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#1 kalip

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Posted 11 May 2019 - 08:07 PM

Update: More Blood Pressure Meds Recalled

 

 

Note: This story was updated on May 6, 2019 with a new losartan recall from Vivimed Life Sciences and on April  29, 2019 with a losartan recall from

Teva Pharmaceuticals USA. 

 

Dozens of medications used to treat high blood pressure have been recalled over the past several months as federal investigators discover potentially

cancer-causing impurities in them. When American Health Packaging recalled one lot of valsartan pills on March 7, the Public Interest Research Group

said it was the 75th recall of blood pressure medications since the problem first appeared. 

 

These common prescription drugs include valsartan, losartan, and irbesartan in different combinations and from different manufacturers. 

The problems have become so widespread that on March 12 the FDA prioritized approval of a new generic of valsartan to help relieve shortages of the drug.

In April, the agency released a list of 40 blood pressure medications it says are free from contamination. You can find the list here

"Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients," the agency said in a statement.

The FDA is also working to determine what exactly has caused the impurities and what changes need to be made in the manufacturing process to prevent it. 

The Public Interest Research Group said in March that the FDA needs to step up the pace. 

 

"After 75 recalls it is clear more aggressive action is needed," PIRG consumer watchdog Adam Garber said in a release. "Americans expect their blood

pressure medication to treat their conditions, not cause cancer. The FDA needs to finish its investigation and develop a plan to prevent further contamination."

Almost 60 million prescriptions were written for losartan drugs in 2016 and 14 million for valsartan or a drug that includes it. An additional 3.6 million

prescriptions were written for irbesartan that year. Here’s what you need to know.

 

What blood pressure drugs have been recalled?

 

Valsartan. There have been so many types of valsartan recalled this year that the FDA has created a website listing just for them. The latest is American

Health Packaging's 160 mg valsartan tablets, lot number 179791 that expire on March 31, 2020. The pills come in 100-count blister packs with NDC

number 60687-139-01. The agency has also created a page that lists drugs that have not been recalled.

 

Losartan. In December, the FDA announced a voluntary recall of losartan potassium tablets USP.  An addition eight lots of Torrent Pharmaceuticals' losartan

tablets were added to a previous recall in January. 

In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles,

NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.

 

Torrent's recall was expanded on Jan. 22 to include 10 additional lots of losartan potassium tablets, and six lots of losartan potassium and hydrochlorothiazide

tablets. Torrent further expanded the recall in April for 36 more lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. 

Macleods Pharmaceuticals Limited on Feb. 25 recalled one lot of losartan potassium/hydrochlorothiazide combination tablets 100mg/25mg, with a July 2019

expiration date.

 

Camber Pharmaceuticals on Feb. 28 recalled 87 lots of losartan tablets USP 25mg, 50 mg and 100 mg. 

Legacy Pharmaceutical Packaging, LLC on March 15 recalled 43 lots of losartan tablets. On April 24, the company recalled an additional lot of 50mg

losartan tablets.

Teva Pharmaceuticals USA on April 26 recalled 35 lots of losartan potassium tablets (6 lots of 25 mg pills and 29 lots of 100 mg) that were sold exclusively

to the Golden State Medical Supply of Camarillo, CA. Golden State re-packages the tablets under its own label for retail sale. 

 

On May 4, Vivimed Life Sciences Pvt Ltd recalled 19 lots of losartan potassium tablets in 25 mg, 50 mg and 100 mg doses. The drugs were made in India

and distributed by Heritage Pharmaceuticals of East Brunswick, NJ. For details on the recalled drugs, visit the FDA's website

 

Irbesartan. In July, the FDA announced a voluntary recall of irbesartan tablets.   In January 2019, Prinston Pharmaceutical Inc., doing business as Solco

Healthcare LLC, voluntarily recalled eight llots of irbesartan-based drugs. These are not yet listed on the FDA's website of all recalled irbesartan products. T

he recall involves irbesartan and irbesartan HCTZ tablets manufactured in China. 

 

Why are the drugs being recalled?

 

In each case, a recalled drug was contaminated with N-nitroso dimethylamine (NDMA), N-nitroso dimethylamine (NDEA) or N-Nitroso N-Methyl

4-amino butyric acid (NMBA).

Those chemicals are believed to cause cancer in humans. Research also suggests NDEA can cause liver and blood cell damage.

NDEA is used to make rocket fuel and can also be found in some food and drinking water, but at low levels. It can also be a created through certain chemical

reactions and as a by-product of industrial processes.

 

What is the risk of getting cancer from one of these drugs?

The FDA says it is very small. The amount of NDMA found in the recalled valsartan drugs exceeds acceptable levels. Records from drug manufacturers

show the impurity may have been in the valsartan products for up to 4 years. The FDA estimates that if 8,000 people took the highest valsartan dose,

which is 320 milligrams, from recalled batches every day for 4 years, there would likely only be one additional case of cancer over the life of those 8,000 people.

For context, 1 in 3 people in the United States will be diagnosed with cancer in their lifetime.

 

What’s driving the spike in recalls?

A common thread among all of these recalls is that the drugs, or ingredients in the drugs, were all made in China or India.

American drug companies since the 1990s have increasingly used factories in other countries to manufacture their products. About 40% of finished

medications are made overseas, the Government Accountability Office says. Nearly 8 out of 10 active pharmaceutical ingredients, which are made into

pills at other plants, are, too.

This globalisation of the nation’s drug supply helps keep prices down, as it is cheaper to have them made in other countries. But with lower costs

sometimes comes lower quality control.

 

What’s being done about products made in other countries?

An FDA spokesman says the agency is still investigating how these drugs became contaminated. Inspectors believe contaminated compounds were

unintentionally created through a chemical reaction.

 

What should people who rely on these medicines do?

Experts say anyone taking a recalled drug should continue to do so, but contact your doctor or pharmacist immediately. The threat from the

contamination may be less than the threat of not taking the drug.

Your doctor or pharmacist can help you find an alternative. But at least one expert says the recalls are making it more difficult to find valsartan drugs

that have not been recalled. And, he says, some blood pressure drugs not on the recall list have seen price increases as demand spikes.

 

 

https://www.webmd.co...-blood-pressure

 

kalip