Category Archives: Women’s Health

Oral antibiotics may raise risk of kidney stones

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Paediatric researchers have found that children and adults treated with some oral antibiotics have a significantly higher risk of developing kidney stones.

This is the first time that these medicines have been linked to this condition. The strongest risks appeared at younger ages and among patients most recently exposed to antibiotics.

“The overall prevalence of kidney stones has risen by 70 percent over the past 30 years, with particularly sharp increases among adolescents and young women,” said study leader Dr Gregory E. Tasian, a paediatric urologist at Children’s Hospital of Philadelphia (CHOP). Dr Tasian noted that kidney stones were previously rare in children.

Study co-author Dr Michelle Denburg, a paediatric nephrologist at CHOP, added, “The reasons for the increase are unknown, but our findings suggest that oral antibiotics play a role, especially given that children are prescribed antibiotics at higher rates than adults.”

The study team drew on electronic health records from the United Kingdom, covering 13 million adults and children seen by general practitioners in the Health Improvement Network between 1994 and 2015. The team analysed prior antibiotic exposure for nearly 26,000 patients with kidney stones, compared to nearly 260,000 control subjects.

They found that five classes of oral antibiotics were associated with a diagnosis of kidney stone disease. The five classes were oral sulfas, cephalosporins, fluoroquinolones, nitrofurantoin, and broad-spectrum penicillins. After adjustments for age, sex, race, urinary tract infection, other medications and other medical conditions, patients who received sulfa drugs were more than twice as likely as those not exposed to antibiotics to have kidney stones; for broad-spectrum penicillins, the increased risk was 27 percent higher.

The strongest risks for kidney stones were in children and adolescents. The risk of kidney stones decreased over time but remained elevated several years after antibiotic use.

Scientists already knew that antibiotics alter the composition of the human microbiome–the community of microorganisms in the body. Disruptions in the intestinal and urinary microbiome have been linked to the occurrence of kidney stones, but no previous studies revealed an association between antibiotic usage and stones.

Dr Tasian pointed out that other researchers have found that roughly 30 percent of antibiotics prescribed in office visits are inappropriate, and children receive more antibiotics than any other age group, so the new findings reinforce the need for clinicians to be careful in prescribing correct antibiotics. He added, “Our findings suggest that antibiotic prescription practices represent a modifiable risk factor–a change in prescribing patterns might decrease the current epidemic of kidney stones in children.”

One co-author of the current paper Dr Jeffrey Gerber, is an infectious diseases specialist at CHOP who leads programs in antibiotic stewardship–an approach that guides health care providers in prescribing the most appropriate antibiotic for each patient’s specific infection, with the aims of improving individual outcomes and reducing the overall risk of antibiotic resistance.

Dr Tasian and colleagues are continuing to investigate the microbiomes of children and adolescents with kidney stones in a single-centre study at CHOP. Their goal is to expand this research into broader, population-based studies to better understand how variations in microbiome composition may influence the development of kidney stones.

SOURCE: www.europeanpharmaceuticalreview.com/news/75652

Largest clinical trial ever conducted in postpartum haemorrhage completed

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Ferring Pharmaceuticals and MSD, through its MSD for Mothersinitiative, has announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).

CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3

Each year, 14 million mothers are affected by PPH.1 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.2 By preventing PPH from ever occurring, heat-stable carbetocin has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.

Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,”3 said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”

The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.2,3 Heat-stable carbetocin could  address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.3,4 Heat-stable carbetocin may remain active long-term in hot and humid climates,3and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,3,4 and where 99% of maternal deaths due to PPH currently occur.4

Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”

If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.

The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L Gerberding, MD, MPH, Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognized that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality.  Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”

References

  1. Say L. et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
  2. Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366743 Last accessed: January 2018.
  3. Widmer M. et al. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial. Trials. 2016;17(1):143. doi: 10.1186/s13063-016-1271-y.
  4. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdfLast accessed: January 2018.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Merck Foundation and Uganada Ministry continue support Heroines of ‘Merck More Than A Mother’

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Merck Foundation, a non-profit organization and a subsidiary of Merck KGaA Germany, and Uganda Ministry of Health continue their commitment towards childless women Through ‘Merck More Than a Mother’ campaign in the heart of Africa.

Merck Foundation evaluated the social and economic impact of ‘Merck More Than a Mother’ on childless women in Uganda and encouraged them to continue leading an independent and happier life.

In 2016, Merck Foundation in partnership with Uganda Ministry of Health had started ‘Merck More Than a Mother’ Campaign In the country with the aim to raise awareness about infertility prevention and management, build fertility care capacity and break the stigma around infertile women. They established various income generating projects to support infertile women across the country with the aim of empowering them socially and economically. The business set by Merck Foundation has benefitted over 800 women across Uganda.

