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Wednesday, September 12, 2012

Upsher-Smith Announces New Formulation Of B-Nexa® Prescription Vitamin To ...

MAPLE GROVE, Minn., Sept. 11, 2012 — /PRNewswire/ — Upsher-Smith Laboratories, Inc. today announced the availability of a new formulation of B-Nexa^®Rx Prenatal Vitamin with B Vitamins and Ginger to help calm morning sickness, also known as Nausea and Vomiting of Pregnancy (NVP). The new formulation contains increased amounts of two key ingredients – folic acid and vitamin B6.¹

(Photo: http://photos.prnewswire.com/prnh/20120123/NY39344 )

“It is well recognized that a woman’s folate intake before and during early stages of pregnancy is critically important,” said Gregory Gilmet, MD, MPH, Senior Medical Director, Medical Affairs, Upsher-Smith Laboratories, Inc.

For the estimated eight out of ten women who experience morning sickness, ensuring that their diet contains an adequate amount of folic acid may be a challenge. B-Nexa^® is an important addition to the prenatal nutrition market. The advanced formulation delivers essential folic acid to help support a healthy pregnancy, especially in the first trimester, while helping to calm morning sickness with ginger and vitamin B6.

The American College of Obstetricians and Gynecologists (ACOG) recommends vitamin B6 as a first-line approach for morning sickness, and also suggests ginger as a non-drug option.² B-Nexa^®‘s newest formulation contains 1.22 mg of folic acid and 42 mg of vitamin B6, in addition to ginger.¹

The NDC number for the new formulation of B-Nexa^® is 0245-0215-60. For more information about B-Nexa^®, visit http://www.b-nexa.com.

About NVP

Although commonly known as morning sickness, NVP can occur at any time throughout the day and affects 70 to 85% of pregnant women.^{Approximately 50% of pregnant women experience both nausea and vomiting, while 25% experience only nausea. Studies have shown that women taking a multivitamin regularly at the time of conception were less likely to have severe cases of NVP.²In most cases, the condition affects women only during the first and early second trimesters, although up to 15% of women continue to have symptoms throughout pregnancy.³}

NVP can cause significant distress in many women and can lead to feelings of anxiety about how the fetus may be affected. Some women do not seek treatment for morning sickness because of concerns about drug therapy during pregnancy or because they don’t know help is available. Even a less severe case of NVP can detract from the joy of pregnancy and can affect a woman’s general well being.⁴

Important Safety Information

You should not take more than 1 mg per day of folic acid unless you are under the care of a healthcare professional, as it may mask the symptoms of a potentially more serious condition.

Taking ginger if you have a bleeding disorder or while you are also taking a blood thinner or other medication that affects the blood may increase the risk of bleeding.

Please see the Full Prescribing Information for a complete list of warnings and precautions. http://b-nexa.com/prescribing-information

About the Nexa^® Family of Products

Upsher-Smith Laboratories, Inc. is committed to providing nutritional support to mothers before, during and after pregnancy. Designed to help support a healthy pregnancy, the Nexa^® family of products includes Nexa^®Plus Capsules (Rx prenatal vitamin with 350 mg plant-based DHA from algal oil), more than any other single gel capsule prescription prenatal vitamin taken once a day,^5-10 Nexa^® Select Capsules (Rx prenatal vitamin with plant-based DHA from algal oil), and PreNexa^®Capsules (Rx prenatal vitamin with plant-based DHA from algal oil), all of which offer essential nutrition for mom and developing baby, including 1.25 mg folic acid. Additionally, B-Nexa^® Tablets (Rx prenatal vitamin formulated with B-vitamins and ginger) are designed to help calm nausea and vomiting of pregnancy while providing important folic acid supplementation. To learn more about the Nexa^® family of products or to obtain complete prescribing information, visit http://www.nexavitamins.com.

About Upsher-Smith Women’s Health

Upsher-Smith Women’s Health is committed to providing options, specifically designed to meet the ever-changing needs of women throughout their lives, for prenatal nutritional support, bone health support, and symptom relief during menopause. For additional information, visit http://www.upsher-smith.com/products/womens-health.

About Upsher-Smith

Upsher-Smith Laboratories, Inc. is a privately held, U.S.-based company devoted to improving health and advancing wellness since 1919. Upsher-Smith demonstrates its commitment to meeting the healthcare needs of its customers by developing, producing and marketing consumer and prescription products. In addition to its strong heritage in generics, Upsher-Smith’s branded businesses focus on women’s health, dermatology and CNS therapeutic areas. For additional information, visit http://www.upsher-smith.com.

