About the author admin

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

To date, Sandoz Inc. has not received any reports of adverse events related to this lot.

Losartan Potassium Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-countplastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

Sandoz Inc. is notifying its distributors by letter via overnight mail and patients by this public notification. Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor.

Patients with questions regarding this recall can contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@novartis.com. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Losartan Potassium Hydrochlorothiazide should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being made with the knowledge of the Food and Drug Administration.

Disclaimer 
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz 
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached more than 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

Source: FDA

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

These 22 batches of Irbesartan drug substance were supplied to ScieGen Pharmaceuticals Inc., U.S. for the manufacturing of finished Irbesartan drug product (see attached annexure).

Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is arranging for the return of all available Irbesartan drug substance. Aurobindo Pharma Limited has further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that has been identified by Aurobindo Pharma Limited.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Annexure -I
Irbesartan batches Supplied to US Customers

S.No Manufacturing Batch Number Dispatch Batch Number Date of Manufacture Date of Distribution Retest/Expiry Date Dispatch Qty Name and Location of the Customer NDEA Impurity Result ug/g
1 1601100782 1601101589 Jan-2016 Jan-2016 Dec-2016 90.29 Kg Sciegen Pharmaceuticals INC, USA 0.23
2 1601100783 1601101590 Jan-2016 3l-Jan-2016 Dec-2016 59.61 Kg Sciegen Pharmaceuticals INC, USA 0.28
3 1701111861 1701113404 l3-Sep-2017 7-0ct-2017 12-Sep-2020 88.48 Kg Sciegen Pharmaceuticals INC, USA 0.47
4 1701112170 1701113405 l8-Sep-2017 7-0ct-2017 l7-Sep-2020 90.92 Kg Sciegen Pharmaceuticals INC, USA 0.15
5 1701112501 1701113406 20-Sep-2017 7-0ct-2017 l9-Sep-2020 93.02 Kg Sciegen Pharmaceuticals INC, USA 1.61
6 1701112056 1701113407 l3-Sep-2017 7-0ct-2017 l2-Sep-2020 88.82 Kg Sciegen Pharmaceuticals INC, USA 0.53
7 1701112558 1701114283 2-0ct-2017 25-0ct-2017 l-Oct-2020 63.76 Kg Sciegen Pharmaceuticals INC, USA 0.6
8 1701112558 1701114284 2-0ct-2017 25-0ct-2017 l-Oct-2020 27.06 Kg Sciegen Pharmaceuticals INC, USA 0.6
9 1701I12559 1701114285 3-0ct-2017 25-0ct-2017 2-0ct-2020 91.82 Kg Sciegen Pharmaceuticals INC, USA 0.45
10 1701112589 1701114286 6-0ct-2017 25-0ct-2017 5-0ct-2020 90.32 Kg Sciegen Pharmaceuticals INC, USA 0.28
11 1701113300 1701114289 7-0ct-2017 25-0ct-2017 6-0ct-2020 91.32 Kg Sciegen Pharmaceuticals INC, USA 0.32
12 1701113301 1701114291 8-0ct-2017 25-0ct-2017 7-0ct-2020 90.12 Kg Sciegen Pharmaceuticals INC, USA 0.32
13 1701113302 1701114708 l7-0ct-2017 30-0ct-2017 l6-0ct-2020 80.82 Kg Sciegen Pharmaceuticals INC, USA 0.85
14 1701113312 1701114709 20-0ct-2017 30-0ct-2017 19 Oct 2020 86.82 Kg Sciegen Pharmaceuticals INC, USA 0.88
15 1701115460 1701117039 23-Nov-2017 2l-Dec-2017 22-Nov-2020 16.72 Kg Sciegen Pharmaceuticals INC, USA 0.31
16 1701115974 1701117040 29-Nov-2017 2l-Dec-2017 28-Nov-2020 91.12 Kg Sciegen Pharmaceuticals INC, USA 0.26
17 1701115460 1701117041 23-Nov-2017 2l-Dec-2017 22-Nov-2020 89.79 Kg Sciegen Pharmaceuticals INC, USA 0.31
18 1701115738 1701117042 24-Nov-2017 21-Dec-2017 23-Nov-2020 90.42 Kg Sciegen Pharmaceuticals INC, USA 0.38
19 1701115739 1701117043 25-Nov-2017 2l-Dec-2017 24-Nov-2020 89.79 Kg Sciegen Pharmaceuticals INC, USA 0.44
20 1701115740 1701117044 26-Nov-2017 2l-Dec-2017 25-Nov-2020 93.42 Kg Sciegen Pharmaceuticals INC, USA 0.34
21 1701115741 1701117045 27-Nov-2017 21-Dec-2017 26-Nov-2020 93.72 Kg Sciegen Pharmaceuticals INC, USA 0.39
22 1701115742 1701117046 28-Nov-2017 21-Dec-2017 27-Nov-2020 93.62 Kg Sciegen Pharmaceuticals INC, USA 0.31

Remark: For Dispatch batch no. 1701114283 & 1701114284, Mother Batch is common 170111255 8

For Dispatch batch no. 1701117039 & 1701117041, Mother Batch is common 1701115460

Total No. of Mother Batches: 20

Total No. of dispatch Batches: 22.

