclegis. Women should avoid using Diclegis when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.”