Doxylamine Succinate/Pyridoxine Hydrochloride

TUESDAY, March 28, 2023 -- Adults exposed in utero to the antiemetic Bendectin (doxylamine/pyridoxine/dicyclomine), prescribed during pregnancy in the 1960s, have an increased risk for colorectal cancer (CRC), according to a study published online March 10 in JNCI Cancer Spectrum . Caitlin C. Murphy, Ph.D., M.P.H., from the University of Texas Health Science Center at Houston School of Public Health, and colleagues examined the association between in utero exposure to Bendectin and the risk for CRC in adult offspring (aged 18 years and older) from the Child Health and Development Studies multigenerational cohort, which included 14,507 mothers and 18,751 liveborn offspring. Overall, about 5 percent of offspring were exposed to Bendectin in utero. The researchers found that exposed offspring had a higher risk for CRC compared with unexposed offspring (adjusted hazard ratio, 3.38). For offspring exposed and unexposed to Bendectin, the incidence rates of CRC were 30.8 and 10.1 per 100,000, respectively. "Our findings suggest medications prescribed to pregnant women in the 1960s may, in part, contribute to recent increases in incidence rates of CRC. As the burden of CRC continues to increase in the U.S. and worldwide, well-conducted experimental studies will be critical to clarify these findings and identify mechanisms of risk," the authors write. "Testing for associations with in utero exposure to dicyclomine-containing medications still used during pregnancy may also be warranted." Two authors disclosed financial ties to the biopharmaceutical industry. Abstract/Full Text Posted March 2023

SAN FRANCISCO--( BUSINESS WIRE )--Today, Phil Inc ., a patient access platform company that revolutionizes life science product commercialization, announced that Duchesnay USA’s Bonjesta® (doxylamine succinate and pyridoxine hydrochloride), 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, is now available to be prescribed via its patient access platform. It is not known if Bonjesta ® is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. The most common side effect of Bonjesta ® is drowsiness. Phil’s customizable platform helps patients receive and refill medicines quickly, easily and affordably while giving life science companies unprecedented end-to-end visibility into the prescription life cycle. The platform offers a one-click system to submit prior authorizations and integrates seamlessly with technology systems already in place. Using the Phil platform, patients can easily access their prescription records, as well as receive assistance navigating insurance benefits. “ Phil can help streamline the prior authorization process for prescribers, which can help increase pull-through rates. By investing in a technology solution like Phil’s patient access platform, it is possible to simplify a complex prescription ecosystem and deliver positive outcomes to all stakeholders,” said Tanya Carro, Executive Vice President & General Manager, U.S. Operations, Duchesnay USA. “ We developed Phil’s technology platform to improve patients’ ability to navigate the complex systems related to prescription medications,” said Deepak Thomas, Founder and Chief Executive Officer at Phil, Inc. “ We are proud to work with Duchesnay USA, a leading pharmaceutical company specializing in women’s health, as aligning our efforts to offer providers and patients a streamlined experience can lead to reduced costs and improved health outcomes.” Learn more about Phil’s patient access platform . About Bonjesta® BONJESTA® 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. It is not known if BONJESTA® is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized. IMPORTANT SAFETY INFORMATION BONJESTA® is intended for use in pregnant women. It is not known if BONJESTA® is safe and effective in children under 18 years of age. Do not take BONJESTA® if you: are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in BONJESTA®. Please refer to the Patient Information leaflet for the complete list of ingredients; take monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate. Before taking BONJESTA®, tell your healthcare provider about all of your medical conditions, including if you: have asthma; have eye problems called increased intraocular pressure or narrow angle glaucoma; have a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction; have a bladder problem called urinary bladder-neck obstruction; are breastfeeding or plan to breastfeed. BONJESTA® can pass into your breast milk and may harm your baby. You should not breastfeed while using BONJESTA®. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should you take BONJESTA®? Talk to your healthcare provider about how much and when to take BONJESTA®. Take BONJESTA® everyday as prescribed by your healthcare provider. Do not stop taking BONJESTA® without talking to your healthcare provider first. Do not take more than 2 tablets (1 in the morning and 1 at bedtime) each day. Take BONJESTA® tablets whole on an empty stomach with a glass of water. If you take too much BONJESTA® (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, urination changes and build-up of fluid in the body. If you have these symptoms and they are severe, they may lead to death. If you take too much BONJESTA®, call your poison control center at 1-800-222-1222. What are the possible side effects of BONJESTA®? The most common side effect of BONJESTA® is drowsiness. Do not drive, operate heavy machinery, or do 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 BONJESTA®. Severe drowsiness can happen or become worse causing falls or accidents. BONJESTA® may cause an incorrect positive result for urine drug screening tests for methadone, opiates and PCP. These are not all the possible side effects of BONJESTA®. Call your doctor for medical advice about side effects. Keep BONJESTA® and all medicines out of the reach of children. Carefully read the storage instruction as detailed in the BONJESTA® Patient Information leaflet. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. About Duchesnay USA Duchesnay USA is a specialty pharmaceutical company with a long-standing commitment to women's health. The company focuses on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding. Duchesnay USA also commercializes a broad 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 various stages of their lives. For more information, visit duchesnayusa.com. About Phil, Inc. Phil, Inc. revolutionizes life science product commercialization with technology to improve prescription access. Our patient access platform removes barriers to medication access and ensures patients can seamlessly start and adhere to therapy. Providing end-to-end visibility into the prescription life cycle, we unlock coverage and maximize reimbursement for brands while integrating into the lives and workflows of patients and providers. We combine a Silicon Valley mindset and deep pharma expertise with data insights and software-driven platform customization to create exponentially better patient outcomes, improve provider experience and elevate brand value.