Regulatory Several drug recalls hit the US market, including Pfizer's...

Several drug recalls hit the US market, including Pfizer’s Accupril


Leading pharmaceutical companies have been hit by recalls recently. These U.S. based drugs  include Jubilant’s Methylprednisolone , Aurobindo Pharma’s Cyanocobalamin Injection, Sun Pharma’s Cequa and pharmaceutical giant Pfizer’s Accupril.

Jubilant, Aurobindo Pharma, Sun Pharma have had to sanction recalls due to the Food and Drug Administration’s (FDA) enforcement report while Pfizer has to pull back on its blood pressure medicine Accupril due to the presence of carcinogens.

Jubilant, subsidiary of Cadista Pharmaceuticals, is recalling its Methylprednisolone tablets, which are for the treatment of inflammatory ailments, after the FDA report terming it “subpotent”. Aurobindo Pharmaceutical and Sun Pharma have been forced to recall their injectable treatment for vitamin B12 deficiency- Cyanocobalamin and dry eye drug Cequa, respectively, for the same reason. 

The FDA stated other reasons for the Cequa recall as well, such as the presence of foreign particles in the tested batch. 

The FDA termed these recalls as Class III. This is to specify that the recalled drugs did not pose a likely risk to the health and wellness of the patients who had ingested the drugs, or had been exposed to the drugs otherwise. 

Pfizer, on the other hand, has had to recall its Accupril tablets in the U.S. due to potential carcinogens being present in high volumes in the tablets. 5 lots of the tablets are being recalled.

This recall was triggered by testing of Pfizer’s blood pressure medicine which revealed the presence of high levels of nitrosamine. Nitrosamines prove carcinogenic to humans in these amounts. 

While most people are exposed to nitrosamines in one way or the other, long-term exposure over a long period of time renders it carcinogenic. Nitrosamines have been found to be present in cured meat, grilled meat, water, vegetables and dairy products. 

Pfizer’s release regarding the matter stated “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. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.”

Accupril is a drug approved to lower blood pressure in hypertensive patients, but it is also used in the management of heart failure and in other therapies as an addition to diuretics.

Pfizer had not yet received safety reports related to the recalled Accupril lots. These lots had been in distribution between the end of 2019 to April 2022 across the U.S. as well as Puerto Rico.

These Accupril lots have 90-count bottles of the drug in 10-, 20- and 40-mg potency. Expiry of the drugs in the lots are next March/May end.

Pfizer had to carry out a similar recall of its Canadian blood pressure medicines Accuretic and Inderal due to nitrosamine being flagged in the country. All Accuretic and 15 batches of Inderal had to be recalled as a result.

Pfizer stressed that its blood pressure drug Accupril has had over 3 decades of success in helping patients and the benefits of the drug have been significant. 

This is not the first time that nitrosamine has triggered a recall. Valsartan blood pressure medicine and metformin the diabetes drugs have seen similar issues, while Pfizer itself had also previously made a recall of its Chantix last year due to high levels of the carcinogen.

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