Duchesnay USA Partners with David and Christina Arquette to Shine a Spotlight on a Safe and Effective Morning Sickness Treatment [1,2]

In late 2016, with their second child on the way, David and Christina were taken aback by how different their first and second pregnancies were. While running around after their then two-year-old son, Christina experienced morning sickness, which lasted into her second trimester⁷.

"When we found out we were expecting our second son, I was over the moon!" recalls David Arquette, best known for his role in the Scream film series. "Christina had such an easy pregnancy with Charlie, but it became clear very quickly that this pregnancy was different. Around the five-week mark her morning sickness really kicked in⁷. I was shocked to see Christina feel worse in the evening, rather than in the morning. We called her nighttime sickness 'The witching hour.³'"

Christina was among the estimated up to 85% of pregnant women who experience morning sickness⁵. Unfortunately, many women see morning sickness as a pregnancy symptom, rather than as a medical condition. In fact, morning sickness is a real medical condition and in some cases, delaying treatment may cause symptoms to worsen¹. Approximately 3.4 of the four million pregnant women in the U.S. annually are affected by morning sickness⁶. Symptoms can start as early as at four to six weeks, which is usually before the first prenatal appointment⁷. 

"My morning sickness hit me like a ton of bricks – I was taking care of our toddler and trying to keep my pregnancy a secret, all while feeling constant nausea. It was really hard to keep my spirits up. David and I are avid cooks. Cooking is something that we have always had a lot of fun doing together, but when my morning sickness started, the smells in the kitchen triggered my nausea," said Christina. "It was really hard not to let my symptoms get the best of me. David was so supportive. We researched every morning sickness remedy in the book, but nothing was helping. That's when we consulted my doctor, who told me about Diclegis^®. Diclegis helped me manage my symptoms, enjoy my pregnancy and get back into the kitchen, which is the heart of our home^2,9."

Diclegis^® (doxylamine succinate, pyridoxine hydrochloride) is the only FDA-approved prescription medication for morning sickness after diet and lifestyle changes have failed. Diclegis^® has not been studied in women with hyperemesis gravidarum. The most common side effect of Diclegis^® is drowsiness².

"We are excited to be partnering with Duchesnay USA to inform women and their loved ones about a morning sickness treatment option. Pregnancy shouldn't be an individual journey, but a shared one, and that includes morning sickness. Don't let your pregnant partner suffer in silence! Remember, there is help available². Be your partner's advocate and encourage her to talk to her doctor — you're in it together!" advises David.

"We are very excited to have David and Christina Arquette join our "Don't Suffer in Silence" campaign to help raise awareness for morning sickness and provide expectant mothers with information about an available treatment option²," stated Dean Hopkins, Duchesnay USA's General Manager. "David and Christina's journey embodies what many couples experience and we believe that their addition to the Duchesnay USA family will prompt couples to support each other and speak to their healthcare professionals about morning sickness."
For more information about morning sickness and Diclegis^®, please visit www.Diclegis.com.
For U.S. Residents Only.

Indication and Important Safety Information

Indication
Diclegis^® is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.

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 inhibitors (MAOIs), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Diclegis^®.

The most common side effect of Diclegis^® is drowsiness. Do not drive, operate heavy machinery, or participate in other activities that need your full attention unless your healthcare provider says that you may do so.

Do not drink alcohol, or take other CNS depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis^®. Severe drowsiness can happen or become worse causing falls or accidents.

Diclegis^® should be used with caution in women who have certain medical conditions, such as asthma, or eye, stomach or bladder problems. Tell your healthcare provider about all of your medical conditions so he/she can assess if Diclegis^® is right for you.

It is not known if Diclegis^® is safe and effective in children under 18 years of age. Keep Diclegis^® and all medicines out of the reach of children.

Diclegis^® is a delayed-release formulation, so signs of overdose may not appear right away. If you take too much Diclegis^® (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis^®, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

Diclegis^® is intended for use in pregnant women.

Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis^® can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis^®.

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 additional important safety information, please see full Prescribing and Patient Information at www.diclegis.com. This information is not intended to replace discussions with your healthcare provider.

About Nausea and Vomiting of Pregnancy (NVP)

Nausea and vomiting of pregnancy (NVP), or "morning sickness", affects up to 85 percent of pregnant women^1,5. NVP can present differently for each woman. Symptoms may include nausea, gagging, retching, dry heaving, vomiting, and odor and/or food aversion⁴. For most pregnant women, symptoms generally cease at approximately 16 to 20 weeks³. However, some women can experience symptoms throughout their pregnancy⁷.

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. Diclegis has proven to be a safe and effective treatment option for NVP and received Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby^2,8

About Duchesnay USA

Duchesnay USA is a specialty pharmaceutical company with a long-standing commitment to women's health. Until recently, we focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe for use during pregnancy and breastfeeding.

Today, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives.

For more information about Duchesnay USA, please visit www.DuchesnayUSA.com.

References:

1. Nausea and Vomiting of Pregnancy, ACOG Practice Bulletin #153: Clinical Management Guidelines for Obstetrician-Gynecologists 2015; 126, 3:e12-e24. 
2. Diclegis Prescribing Information. Duchesnay USA. 2013. 
3. 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. 
4. Clark S, Costantine M, Hankins GDV. Review of NVP and HG and early pharmacotherapeutic Intervention. Obstetrics and Gynecology International Volume.2012. 
5. 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. 
6. Centers for Disease Control and Prevention (CDC). (2016). "Births and Natality." Retrieved from: https://www.cdc.gov/nchs/fastats/births.htm 
7. Vellacott, I. D., et al. (1988). "Nausea and vomiting in early pregnancy." Int J Gynecol Obstet 27 (1): 57–62. 
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, Shannon; Hughes, Barbara; McDonald, Susan Schwartz. Obstetrical & Gynecological Survey. 68(9):S1-S10, September 2013.

SOURCE Duchesnay USA

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