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Blood Pressure Medication Recall – Know The Facts

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We’ve grown to be pretty familiar with romaine lettuce recalls or raw meat recalls due to product contamination with bacteria and other pathogens, but it’s important to know that more than just these types of foods can undergo recalls due to a lack of consumer safety.

In fact, the United States Food and Drug Administration (FDA) recently announced a third blood pressure medication recall over extreme concern that the drug might result in cancer. Understanding the facts of a recall is highly important in order to not only avoid the appropriate product, but also to be able to find a safe replacement. (1, 2)

Here are the facts of this blood pressure medication recall! 

What’s Happening With The Blood Pressure Medication Recall

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According to the FDA, “Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level.” The FDA issued the announcement carefully detailing the recalled product, explaining that the medication was recalled due to the trace amount of an impurity, which the FDA names as, “N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc.”

The impurity found within this medication, a substance that occurs naturally in certain foods, as well as  “drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).” The recalled medication contained a substance that has been linked to the causation of cancer. (1, 3)

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Thankfully, Sandoz Inc. has not received any reports detailing any sort of adverse events related to this lot of recalled medication. However, the product has been recalled out of an abundance of caution in accordance with research gained from IARC. The FDA clearly states that “Sandoz Inc. is notifying its distributors by letter via overnight mail and patients by this public notification.”  (1, 2)

What To Do If You Are Currently Taking The Recalled Blood Pressure Medication

Many people have been relying on this medication to help maintain their blood pressure and health. However, the FDA clearly advises that any and everyone currently taking this medication should speak with their doctor immediately before stopping their use. The reason for this is that the health risks of going off of their medication could be far greater than their risk for cancer. Patients with specific questions are free to contact Sandoz Inc. at  800-525-8747 or email usdrugsafety.operations@novartis.com in order to get the most updated and accurate information about the recall. (1, 2)

The FDA has clarified to distributors and retailers that any of the recalled product that remains on their shelves should not be offered to consumers. According to the FDA, “Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor.” (1)

Conclusion

Remember that if you are currently taking this recalled medication, don’t cease taking your prescribed dosage before getting advice from your doctor. You should only dispose of the recalled medication at your doctor’s direct suggestion and then follow their directions on a different medication to take.

https://www.fda.gov/Safety/Recalls/ucm625492.htm

  1. https://www.usatoday.com/story/money/nation-now/2018/11/13/fda-losartan-recall-cancer-risk-tied-blood-pressure-drug/1985858002/
  2. http://www.who.int/water_sanitation_health/dwq/chemicals/ndmasummary_2ndadd.pdf

Abbey Ryan

Abbey Ryan

Abigail is an avid writer, determined traveler, incessant artist, and curious adventurer. She’ll try practically anything once, including eating shark, visiting foreign countries, jumping out of airplanes, hiking after midnight, and starting new businesses. Many of these she’ll do more than once, some she wouldn’t recommend doing at all, but that’s the fun of it, see? She completed her double major BA degree in two years, with a focus in Project Management and Human Resource Management with a Psychology minor. She graduated with honors from Liberty University in 2017. Currently, she lives somewhere in America with her new husband and works as a professional copywriter and researcher.
Abbey Ryan

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