Drugmaker Pfizer has announced a voluntary recall of its blood pressure medication Accuretic and two authorized generic versions.
An impurity called N-nitroso-quinapril was found in six lots of Accuretic, one lot of generic quinapril and hydrochlorothiazide, and another four lots of quinapril HCl/hydrochlorothiazide tablets, according to Pfizer.
This compound is one of several known as
“Nitrosamines are a group of natural occurring compounds that have a similar group of elements as part of their chemical structure,” Mary Ann Kliethermes, PharmD, director, medication safety and quality, American Society of Health-System Pharmacists (ASHP), told Healthline.
“These compounds are known to be carcinogenic,” she explained.
In a press release, Pfizer confirmed that the recalled medications treat high blood pressure (hypertension).
“The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program,” said Pfizer. “To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.”
The drugmaker pointed out while long-term ingestion of N-nitroso-quinapril may be associated with potential increased cancer risk in humans, “there is no immediate risk to patients taking this medication.”
In a related
Kliethermes said nitrosamines are prevalent throughout the environment, and food, water, and medication are monitored for nitrosamine content to minimize exposure.
“The risk of cancer is thought to occur from high exposure over a long period of time,” she noted, emphasizing that there is a “threshold amount” that has been determined to be too much exposure in water, food, or medicines.
Kliethermes added that nitrosamines could be formed from chemical reactions in manufacturing the medications. There is an authorized amount that can be in medications and recalls can happen if the chemical exceeds these amounts.
“There always is a concern about long-term exposure to these agents,” she continued. “Important to note is that the concern is to overall exposure.”
Asked what this means for people with recalled medication, Kliethermes said they should not stop taking their prescriptions.
“As the risk of stopping their medications and poor control of their medical condition may be significantly more dangerous than the risk of the nitrosamine exposure, until the lot of medication they have can be replaced,” she said.
Kliethermes also suggested patients could speak with their doctor about switching to another drug in this class of medications.
“There are a number of medications within the ACE inhibitor class to treat their medical condition,” she confirmed.
According to Pfizer, patients who use one of the recalled medications should check with their healthcare professional or pharmacy to determine if it’s from one of the affected lots.
You can also find a list of the recalled drugs in this Pfizer press release.
Pfizer asks patients to contact Sedgwick at 888-843-0247, Mon. to Fri. from 8:00 a.m. to 5:00 p.m. ET, for instructions on how to return the product and obtain a refund for the cost.
Healthcare professionals inquiring about this recall can contact Pfizer Medical Information at 800-438-1985, option 3, weekdays from 8 a.m. to 9 p.m. ET.
They can also call Pfizer Drug Safety at 800-438-1985, option 1, to report product complaints or adverse events.
Last October, the FDA
This was after analysis by the drugmaker revealed that certain active pharmaceutical ingredient (API) batches they tested were above the specification limit for another nitrosamine called N-nitrosoirbesartan.
Lupin discontinued the marketing of irbesartan and HCTZ tablets on Jan 7, 2021.
Peter Pitts, former FDA Commissioner, president of the Center for Medicine in the Public Interest, and a visiting professor at the University of Paris School of Medicine, said these recalls show that the system is working to protect the safety of patients.
“Pfizer found the problem, called the FDA, and is addressing the problem publicly, in a timely manner, and aggressively – so bravo Pfizer,” said Pitts. “I think that rather than cause concern, it should show people that there is a potent quality control system in place here and it works.”
He added that many times, companies will try to “bury these sort of things” since they feel that it somehow reflects poorly on their quality control.
“The reality is finding the problem and correcting it and being honest about it. That’s what quality control means,” Pitts said. “That’s what leaders do, so I’m very happy with that.”
Pfizer recently announced a recall of certain lots of their blood pressure medication Accuretic and its generic versions.
The drugmaker found they were contaminated with nitrosamines, a chemical compound associated with cancer after long-term exposure.
Experts say the recall demonstrates how well safety regulations work and that Pfizer responded rapidly and appropriately to the situation.