The United States Food and Drug Administration last week granted approval of the use of Diclegis for the treatment of nausea and vomiting of pregnancy in women suffering from NVP (Nausea Vomiting Pregnancy) commonly known as morning sickness. This is the only FDA-approved treatment for morning sickness, in more than 30 years, since the drug was removed from use by the FDA.
“It’ an old but new drug,” explained Dr. Shannon Clark in an interview with Guidry News Service. Listen (11:20)
“It’s composed of two components, pyridoxine hydrochloride, which is Vitamin B6, and you can get that over the counter; and then also doxylamine succinate, which is an antihistamine and you can also get that over the counter as Unisom.”
The drug was removed from the market in 1983 based on concerns that it caused birth defects. That concern proved unfounded and the FDA has reversed the ban.
The two components of Diclegis, available over the counter in the United States, have continued to be prescribed for treatment of morning sickness by doctors; and the drug, under the name Diclectin, has been in use in Canada throughout the years.
“We’ve been without anything in the United States that’s FDA approved or indicated for nausea, vomiting and pregnancy since 1983,” Dr. Clark said, adding that during the last three decades there has been an increase in hospitalizations for pregnant women with nausea. “So, around 2008 and 2009, we spoke with the big guys, researchers in Canada and we decided to do a trial here of Diclectin in the United States with the hopes of getting the drug back on the market and available to U.S. women.”
The study was designed by Dr. Gideon Koren, who Dr. Clark calls a “kind of guru of nausea, vomiting and pregnancy”, and included participation by UTMB, Georgetown University in Washington, D. C, and MaGee-Women’s Hospital in Pittsburgh. Dr. Gary Hankins of UTMB was the lead investigator at all three sites.
The study included 131 women who received Diclectin and 125 who received placebos in a randomized, double-blind placebo-controlled 15-day study.
“One of the ways we used to assess how severe these women were affected with nausea, vomiting and pregnancy was something called the PUQE Score,” she said, explaining that the term was coined by Dr. Koren. “It stands for pregnancy-unique quantification of emesis.”
Dr. Clark said the study satisfied the concerns of the FDA and Diclegis should be available to pregnant women soon.
“It’s FDA approved, Category A, specific indication of pregnancy for nausea and vomiting in pregnancy,” she said. “It will be available probably sometime this summer.”