Thanks to Ah Neh, Cancer causing drug inside Lorsatan Hypertension Drug! Check your phamacists!

[motormafia]

https://tw.news.yahoo.com/降血壓藥驚傳含致癌物-這2款藥品下架回收3188萬顆-034228681.html

降血壓藥驚傳含致癌物！這2款藥品下架回收3188萬顆

新頭殼

4.5k 人追蹤

新頭殼newtalk |張嘉哲 綜合報導
2019年3月23日 上午11:42

壓膜衣錠50毫克 (上)、壓寧悅膜衣錠50/12.5毫克 (下) 。 圖：食藥署/提供
[新頭殼newtalk] 衛福部食藥署日前接獲美國食藥局通知，印度一家原料藥廠生產的ARB類降血壓藥，含有致癌物「N-亞硝基-N-甲基-4-氨基丁酸」（NMBA），國內有「緩壓膜衣錠50毫克」與「壓寧悅膜衣錠50/12.5毫克」2款藥，使用到該廠原料藥，食藥署立刻進行清查，結果發現這兩款藥均有NMBA，目前已要求藥廠下架回收3188萬顆藥品。
美國食藥局在3月初在印度製藥廠Hetero的降血壓藥主成分發現第3種致癌物NMBA，因此對全球發出警訊，而食藥署於3月2日表示，國內有「緩壓膜衣錠50毫克」與「壓寧悅膜衣錠50/12.5毫克」2款藥使用到該廠原料藥，宣布共計3188萬顆已出貨的藥品需預防性下架。
食藥署藥品組科長洪國登表示，食藥署於3月初清查時，已先要求2家藥廠當天對2款產品預防性下架，先存放在藥局或醫院的倉庫，今檢驗報告出爐，確定2款降血壓藥的原料藥中驗到不純物後，也再要求2藥廠於1個月內完成回收
洪國登說，因運送時間、統計數量、處理退換貨事宜，回收日期至4月22日止，若未在期限內下架回收完畢，將會依《藥事法》94條，針對廠商或業者處以2萬元以上到10萬元以下罰鍰。


Blood pressure lowering drugs contain carcinogens! The two drugs were collected and recovered 31.88 million
[new head shell]
New head shell
4.5k person tracking
New head shell newtalk | Zhang Jiazhe Comprehensive report
March 23, 2019, 11:42 am
Pressed film ingot 50 mg (top), pressed Ning Yue film ingot 50/12.5 mg (bottom). Figure: Food and Drug Administration / Provided
Pressed film ingot 50 mg (top), pressed Ning Yue film ingot 50/12.5 mg (bottom). Figure: Food and Drug Administration / Provided

[New head shell newtalk] Weifu Department of Food and Drug Administration recently received notification from the US Food and Drug Administration that ARB blood pressure lowering drugs produced by a raw material drug factory in India contain carcinogen "N-nitroso-N-methyl-4- "Aminobutyric acid" (NMBA), there are two drugs in the country: "Relief film ingot 50 mg" and "pressing Ning Yue film ingot 50/12.5 mg". The drug is used in the factory, and the Food and Drug Administration immediately conducts an inventory. The results showed that both drugs had NMBA, and the drug factory has been required to remove 31.88 million drugs.

The US Food and Drug Administration discovered the third carcinogen NMBA in the main component of the antihypertensive drug of Hetero, an Indian pharmaceutical factory in early March, and therefore issued a warning to the world. The Food and Drug Administration said on March 2 that there is a "slow-pressure film" in the country. Two tablets of "50 mg of ingots" and "50/12.5 mg of pressed Ningfu film ingots" were used in the drug, and a total of 31.88 million drugs shipped were required to be removed.

Hong Guodeng, head of the drug group of the Food and Drug Administration, said that when the Food and Drug Administration inspected it in early March, it had requested two pharmaceutical companies to prevent the two products from being placed on the pharmacy or hospital warehouse. After confirming the detection of impurities in the raw materials of the two blood pressure lowering drugs, the 2 pharmaceutical companies are required to complete the recycling within one month.

