Tag Archives: irbesartan

drug recall perplexed

This Product Has Been Recalled 75 Times

On May 6, 2019, Vivimed Life Sciences put out another recall for losartan.

The American Health Packaging recall of valsartan on March 7, 2019, the 75th recall of blood pressure medication since the initial contamination occurred.

The problem with the contamination of blood pressure medication has gotten so widespread that the FDA authorized a new generic of valsartan to help relieve shortages when lots after lots of the existing medication were recalled.

Also, the agency compiled a list of 40 blood pressure medications that seem free of contamination. You can find that list here.

Which blood pressure drugs have been recalled?

The common prescription drugs for blood pressure that have been recalled so far include valsartan, losartan, and irbesartan in different combinations and from different manufacturers.

Why have the drugs been recalled?

In each case, a recalled drug was contaminated with N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (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 a byproduct of industrial processes, and the FDA is working on identifying how it has been getting into the medication. It can also be created by other chemical reactions. It is found in very low levels in some food and in drinking water, and is used to make rocket fuel.

Can you get cancer from the contaminated drugs?

The FDA says the risk is very low. They estimate 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.

What should you do if you have a perscription for one of the recalled drugs?

Don’t stop taking the medication. The threat from the contamination in the drug is a lesser threat than the consequences of stopping the use of the medication.

However, do contact your pharmacist or Doctor as soon as possible.

They can help you find an alternative.

Because so much of the blood pressure drugs have been recalled, this may be a little more difficult than usual. Also, keep in mind that drugs that are not on the list of recalls are more in demand and therefore the price may have gotten higher.

WebMD has an article up that summarizes the rash of blood pressure medication recalls. You can read the full report here.

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dangerously high blood pressure

Losartan: Another Blood Pressure Medication Is Being Recalled

The FDA is recalling Irbesartan and Losartan, more angiotensin II receptor blockers (ARBs), after discovering traces of NDEA in them.

This new recall is for Losartan sold by Sandoz.

The recall is only for the 100mg/25mg tablets and does not involve other versions of the losartan drug.

This recall impacts less then 1% for the total losartan drug products in the US market. However, it is only the tip of the iceberg for pharmaceutical products  from the same manufacturer found tainted with amounts NDMA and NDEA that are not safe by the FDA’s standards.

The active ingredient in the recalled lot of losartan tested positive for NDEA.

NDEA is a suspected human and animal carcinogen. It was found within an ingredient that was made and supplied by the Zhejiang Huahai Pharmaceutical Company Co. Ltd. This same company supplied the tainted active ingredient used in the recalled lots of valsartan.

After the European Medicines Agency, (EMA), and then the FDA, confirmed the presence of NDMA and NDEA impurities in Valsartan, the FDA launched an investigation, including an inspection of the Zhejiang Huahai facility. They found traces of both NDEA and NDMA.

At the end of September, the FDA placed the Chinese company on an import alert, which means that any  active pharmaceutical products or finished products from the company would not enter the United States.

Valsartan is used in blood pressure medication and some vaccine products, among others.

The FDA is testing all ARBs- for NDEA and NDMA impurities and is keeping an ongoing list of recalled medicines and those that are not going to need to be recalled.

In August, 2018, FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, released a statement on the FDA’s ongoing investigation into valsartan impurities and recalls.

They described what caused the impurity in the drugs, what the FDA is doing about it, and the risk assessment for patients who have been taking the tainted drug.

The scientists working for the FDA estimated that,  “if 8,000 people took the highest valsartan dose (320 mg) from NDMA-affected medicines daily for four years, (this is the amount of time they estimated the affected drugs were being marketed), there may be one additional case of cancer over the lifetimes of these 8,000 people beyond the average cancer rate among Americans.”

That estimate was based on the highest daily dose, however many people may have taken lower doses, and therefore their risks would be less.

FDA expects the actual cancer risk to most consumers to be lower than the estimate.

The losartan recall is for lot number JB8912. If you are taking losartan, you can check the lot number on the bottle and see if the numbers match.

If your drug is on the recall list, the FDA suggests that you continue to take it until you can get a replacement from a Doctor or Pharmacist.

Questions regarding this recall can be directed to Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@novartis.com.

_________

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management brings great benefit to the healthcare industry and the general public alike. We publish this blog to to spread useful and practical information to help people stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to speak!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services 

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store 

Home Generated Medical Waste Drop-Off Points In California