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  • January 09, 2017 9:02 AM | Deleted user

    THURSDAY, Jan. 5, 2017 -- A drug commonly prescribed to ease the nausea of morning sickness may not be as effective as once believed, a new analysis suggests.

    Diclectin has been prescribed for millions of pregnant women for years. But an unpublished study from the 1970s used by the U.S. Food and Drug Administration and Health Canada to approve the drug may have overstated its benefits, the Canadian researchers behind the new research said.

    Study co-author Dr. Nav Persaud, a family physician at St. Michael's Hospital in Toronto, said the earlier study's data about the effectiveness of Diclectin is shaky at best.

    "We found two main problems with the [unpublished] study. Data was missing for 31 percent of participants. There are questions about the integrity of the data," Persaud said.

    "The approval and prescribing of this medication are based on this study. The decision to approve this medication should be revisited. The prescribing of the medication should be revisited," Persaud added.

    However, one gynecologist who has been prescribing Diclectin for years thinks the new analysis adds nothing new about the drug's effectiveness.

    "Women prescribed Diclectin should not be worried," said Dr. Mitchell Kramer, chairman of obstetrics and gynecology at Northwell Health's Huntington Hospital, in New York.

    "The comments about the study are of no value," he said. "They will not alter my use of Diclectin, nor would I recommend people use this critique as a guideline."

    Another gynecologist was less strident.

    "The safety of Diclectin has been established, but there is a question about efficiency, so more studies are needed," said Dr. Jennifer Wu. She is an obstetrician/gynecologist at Lenox Hill Hospital in New York City.

    According to Kramer, the two ingredients in Diclectin are pyridoxine, which is vitamin B6, and doxylamine, a sleep aid found in the over-the-counter medicine Unisom.

    "Diclectin is very safe and effective for nausea and vomiting in pregnancy," he said.

    The most common side effect is fatigue or sleepiness, but most people tolerate it very well, he said. "We prefer using it over some of the other anti-nausea medications," he added.

    Kramer said he doesn't think new trials are needed, but a well-done study that shows which drug is most effective for morning sickness would be welcome and helpful.

    However, Wu also noted that Diclectin is an expensive drug.

    "Patients say it's over $100, and they complain about the cost. Some patients take vitamin B6 and Unisom separately. We need to know why the cost is so high when each component is so inexpensive," she said.

    In the analysis, Persaud and his colleague, Dr. Rujun Zhang, also from St. Michael's Hospital, contend that the original study was deeply flawed, which may be why it was never published in a medical journal.

    The Canadian researchers reviewed 36,000 pages of documents from the FDA, including the original study and a summary of the results. The investigators also obtained other documents from Health Canada through freedom of information requests.

    The original trial was done in 14 U.S. clinics among more than 2,300 women who experienced morning sickness during their first 12 weeks of pregnancy.

    The women were randomly assigned to eight groups, one of which was given a placebo and the other seven a variety of drugs, including Diclectin.

    Data from nearly 1,600 women was analyzed. More women rated the drugs as moderate or excellent, compared with those given a placebo. For Diclectin, 14 percent gave it a moderate or excellent rating.

    But Persaud said the 1970s study is rife with problems.

    For example, the final results are not available, and many women did not complete the trial, even though it lasted only one week.

    Another flaw, according to Persaud, is that outcomes are unavailable for 37 percent of women in the placebo group used as the basis for comparisons with the active drugs.

    Also, the method that doctors used to score morning sickness symptoms was not clear, he said.

    Persaud said he could not contact any of the original researchers, and many of them had died.

    The original study was conducted by the now shuttered Merrell-National Laboratories.

    Persaud's team published their analysis online Jan. 4 in PLOS One.

    More information

    Visit the American Pregnancy Association for more on morning sickness.

    Copyright © 2017 HealthDay. All rights reserved.

  • January 06, 2017 10:07 AM | Deleted user

    HealthDay News — For high-risk women, letrozole is more effective than aspirin for decreasing the incidence of moderate and severe early-onset ovarian hyperstimulation syndrome, according to a study published in the January issue of the American Journal of Obstetrics & Gynecology.