Hong Guodeng said that due to the delivery time, the number of statistics, and the handling of return and exchange, the collection date will be until April 22, and if it is not completed within the time limit, it will be directed to the manufacturer or the manufacturer according to Article 94 of the Pharmaceutical Affairs Law. It is fined between 20,000 yuan and 100,000 yuan.

 

[motormafia]

I am sure this is affecting Singapore, it is a matter of which brand and source only! As long as the supplies up-steam are the same!

 

[motormafia]

https://www.channelnewsasia.com/new...und-in-recalled-blood-pressure-pills-11303908

Health New cancer-causing toxin found in recalled blood pressure pills

02 Mar 2019 12:01AM (Updated: 02 Mar 2019 03:35AM)
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REUTERS: U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
The U.S. Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.


The latest toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero's losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.
Most recently, the U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd expanded the recall of its hypertension medicines containing valsartan to 38 more lots due to the presence of probable carcinogen, N-nitrosodiethylamine (NDEA), the FDA said https://bit.Iy/2Xq3ezI on Friday.
Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with NDEA and another probable carcinogen N-nitrosodimethylamine (NDMA).
The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.


The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.
The recalls began last year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.
Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis' Sandoz have recalled products containing the tainted ingredients.
In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.
The FDA also said it is working to develop testing methods to detect other cancer-causing impurities.
(Reporting by Saumya Sibi Joseph in Bengaluru and Michael Erman in New York; Editing by Saumyadeb Chakrabarty and Dan Grebler)
Source: Reuters
Tagged Topics

 

[motormafia]

https://www.straitstimes.com/world/...-toxin-found-in-recalled-blood-pressure-pills

New cancer-causing toxin found in recalled blood pressure pills

A photo illustration shows a stethoscope and blood-pressure machine.PHOTO: REUTERS
Published
Mar 2, 2019, 12:33 am SGT
Updated
Mar 2, 2019, 7:15 pm
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NEW YORK (REUTERS) - US health regulators said on Friday (March 1) a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
The US Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.
The latest toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero's losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.
Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with two probable carcinogens - N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).
The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.
Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.


The FDA said increased risk of cancer to patients exposed to the new impurity NMBA appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.
The recalls began last year after European regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals to produce valsartan contained cancer-causing impurities.
Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis' Sandoz have recalled products containing the tainted ingredients.
In January, the FDA had warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.
The FDA also said it is working to develop testing methods to detect other cancer-causing impurities.
In Singapore, the Health Sciences Authority (HSA) said in December that it has been testing the ARBs marketed in Singapore for the presence of NDMA and NDEA.
"To-date, none of the marketed ARBs that were tested by HSA has been detected to contain unacceptable levels of NDMA or NDEA. Hence, Singapore is not affected by the product recalls overseas," it said on Dec 19, 2018.
"While the ARB medicines that are available in Singapore are not affected, HSA will continue to monitor the local situation and update the public if there are any new findings," it added.
The HSA also said that patients should continue to take their ARB medicines unless otherwise advised by their doctors.

 

[motormafia]

https://edition.cnn.com/2019/03/01/health/losartan-recall-bn/index.html

Blood pressure medication recall expands again to include losartan

By Jacqueline Howard, CNN

Updated 1428 GMT (2228 HKT) March 4, 2019




(CNN)A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. The recall is due to an "impurity" that is classified as a potential human carcinogen.


FDA official says ongoing blood pressure drug investigation will probably uncover more tainted pills
The impurity, N-Nitroso-N-methyl-4-aminobutyric acid or NMBA, is also classified as a known animal carcinogen, the US Food And Drug Administration noted in a news release about the recall Friday.
Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets in the United States on Thursday. The recalled tablets, made by Hetero Labs Ltd. in India and distributed by Camber Pharmaceuticals, were found to contain trace amounts of the impurity.
The recall noted that Camber has not received any reports of adverse events related to the recall.
The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.


