Prescription Treatment Hits Pharmacies for More Than 30,000 Pregnant Women Who Suffer from Nausea and Vomiting of Pregnancy (NVP) in Puerto Rico[1],[2],[3],[4],[5]
ROSEMONT, Pa., April 9, 2015 /PRNewswire/ -- Duchesnay USA announced today the market introduction of Diclegis® (doxylamine succinate and pyridoxine hydrochloride) Delayed-Release Tablets in pharmacies throughout Puerto Rico. Diclegis was approved by the U.S. Food and Drug Administration (FDA) in April 2013, and is the only prescription treatment indicated for nausea and vomiting of pregnancy (NVP),6 more commonly known as morning sickness.7
Diclegis offers pregnant women suffering from morning sickness a safe and effective option for reducing symptoms of nausea, retching and vomiting when conservative management, such as diet modifications, have failed.6 The FDA granted Diclegis with the best rating available, Pregnancy Category A, which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.6,8
"Duchesnay USA is excited to expand the availability of Diclegis to Puerto Rico. Now, more pregnant women and healthcare professionals can benefit from this safe and effective therapy," said Dean Hopkins, General Manager of Duchesnay USA.
Morning sickness is a medical condition that affects 70 to 85 percent of pregnant women,2,3,4,5 with symptoms ranging from mild to severe nausea and vomiting[9] that can occur throughout the day.5
The two active ingredients in Diclegis that help reduce symptoms of nausea and vomiting – doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6)6 – continue to be recommended as a first-line pharmacotherapy for morning sickness treatment by the American Congress of Obstetricians and Gynecologists (ACOG)7 and the Association of Professors of Gynecology and Obstetrics (APGO).10
Pregnant women prescribed Diclegis should take two tablets at bedtime every day. If symptoms are not adequately controlled, the dose can be increased over a period of three days as described in the Full Prescribing Information to a maximum recommended dose of four tablets daily – one in the morning, one mid-afternoon and two at bedtime. Diclegis is to be taken as a daily prescription and not on an as needed basis to help control symptoms throughout the day.6
Diclegis® is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
Diclegis has not been studied in women with hyperemesis gravidarum.
Important Safety Information
Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase (MAO) inhibitors, as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Diclegis. Use of MAOs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.
The most common side effect of Diclegis is drowsiness. You should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis until cleared to do so by your healthcare provider.
Do not take Diclegis with alcohol or sedating medicines, including other antihistamines (present in some cough and cold medications), opiates, or sleep aids, because severe drowsiness can happen or become worse, causing falls or accidents.
Diclegis should be used with caution in women who have: (1) asthma, (2) increased pressure in the eye, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction.
Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis in children younger than 18 years have not been established.
Diclegis is a delayed-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. If you suspect an overdose or seek additional overdose information, you can contact a poison control center at 1-800-222-1222.
The FDA granted Diclegis Pregnancy Category A status, which means that the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
Women should not breast-feed while using Diclegis because the antihistamine component (doxylamine succinate) in Diclegis can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Diclegis resulting in worsening of their apnea or respiratory conditions.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full prescribing information, please visit www.diclegis.com.
About Nausea and Vomiting of Pregnancy (NVP)
Nausea and vomiting of pregnancy (NVP), or morning sickness, affects 70 to 85 percent of pregnant women.2,3,4,5 NVP can present differently for each woman; the symptoms include nausea, gagging, retching, dry heaving, vomiting, and odor and/or food aversion.9 For most pregnant women, symptoms generally cease at approximately 16 to 20 weeks.4 However, some women can experience symptoms throughout their pregnancy.5
About Diclegis
Diclegis (doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg) Delayed-Release Tablets are the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.6 Diclegis has proven to be a safe and effective treatment option for NVP, and received a Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby.6,8
About Duchesnay USA
Duchesnay USA is a unique healthcare company devoted to safeguarding the health and well-being of expectant mothers and their unborn babies. Its affiliate company, Duchesnay Inc., was founded in 1970 in Canada. The family-owned company realigned its business in 1992 to focus specifically on pregnant women after a family member experienced a very difficult pregnancy. Duchesnay USA was established in Rosemont, Pennsylvania in 2011 to pursue that same mission. Realizing a lack of sufficient information on medications for use in pregnancy, Duchesnay USA strives to ensure that expectant women who require pharmacological treatments have access to evidence-based medical information and therapies that are safe for them and their unborn babies. Duchesnay USA's mission is to develop pharmacological solutions to reduce the symptoms of nausea and vomiting during pregnancy (NVP). For more information on Duchesnay USA, please visit www.DuchesnayUSA.com.
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[2] Jewell, D, Young, G. Interventions for Nausea and Vomiting in Early Pregnancy. The Cochrane Library. 2002; 1
[3] Medalie, J. Relationship between Nausea and Vomiting in Early Pregnancy and/or Abortion. The Lancet. 1957; 117-119.
[4] Whitehead, SA, Andrews, LR, Chamberlain, VP. Characterisation of Nausea and Vomiting in Early Pregnancy: A Survey of 1000 Women. Journal of Obstetrics and Gynaecology. 1992; 12: 384-369
[5] Gadsby, R, Barnie-Adshead, A, Jagger, C. A Prospective Study of Nausea and Vomiting During Pregnancy. British Journal of General Practice. 1993; 43: 245-248.
[6] Diclegis® (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets. Full Prescribing Information. Bryn Mawr, PA: Duchesnay USA, Inc.; 2013.
[7] American College of Obstetricians and Gynecologists. Nausea and Vomiting of Pregnancy. ACOG Practice BulletinNo. 52. 2004;103(4):803-15..
[8] Department of Health and Human Services, Food and Drug Administration. Content and Format Of Labeling For Human Prescription Drug And Biological Products; Requirements For Pregnancy And Lactation Labeling. Federal Register. 2008; 73 (104):30831-68.
[9] Clark S, Costantine M, Hankins GDV. Review of NVP and HG and Early Pharmacotherapeutic Intervention. Obstetrics and Gynecology International Vol. 2012.
[10] Association of Professors of Gynecology and Obstetrics. Nausea and Vomiting of Pregnancy. APGO Continuing Series on Women's Health Education. February 2015. Available at: https://www.apgo.org/images/nvp/nvp_monograph_021015_final.pdf. Accessed on February 23, 2015
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