Get a free visit for ED treatment. Start now

Last updated: Sep 10, 2020
6 min read

Blood pressure medication losartan recall

It can be more dangerous to abruptly stop taking your medication than to continue to take losartan products affected by this recall.

Disclaimer

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

Certain batches of generic medications containing losartan were voluntarily recalled in 2019 (FDA, 2019-d). Some batches of this medication were also recalled in 2018 (FDA, 2018-b). 

Losartan belongs to a class of medications called angiotensin II receptor blockers, or ARBs. These drugs are considered the first-line treatment for high blood pressure (hypertension), but they can be used to treat other conditions as well. Losartan is also approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of stroke and kidney problems in people with diabetes (diabetic nephropathy) (DailyMed, 2020). Losartan is available as a generic drug but is also sold under the brand name Cozaar.

Losartan may also be used off-label after a heart attack to help people with heart failure and to treat kidney disease in people who don’t have diabetes. It may also be used to help prevent a life-threatening heart condition common in people who have Marfan’s syndrome, a rare, inherited connective tissue disorder (UpToDate, n.d.). 

Men’s healthcare, without the waiting room

Connect with a US-licensed healthcare provider about ED, premature ejaculation, hair loss, and more.

Learn more

Recall of losartan potassium

In 2018 and 2019, certain batches of losartan produced in its generic form by Torrent Pharmaceuticals, Teva Pharmaceuticals, Macleods Pharmaceuticals, and Camber Pharmaceuticals were recalled by the FDA (FDA, 2019-a; FDA, 2019-e; FDA, 2019-b; FDA, 2019-c). The brand name medication, Cozaar, which is manufactured by Merck, was not involved in the recall.

The recall included both losartan potassium tablets USP and combination tablets containing both losartan and hydrochlorothiazide. The recall did not include all batches (also called lots) of these medications, so you need to check your prescription label to see if yours is affected. To check your medication, compare the lot number and expiration date from the label against the list of lots of losartan potassium tablets recalled (FDA, 2019-f).

The recall was initiated because these batches of the medications contained more than the acceptable amount of a compound called N-Methylnitrosobutyric acid, or NMBA. The FDA allows only a certain amount of NMBA in products, but some lots of these medications contained more than the permitted amount. It’s important to know that no adverse events have been reported by people taking the recalled medications (FDA, 2019-d).

If you are concerned that your medication is part of the affected lot, do not stop taking your medication before consulting with your healthcare provider. It can be more dangerous to abruptly stop taking your medication than to continue to take losartan products affected by this recall. Your healthcare provider may offer you a new prescription or alternative medication to ensure that your blood pressure remains stable (FDA, 2019-d).

Losartan dosage

The standard starting dose for adults taking losartan is 50 mg, taken once a day in the form of a tablet but dosages vary based on the indication and your personal treatment regimen established by your healthcare provider. If you are receiving treatment for high blood pressure and left ventricular atrophy, you may be prescribed losartan in combination with a diuretic such as hydrochlorothiazide to reduce how hard your heart has to work to pump (FDA, 2018-a).

Some individuals with specific health considerations may be started on a lower dose of losartan (25 mg), taken once daily. A lower dose is more commonly prescribed in individuals with underlying liver conditions or those with volume depletion (low fluid levels in the body), which can be caused by diuretic medications (FDA, 2018-a).

For some people, 50 mg of losartan may not be enough to adequately lower high blood pressure. These individuals may have their dosage increased from 50 mg to 100 mg, taken once daily (FDA, 2018-a).

Losartan side effects

The most common possible side effects of losartan include dizziness, stuffy nose, back pain, chest pain, diarrhea, high potassium levels, low blood pressure, low blood sugar, and tiredness (FDA, 2018-a). In rare cases, Cozaar may cause a severe allergic reaction, which can include hives, itching, rash, or trouble breathing. If you experience any of these symptoms, seek medical attention immediately. 

Since losartan is a medication used to lower blood pressure, sometimes it can lower blood pressure too much, which can cause dizziness or even fainting. In certain cases, it can reduce blood flow to the kidneys, causing kidney failure. In addition, it can cause high blood potassium (hyperkalemia) (UpToDate, n.d.). Hyperkalemia can be mild or serious, potentially causing heart problems such as arrhythmias (irregular heartbeat) that can be life-threatening (Simon, 2020). 

Since high blood levels of potassium can be dangerous, you may need to avoid high-potassium foods when taking ARBs such as generic Cozaar. Past research suggests that high dietary potassium may be safe for people with proper kidney function since the kidneys get rid of any excess potassium in the body (Malta, 2016; National Kidney Foundation, 2020). But that also means those taking ARBs such as losartan who already have kidney problems such as chronic kidney disease (CKD) may need to limit high-potassium foods such as potatoes, tomatoes, oranges, and bananas (Han, 2013). 

