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MIDDLE EASTERN (H)

Do Colonoscopies Raise Appendicitis Risk?

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A colonoscopy can save your life by detecting and removing colon cancer, but it might also trigger appendicitis, a new study suggests.

Experts aren’t sure exactly why that happens, and, fortunately, it’s rare. And it shouldn’t stop you from getting a colonoscopy, according to lead researcher Dr. Marc Basson.

“Having a colonoscopy, or something about a colonoscopy, predisposes you to have appendicitis in the next week,” said Basson, senior associate dean at the University of North Dakota School of Medicine and Health Sciences.

Though the appendicitis risk is small, it’s at least four times higher the week after a colonoscopy than in the 51 weeks that follow, the study found. And by some measures, the increase is 12 times higher.

A colonoscopy involves advancing a flexible instrument through the rectum to the colon, or large intestine, to detect polyps or precancerous growths.

The appendix is a small, tube-shaped sac attached to an opening into the large intestine. Appendicitis occurs when it gets infected, causing intense abdominal pain, often on the right side. Treatment usually involves surgery to remove it, though sometimes antibiotics are enough.

Most cases of appendicitis occur in children and young adults. The older one gets, the rarer it is, Basson said.

He said he has seen a number of patients who experienced appendicitis after a colonoscopy, but this study is the first to go beyond anecdotal evidence to gauge the risk.

“Colonoscopy is generally a safe test, and the risk of having appendicitis is lower than the risk of having some of the other complications,” Basson said.

More common complications of a colonoscopy include an allergic reaction to the sedative, bleeding from the site where a polyp was removed and a tear in the colon.

Using data from the Fargo Veterans Affairs Health Care System, Basson’s team reviewed medical information on nearly 393,000 veterans nationwide who had a screening colonoscopy between January 2009 and June 2014.

Exactly how a colonoscopy leads to appendicitis isn’t clear, Basson said. He thinks it might stem from preparations for the procedure. Those preparations clear the bowel, which can cause changes in gut bacteria that could result in an infected appendix, he said.

Or, Basson said, pressure created in the bowel by the procedure itself might trigger an appendicitis attack.

Basson said doctors should be on watch for appendicitis after a colonoscopy, especially if a patient complains of continued abdominal discomfort.

One specialist says some patients may already be suffering from mild appendicitis, which the colonoscopy aggravates.

“There are potential biological reasons for why this association was found. It is possible, however, that this association may be due to an artifact of the data,” said Dr. Andrew Chan, a professor of medicine at Harvard Medical School.

For example, it could be that some people are having a colonoscopy to evaluate abdominal symptoms associated with mild appendicitis that may only be diagnosed after the exam, he said.

“Thus, it may only look like the incidence of appendicitis is higher immediately after a colonoscopy,” said Chan, who was not involved with the study.

The report was published online Jan. 26 in the journal JAMA Surgery.



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INDIAN (H)

Lupin sets off down Indian pharma's long road to redemption

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Lupin sets off down Indian pharma's long road to redemptionGOA: In 28 years in India’s pharmaceuticals sector, Rajiv Desai has never been busier.

Most of the last six months on his desk calendar is marked green, indicating visits to the 12 plants of Lupin, India’s No. 2 drugmaker, where Desai is a senior quality control executive. Only one day is red – a day off.

That’s what is needed these days to satisfy the US Food and Drug Administration that standards are being met.

“In this sector, you’re only as good as your last inspection,” Desai said in his office in suburban Mumbai.

Often dubbed “the pharmacy of the world”, India is home to the most FDA-approved plants outside of the United States and supplies about 40 percent of the $70 billion worth of generic drugs sold in the country.

But sanctions and bans have badly damaged India’s reputation and slowed growth in the $16 billion sector. Drug exports fell in the fiscal year ending in March 2017.

More than 40 plants have been banned by the FDA for issues ranging from data fraud to hygiene since India’s then-largest drugmaker Ranbaxy was pulled up for serious violations in 2008.

Drug companies have spent millions of dollars on training, new equipment and foreign consultants. Yet the Indian Pharmaceutical Alliance of the top 20 firms says its members still need at least five more years to get manufacturing standards and data reliability up to scratch.