FDA warns of common blood pressure medicine shortage due to recalls
Starting in July, separate lots of ARB blood pressure and heart failure medications from various companies were recalled around the world, including in the United States, due to containing similar impurities that are potential or suspected human carcinogens: N-nitrosodimethylamine or NDMA and N-nitrosodiethylamine or NDEA.
Recent FDA analyses of NDMA and NDEA in the recalled drugs have found that "overall, the risk to individual patients is very low," but the agency added that those findings don't diminish the significance of this issue and that it continues to evaluate the risks posed to patients.
Now, the FDA is "deeply concerned" about the presence of a third impurity in certain ARB medications, Commissioner Dr. Scott Gottlieb said in the news release. NMBA had not been found in previously recalled ARB products, but the FDA continues its investigations.


Valsartan recall: 4 things patients should know
"It's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products," Gottlieb said.
"Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA," he said.
"We're continuing to share these testing methods with international regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity."


FDA sends warning to company at center of heart medication recall
There are FDA safeguards in place to prevent drug contamination, Maisha Kelly Freeman, a professor and director of Samford University's Center for Healthcare Innovation and Patient Outcomes Research, said this week.
Manufacturers are compelled to report impurities, for example, and the agency inspects factories on a risk-prioritized basis. However, there's a catch.
"Obviously, if they're not looking for it, they don't really know that it's occurring," Freeman said. And that's what happened in the case of tainted ARBs.
"Before they found this particular compound, they didn't even know there could be a chemical reaction that could produce the compound," she said.
Regarding how the recall has affected patients and pharmacists, "most patients have to come in and get their medications changed out" to lots of medication that have not been affected, Freeman said. Other people are getting their prescriptions changed.
From a community pharmacy perspective, this recall has been difficult because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively."
She hopes that in the next few years, technologies such as bar codes will be in place to help identify affected patients.
Get CNN Health's weekly newsletter
Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
As for the latest recall, the FDA has reminded patients prescribed an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or offers a different treatment option. Patients also are encouraged to talk to their doctor or pharmacist as soon as possible.
According to the FDA, "Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition."
CNN's Susan Scutti contributed to this report.

 

[laksaboy]

Maybe they're special ayurvedic ingredients added to boost the effectiveness of the drug.

 

[Ebolar8SG]

CB fucking Ah Neh!

People only high blood pressure they want to give FOC cancer to patients?

CB!

 

[A Singaporean]

We should always be cautious about anything from Ah Neh land. Anything.

 

[laksaboy]

We should always be cautious about anything from Ah Neh land. Anything.

Then you have to avoid going to most GP clinics, for many drugs come from India. From cough syrup to sore throat lozenges, to pills and skin creams and medicated lotions.

 

[eatshitndie]

don't need drugs. just dealing with ah neh tenant can be cancer-causing.

 

[halsey02]

We should always be cautious about anything from Ah Neh land. Anything.

In recent memory, there was a recall here on the simple paracetamol by ministry of health, in which they bought cheap from Bangladesh, on some quality issues.

 

[Leongsam]

Ah Neh drugs are cancer causing but you still stand a chance with cancer.

On the other hand the Tiongs will simply kill you outright with poison.

Ah Nehs are bad people. The Tiongs are even worse!


HUFFINGTON POST

06/18/2012 02:26 am ET Updated Aug 17, 2012
Toxic Capsules: China Drug Industry Tainted By Unsafe Chemicals

By Donny Kwok and Tan Ee Lyn

HONG KONG, June 18 (Reuters) - Hou Zhihui breaks open a cold-medicine capsule, pours the powder on to a piece of steamed dough and folds it together. He passes the miniature bun to a colleague who pops it in her mouth.

That is his response to the discovery of 77 million capsules made of industrial gel containing chromium, a carcinogenic heavy metal, the latest in a series of safety problems blighting China’s healthcare industry, including the widespread manufacture of fake drugs.

The government has repeatedly promised to tighten regulatory systems after safety scandals involving fish, drugs, toys, toothpaste, children’s clothes, tyres, drugs and milk fortified with melamine, used in the manufacture of tabletops. But little has been done apart from a few, highly publicised arrests.

“I read about the capsule problem ... the next morning, a colleague of mine had a cold, so I thought of a way for her to take the medicine,” Hou said.