References

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Breast Cancer Screening Does Save Lives

By Nancy Walsh, Staff Writer, MedPage Todaymammography should be put off until after age 50, and even then should be done just every other year.

To sort out these conflicting findings, the cooperative Euroscreen network was formed to assess the evidence and provide a “balance sheet” that could be used to aid women in deciding whether to undergo screening.

They reviewed the effects of screening in both incidence-based mortality and case-control studies, and found that in the incidence-based studies, there was a 25% reduction in deaths (RR 0.75, 95% CI 0.69 to 0.81) among women invited for screening and a 38% decrease (RR 0.62, 95% CI 0.56 to 0.69) among those who actually underwent screening.

In the case-control studies, the mortality reduction for screening invitation was 31% (OR 0.69, 95% CI 0.57 to 0.83) and 48% (OR 0.52, 95% CI 0.42 to 0.65) with participation in screening.

When they reviewed the evidence on false-positive screening results, they estimated a cumulative incidence of approximately 17% for noninvasive additional testing and 3% for invasive tests such as needle or surgical biopsies.

To create their balance sheet, they first determined the cumulative risks among women ages 50 to 80 during the years 1985 and 1986, before screening was routinely implemented, and found an average incidence of 6.7% and mortality of 3%.

This translated to 17 deaths per 1,000 for women between the ages of 50 and 70 and 13 between ages 70 and 80.

Out of these 30 deaths, 19 could have been prevented by screening, Paci and colleagues calculated.

Their data also showed that 14 women would need to be screened to diagnose one case of breast cancer, and 111 to 143 would need to be screened to save one life.

And for every 1,000 women screened biennially from age 50–51 until age 68–69 and followed up to age 79, an estimated seven to nine lives would be saved, four cases overdiagnosed, 170 women would have at least one recall followed by noninvasive assessment with a negative result, and 30 women would have at least one recall followed by invasive procedures yielding a negative result.

One difficulty they noted with regard to overdiagnosis was determining the contribution of ductal carcinoma in situ, which is more commonly being diagnosed with widespread screening.

Some studies have suggested that the increase in cases of these in situ carcinomas was balanced by a decrease in invasive cancers, but others found that recurrences are common and the tumors may be aggressive.

These concerns have yet to be clarified, and further work will be needed to more fully understand the impact of ductal carcinoma in situ on screening and outcomes, the researchers noted.

They also pointed out that their analysis did not attempt to consider larger issues such as the economic and social effects of screening.

Rather, their intention in this work was “to ensure that women are fully aware of the chief benefit and harms when they decide whether or not they wish to attend screening.”

But the analysis is far from complete, and only after longer follow-up can firmer estimates be made, they said.

Future research also will have to consider the improvements in technology, such as digital mammography, and changes in practice such as the appearance of specialized breast diagnostic and treatment centers.

The researchers concluded that, although their estimates are only approximations at this time, “they clearly indicate … that the relationship between benefit and harm of mammographic screening is much more favorable than some recent publications suggest.”

This work was supported by the National Monitoring Italian Center and the National Expert and Training Center for Breast Cancer Screening in Nijmegen, the Netherlands.

The authors reported no financial conflicts of interest.

Primary source: Journal of Medical Screening
Source reference:
Paci E, et al “Summary of the evidence of breast cancer service screening outcomes in Europe and first estimate of the benefit and harm balance sheet” J Med Screen 2012; DOI: 10.1258/jms.2012.012077.

Add Your Knowledge ™

Nancy Walsh

Staff Writer

Nancy Walsh has written for various medical publications in the United States and England, including Patient Care, The Practitioner, and the Journal of Respiratory Diseases. She also has contributed numerous essays to several books on history and culture, most recently to The Book of Firsts (Anchor Books, 2010).

Question Corner: Tea's effect

What happens to the minerals and vitamins of milk, when we prepare tea? Do they remain unchanged?

MANISH KUMAR

New Delhi

Milk is heat treated (pasteurized) at the dairy to kill any pathogenic microorganisms that may be present without affecting its nutritional quality.

But milk boiling (100C) in houses for the preparation of tea causes changes in its constituents. The higher the temperature and longer the exposure to heat, the greater the changes. Milk is an important source of A, D and group B vitamins. The fat soluble vitamins (A D) are very thermostable and their level is not lowered by heat treatment. Losses of water soluble vitamins (B C) mainly concern vitamin C and some of the group B vitamins.