The case of Lupin, whose shares are down about 27 percent since 2015 compared to a 13 percent drop in the Nifty pharma index, shows why.

The FDA is in the next few months expected to clear Lupin’s Goa plant, which supplies around a third of its US sales, of problems found in 2015, Desai said.

However, the agency also published a new notice just last week citing issues with data storage at its plant in Pithampur, central India.

If companies want to continue to sell into the world’s biggest health care market, they must keep constant vigilance.

Many in the industry expect to see consolidation among manufacturers after a wave of mergers among US drug distributors and increasing price pressures.

“A lot of companies will struggle to meet the requirements that are the need of the day, and I would expect to see additional consolidation on the supply side,” Lupin’s Chief Executive Vinita Gupta told analysts last month.

Asked about Lupin’s case, the FDA said in a statement it did not “comment on compliance matters”, but said generally:

“India’s regulatory infrastructure must keep pace to ensure that relevant quality and safety standards are met.”

FORM 483
India has its own standards body, the Central Drug Standard Control Organisation (CDSCO), which maintains that its quality controls are stringent enough to ensure drugs are safe.

“India’s standards are different,” CDSCO head G.N. Singh said in an interview in his New Delhi office. “Indian companies are compliant with our manufacturing standards. We cannot regulate them according to the US standards.”

The FDA has taken matters into its own hands and gradually expanded in India to more than a dozen full-time staff.

Inspections are frequent and increasingly unannounced. If the agency finds problems, it issues a Form 483 – a notice outlining the violations – which if not resolved can lead to a “warning letter” and in worst case, a ban.

Violations range from hygiene, such as rat traps and dirty laboratories, to inadequate controls on systems that store data, leaving it open to tampering.

None of the violations the FDA has cited in India have explicitly said the drugs are unsafe, and when companies are banned by the FDA they can sell into other markets, including in the developing world, until the bans are lifted.

There are also no studies showing that the drugs have harmed anyone in the world. But by definition, the notices are issued when the FDA finds conditions that might harm public health.

DON’T TELL ANYONE
Industry watchers say Lupin, which specialises in oral contraceptives and drugs for diabetes and hypertension, is doing better than most. So far none of its infractions have extended to a ban.

On a recent visit by Reuters to its Goa plant, blue-uniformed employees could be seen working on giant machines, then making notes in hardbound registers. These are being phased out as Lupin transitions to more secure e-files.

Employees are often videotaped to ensure they follow standard operating procedure. Manufacturers have cut back to focus on quality over quantity: five years ago, Lupin was making one billion pills a month at one of its Goa plants. Now it makes just 450 million.

Both the company and employees needed to be willing to acknowledge errors, Desai said. The first impulse in the past was often “don’t tell anyone”, he said.

“We’re humans after all, not robots. We make mistakes,” said Amol Kolatkar, a production head at the Goa site.

As recently as three years ago, training was a “formality”, Desai said. Now, when an error is traced to an employee, the entire team undergoes fresh training.

“I have worked at a pharma company before, but this is the first time I went through such a training,” said another Lupin quality control officer, who asked not to be named because he was not authorised to speak to the media.

“They told us a lot about the Lupin culture and quality, and also stressed on good manufacturing practices.”

The quality control role is key.

“They (Lupin) have had a practice where company’s quality heads report directly to Nilesh Gupta (the managing director),” said Amey Chalke, an analyst at HDFC Securities. “Some other companies have also started doing that now.”

The companies also have to be willing to spend big. Lachman, PwC and Boston Consulting conduct mock audits at the Goa plant every three to six months, at a cost of up to $400 an hour.

“These days the FDA is giving us 483 on small, small things,” a third quality control officer said. “So we are always auditing.”



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ASIAN (H)

Chinese New Year: A time for Muslims to uphold spirit of togetherness

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Muslims in Malaysia are called to uphold the concept of fiqh ta’ayush (togetherness) as the Chinese community is scheduled to celebrate Chinese New Year next week.

Islamic Development Department (Jakim) director-general Tan Sri Othman Mustapha made the call today based on the spirit of wasatiyyah (moderation) which had become part of the government’s policy.

“Although the Chinese zodiac signs are represented by animals, it is required for all to respect and uphold the racial harmony based on the spirit of fiqh ta’ayush (togetherness) concept,” he said in a statement today.