China announced in May that 254 pharmaceutical suppliers, or 12.7 percent of the total, were producing tainted capsules. At least 10 are listed or linked to China-listed firms, according to the official Chinese media. Of 11,561 batches of drugs tested, 5.8 percent contained excessive levels of chromium.

Instead of using gelatine derived from animal parts, they used cheap industrial gelatine from leather scraps treated with chromium that tans and softens animal hide.

The problem is pervasive because of the pressure to produce low-cost drugs and still make a profit, and the popularity of traditional Chinese medicine, which is often made into powders and packed into capsules.

Authorities swooped in on 236 capsule makers, ordered 42 of them to stop production, closed 84 production lines, revoked the licences of seven companies and referred 13 to the police.

HEALTH IN JEOPARDY

As China revamps its healthcare system to make it more affordable to its 1.3 billion population, bureaucrats have gone all out to lower drug prices in large drug tenders that give winners a captive market spanning several provinces.

Toxic capsules have also been uncovered in Hong Kong, where drugmakers source 90 percent of their capsules from China.

“The current tendering system of the essential drug list has three major problems: first, essential drug tendering in provinces has become a political competition to depress prices among local governments, which results in constant decreases in prices of some essential drugs,” the Chinese Pharmaceutical Industry Association said in a report.

“The unreasonably low winning prices directly challenge the safely bottom lines of the essential drugs, put Chinese people’s health in severe jeopardy and affect normal production and supply of these essential drugs.”

Analysts say the cutting of corners won’t go away overnight.

“It will continue to haunt the market as long as enterprises have to make a profit,” said Gideon Lo, analyst at Nomura Equity Research in Hong Kong.

“Consolidation must happen and is already happening. It will be good if we can see the number of pharmaceutical makers coming down to 1,000 (from over 6,000) in the next five years.”

As for breaking open capsules and taking their contents separately, experts say that is dangerous, assuming the toxic capsules work, as they should, on a timer.

“The formulation of some drugs is prepared for sustained release, meaning the drug is prepared in a way to release the drug slowly,” said William Chui, president of the Society of Hospital Pharmacists of Hong Kong.

“If you break the capsule, you destroy the mechanism of sustained release. The drug will immediately be released and you risk increasing the drug level in your blood and developing side effects.” (Additional reporting by Beijing Newsroom; Editing by Nick Macfie)

 

[Leongsam]

And let's not forget that the chinks are so greedy they have absolutely no qualms over feeding poison to innocent babies and children!!!!

They are truly the scum of the earth!

49,957 viewsJul 16, 2014, 10:46am

The 2008 Milk Scandal Revisited



Yanzhong Huang
Contributor
Forbes AsiaI write about China and global health.

Six years ago today, sixteen infants in China’s Gansu Province were diagnosed with kidney stones. All of them had been fed milk powder that was later found to have been adulterated with a toxic industrial compound called melamine. Four months later, an estimated 300,000 babies in China were sick from the contaminated milk, and the kidney damage led to six fatalities. The Sanlu Group, one of the largest dairy producers in China, was identified as the chief culprit. But as the scandal unfolded, more Chinese dairy firms became implicated.

The incident not only damaged the reputation of China’s food exports, but also dealt a devastating blow to the booming domestic dairy industry, leading to a series of mergers and consolidations. The inelastic baby formula market boosted the demand for foreign products—indeed, after 2009, more than 100 foreign brands flooded into the Chinese market. In hindsight, it is not an overstatement that the 2008 incident is one of the largest food safety scandals in PRC history.

The scandal lays bare China’s failure to build an effective regulatory state in its transition to a market economy. Drawing lessons from the crisis, the government sought to strengthen its regulatory capacity in food safety control. In June 2009, China promulgated the Food Safety Law, which prohibits any use of unauthorized food additives. The law also led to the establishment of a high-profile central commission to improve inter-state coordination and enforcement of food safety regulation at the national level. In March 2013, China Food and Drug Administration (CFDA) was set up as a ministry-level agency to consolidate authorities in food and drug safety.