The loss of vitamin C as such is generally of minor importance, as milk is not an important source of this vitamin, but it may influence the nutritional value anyway. The breakdown of vitamin C is connected with that of Vitamin B 12 and protects folic acid from oxidation.

Milk is a major source of the important mineral calcium (1200 mg/lit). Solubility of calcium phosphate is very temperature dependent.Unlike most compounds, the solubility of calcium phosphate decreases with temperature. This means that heating the milk for the preparation of tea causes precipitation of Calcium Phosphate in the micelle, while cooling increases its concentration.

After cooling, the reaction is readily reversible but after heating to high temperature, the reversibility is more sluggish and incomplete. Hence for the preparation of tea instead of boiling the milk it can be warmed up to retain the minerals and vitamins.

K. ANBARASU

Deputy Manager, Quality Control, Tamil Nadu Co-operative Milk Producers Federation, Chennai

Kathy Bates reveals breast cancer diagnosis, double mastectomy

Kathy Bates has beaten cancer yet again, she revealed Wednesday.

“Hey All, sorry for the long silence,” she said in a two-part Twitter message. “I was diagnosed with breast cancer 2 months ago am recovering from a double mastectomy. … I don’t miss my breasts as much as I miss Harry’s Law. Thanks for all the sweet tweets. Y'all kept me going.”

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The “Titanic” actress was diagnosed with ovarian cancer in 2003, an experience she discussed in the video above, for the Ovarian Cancer National Alliance.

This time around, however, she won’t need radiation or chemotherapy, she said in a statement to People on Wednesday.

“My doctors have assured me I’m going to be around for a long time,” Bates told the magazine. “I’m looking forward to getting back to work doing what I love to do.”

She’d been silent on Twitter since the end of May, shortly after her show “Harry’s Law” was canceled by NBC. Though the show was the network’s second most-viewed drama, behind “Smash,” its audience reportedly skewed too old for advertisers’ preferences.

Bates is, however, up for an Emmy on Sept. 23 for outstanding actress in a drama for “Harry’s Law,” as well as outstanding guest actress in a comedy for a stint on “Two and a Half Men” that saw her playing the ghost of Charlie Sheen’s Charlie Harper.

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Wanda Sykes reveals double mastectomy, cancer, dislike of walking

Kathy Bates on her ovarian cancer: ‘I was focused on my own survival’

Giuliana Rancic keeps her sense of humor as she faces a double mastectomy

ollow Christie D’Zurilla on Twitter and Google+. Follow the Ministry of Gossip on Twitter @LATcelebsand on Facebook facebook.com/ministryofgossip.

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U.S. to cover cancer treatment for 9/11 responders

The act, which also covers responders and survivors of the 9/11 attacks on the Pentagon outside Washington, was signed into law by President Barack Obama on January 2, 2011.

The decision addresses concerns over the rising health toll for emergency workers in the wake of the attacks, when aircraft slammed into the World Trade Center’s Twin Towers in New York and the U.S. military command center in northern Virginia.

It “marks an important step in the effort to provide needed treatment and care to 9/11 responders and survivors,” said Dr. John Howard, administrator of the World Trade Center Health Program established by the Zadroga law.

“We have urged from the very beginning that the decision whether or not to include cancer be based on science,” New York City Mayor Michael Bloomberg said in a statement.

The decision “will continue to ensure that those who have become ill due to the heinous attacks on 9/11 get the medical care they need and deserve.”

Illnesses related to the September 11 attacks have caused an estimated 1,000 deaths. Last week, the New York City Fire Department etched nine more names into a memorial wall honoring firefighters who died from illnesses after their work at Ground Zero, bringing the total to 64.

Cancers to be covered include lung and colorectal, breast and bladder, leukemias, melanoma and all childhood cancers.

The program had already covered respiratory diseases such as asthma and pulmonary fibrosis, mental disorders including depression and post-traumatic stress disorder as well as musculoskeletal conditions.

But researchers have known that responders and survivors, including local business owners and residents, were exposed to a complex mixture of chemical agents, including human carcinogens.

That mix included combustion products from 20,000 gallons of jet fuel, 100,000 tons of organic debris, and 100,000 gallons of heating and diesel oil.

Pulverized building materials created a toxic pall of cement dust, glass fibers, asbestos, crystalline silica, metals, polycyclic aromatic hydrocarbons, polychlorinated biphenyls, pesticides and dioxins – “a total of 287 chemicals or chemical groups,” the WTC health program reported in 2011.