15-Apr-13 7:00 AM  CST

FDA Approves Diclegis for Nausea and Vomiting Associated with Morning Sickness

Recently the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride), a drug used to treat the symptoms of nausea and vomiting associated with pregnancy.  Diclegis is marketed by Duchesnay, Inc, and is currently the only drug approved by the FDA for this condition.  The drug was taken off of the market 30 years ago due to lawsuits filed by women that said the medication caused birth defects, however, the claims were untrue and the drug become one of the most often tested pregnancy drugs in the FDA’s Category A status.  Pharmacy technicians will recall that a Category A status for a drug is for medications that do not show any risks to a fetus when clinical trails were performed.


The most common side effects associated with Diclegis is drowsiness or sleepiness that may be quite severe in some patients.  Hylton V. Joffe, M.D.,M.M.Sc, director of the division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research recently commented on the approval of Diclegis.  “Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle.  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,” said Joffe. 


Pharmacy technicians should note that the recommended dose of Diclegis is two tablets at bedtime daily on an empty stomach.  If patients find that the recommended dose is not working for them then the dose can be increased to four tablets daily maximum.  The dose would be given once in the morning, one mid-afternoon, and two tablets should be taken at bedtime.  Interested pharmacy technicians can learn more about the new drug approval by going to www.diclegis.com


1.  Fischer, Andrea.  “FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting.”  FDA Press Release.  Web.  8 Apr 2013.   


2.  Neporent, Liz.  “FDA Approves Morning Sickness Drug Once Feared Unsafe.”  ABC News.  Web.  9 Apr 2013. 


3.  Duchesnay Press Release.  “FDA Approves Duchesnay USA’s Diclegis for Treatment of Nausea and Vomiting of Pregnancy (NVP).”  Duchesnay.  Web.  8 Apr 2013.  

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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