Pharmaceutical giant Pfizer is voluntarily recalling five batches of its Accupril blood pressure tablets after discovering high levels of a 'potential cancer-causing agent' in the medicine. The company released a statement adding that the distribution of the medicine took place across United States and Puerto Rico between December 2019 and April 2022.
With the official announcement on 22 March, Pfizer stated that it did not have any information regarding the reports of any detrimental events linked with the batches being recalled.
Nitrosamine is the cancer-causing agent which is said to have been discovered in the Pfizer drug. As explained by the US Food and Drug Administration (FDA), Nitrosamine is also known as Nnitroso-quinapril, which are usually found in water and foods and also include cured and grilled meats, dairy products as well as vegetables, however exposure to the agent above a certain level for a long period could bring up a risk of cancer, as reported by Fierce Pharma News.
The drug giant further stated, "everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."
In a release posted on the FDA's website, Pfizer stated, "although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication, patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them."
Pfizer states that, while Accupril is approved for hypertension to lower blood pressure it is also to known to manage heart failure as an add-on therapy to medicines like diuretics or digitalis.
As of Friday, the drug giant has not received any safety reports associated with the batches of recalled drugs. The company however recognized Accupril's safety track record of more than 30 years, adding that it believes the benefits of the medicine far exceed the risks based on current data according to Fierce Pharma News.
Pfizer Canada also had to recall all batches of three doses of Accupril on Thursday after discovering the same high levels of impurity. While there is no discovery of an immediate risk to patients taking this medication. "Pfizer believes the benefit/risk profile of the products remains positive based on currently available data," it said.
Last Month also saw the drug giant recalling some batches of another blood pressure drug Accuretic and two authorized cheaper versions because of the presence of high levels of potential carcinogen.