Salt substitutes that use potassium chloride and potassium supplements should also be avoided by anyone taking Cozaar. These sources of potassium have not been proven safe like dietary potassium and should be avoided even if you have normal kidney function. Your serum potassium levels may be used to determine how much high-potassium foods should be limited. 

Losartan warnings

Losartan may also cause serious adverse effects when combined with certain medications. Toxicity may result from combining losartan and lithium. Taking NSAIDs (over-the-counter pain killers like ibuprofen and naproxen) while you’re on losartan may limit its effect on your blood pressure. Drug interactions such as dangerously low blood pressure may also occur if this prescription medicine is mixed with ACE inhibitors or aliskiren, two other types of medications used to lower blood pressure (DailyMed, 2020).

People with liver problems should be cautioned when taking losartan. The liver is responsible for clearing this drug from the bloodstream, so if the liver isn’t working properly, people can experience increased drug levels, which can lead to serious drops in blood pressure. 

Tell your healthcare provider if you have any history of kidney problems as losartan can worsen kidney function, particularly in patients with a condition called renal artery stenosis (where the blood vessel that supplies the kidneys doesn’t supply enough blood) (DailyMed, 2020).

You should stop taking losartan if you become pregnant as the drug may cause fetal injury or even fetal death if taken during the final six months (second and third trimesters) of pregnancy. You should not breastfeed when taking losartan as the medication may pass into the breast milk (FDA, 2018-a). 

Tell your healthcare provider or pharmacist about any other drugs or supplements you’re taking before starting this medication.

References

  1. DailyMed. (2020). Losartan Potassium tablets 25 mg, film coated. Retrieved on Sep. 2, 2020 from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a3f034a4-c65b-4f53-9f2e-fef80c260b84
  2. Food and Drug Administration (FDA-a). (2018, June 01). Generic Drug Facts. Retrieved August 09, 2020, from https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
  3. Food and Drug Administration (FDA-b). (2018, December 12). FDA Updates & Press on ARB Recalls: Valsartan, Losartan and Irbesartan. Retrieved Sep. 10, 2020 from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan 
  4. Food and Drug Administration (FDA-a). (2019, January 22). UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP. Retrieved Sep. 10, 2020 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-losartan-potassium 
  5. Food and Drug Administration (FDA-b). (2019, February 22). Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity. Retrieved Sep. 10, 2020 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/macleods-pharmaceuticals-limited-issues-voluntary-nationwide-consumer-level-recall-one-lot-blm-715a 
  6. Food and Drug Administration (FDA-c). (2019, February 28). Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API). Retrieved Sep. 10, 2020 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-losartan-potassium-tablets-usp-25-mg 
  7. Food and Drug Administration (FDA-d). (2019, April 18). Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP. Retrieved Sep. 9, 2020, from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium 
  8. Food and Drug Administration (FDA-e). (2019, June 11). Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc. Retrieved Sep. 10, 2020 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-expands-voluntary-nationwide-recall-losartan-potassium-50-mg-and-100-mg 
  9. Food and Drug Administration (FDA-f). (2019, September 23). Search List of Recalled ARBs: Valsartan, Losartan and Irbesartan. Retrieved Sep. 10, 2020 from https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and 
  10. Han, H. (2013). Blood pressure medications: ACE-I/ARB and chronic kidney disease. Journal of Renal Nutrition, 23, e105–e107. Retrieved from https://www.jrnjournal.org/article/S1051-2276%2813%2900152-0/pdf 
  11. Malta, D., Arcand, J., Ravindran, A., Floras, V., Allard, J. P., & Newton, G. E. (2016). Adequate intake of potassium does not cause hyperkalemia in hypertensive individuals taking medications that antagonize the renin angiotensin aldosterone system. The American Journal of Clinical Nutrition, 104(4), 990-994. doi:10.3945/ajcn.115.129635. Retrieved from https://academic.oup.com/ajcn/article/104/4/990/4557116 
  12. National Kidney Foundation. (2020, August 26). What is Hyperkalemia? Retrieved Sep. 2, 2020 from https://www.kidney.org/atoz/content/what-hyperkalemia 
  13. Simon, L. V., Hashmi, M. F., & Farrell, M. W. (2020). Hyperkalemia. Treasure Island, FL: StatPearls Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK470284/ 
  14. UpToDate. (n.d.). Losartan: Drug Information. Retrieved on Aug. 24, 2020 from https://www.uptodate.com/contents/losartan-drug-information?search=losartan&source=panel_search_result&selectedTitle=1~69&usage_type=panel&kp_tab=drug_general&display_rank=1#F25472738