Duchesnay USA Partners with Country Music Singer and Actress Jana Kramer to Raise Awareness about a Safe and Effective Morning Sickness Treatment

Jana Kramer is one of country music's brightest stars and is known for her role as Alex Dupre on the television series One Tree Hill. This new mom is a woman of many talents. Last year, she spent months on the road touring and promoting her new album, Thirty One, and her single, I Got the Boy—all while pregnant and silently suffering from morning sickness.

"Going on tour pregnant with all-day "morning" sickness³ was no easy feat—it was a struggle to keep my energy and spirits up and my lunch down while powering through performances, photoshoots and interviews. Morning sickness is no joke and trying to hide it with a smile while walking the red carpet or hitting those notes on stage was even harder!" said Jana. "I loved being pregnant, but my morning sickness made that very challenging⁹."

Jana was among the estimated 70 to 85% of pregnant women who experience morning sickness⁵. Approximately 3.4 of the 4 million pregnant women in the U.S. are affected by morning sickness symptoms each year⁶. Symptoms can start as early as 4 to 6 weeks of pregnancy, which is usually prior to the first prenatal appointment⁷. Morning sickness is a real medical condition that requires appropriate treatment, since delaying treatment can make symptoms worse¹.

"Thankfully, I finally found relief after trying countless home remedies, including diet and lifestyle changes². I talked to my doctor about 9 weeks into my pregnancy and he told me about Diclegis^®. It helped me manage my symptoms and begin to enjoy my pregnancy journey. I am so excited to be working with Duchesnay USA and helping to empower women by letting them know that they don't have to suffer in silence! There is help available, so talk to your doctor—it can make all the difference," advises Jana.

Diclegis® (doxylamine succinate and pyridoxine hydrochloride) is the only FDA-approved and Pregnancy Category A 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 thrilled to welcome Jana Kramer to the Duchesnay USA family and look forward to connecting with her fans and empowering women across the country to speak to their healthcare providers about Diclegis®, a safe and effective treatment for morning sickness for women whose symptoms are not adequately controlled by diet and lifestyle changes²," stated Dean Hopkins, Duchesnay USA's General Manager.

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.

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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