“The childless women groups we created in each village are doing a great job. I remember last year they had no purpose in life, no respect from their community and no source of income. Today they have a bank account and a steady monthly income; now they are much happier and stronger,” said Rasha Kelej, CEO Merck Foundation.

“For me, it’s essential to frequently visit ‘Merck More Than a Mother’ heroines across Africa to influence their transformation. The base of change in these villages is remarkable, and with our efforts and passion this change will be sustainable,” she added.

“The journey that Merck Foundation has started is a very special journey that has touched the lives of women who have been forgotten in the communities. It has touched not only women but also the lives of men who have been mistreating their women thinking that infertility is an issue of women, not know that 50% infertility is due to the malefactor. I want to thank Merck Foundation for thinking about these women,” said Sarah Opendi, Minister of State of Health, Uganda.

“I feel grateful and honored to be a part of the joy and happiness of these amazing women, who suffered the infertility stigma all their lives. I am glad that the efforts of ‘Merck More Than a Mother’ paid off. Now, these women are independent and getting the respect and support they deserved from the community,” said Kelej.

About ‘Merck More Than a Mother’ campaign; in many cultures, childless women suffer discrimination, stigma, and ostracism. Their inability to have children results in great isolation, disinheritance, and assaults. ‘Merck More Than a Mother’ empowers such women through the access to information, health, change of mindsets and economic empowerment.

Merck Foundation provided for more than 40 candidates, three months to six months clinical and practical training for fertility Specialists and embryologists in more than 15 countries across Africa and Asia.

Merck Foundation is making history in many African countries where they never had fertility specialists or training facilities before ‘Merck More Than a Mother’ intervention to train the first Fertility specialists such as; in Sierra Leone, Liberia, The Gambia, Niger, Chad, and Guinea.

Merck Foundation plan supported the establishment of the first public IVF in Ethiopia through providing the clinical and practical training necessary for their staff. Merck Foundation also plans to support the establishment of the first public IVF in Tanzania soon.

Over 1,200 infertile women in Kenya, Uganda, Nigeria, Ghana, Tanzania, CAR, Ethiopia, Liberia, Tanzania, Niger, The Gambia and Cote D’Ivoire who can no longer be treated have been empowered socially and economically to lead independent and happier lives through “Empowering Berna”.(ANI)

SOURCE: www.aninews.in/news/business/business

MSD cuts 1,800 jobs in US operations restructure

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MSD has revealed its intention to cut 1,800 sales positions from its workforce in the US.

Across the total number, the cuts include the elimination of US sales teams in primary care, endocrinology and hospital chronic care. In their place, the company will add 960 positions with the formation of a new chronic care sales force.

This new force will focus on key products in the company’s pipeline including its diabetes treatment Januvia (sitagliptin) and insomnia therapy Belsomra (suvorexant) in addition to women’s health and respiratory disease products.

It should be noted however that this still leaves 840 positions which will not be replaced, and the company has confirmed it will not be shifting the roles to outside the US.

The move follows MSD’s decision not to seek regulatory approval for its cholesterol therapy anacetrapib after it failed to achieve adequate results during clinical trials, as well as the discontinuation of its development of a drug combination to treat chronic hepatitis C last month.

“This is part of ongoing prioritisation efforts and the ebb and flow of our business means that at the same time we’re eliminating certain US jobs, we’re also adding new US jobs in growth areas,” the spokeswoman explained, continuing “these changes are part of ongoing company-wide efforts to sharpen Merck’s focus on innovative R&D that addresses significant unmet medical needs and on our best opportunities for growth, while reducing overall costs.”

SOURCE: www.pharmafile.com/news/515444

Lupin scoops up women’s health specialist Symbiomix for $150 million

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The US arm of Mumbai’s Lupin Pharmaceuticals has announced that it is has acquired US-based gynaecologic treatment specialist Symbiomix Therapeutics for $150 million in a move to double down on its offerings in the women’s health market.

The deal comprises an upfront payment of $50 million in addition to a number of time-based and performance-based milestone payments, all funded from internal funds. “The acquisition of Symbiomix and Solosec franchise significantly expands Lupin’s branded women’s health specialty business, which is presently anchored by Methergine tablets,” the company said of the deal.

Solosec, Symbiomix’s key offering, is an oral granule treatment of bacterial vaginosis, approved by the FDA in September his year and expected to hit the market by mid-2018, with at least ten years of exclusivity in the US thanks to its designation as a Qualified Infectious Disease Product (QIDP).

“This transaction is an important milestone in the evolution of our specialty business and gives Lupin a new therapeutic to bring to obstetricians and gynaecologists to treat a serious health condition they see frequently in their practices,” commented Vinita Gupta, Chief Executive Officer of Lupin.

The move from Lupin represents a step forward in its drive to pursue expansion of its speciality drugs portfolio in the US, a strategy which has seen the company recently shift focus onto the areas of women’s health, paediatrics and neurology.

SOURCE: www.pharmafile.com/news