Muslims in Malaysia are called to uphold the concept of fiqh ta’ayush (togetherness) as the Chinese community is scheduled to celebrate Chinese New Year next week. Pic by NSTP/ROSDAN WAHID

Othman added the spirit of togetherness in this matter should be wisely understood by all to maintain unity in Malaysia’s multiracial society of various faiths.

Millions of Chinese will celebrate Chinese New Year on February 16 and 17 to usher in the Year of the Dog, which is the zodiac sign this year.

Chinese New Year is also called the Spring Festival and Lunar New year. It is celebrated for 15 days, but the first three days are deemed to be most important.

https://sg.news.yahoo.com/chinese-time-muslims-uphold-spirit-145038716.html

 

Category: Malaysia


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MIDDLE EASTERN (H)

Eiffel Tower forced to close as snow blankets Paris

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    INDIAN (H)

    USFDA to lift import alert on Visakhapatnam unit: Divi's Labs

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    USFDA to lift import alert on Visakhapatnam unit: Divi's LabsNEW DELHI: Drug firm Divi’s Laboratories today said US health regulator will lift an import alert imposed on the company’s Unit-II at Visakhapatnam.

    The company “has been informed by the United States Food and Drug Administration (USFDA) that it will lift the Import Alert 99-32 imposed on the company’s Unit-II at Visakhapatnam”, Divi’s Laboratories said in a filing to BSE.

    The company had earlier said that the USFDA had issued an import alert under clauses 99-32 and 66-40 in March, and a warning letter later for the Vishakhapatnam facility.

    As per US Food and Drug Administration (USFDA), a import alert under 66-40 entails “detention without physical examination” of drugs from firms which have not met drug GMPs, while alert under 99-32 is issued to “firms refusing FDA foreign establishment inspection”.

    The company has filed detailed responses and given updates to the Form-483 as well as the warning letter within the stipulated time, it added.

    Divi’s said it has taken up appropriate remediation measures to address the concerns raised by USFDA and awaits further action from the regulator in this regard.



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    ASIAN (H)

    700 students in Malaysia to be trained for rail industry this year

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    700 new trainees will be taken in this year for the East Coast Rail Link Industrial Skills Training Programme (PLKI-ECRL), Bernama reports.

    The Universiti Malaysia Pahang (UMP), the main training university selected by the Ministry of Higher Education to manage the programme, has a responsibility to train a total of 3,600 students by 2022.

    UMP collaborated with two renowned universities in the rail engineering and technology sector, Beijing Jiaotong University and Southwest Jiaotong University, to develop the programme syllabus, according to UMP Rail Industry Academy director, Dr Fadzil Mat Yahaya.

    The director noted that this collaboration, geared towards professional and industrial training, preparation for trainers, training facilities and research and development, would enhance the marketability of graduates from the institutions of higher learning (IPT) in Malaysia.

    The opportunity to take part in the programme is open to all degree, diploma and technical certificate holders, stated Fadzil.

    “Over the three-month course, they will become employees under Malaysia Rail Link (MRL) and undergo job training in upskilling as well as reskilling, following which they will be absorbed as employees until the completion of the ECRL project in 2023,” he said.

    According to Fadzil, 49 students have been trained for ECRL’s construction, with the help of MRL and China Communications Construction Company (CCCC).

    “CCCC is the sponsor for this training programme involving RM23 million. At end-2017, there were 138 graduates who will finish training in early February,” he added in a press statement.

    The first intake of 30 students has been completely early this month, with the next enrolment to be implemented in the second quarter of 2018.

    Urging those planning on continue their education to IPTs to consider this sector as a bright career prospect due to the rapid growth of the rail industry in the country, Fadzil commented: “Prime minister Datuk Seri Najib Tun Razak previously stated that the public transportation transformation is one of the government’s main agenda and it is expected that some RM160 billion will be spent for rail-related projects until 2020.”

    “This is why the country desperately needs more trained workforce in this industry to meet the industry demand,” he concluded.

    http://www.humanresourcesonline.net/700-students-in-malaysia-to-be-trained-for-rail-industry-this-year/

     

    Category: Malaysia


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    MIDDLE EASTERN (H)

    SpaceX's big new rocket blasts off for Mars carrying red sports car

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