    Qingyun Mai, MD, PhD, from the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China, and colleagues compared the efficacy of letrozole with aspirin in primary prevention of early ovarian hyperstimulation syndrome in a prospective randomized trial. Data were included for 238 participants undergoing cryopreservation of the whole embryos after oocyte retrieval with at least one high-risk factor for ovarian hyperstimulation syndrome. After human chorionic gonadotropin triggering, experimental and control groups (119 participants in each) received five days of letrozole and aspirin. 

    The researchers found that women receiving aspirin versus letrozole had significantly higher incidence of ovarian hyperstimulation syndrome (90.2 versus 80.4%, respectively). The aspirin group also had significantly higher incidence of moderate and severe ovarian hyperstimulation syndrome (45.1 versus 25.0%). Compared with the aspirin group, the letrozole group had a significantly shortened duration of the luteal phase (8.1 ± 1.1 days versus 10.5 ± 1.9 days). The letrozole group had a significantly higher vascular endothelial growth factor level than the aspirin group (0.49 ± 0.26 versus 0.42 ± 0.22).

    "Letrozole was more effective than aspirin in decreasing the incidence of moderate and severe early-onset ovarian hyperstimulation syndrome," the authors write.

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    Original Post: MPR

  • January 03, 2017 11:23 AM | Deleted user

    Cresta Jones, MD will provide a live educational webinar on February 21, 2017. 

    APAOG Members: Be sure you are logged in to receive the member rate!

    Topic: Opiate use disorders and women’s health

    Learning Objectives:

    • Understand the significance of the opiate use disorder crisis in the United States as it applies to women’s health
    • Identify the pregnancy complications associated with opiate use disorder and chronic opiate use
    • Describe the treatment options for opiate use disorder in pregnancy
    • Understand the basic symptoms and treatment of neonatal opiate withdrawal syndrome

  • December 29, 2016 12:40 PM | Deleted user

    The awards process is the single most important means that APAOG has for recognizing PAs who have made significant contributions in women's health. Awards can be nominated at any time throughout the course of the year, but will be presented at the APAOG Reception at the AAPA National Conference (more information to come). 

    2017 Awards - Nominations due March 15, 2017!

    View the 2017 Awards Grid for full award details.

    • Preceptor Award

    • Outstanding PA in Women's Health Award
    • Student Award

    Questions concerning the awards process should be submitted to

  • December 20, 2016 9:11 AM | Deleted user
    Dec. 8, 2016

    On December 7, the Senate followed the House of Representatives and passed the 21st Century Cures Act by an overwhelming majority. The bipartisan bill will now be sent to President Obama who has said he will sign the measure into law. The legislation will accelerate Food and Drug Administration (FDA) approved treatments, therapies, and drugs by modernizing FDA regulations considered by Congress to unnecessarily delay the approval of new drugs and devices. Additionally, the legislation provides $4.8 billion to the National Institutes of Health which covers support for the president’s Precision Medicine Initiative to drive research on the effects of genetics, lifestyle, and environment on disease, as well as support for Vice President Biden’s “Cancer Moonshot” initiative and increased research to improve understanding of diseases affecting the brain, such as Alzheimer’s. The bill also provides $1 billion in grants to states to combat opioid addiction and addresses the country’s mental health crisis.

    The role of PAs in mental healthcare is acknowledged for the first time in federal mental health policy through key mental health provisions of the soon-to-be law, such as:

    • Inclusion of PAs as high-need providers in mental healthcare through a required mental health strategic plan;
    • Including PAs who specialize in mental healthcare as members of advisory councils authorized by the Public Health Service Act;
    • Adding PAs with experience in treating serious mental illnesses or serious emotional disturbances as potential committee members to a federal Interdepartmental Serious Mental Illness Coordinating Committee;
    • Strengthening the mental and substance use disorders workforce by awarding grants to eligible entities to support training for PAs and other providers to offer integrated primary care, mental health, and substance use disorder treatment services in underserved areas; and
    • Requiring the Department of Health and Human Services (HHS) to identify model programs and materials for training PAs and other healthcare providers on permitted uses and disclosures of health information when caring for patients with mental illnesses.