These measures, while important and necessary, have not led to significant improvement in China’s food safety. At the State Council Food Safety Commission meeting in January 2013, Premier Li admitted that while food safety has improved, “there are still a great deal of outstanding problems and potential hidden dangers; the situation remains grim.” China’s efforts to address food safety are complicated by new environmental health hazards, such as pollution of water and soil. Rice and garden vegetables contaminated by heavy metals poses major health risks, but the cleanup is highly costly and may take decades. Consumer confidence in Chinese dairy products remains extremely weak. Official media suggests that over half of the Chinese baby formula market is dominated by foreign brands, and in some cities, the share is as high as 80 percent. In a desperate and bizarre move to beef up the domestic dairy industry, China issued a new regulation that banned the import of dairy products from unregistered overseas manufacturers.

In recognition of the challenges, the government leaders over the past months have upped the ante for food safety. In March, Premier Li Keqiang used the melamine scandal to argue for “the strictest possible oversight and accountability” and “toughest possible punishment” in safeguarding food safety. Under Li’s blessings, China last week unveiled the draft amendment to the 2009 Food Safety Law. Dubbed “the strictest food safety law in history,” the new version has raised the bar of food safety management and provided more explicit requirements for government agencies to follow in the food supply chain.

But how effective these efforts remains to be seen. Since the regulation of food safety incorporates several mutually reinforcing activities (production, marketing and consumption) and involves various stakeholders (e.g., manufacturers, traders, consumers, governmental actors), it is highly unlikely that pure top-down, state-centric regulatory and legal frameworks will be sufficient to defuse China’s food safety crisis. In order to achieve robust and sustainable regulatory capacity, the government should invest in the building of a vigorous civil society and a free and socially responsible media, which would serve as sources of information and discipline in enforcing food safety laws and regulations. It should be committed to the building of an independent court system to protect the food safety legal framework from being hijacked by self-serving bureaucrats or other vested interests. It should also be serious about establishing a code of business ethics at corporate and individual level to keep the “capitalism without ethics” in check. Such institutional support, as a demonstrated in my recent book, will enable China to build its regulatory state from more solid ground.

 

[shittypore]

All Med. dispense at Polys and Hospitals are manufactured in Ah NEH land.

 

[motormafia]

All Med. dispense at Polys and Hospitals are manufactured in Ah NEH land.

CONFIRMED! Singapore kenna! 137,000 patients affected by losartan high blood pressure medicine recall: MOH = CCB AH NEH!


https://www.channelnewsasia.com/new...artan-blood-pressure-medicine-recall-11389466

Health 137,000 patients affected by losartan high blood pressure medicine recall: MOH

The affected products contain the active ingredient losartan potassium. (Photo: Health Sciences Authority)

28 Mar 2019 07:36PM (Updated: 28 Mar 2019 07:45PM)
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SINGAPORE: About 137,000 patients in Singapore are using the three recalled brands of high blood pressure medicine containing losartan, the Ministry of Health (MOH) said on Thursday (Mar 28).
Earlier, the Health Sciences Authority (HSA) said that the brands Losartas, Losagen and Hyperten were being recalled as the medicines contained higher than acceptable levels of a nitrosamine impurity.


Exposure to nitrosamines at higher quantities over a long-term period may potentially increase the risk of cancer, said HSA.
READ: HSA recalls 3 brands of blood pressure drugs over potentially harmful impurity
Seven other brands of losartan medicine approved in Singapore are not affected by the recall.
“About 137,000 patients in Singapore are using the three recalled brands of losartan medicine. Of these, about 130,000 patients have been prescribed Losartas at the public healthcare institutions,” said MOH.


There is no immediate risk associated with taking the affected brands of medicine, according to the ministry.

(Source: Health Sciences Authority)


“Patients are strongly advised to continue taking their medicine until their healthcare providers arrange for them to stop or switch to suitable alternatives.
"Patients who are unsure whether they have been using an affected product should contact their healthcare providers,” said MOH.
CONSULT DOCTOR FOR ALTERNATIVES: MOH
Public healthcare institutions will be reaching out to their patients, MOH said.
Patients whose medical appointments are scheduled before Jul 1 should proceed with these appointments and their doctor will advise them on suitable alternative medicines.
Patients whose medical appointments are scheduled on or after Jul 1 will be contacted for an earlier consultation or medication review, or both.
The public healthcare sector has made additional orders of unaffected brands of losartan, said MOH. The additional supplies will arrive progressively from a few weeks’ time. Importers will also be setting aside additional supplies for private healthcare providers.

