Pharmaceutical giant Pfizer is recalling five batches of its hypertension drug Accupril after it was found to contain chemicals that can cause cancer.
The recall comes after research found that batches of the drug contained increased levels of a cancer-causing agent, nitrosamine. It was announced on March 22 and involves five batches of pills, each containing 90 bottles.
Pfizer says those bottles may have been split into smaller prescriptions, and has urged any doctor or pharmacist who dealt with the shipments in question to contact them immediately.
The drugs were distributed in the United States and Puerto Rico between December 2019 and April 2022, a Pfizer news release said.
In the statement, Pfizer described the recall as ‘voluntary.’
The bottles come with 90 pills and are prescribed in 10mg, 20mg and 40mg increments. The number of pills per bottle can be broken down into smaller amounts.
In Canada, Pfizer had already announced a similar recall after finding the same impurity to be above acceptable levels.
A statement from the Canadian government said that people ingesting nitrosamine at the acceptable level or below for 70 years are ‘not expected to have an increased risk of cancer.
The company said in announcing the recall that they received no reports of specific incidents related to the drug. The giant also stressed that there is no immediate risk to patients already taking the drug.
Nitrosamines are common in water, foods such as smoked and cured meats as well as dairy products. However, exposure above acceptable levels over long periods of time could increase the risk of cancer.
Accupril works by decreasing the chemicals that narrow blood vessels. This allows blood to flow more smoothly and for the heart to work more efficiently.
The common side effects of the drug include muscle and joint pain, sensitivity to light, a dry cough and dizziness.
In 2019, there were 1.3 million active Accupril prescriptions in the United States, according Clinical Calculators.
This is the second recall that Pfizer has faced in six weeks after the company recalled the blood pressure drug Accuretic in early March due to apparent accelerated levels of nitrosamine.
An FDA statement on the recall instructed patients who are taking this product to consult with their healthcare provider or pharmacy to determine if they have the affected product.