    AAPA continues to seek clarification that PAs are also included in legislative provisions on peer review, mental and behavioral health education and training grants, the minority fellowship program, and increasing access to pediatric mental healthcare.

    Mental health system reforms passed by the House in July through the Helping Families in Mental Health Crisis Act were also part of the bill's package. In addition to strengthening the mental health workforce, these provisions are intended to reform the nation’s mental health delivery system by establishing a new assistant secretary for mental health within the HHS; creating a system to award grants based on evidence-based mental health and substance use treatment policy; evaluating privacy law to improve mental health treatment through increased communication among providers, families, and patients; and improving care for children and adults with serious behavioral and mental illness.

    AAPA worked closely with relevant House and Senate committees and members throughout the development of the mental health provisions in the bill, educating them on the interface of PAs in primary and other medical care with patients experiencing behavioral health issues, the increasing number of PAs who provide mental healthcare , and the valuable role of PAs in building the behavioral healthcare workforce.

    Read AAPA article here.

  • December 19, 2016 12:13 PM | Deleted user

    HealthDay News 
    Zika's ability to damage the infant brain may be even more far-reaching and insidious than previously thought, two new studies suggest. Analyzing data from the U.S. Zika Pregnancy Registry, researchers found that among 442 women possibly infected with Zika, 6 percent had infants with one or more birth defects related to Zika. Among women infected in the first trimester, 11 percent had fetuses or infants with birth defects. The 18 infants who developed microcephaly accounted for 4 percent of the infants with birth defects.


  • December 19, 2016 12:09 PM | Deleted user

    In a study published in Diabetes Care, researchers reported that the absolute risk of thromboembolism among women with type 1 or type 2 diabetes using hormonal contraceptives was low. Researchers conducted a study to evaluate the safety of hormonal contraception with regard to thromboembolic events in women with type 1 or type 2 diabetes. They analyzed data from 2002-2011 in the Clinformatics Data Mart to identify women in the U.S. aged 14-44 years old with an ICD-9-CM code for diabetes and a prescription for a diabetic drug or device.


  • December 19, 2016 12:08 PM | Deleted user
    Risk of hearing loss appears to be modestly higher in women who use acetaminophen or non-steroidal anti-inflammatory drugs - such as ibuprofen - for 6 years or more, compared with counterparts who use these painkillers for a year or less.

    older woman looking thoughtful
    Two thirds of women in the U.S. over the age of 60 report having some hearing loss.

    Researchers come to this conclusion in a study published in the American Journal of Epidemiology, in which they analyze the links between duration of painkiller or analgesic use and self-reported hearing loss in a large group of women in the United States.

    Senior author Gary Curhan, a Harvard Medical School professor and physician in the Channing Division of Network Medicine at Brigham and Women's Hospital in Boston, MA, says:

    "Although the magnitude of higher risk of hearing loss with analgesic use was modest, given how commonly these medications are used, even a small increase in risk could have important health implications."

    In the U.S., the use of analgesics such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDsis significant and more widespread than 2 decades ago.

    In 2010, around 43 million U.S. adults (19 percent) took aspirin regularly, and more than 29 million (12.1 percent) were regular users of NSAIDs. These numbers are considerably higher, at 57 and 41 percent, respectively, than they were in 2005.

    As many as two thirds of women in the U.S. over the age of 60 report some degree of hearing loss. Having previously reported a link between analgesic use and an increased risk of hearing loss in men, the researchers decided to look at women and focus on duration of painkiller use.

    Findings support a growing body of evidence

    For their new analysis, the researchers used data on 55,850 women enrolled in the Nurses' Health Study, one of the largest and longest running investigations into the health of U.S. women.

    Fast facts about hearing loss

    • In the U.S., an estimated 37.5 million adults (15 percent) report some trouble hearing
    • Nearly a quarter of those aged 65-74 and half of those aged 75 and older have disabling hearing loss
    • Men are more likely than women to report having hearing loss.

    Learn more about hearing loss

    They analyzed links between the women's self-reported hearing loss and their use of ibuprofen, acetaminophen, and aspirin.

    The results showed that prolonged use (lasting 6 years or more) of ibuprofen and acetaminophen was linked to a slightly higher relative risk of hearing loss, at 10 percent and 9 percent, respectively, in the women.