HSA has advised patients to not stop treatment on their own. (Photo: Health Sciences Authority)


“To ensure continued availability of high blood pressure medication for all patients who need them, medical practitioners are advised to initially prescribe the medication on a one-month basis.
"This ensures that patients in all settings are able to promptly receive the medication they need. This may be the practice for the next six months,” MOH said.
At public healthcare institutions, patients currently on losartan will not have to pay more during the interim period should they switch to replacement medicines, which will be priced the same or lower.
Charges incurred for services such as additional consultations or tests to assess suitability for a switch in medicine will also be waived. Refunds will be provided to patients returning the affected losartan medication at their public healthcare institutions, MOH said.
Alternative high blood pressure medication include the Angiotensin Converting Enzyme Inhibitor (ACE-I) class of medicines as well as other angiotensin receptor blocker (ARB) classes of medicines.
Additional information and updates on impurities in high blood pressure medicines are also available at HSA's website.
Source: CNA/zl(hs)



https://www.channelnewsasia.com/new...ood-pressure-drugs-losartan-impurity-11389238

Singapore HSA recalls 3 brands of high blood pressure drugs over potentially harmful impurity

HSA has advised patients to not stop treatment on their own. (Photo: Health Sciences Authority)

28 Mar 2019 07:12PM (Updated: 28 Mar 2019 07:46PM)
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SINGAPORE: Three brands of high blood pressure medicine containing the ingredient losartan have been recalled because they contain higher than acceptable levels of a potentially harmful impurity, the Health Sciences Authority (HSA) said on Thursday (Mar 28).
The drugs contain the active ingredient losartan potassium, which was manufactured by Indian pharmaceutical company Hetero Labs.


The affected products are the 50mg and 100mg tablets from the brands Losartas, Losagen and Hyperten and distributed by local suppliers Apotheca Marketing, Medicell Pharmaceutical and Goldplus Universal, respectively.
About 137,000 patients in Singapore are using the three recalled brands of losartan medicine, said the Ministry of Health (MOH).
Losartas is prescribed in public healthcare institutions, while Losartas, Losagen and Hyperten are prescribed at private healthcare institutions.
HSA has advised patients not to stop treatment on their own as there is no immediate health risk and sudden stopping of the drugs can pose greater immediate risk to their health.

READ: 137,000 patients affected by losartan high blood pressure medicine recall: MOH

(Source: Health Sciences Authority)

HIGH EXPOSURE OVER A LONG PERIOD MAY INCREASE CANCER RISK
The recalled products were found to contain trace amounts of a nitrosamine impurity, N-nitro-N-methyl-4-aminobutyric acid (NMBA), which are above internationally accepted levels, HSA said.
Exposure to nitrosamines at high quantities over a long-term period may potentially increase the risk of cancer.
For example, the added cancer risk from an additional six-month exposure is estimated to be less than 0.0002 per cent.
“The risks of trace amounts of NMBA are associated with long term exposure. Sudden stopping of the medicines can pose greater and more immediate risk to patient’s health … We have advised healthcare professionals to review the medicine and treatment plans of their patients,” HSA said.


The affected products contain the active ingredient losartan potassium. (Photo: Health Sciences Authority)



Affected consumers are advised to consult their medical providers. (Photo: Health Sciences Authority)


HSA said that several losartan medicines have been recalled overseas since end-February due to the presence of NMBA. It tested all locally marketed losartan products for the presence of the NMBA impurity and in March found the three brands contained trace amounts of NMBA above acceptable levels.
The other seven brands of losartan medicines marketed in Singapore are not affected by this impurity.

