FDA recalls blood-pressure drugs due to cancer-risk ingredient

By The Nation

 

 

THE FOOD and Drug Administration (FDA) has recalled immediately five registered drugs to control blood pressure because of a potentially dangerous key ingredient.
 

“It contains something that poses cancer risk,” FDA secretary-general Dr Wanchai Sattayawuthipong said during the weekend. 

 

The recall is now underway and will conclude within the next 14 days. Recalled 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 by Unison Laboratories. 

 

Their manufacturing processes are not at fault, but an impurity has been introduced during the production of key ingredient valsartan by its supplier – China-based Zhejiang Huahai Pharmaceuticals. 

 

Recall of drugs containing valsartan are now underway in 22 countries around the world. 

 

“In Thailand, there are only two firms that have used valsartan from Zhejiang Huahai Pharmaceuticals,” FDA secretary-general Dr Wanchai Sattayawuthipong said recently. 

 

‘These drugs must be destroyed’

 

He urged people to check if they were using the drugs being recalled. 

 

“If yes, please return them to the hospital or pharmacy that gave them to you,” Wanchai said. “These drugs must be destroyed.”

 

Wanchai said Silom Medical and Unison Laboratories had been ordered to stop manufacturing drugs containing valsartan coming from the Chinese supplier. 

 

“Urgent alerts have already been issued to all relevant authorities, too,” he said. 

 

Valsartan, an angiotensin II receptor blocker, is usually prescribed for patients with hypertension. 

 

“Patients can continue to use drugs containing valsartan as long as they are not the ones that are now being recalled. Other batches are not contaminated,” Wanchai explained. 

 

A Thai-language community Facebook page “1412 Cardiology”, which is often used as an online source of useful medical information, has recommended Diovan, Co-Diovan, Tareg, Co-Tareg, Valpres, Exforge, Exforge-HCT, Dafiro, and Entresto brands. 

 

Their ingredients are from European manufacturers and not from Zhejiang Huahai Pharmaceuticals.

 

Source: http://www.nationmultimedia.com/detail/national/30350123

 

-- © Copyright The Nation 2018-07-16

2 minutes ago, webfact said:

Their manufacturing processes are not at fault, but an impurity has been introduced during the production of key ingredient valsartan by its supplier – China-based Zhejiang Huahai Pharmaceuticals. 

Pesky Chinese. 

The US FDA issued this recall a WEEK after 20 European countries did a recall. There are so many agencies in the US government that have become bloated, bureaucratic cesspools. I love my home country, but so much of the government is beyond useless. 

 

Yes, I have Valsartan purchased from my local Walgreens and the manufacturer is  Zhejiang Huahai Pharmaceuticals. Since I'm retiring to Thailand next month I was stocking up on this med. The only good part is that within 3 weeks of arriving in Thailand, I usually no longer need hypertension meds, but I was stocking up just in case.

Edited July 15, 20187 yr by JerseytoBKK

Consumers ask: Who will take responsibility for recalled drug? What about compensation?

 

Picture: Daily News

 

Thai consumers are asking pertinent questions in the wake of the decision to remove the popular blood pressure drug Valsartan from shelves.

 

The Thai food and drug administration has stopped the drug being sold after 22 other countries including the US made the decision.

 

It has been found that the drug contains a chemical that poses a potential cancer risk.

 

Wirot Jiraprasertwong,56, a shop owner in Lang Suan, Chumpon said he had been taking medicine for high blood pressure for 20 years and that includes Valsartan.

 

"I was shocked when I heard the news," he said at the weekend. "Cancer is a scary disease. I am getting on in years but what about younger people.

 

"Who is going to take responsibility for this and what compensation will there be?"

 

The drug was widely used to prevent the risk of heart attacks in heart patients.

 

Source: Daily News

 

-- © Copyright Thai Visa News 2018-07-16

I would like a lot more information on this recall as a user of this drug

 

- How long has this issue been going on

- The risk factors

- The type of cancer it causes 

- Is it being corrected and will the drug become available again once rectified

- How was this discovered

 

I want to know just exactly what I've been exposed too and for how long and if I need to take further action.

 

 

https://edition.cnn.com/2018/07/13/health/valsartan-recall-fda-bn/index.html

3 hours ago, JerseytoBKK said:

The US FDA issued this recall a WEEK after 20 European countries did a recall. There are so many agencies in the US government that have become bloated, bureaucratic cesspools. I love my home country, but so much of the government is beyond useless. 

