Yesterday, Pfizer announced that it was recalling a popular blood pressure medication (Accuretic) after several lots of the drug were found to contain unsafe levels of a known carcinogen called nitrosamine. At least for now, the recall appears to be related to isolated batches of the drug and Pfizer claims that it has no evidence of “adverse events” related to the contamination. There is still the possibility, however, that this could turn into a much wider problem and lead to a wave of product liability litigation. In this post, we will review the details of the recall and assess the likelihood of any mass tort litigation.
Accuretic (quinapril/hydrochlorothiazide ) is a popular prescription drug that is used for the treatment of hypertension (high blood pressure). Accuretic is what is known as a “2-in-1” because it is a unique blend of 2 different types of traditional blood pressure medications: quinapril and hydrochlorothiazide. Quinapril is an ACE inhibitor that relaxes blood vessels in the body making it easier for blood to circulate. Hyrdrochlorothiazide is a diuretic which induces more frequent urination. Frequent urination helps speed up the process of getting sodium out of the body.
In many instances, diuretics (water pills) would be prescribed along with ACE inhibitors for hypertension treatment, but 2-in-1 medications like Accuretic eliminate the need for two separate prescriptions. The standard starting dose for Accuretic is 10 mg once a day, but some people take up to 25 mg a day.
On Monday, March 21, Pfizer issued a public notice stating that it was voluntarily recalling several lots or batches of Accuretic (as well as several lots of its separate quinapril and hydrochlorothiazide tablets). The recall was issued after Pfizer conducted quality control testing on random lots of the medication and discovered alarmingly high levels of a cancer-causing nitrosamine N-nitroso-quinapril. Nitrosamines are often found at very low levels in water, vegetables and processed foods. However, the levels found in the recalled Accuretic pills were significantly above the maximum safe daily limit.
Nitrosamines are impurities that are formed from the combination of nitrates and certain amines. They can be found at low levels in a wide range of foods and consumer products including: processed foods, cured meats, cigarettes, and produce. Nitrosamines are toxic to the human body and well recognized as very strong carcinogens. Prolonged ingestion or exposure to nitrosamines has been shown to cause various types of cancer including: lung, liver, kidney, bladder, stomach and esophageal cancer.
Everyone is exposed to low levels of nitrosamines on a regular basis. When nitrosamines are present in higher levels, however, they become harmful and carcinogenic. This is why the FDA has established maximum safe daily levels for nitrosamines in various products. The levels of nitrosamines found the recalled medications were significantly above these maximum safe limits (although we don’t know how far above).
The type of nitrosamine found in the contaminated Accuretic batches was identified as N-nitroso-quinapril. In the recall notice, Pfzier admits that “long- term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans,” but claims that there is “no immediate risk to patients taking this medication.” The recall notice also goes on to point out that the recalled medications have been around for 20 years with a well-documents history of being safe and effective. Pfzier also insists that it has no reports of adverse health incidents related to the medication.
The medication lots subject to the recall were manufactured and distributed in the U.S between 2019 and 2022. They include all
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
Will the Accuretic Recall Lead to Lawsuits?
Pfizer is clearly downplaying both the extent and possible significance of the recall in an effort to prevent any wave of product liability lawsuits. For starters, Pfizer only recalled certain lots of the drug suggesting that this was a limited contamination event. The implicit message in doing this is that the medication only contained the nitrosamine contamination for a limited period of time and only the recalled lots. In other words, Pfizer is trying to suggest that all of the previous lots of the drug over the course of its 20-year history were perfectly fine and did not contain high nitrosamine levels.
Whether this is true and accurate remains to be seen. Pfizer did not offer any obvious explanation for how the recalled lots ended up with such high nitrosamine levels yet everything made before that was fine. Further investigation and testing could eventually reveal that the high nitrosamine levels were inherently present in the medication all along and that Pfizer just never realize it before. This is almost exactly what happen with the discovery of NDMA in Zantac.
In 2018 random testing by an independent laboratory found that Zantac contained incredibly high levels of a known carcinogen called NDMA (N-nitrosodimethylamine). At first, the manufacturers suggested that this was simply the result of isolated contamination in certain lots, but eventually, it was discovered that extremely high NDMA was always present in the Zantac and was a byproduct of the manufacturing process. This led to the total recall of Zantac and thousands of Zantac cancer lawsuits.
The question is whether the nitrosamine contamination in certain lots of Accuretic will follow a similar path as the NDMA in Zantac. If it turns out that the nitrosamine was present in Accuretic all along and was simply never detected, Pfizer could be facing a massive wave of litigation. The evidence connecting nitrosamine ingestion to various types of cancer is extremely strong.