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Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

Get current information about recalls of blood pressure medications

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan


 

Video: A Message for Patients about Angiotensin II Receptor Blockers (ARBs)


What do I need to know about this recall?

Valsartan, losartan, irbesartan and other “-sartan” drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure.

Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards.

  • Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens (a substance that could cause cancer), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen.
  • Nitrosamines are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables.
  • The presence of these nitrosamine impurities in ARB medicines was unexpected. Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.

Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled.

Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled.  FDA has posted a list of currently available ARBs and the status of our assessment of those medications.

Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled.

Some manufacturers are recalling some medications containing amlodipine in combination with valsartan or losartan, and some medications containing hydrochlorothiazide HCTZ in combination with valsartan or losartan are also being recalled.

To find out if your medication has been recalled, you need the following information:

  • Manufacturer or labeler name
  • National Drug Code (NDC)
  • Lot number
  • Active ingredient(s)

Following is an example of an ARB medication label to help you identify the information on your medication:

Image depicting parts of a drug label: NDC, Manufacturer, Labeler, Dosage, Active ingredient

Note the manufacturer may be different from the distributor or labeler of your medication. Learn more about the NDC.

Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.

If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. It will also be printed on the back of a blister pack.

Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.

Yes. Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option.

Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled.

If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled.

  • If you have medicine included in a recall, contact your pharmacist. The pharmacist may be able to provide you with an unaffected ARB made by another company.
  • If the pharmacist cannot provide this, contact your doctor to discuss other treatment options.

Report any unexpected side effects with ARB-containing medicines, to FDA’s MedWatch program to help the agency better understand the scope of the problem:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

Return it to your pharmacist when you get your new medication.

FDA has determined the recalled ARBs pose an unnecessary risk to patients.

FDA recommends that pharmacists provide a replacement medicine not affected by the recall or prescribers consider other available treatment options for their patient’s medical condition.

A list of ARB medications affected by the recall are available on FDA’s website for healthcare professionals and patients to monitor. FDA has also posted a list of ARBs that are currently available, along with information regarding the status of FDA’s assessment for those medications.

FDA suggests health care professionals check the lists regularly for updates.

Samples can also be affected and part of the recall. Be certain to check samples to ensure affected products are not given to patients.

  • If you have medication samples from these companies, quarantine the products, and do not provide them to patients.  

Report any adverse reactions with ARB-containing products, to FDA’s MedWatch program to help the agency better understand the scope of the problem:



Where can I get more information?