Tag Archives: valsartan

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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.

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Drug Recall: Valsartan

The U.S. Food and Drug Administration has twice expanded its recall of several drug products containing the active ingredient Valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.

The reason for the recall is the presence of N-nitrosodimethylamine (NDMA).

NDMA was found in the batches that contained the valsartan ingredient manufactured by  Zhejiang Huahai Pharmaceuticals, Linhai, China.

NDMA is classified as a probable human carcinogen.

The presence of NDMA was unexpected, said the FDA, and is possibly related to changes in how the active substance was manufactured.  According to the EPA, NDMA — which was formerly used in rocket fuel, among other things — can be an unintended byproduct of wastewater treatment plants that use chemical compounds called chloramines for disinfection.

Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products. 

The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

The FDA will continue to investigate this issue and provide additional information when it becomes available.

The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

You can see a list of the recalled medications, as well as a list of products containing valsartan that have not been recalled, on the FDA’s website. Only products contaminated with NDMA are being recalled — not all valsartan tablets.

Not all valsartan products contain NDMA.

Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.

If you are taking valsartan, you should continue taking the medicine until you can determine if you need a replacement product. You can do this by checking the list of affected companies and batches on the FDA’s website.

The risk of stopping treatment can be more harmful to your health than taking the contaminated valsartan for just a bit longer, until you can get it replaced.

Contact your Doctor or Pharmacist. You may get a prescription for a different medication that treats the same indications, or a refill of valsartan medication from a batch that was not affected by the recall.

CBS News has a segment playing on the valsartan recall.

Customers and patients with Medical-related Questions, information about an Adverse Event or other questions about the Teva product’s being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, option 4, then option 1.

  • Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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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