Source: FDA

How climate change will affect your health

How climate change will affect your health

A new report from the UN Intergovernmental Panel on Climate Change warns of dire consequences if governments don’t make “rapid, far-reaching, and unprecedented changes in all aspects of society” to stem global warming. But the planet isn’t the only thing at risk as temperatures rise; your health might be in danger, too.

Here are six ways that climate change might affect you, whether it’s insect-borne disease or Type 2 diabetes.

An increase in disease-carrying mosquitoes and ticks

Hot and humid climates provide a perfect breeding ground for critters, and experts say that a warming world might put us at greater risk for vector-borne diseases, which are those transmitted by ticks, mosquitoes or other organisms.
Tick- and mosquito-borne diseases more than triple, since 2004, in the US
In a 2017 report, the Medical Society Consortium on Climate and Health warned that “mosquitoes that carry diseases like West Nile virus and dengue fever thrive in conditions that are becoming more common, and there is concern that malaria could reemerge in the United States.”

Environmental changes affect not just the distribution of insects like mosquitoes but also how quickly viruses replicate within them and how long the bugs live. All of that might have contributed to recent Zika virus outbreaks, according to the CDC.

More than 2,400 pregnant women in the United States have tested positive for Zika since 2015, and the United States has seen a rise in Lyme disease, Rocky Mountain spotted fever and other vector-borne diseases. Only 27,388 such cases were reported in 2004, but that number jumped to 96,075 in 2016, according to a CDC report.

Contaminated water sources and dangerous bacterial infections

Extreme weather and rainfall have contributed to the spread of bacterial infections through contaminated water, especially in summer. Warmer temperatures will only make those storms worse.
Where climate change is threatening the health of Americans
Dr. Mona Sarfaty, director of the program on climate and health at George Mason University’s Center for Climate Change Communication, said that “when increased rainfall leads to flooding, there can be a mixing of stormwater and sewage that leads to bacterial contamination in the water.”
That contamination can affect crops too, contributing to foodborne diseases. “Heavy downpours and flooding can spread fecal bacteria and viruses into fields where food is growing,” said a report from the Medical Society Consortium on Climate and Health.
“Warmer ocean water also makes a difference,” Sarfaty said. “Along the coast, there are cases of bacterial contamination in shellfish in the warmer months that make those waters more likely to cause infection when people swim there, especially if they have open cuts in their skin.”

An increase in mental health issues

Even a modest rise in temperatures is associated with an increase in mental health issues, according to  a study published this year that surveyed nearly 2 million US residents. The research, in the journal PNAS, looked at individual cities and found that warming of just 1 degree over five years was linked to a 2% increase in mental health issues.
Climate change study ties warming temperatures to rising suicide risk
Using a different approach, the study also found that an increase in average monthly temperatures to over 30 degrees Celsius (86 Fahrenheit), up from an average of 25 to 30, was correlated with a 0.5% increase in mental health issues.
That might seem like a small change, but Nick Obradovich, the study’s lead author and a scientist at MIT’s Media Lab, noted that those results, if consistent across the country, “would produce approximately 2 million additional individuals reporting mental health difficulties.”
Those challenges can turn deadly. A study published this year in the journal Nature Climate Change found that a rise of 1 degree Celsius in monthly temperatures correlated with a 0.68% increase in the United States suicide rate. Using that data, researchers estimate that climate change could be linked to over 14,000 suicides by 2050.
Though more research is needed to determine what exactly causes that increase in suicide, the study’s lead author said economic factors or biological changes might be to blame.
“As economic conditions worsen, that might also worsen mental health,” said Marshall Burke, an assistant professor in the Department of Earth System Science at Stanford University. There also might be “a plausible biological linkage between temperature, thermal regulation and how the brain regulates its own emotion.”

An increase in Type 2 diabetes

Is there a link between climate change and diabetes?

Rising temperatures are associated with an increase in Type 2 diabetes, according to a 2017 study published in the journal BMJ Open Diabetes Research & Care. However, researchers looked only at the correlation between temperatures and diabetes, so the study didn’t establish that temperatures necessarily caused the disease.
Still, researchers found that diabetes rates increased by about 4% for every 1 degree Celsius of warming in the United States. Worldwide, glucose intolerance rose by 0.17% per degree Celsius of warming.
Lead study author Lisanne Blauw, a researcher at Leiden University Medical Center in the Netherlands, said that “a 1-degree Celsius rise in environmental temperature could account for more than 100,000 new diabetes cases per year in the USA alone.”
Although calorie consumption and obesity are likely to be the biggest risk factors for diabetes, the study hypothesizes that warmer temperatures might decrease the activity of brown fat tissue, which burns fat and generates heat in colder weather.
“In warmer climates, brown fat may be less activated,” Blauw said, “which may causally lead to insulin resistance and diabetes.”