 

Yes, I have Valsartan purchased from my local Walgreens and the manufacturer is  Zhejiang Huahai Pharmaceuticals. Since I'm retiring to Thailand next month I was stocking up on this med. The only good part is that within 3 weeks of arriving in Thailand, I usually no longer need hypertension meds, but I was stocking up just in case.

I use Diovan here in Chiang Mai. 555 Think I may only need it as a result of riding my motorbike!!! When I go for checkups, if they take the blood pressure soon after arriving, it is elevated. Course it could also be a result of having a pretty Thai nurse paying attention!!!

5 hours ago, JerseytoBKK said:

The US FDA issued this recall a WEEK after 20 European countries did a recall. There are so many agencies in the US government that have become bloated, bureaucratic cesspools. I love my home country, but so much of the government is beyond useless. 

 

Yes, I have Valsartan purchased from my local Walgreens and the manufacturer is  Zhejiang Huahai Pharmaceuticals. Since I'm retiring to Thailand next month I was stocking up on this med. The only good part is that within 3 weeks of arriving in Thailand, I usually no longer need hypertension meds, but I was stocking up just in case.

Yes, a good soapy usually does the trick!

The recall only concerns the valsartan under a number of brand names that were manufactured in China.

 

Valsartan was protected under patent until a few years ago under its original manufacturer, Novartis which manufactured the drug under the brand name, Diovan. Novartis continues to manufacture Diovan and this is NOT being recalled. In Thailand or anywhere else -  you can easily buy it in the kingdom but it is probably a bit more expensive than the copies - this original version is manufactured in the EU according to EU standards.

 

For your information, I do not work for Novartis nor any other pharma company. But I had to do this due diligence on behalf of someone I know because of the confusion in the media which at times made it seem that all valsartin was risky.

I have a huge supply of this medicine,, which both I and my wife have to take . I bought it in Bangkok, from a Chinese pharmacy, since I live quite far away, I buy about six months supply. I thikk I should return it. Will I get a refund?

37 minutes ago, gamini said:

I have a huge supply of this medicine,, which both I and my wife have to take . I bought it in Bangkok, from a Chinese pharmacy, since I live quite far away, I buy about six months supply. I thikk I should return it. Will I get a refund?

5 5 5......a refund it this place?!

I have indeed made some inquiries since i take similar vastarel (French  and expensive) but was quickly re-assured that the batches of contaminated Chinese manufactured drugs were up 50 mg to 150 mg i was told at the hospitals pharmacy this morning.

In this logic.  Tobacco products should be controlled like heroin and meth.  

Or maybe not,  the heroin and meth  prohibition thing isn't going too well for them.  

 

I'm surprised the tablets weren't made from cement dust.if it wasn't for the euro/us ban Thailand would of kept selling these drugs without doubt.

4 hours ago, gamini said:

I have a huge supply of this medicine,, which both I and my wife have to take . I bought it in Bangkok, from a Chinese pharmacy, since I live quite far away, I buy about six months supply. I thikk I should return it. Will I get a refund?

I'm in the same boat -- twenty boxes of the stuff bought in Bkk in March.  I live amidst Isaan rice paddies.  Planning on calling the pharmacy tomorrow and see if I can mail this to them for a replacement.

I always throw the box away

only record i can see is LOT HF0008A EXP030820

That dont help me much

 

Shame as its a lot cheap than Co Diovan

Anyway what are alternatives to this 

 

 

On 7/15/2018 at 5:42 PM, JerseytoBKK said:

Since I'm retiring to Thailand next month I was stocking up on this med. The only good part is that within 3 weeks of arriving in Thailand, I usually no longer need hypertension meds, but I was stocking up just in case. 

Jersey, I was pleased to hear your experience. I was on pressure meds (which I despise for a number of reasons) for about 5 months after settling in LOS. Because I felt so relaxed and peaceful (except for the daily near-death traffic episodes) I was curious to see what would happen to my pressures if I stopped the meds.

 

Well, I stopped the meds and my pressure didn't go up. It is now 5 months and I am visiting my homeland doctor. He confirmed my pressures being low and smiled when I showed him my tanned arm and told him I had also discontinued my vitamin D3.

 

Just another confirmation of the Stress Kills argument. Beach life may be boring but it's not stressful!