    The higher risk was relative to women who did not use the analgesics for more than a year.

    However, no such link was found for usual-dose aspirin use. The researchers note that hearing loss is a known side effect of high-dose aspirin use, but such dosages have become much less common in the last 2 decades.

    The findings support a growing body of evidence linking the use of NSAIDs or acetaminophen with hearing loss, although the underlying biological explanation is not known.

    Prof. Curhan says that, should the link be causal, then this would mean that about 16.2 percent of hearing loss occurring in the women that they studied could be due to their use of ibuprofen or acetaminophen.

    He and his colleagues urge caution in using their findings; the study was confined to a cohort of mainly white, older women. They say that studies of larger groups including other populations are needed in order to properly understand the link between painkiller use and hearing loss.

    "Hearing loss is extremely common in the U.S. and can have a profound impact on quality of life. Finding modifiable risk factors could help us identify ways to lower risk before hearing loss begins and slow progression in those with hearing loss."

    Prof. Gary Curhan

    Written by Catharine Paddock PhD

  • December 19, 2016 12:05 PM | Deleted user

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  • December 19, 2016 12:00 PM | Deleted user

    Written by Heather Punke 

    Becker's Hospital Review

    The CDC had a busy year in 2016, working on Zika, antibiotic resistance and more. The federal agency highlighted seven health threats it focused on in 2016 and looked ahead at to what's to come in 2017.

    1. Zika and pregnancy. The CDC was on alert for Zika since it swept through Brazil in the middle of 2015, and the agency jumped into action in 2016 when the virus spread to the U.S. It has kept Zika and pregnancy in focus in particular, as the virus has been linked to birth defects like microcephaly. For instance, the CDC established registries to track outcomes of pregnancies of women with Zika.

    "Although there has been much progress understanding and combating Zika, CDC's work is far from finished," the agency wrote. "Every day, we are learning more about Zika, and we will not stop fighting to protect pregnant women and all people from the devastating effects of this disease."

    2. Antibiotic resistance. In 2016, the CDC supported the National Strategy to Combat Antibiotic-Resistant Bacteria and funded state health departments to help screen for and tackle antibiotic resistance. The agency also released the Antibiotic-Resistance Patient Safety Atlas web app this year, which shows the types of resistance most common in states and regions. Next year, the CDC plans to launch an interactive map to show its investments in health departments, labs and healthcare partners. It will also describe nationwide activities that combat antibiotic resistance.

    3. Cancer. This year, the CDC updated its guidelines on who should receive the human papillomavirus vaccine to help prevent cancers caused by HPV infections. Moving forward, the agency plans to improve HPV vaccination coverage through public policy and clinical practice.

    4. Prescription drug overdose. The CDC issued guidelines for opioid prescription for chronic pain this year in hopes it would reduce the risk of opioid addiction and overdose. It also increased funding for state programs aimed at preventing opioid overdoses. The agency will continue to fund and focus on such programs next year.

    5. Global health security. According to the CDC, "[K]eeping America safe means stopping — or better still, preventing — health threats everywhere." This year, the agency wound down its Ebola response in March but made other advances globally — for instance, its Global Rapid Response Team has responded to 18 countries for diseases like cholera, yellow fever, Ebola, measles, polio and Zika. The agency will continue this work in 2017 and has committed to the milestones of the Global Health Security Agenda.

    6. Tobacco use. 2016 was the fifth year of the CDC's "Tips From Former Smokers" tobacco education campaign, in which Americans share personal stories relating to tobacco illnesses. The CDC plans to continue running TFFS ads in 2017.

    7. Rapid response to outbreaks. The CDC used advanced molecular detection technology this year to sequence the DNA of bacteria, viruses, parasites and fungi and then used supercomputers to discover molecular patterns to better understand diseases. The process helped identify a source of a Legionnaires' disease outbreak and is being used to map Zika virus strains. In 2017, the agency plans to build AMD capacity in state and local labs.

    "The agency continues to reflect on the lessons learned over the past year and is committed to helping make 2017 the nation's healthiest year yet," the agency wrote.

    To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.

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