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FDA cautions after recall of five drugs: Patients ‘must find alternative’

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Patients ‘must find alternative’

By CHULARAT SAENGPASSA, 
KORNRAWEE PANYASUPPAKUN 
THE NATION

 

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FDA cautions after recall of five drugs.

 

WHILE FIVE medicines containing valsartan are being recalled over their potential links to cancer, experts warn that abandoning them without alternative medication is even more dangerous. 

 

The Food and Drug Administration (FDA) has emphasised that patients must get alternative medicine before abandoning the drugs that are being recalled. 

 

About 20,000 people with blood-pressure problems in Thailand rely on the five drugs that the FDA intends to recall over the next two weeks. 

 

“Without equivalent medication for blood-pressure issues, the decision to stop taking these drugs is more dangerous than taking it,” FDA secretary-general Dr Wanchai Sattayawuthi-pong warned yesterday.

 

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Dr Wanchai Sattayawuthi-pong

 

“This means you should urgently contact your doctor, hospital or pharmacy over the recalls and immediately get alternative medication.” 

 

On the recall list are Valatan 80 drug registration No 1A/54 (NG); Valatan 160 drug registration No 1A 10/54; Valsarin 80 drug registration No 1A 4/60; Valsarin 160 drug registration No 1A 5/60; and Valsarin 320 drug registration No 1A 6/60.

 

The first two drugs are manufactured by Silom Medical while the other three are made by Unison Laboratories. 

 

An impurity has been introduced during the production of key ingredient valsartan by a supplier – China-based Zhejiang Huahai Pharmaceuticals.

 

Thailand is the first country in Asia to order the recall, which has been underway in 21 other nations across the globe. “Scientific tests have detected cancer risks in guinea pigs, not yet in humans. But for safety reasons, recalls have started in many countries,” Wanchai said. FDA deputy secretary-general Dr Surachoke Tangwiwat said doctors had prescribed 30 million pills to treat blood-control problems in Thailand last year. Of them, about six million were produced by Silom Medical and Unison Laboratories.

 

“These pills were prescribed to about 20,000 patients. We are going to contact them via their hospitals,” Surachoke said. He added that alerts were also issued via provincial public health offices, medical centres and pharmacists’ networks. 

 

Atthaporn Limpanyalerd, assistant secretary-general of the National Health Security Office (NHSO), said about five million people in Thailand had blood-pressure issues.

 

“Of them, about 10 per cent have received treatments via the universal healthcare scheme,” he said. 

 

The scheme is Thailand’s largest healthcare programme, covering about 48 million Thais. “We are in the process of checking with the scheme’s hospitals to determine how many patients will be affected by the ongoing recalls,” Atthaporn said. 

 

Khon Kaen-based Chum Phae Hospital’s director Dr Kriangsak Vacharanukoonkiet said that before the recall order came out, his hospital had prescribed valsartan-containing medicine to 35 or 36 patients for high blood-pressure treatment. “But after the FDA ordered the recall, we immediately stopped prescribing it and implemented the recall,” he said. 

 

Kriangsak said his hospital was working with networked tambon-level hospitals and hospital staff to collect the problematic valsartan from patients’ houses. 

 

He said his hospital was considering several options to replace the problematic medicine. 

 

“We may use valsartan-containing medicine from another manufacturer, one that doesn’t have the [carcinogenic] ingredient or we can order an alternative medicine,” he said.

 

Source: http://www.nationmultimedia.com/detail/national/30350197

 
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-- © Copyright The Nation 2018-07-17

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surely the simple solution is for the Chinese supplier to modify their manufacturing process to remove this impurity - it has got to be in their interest to do so, or Silom Medical switches its supplier of Valsartan

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The headline is misleading. The drug, valsartin, is NOT being withdrawn. Just certain VERSIONS made in China are being withdrawn. Anyone who is currently on the versions being withdrawn can stop taking them and switch to any other version of valsartin without a problem. Other versions of valsartin are available in the kingdon, including the original version of valsartin, Diovan, manufactured by Novartis in the EU.

 

Disclaimer: I do not work for Novartis nor for any other  pharma interest.

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1 hour ago, Proboscis said:

The headline is misleading. The drug, valsartin, is NOT being withdrawn. Just certain VERSIONS made in China are being withdrawn. Anyone who is currently on the versions being withdrawn can stop taking them and switch to any other version of valsartin without a problem. Other versions of valsartin are available in the kingdon, including the original version of valsartin, Diovan, manufactured by Novartis in the EU.

 

Disclaimer: I do not work for Novartis nor for any other  pharma interest.

they are 2-3x times the price

 

the option for me will be asking my pharma to source 100mg losartan which is the same dosage as 160mg valsartan and the drugs are almost identical, I switched from losartan because the pharma I was with refused to source 100mg and only supplied 50mg (for obvious reasons) requiring me to take 2x per day, that was when I went on the hunt for valsartan and switched pharmacies, I will now ask my current pharma to source 100mg losartan which I'm sure they can do and they are a fraction of the price, I currently pay 450b for 28x valatan, I believe 100mg losartan are about 200b x28

 

I am also a little concerned the Losartan sold here in Thailand could very possibly be coming from China !!

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6 hours ago, webfact said:

An impurity has been introduced during the production of key ingredient valsartan by a supplier – China-based Zhejiang Huahai Pharmaceuticals.

Made in China.....What did you expect?

 

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The best alternative I found are bananas and no alcohol. I had very high blood pressure (around 200). I stopped drinking beer and eat every day 1 to 2 bananas. My blood pressure is below 120 now. Before I took Losartan and got sometimes Tinnitus at this time.

 

Bananas and Losartan have one ingredient in common - Potassium what reduces the blood pressure. And yes this is no joke. Because of this Potassium too many Bananas (they say more than 8 every day) could kill you the same way as if you would take too many Losartan pills. Bananas have very high Potassium levels.

 

In respect of alcohol. If I had some hard nights it takes about 10 days for my blood pressure to get back to low levels again. So don't expect a change within a day.

 

It is also a good idea to have something at home to measure your blood pressure. I bought something on ebay for about 700 Bath and it works great. Compared it with the values at the hospital with their device and they were pretty much the same. This you should do if you buy something for at home.

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2 hours ago, Beggar said:

The best alternative I found are bananas and no alcohol. I had very high blood pressure (around 200). I stopped drinking beer and eat every day 1 to 2 bananas. My blood pressure is below 120 now. Before I took Losartan and got sometimes Tinnitus at this time.

 

Bananas and Losartan have one ingredient in common - Potassium what reduces the blood pressure. And yes this is no joke. Because of this Potassium too many Bananas (they say more than 8 every day) could kill you the same way as if you would take too many Losartan pills. Bananas have very high Potassium levels.

 

In respect of alcohol. If I had some hard nights it takes about 10 days for my blood pressure to get back to low levels again. So don't expect a change within a day.

 

It is also a good idea to have something at home to measure your blood pressure. I bought something on ebay for about 700 Bath and it works great. Compared it with the values at the hospital with their device and they were pretty much the same. This you should do if you buy something for at home.

 

 

If you look up the lethal dose for potassium chloride on a page like this, the oral value is 2,600 mg per kilogram. If you weigh 75 kilograms (165 pounds), you would need to consume 75 * 2,600 = 195,000 mg of potassium to reach fatal levels. That's 487 bananas worth.

 

https://www.brainstuffshow.com/blogs/can-you-die-from-eating-too-many-bananas.htm

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If you have healthy kidneys and drink a lot you are right. If not Potassium levels can reach very high values.

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