(Source: Health Sciences Authority)

NO IMMEDIATE HEALTH RISK
National Heart Centre Singapore Cardiologist Professor Ding Zee Pin said that there is no immediate health risk associated with taking the affected medicines and that patients are advised not to stop or change treatment on their own.
“As losartan is used to treat high blood pressure, stopping the medicine without replacement of other equivalent medication can increase the risk of poor control of blood pressure,” said Professor Ding, who is also on HSA's Expert Panel on Nitrosamines.
Consumers who are taking the affected medication are advised to discuss their treatment plan with their healthcare provider.
“Do not stop taking the medicines on your own until you have been provided with a replacement brand of losartan or a different medicine by your healthcare provider,” HSA said.
MOH said in its release that public healthcare institutions will be reaching out to their patients.
Those with medical appointments scheduled before Jul 1 should proceed with their appointments, at which point their doctor will advise them on alternative medicines, MOH said.
Patients whose medical appointments are scheduled on or after Jul 1 will be contacted for an earlier consultation.
TESTS CONDUCTED ON OTHER BLOOD PRESSURE MEDICATION
Losartan belongs to a class of medicines called angiotensin II receptor blockers (ARBs), which are used to treat high blood pressure, also known as hypertension.
HSA said that since June 2018, several ARB medicines have been recalled overseas due to the presence of two other nitrosamine impurities, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
HSA said it has tested the locally marketed ARB medicines and found that none of them contained unacceptable levels of the two impurities.
"HSA is working with companies and international regulatory agencies to verify the cause of contamination, and to formulate measures to address the issue," it said.
"HSA will require companies to make the necessary changes to their manufacturing process to ensure that the medicines do not contain these impurities in future," it added.
Source: CNA/zl

 

[motormafia]

http://fortune.com/2019/02/27/fda-blood-pressure-medication-recall-list-losartan-2019/

1. Briefing
2. drug recall

FDA Recalls More Blood Pressure Medication






FDA Asked These Companies to Recall Blood Pressure Medications
Over cancer fears.



Current Time 0:00
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Duration 1:24






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By Brittany Shoot
February 27, 2019

The United States Food and Drug Administration (FDA) announced another blood pressure medication recall for one lot of losartan tablets, according to a safety announcement posted on the agency’s website.

The latest voluntary blood pressure drug recall includes a lot of losartan potassium/hydrochlorothiazide combination tablets manufactured by Macleods Pharmaceuticals Limited. These blood pressure meds are being recalled for the same reason as the numerous hypertension drug recalls issued last year. Trace amounts of a cancer-causing impurity, N-nitrosodiethylamine (NDEA), were detected. NDEA is classified as a probable human carcinogen, and while it does occur naturally in certain foods, NDEA is used to make liquid rocket fuel and is a byproduct of fish processing as well as pesticide manufacturing. The FDA notes that Macleods has not received any reports of adverse events related to this recall.

Recalls on losartan tablets produced by various pharmaceutical companies have been ongoing since 2018. Similar hypertension drugs have also been the subject of ongoing, FDA-led recalls due to carcinogenic impurities, including some valsartan tablets that also contain amlodipine, as well as certain lots of hydrochlorothiazide and irbesartan. These recalls have been so numerous that lawmakers have started to ask questions. In mid-February, members of the House Energy and Commerce Committee began asking the FDA for further details about quality control measures in overseas drug plants, where these contaminated cardiovascular drugs were made.

As with previous blood pressure medication recalls, it is important for patients taking this medication to contact their physician and continue taking their pills as prescribed. Discontinuing use of hypertension medication can have serious implications, and only a medical professional can advise on a replacement.

 

[motormafia]

Ah Neh KNN CCB! Fuck You Dead!!

 

[ChristJohnny]

Actually we should be grateful to ah Neh. At least you live till today to tell your tales. Else you already died long time ago without their medicine.

 

[obama.bin.laden]

Actually we should be grateful to ah Neh. At least you live till today to tell your tales. Else you already died long time ago without their medicine.

Rather pay a bit more buy the same medicine from Niggers or Malaysia.

 

[LordElrond]

Mine supplied by Zuellig and made in Turkey.
How many more days will I live?