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Will Diabetes Drug Pioglitazone Go The Sartan Way?

recall may03

The recall of certain Sartans, which are angiotensin II receptor blockers (ARBs) used to treat high blood pressure, has been making headlines since last year.

For the uninitiated, here's what the tainted Sartan drug recall news is all about.

Last year, more than 23 countries, including the U.S., and EU, recalled medicines containing Valsartan, supplied by one particular Chinese company, Zhejiang Huahai Pharmaceuticals, due to the presence of N-nitrosodimethylamine (NDMA), a substance that could cause cancer. Valsartan is an active pharmaceutical ingredient in drugs used to treat high blood pressure and heart failure.

In January of this year, Solco Healthcare LLC recalled one lot of Irbesartan and seven lots of Irbesartan and hydrochlorothiazide (HCTZ) combination tablets due to "unacceptable" amounts of N-Nitrosodiethylamine (NDEA), a human carcinogen in the active pharmaceutical ingredient. Irbesartan is also an ARB, which is used to treat high blood pressure. The active ingredient in the recalled Irbesartan products was also manufactured by the Chinese company Zhejiang Huahai.

In February of 2019, one lot of blood pressure drug Losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets made with active pharmaceutical ingredient manufactured by Hetero Labs Limited was recalled by Macleods Pharmaceuticals due to unacceptable amounts of N-Nitrosodiethylamine (NDEA).

More bad news followed for Hetero Labs in March of this year, with 87 lots of Losartan potassium tablets (25 mg, 50 mg, and 100 mg) made by Hetero Labs and distributed by Camber Pharmaceutical getting recalled due to the presence of another impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). This was the first ARB (angiotensin II receptor blocker) recall resulting from the presence of NMBA, a known animal and potential human carcinogen.

The list of companies recalling the blood pressure medicine Losartan has only been growing.

Last month, Teva Pharma recalled 35 lots of bulk Losartan Potassium USP Tablets due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The active ingredient in the recalled drug was also manufactured by Hetero Labs.

Following the recall of the tainted Sartans, lawsuits against the makers and distributors of the adulterated drugs have begun to stack up. (Read more about Valsartan Lawsuits).

Are Sartans the only drugs under the radar?

No, similar concerns about the presence of N-nitrosodimethylamine (NDMA) in Pioglitazone, a diabetes medicine, are also being raised now.

In a few batches of Pioglitazone manufactured by Hetero Labs in India, low levels of NDMA have been detected. Although the levels of NDMA are within strict limits that are considered acceptably safe, the European Medicines Agency has alerted companies using certain reagents to manufacture Pioglitazone to test their products and check their processes to rule out the presence of NDMA.

The nitrosamine impurities like NDMA, NDEA and NMBA, which are potential carcinogens, are formed from a specific sequence of manufacturing steps and chemical reactions when certain solvents, reagents, and other raw materials are used. It is also possible for these impurities to find their way into the drugs when manufacturers inadvertently use contaminated equipment or reagents in the manufacturing process.

Unless the drug manufacturers adopt stringent manufacturing processes and put in place rigorous testing regimes, the recall saga is here to stay.

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