Kim Kardashian West Found Morning Sickness Relief with Diclegis

Kim Kardashian West Found Morning Sickness Relief with Diclegis

Duchesnay USA encourages pregnant women to speak with their healthcare professional about the only FDA-approved prescription treatment for morning sickness

PR Newswire – Rosemont, PA. – July 20, 2015 – Duchesnay USA today expresses appreciation and well wishes to global celebrity Kim Kardashian West who announced on Instagram that she took Diclegis® (doxylamine succinate, pyridoxine hydrochloride) Delayed-Release Tablets for the treatment of Nausea and Vomiting of Pregnancy (NVP),1 more commonly known as morning sickness.2

Kim revealed on July 19: "OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby. I'm so excited and happy with my results that I'm partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com."

Diclegis is for pregnant women like Kim, who do not find symptom relief from conservative management, such as changes in diet or lifestyle. Diclegis is the only FDA-approved prescription medicine that is proven effective for treating morning sickness, and has been granted Pregnancy Category A status1 – the best rating granted by the FDA,3 for its safety.

"Kim Kardashian West has been vocal about her struggle with morning sickness and how it has interfered with her daily schedule, her work and her ability to spend time with her family," said Dean Hopkins, General Manager of Duchesnay USA. "We are proud that Diclegis helped her feel better during her pregnancy. Duchesnay USA applauds Kim for bringing greater awareness to nausea and vomiting of pregnancy, an often-downplayed medical condition, and for encouraging millions of pregnant women in America to talk to their healthcare professionals about safe and effective treatment options."

The Association of Professors of Gynecology and Obstetrics (APGO) recommends Diclegis, easily identifiable by the pregnant woman on the pill, as first-line pharmacotherapy.4

"The safety profile of Diclegis and its proven clinical effectiveness makes it the ideal treatment for women who are seeking morning sickness symptom relief. The active ingredients of Diclegis are the most studied for this purpose," said Dr. Shelly Leeds-Richter, MD Obstetrical and Gynecological Associates, PLLC.

Duchesnay USA, the maker of Diclegis, is committed to improving women's quality of life during pregnancy by providing women with safe and effective pharmacological treatments. In an effort to make Diclegis affordable, accessible and broadly available, the Diclegis Savings Offer enables most patients with commercial insurance coverage to pay as little as $30 for a prescription of Diclegis.

For more information about Diclegis, visit www.Diclegis.com.

Important Safety Information for Diclegis

Indication
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.5,6,7,8 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.7 However, some women can experience symptoms throughout their pregnancy.8

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.1 Diclegis is a safe and effective treatment option for NVP, and received a Pregnancy Category A status,1 which means the results of controlled studies have not shown an increased risk to an unborn baby.3

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.

Contact
Laney Cohen
Makovsky
[email protected]
212-508-9643

2015-0067-01

1Diclegis® (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets. Full Prescribing Information. Bryn Mawr, PA: Duchesnay USA, Inc.; 2013.
2American College of Obstetricians and Gynecologists. Nausea and Vomiting of Pregnancy. ACOG Practice Bulletin No. 52. 2004;103(4):803-15.
3Department 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.
4Association 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
5Jewell, D, Young, G. Interventions for Nausea and Vomiting in Early Pregnancy. The Cochrane Library. 2002; 1.
6Medalie, J. Relationship between Nausea and Vomiting in Early Pregnancy and/or Abortion. The Lancet. 1957; 117-119.
7Whitehead, 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.
8Gadsby, R, Barnie-Adshead, A, Jagger, C. A Prospective Study of Nausea and Vomiting During Pregnancy. British Journal of General Practice. 1993; 43: 245-248.
9Clark S, Costantine M, Hankins GDV. Review of NVP and HG and early pharmacotherapeutic Intervention. Obstetrics and Gynecology International Volume. 2012.

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