Pfizer Issues Recall of Blood Pressure Medications

On March 21, 2022, Pfizer announced a voluntary recall of three of the company’s blood pressure medications. The recall applies to the company’s brand-name blood pressure medication Accuretic (quinapril HCl/hydrochlorothiazide) as well as two generic medications, quinapril with hydrochlorothiazide and quinapril HCl/hydrochlorothiazide. These two generic medications are distributed by a company called Greenstone.

According to the U.S. Food and Drug Administration (FDA), Pfizer announced the recall due to, “the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level,” in the company’s blood pressure medications. As the FDA explains, “[nitrosamines] may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

Scope of Pfizer’s March 2022 Blood Pressure Medication Recall

Pfizer’s recall applies to medications sent to wholesalers and distributors between November 2019 and March 2022. Accuretic tablets covered under the recall include:

• Lot Number FG5379 with an expiration date 08/2024 (90-count bottles with a strength of 10/12.5 mg)
• Lot Number EA6686 with an expiration date 04/2022 (90-count bottles with a strength of 10/12.5 mg)
• Lot Number FG5381 with an expiration date 08/2024 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number EA6665 with an expiration date 04/2022 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number CN0640 with an expiration date 04/2022 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number ET6974 with an expiration date 02/2023 (90-count bottles with a strength of 20/25 mg)

Quinapril with hydrochlorothiazide and quinapril HCl/hydrochlorothiazide tablets covered under the recall include:

• Lot Number FE3714 with an expiration date 02/2023 (90-count bottles with a strength of 20/25 mg)
• Lot Number DN6931 with an expiration date 03/2023 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number ED3904 with an expiration date 03/2023 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number ED3905 with an expiration date 03/2023 (90-count bottles with a strength of 20/12.5 mg)
• Lot Number DP3414 with an expiration date 02/2023 (90-count bottles with a strength of 20/25 mg)

Long-Term Exposure to Nitrosamine in Pfizer Blood Pressure Medications May Increase Patients’ Risk of Multiple Cancers

Pfizer has advised that wholesalers and distributors should stop selling and quarantine the recalled blood pressure medications, and that, “[p]atients who are taking [these medications] should consult with their healthcare provider or pharmacy to determine if they have the affected product.” The company also reports:

“To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. . . . Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.”

However, patients who have taken Pfizer’s blood pressure medications long-term may be at risk even if they stop taking these medications. Additionally, as other sources note, the “nitrosamine levels in the recalled medicines were high enough that daily pills might eventually raise users’ cancer risk.” Thus, while taking Accuretic, quinapril with hydrochlorothiazide or quinapril HCl/hydrochlorothiazide may not immediately present a concern as Pfizer suggests, this does not mean that patients can ignore the risk associated with exposure to the high levels of nitrosamine in these medications over an extended period of time.

According to an article published in the journal Occupational & Environmental Medicine:

“Exposure to high concentrations of nitrosamines is associated with increased mortality from cancers of the esophagus, oral cavity, and pharynx, but not with increased mortality from cancers of the stomach or lung.”

Pfizer and Other Companies Have Recalled Drugs Due to High Nitrosamine Levels Previously

This isn’t the first time Pfizer has recalled a drug due to high nitrosamine levels. The company recently removed its anti-smoking drug Chantix from the market due to high nitrosamine levels as well. GlaxoSmithKline recalled its over-the-counter acid reflux medication Zantac in 2020, and Sandoz Inc. recalled its muscle spasm medication due to high nitrosamine levels the same day Pfizer announced its recall of Accuretic and its generic alternatives.

Understanding the Cancer Risks Associated with N-Nitroso-Quinapril and Other Nitrosamines

Nitrosamines such as N-nitroso-quinapril exist in water, meats, vegetables and dairy products, and most people encounter nitrosamines in their everyday lives. However, the quantities of nitrosamines in these sources are so low that it does not present a risk. As the FDA notes, people who consume nitrosamines, “at or below the acceptable intake limits every day for 70 years are not expected to have an increased risk of cancer.”

The risk of cancer comes when individuals consume nitrosamines such as N-nitroso-quinapril in quantities above the acceptable intake limit—and especially when individuals consume nitrosamines above the acceptable intake limit repeatedly over an extended period of time. This is why drugs like Accuretic that have levels of nitrosamines above the acceptable intake limit are so dangerous. By taking tablets every day, patients unknowingly increase their risk of cancer, and they do so with potentially irreversible consequences.

What To Do if You Have Been Diagnosed with Cancer After Taking a Pfizer Blood Pressure Medication

If you have been diagnosed with cancer after taking Accuretic or one of its generic alternatives, you should speak with a lawyer about your legal rights. You may have a dangerous drug claim against Pfizer. Drug manufacturers like Pfizer have a duty to avoid putting dangerous drugs on health care providers’ and pharmacies’ shelves. When they violate this duty, they can be held liable for patients’ losses. This includes not only out-of-pocket losses such as medical bills and lost income but also non-financial losses such as pain and suffering, loss of consortium and loss of enjoyment of life.

Schedule a Free, No-Obligation Consultation at Searcy Denney

If you would like more information about pursuing a dangerous drug claim against Pfizer, please contact us to arrange a free, no-obligation consultation. An experienced lawyer at Searcy Denney will be happy to review your case and explain your legal rights. To schedule an appointment at your convenience, call 800-780-8607 or contact us confidentially online today.