Big news this week when the FDA announced approval of Diclegis for morning sickness.
Who will use it? The FDA has approved the use of Diclegis for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is the only FDA-approved treatment for “morning sickness” in over 30 years.
Does it hurt the baby? Listen up! Diclegis was granted Pregnancy Category A status indicating that results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
Does it work? Diclegis was approved based on a 15 day trial studying pregnant women during their 7th – 14th week of gestation with nausea and vomiting from pregnancy. Treatment with Diclegis resulted in significantly larger improvement in symptoms compared to placebo.
When can you get it? Diclegis will be available as a combination delayed-release tablet containing 10mg of doxylamine succinate and 10mg of pyridoxine HCL and is expected to hit the market by the end of May 2013.