Respiratory problems and stroke

Most scientists agree that greenhouse gases like carbon dioxide are contributing to global warming, but those emissions aren’t just hurting the planet. Fossil fuel pollutants can also generate a mixture of solid particles and liquid droplets in the atmosphere that can enter your lungs and even your bloodstream.
Pediatricians are concerned about climate change, and here's why
That mixture, called particulate matter, can aggravate asthma, decrease lung function and increase your risk of cardiovascular events such as strokes, according to a study published last year in The Lancet. That same study estimated that over 8 million people die early due to air pollution every year.
A warming planet also means more wildfires, which routinely release smoke that further worsens air quality. A 2011 report from the National Research Council found that a warming of just 1 degree Celsius could lead to a 400% increase in the area of land burned by wildfires.
But it’s not just smoke and pollutants you’re inhaling; it’s pollen, too. Increases in carbon dioxide can trigger plants to produce more polle, which might explain why the pollen season seems to get worse each year.
A 2012 study presented at the American College of Allergy, Asthma and Immunology conference estimated that pollen counts were expected to reach 21,735 grains per cubic meter in 2040. In 2000, that number was just 8,455.

More car crashes and fewer food inspections

Even small changes in climate can impact human behavior, leading to an increase in fatal car accidents and a decrease in food safety inspections, according to a study published this year in PNAS.
Researchers analyzed data from more than 70 million police stops, more than 500,000 motor vehicle accidents and nearly 13 million food safety violations.
Unexpected effects of climate change: worse food safety, more car wrecks
They found that above 29 degrees Celsius (84 Fahrenheit), police conduct fewer traffic stops, which can contribute to unsafe driving conditions. A 10-degree Celsius increase in maximum temperatures decreased traffic stops by 1.5%, according to the study, and that same temperature change amplified the risk of a fatal car crash by half a percentage point.
The researchers also found that health officials were less likely to conduct food safety inspections when temperatures exceeded 26 Celsius (79 Fahrenheit). Across the 750,000 restaurants and food production facilities they studied, they found that a 10-degree increase in temperatures translated to 8,000 fewer inspections per day.
When those facilities were inspected, though, hotter temperatures led to more violations, probably because pathogens like E. coli and salmonella grow faster in warmer weather.
Obradovich, the MIT Media Lab research scientist who co-authored the study, noted that “hot temperatures are basically bad for human functioning.” The crux of the idea, he said, was that “weather affects how we perform our duties and how we go about our daily lives and the risks that we experience.”
By Arman Azad, CNN

Add Asthma to List of Possible Causes of Childhood Obesity

Add Asthma to List of Possible Causes of Childhood Obesity

Children with asthma are at increased risk for childhood obesity, a new study suggests.

Obesity is widely regarded as a risk factor for asthma, but these new findings suggest the reverse is true, too, according to the researchers.

The study authors analyzed data from more than 21,000 children in nine European countries who were diagnosed with asthma at ages 3 to 4 years old and followed up to age 8.

Compared to toddlers without asthma, those with asthma were 66 percent more likely to become obese, and the risk was 50 percent higher among those with persistent wheezing.

Children with active asthma were nearly twice as likely to become obese than those without asthma and wheezing, according to the study.

“Asthma may contribute to the obesity epidemic. We urgently need to know if prevention and adequate treatment of asthma can reduce the trajectory toward obesity,” study co-author Frank Gilliland, professor of preventive medicine at the University of Southern California, said in a university news release.

One way that asthma may contribute to obesity is by limiting children’s physical activity, the researchers said.

It’s also been suggested that higher doses of inhaled corticosteroids used to treat asthma may increase the risk of obesity. In this study, children with asthma who used medication had the greatest risk of becoming obese.

“We care about this issue because asthma affects approximately 6.5 million children — about 1 in 10 — in the United States,” said study senior author Lida Chatzi, also a professor of preventive medicine at USC.

“It’s a chronic childhood disorder and if it increases the risk of obesity, we can advise parents and physicians on how to treat it and intervene to help young children grow up to enjoy healthy, adult lives,” Chatzi said.

The U.S. Centers for Disease Control and Prevention says about 40 percent of Americans — or 93 million people — are obese. Obesity is linked to diseases such as diabetes, high blood pressure and stroke.

Meanwhile, the number of Americans with asthma in the United States is growing every year. About 1 in 12 people now has the illness, the study authors said.

The study was published recently in the European Respiratory Journal.

HeathDay