The Food and Drug Administration (FDA) yesterday said that pharmaceutical company Sanofi Taiwan is recalling nine batches of three types of irbesartan, an antihypertensive drug, due to the presence of an impurity.
The types of irbesartan being recalled are Sanofi Taiwan’s Aprovel 150mg film-coated tablets (license No. 022551), Aprovel 300mg film-coated tablets (license No. 022843) and Coaprovel 300mg/12.5mg film-coated tablets (license No. 023267).
The nine batches being recalled are: AA191, AA204 and AA269 of the Aprovel 150mg tablets; AA642, AA645, AA658, AA659 and AA707 of the Aprovel 300mg tablets; and AA531 of the Coaprovel 300mg/12.5mg tablets, the FDA said.
While monitoring international drug safety data, the FDA noticed that some sartan medicines — angiotensin II receptor blockers — contained a chemical compound known as azidomethyl-biphenyl-tetrazole (AZBT) and requested that drugmakers self-inspect their sartan drugs for the substance.
Hung Kuo-teng (洪國登), head of the FDA’s Medicinal Products Division, said that the agency received a report from Sanofi Taiwan last month saying that AZBT was detected in its irbesartan drugs in excess of the acceptable levels listed in the ICH guideline M7.
The guideline emphasizes considerations of safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk, the European Medicines Agency Web site says.
Hung said that AZBT is a mutagenic azido impurity that can form during the manufacture of sartan active substances, but it is not a nitrosamine — carcinogenic to animals — and that the specific risk posed by AZBT to the human body is unclear.
The nine batches of Sanofi Taiwan’s irbesartan drugs — about 9 million tablets — are undergoing a recall until Nov. 26, and the company is required to submit a recall progress report, Hung said.
National Health Insurance data shows that nearly 40 million tablets of the three types of drugs are consumed in Taiwan each year, he said.
The FDA strongly recommends that people with high blood pressure who are taking the drugs in these batches consult with their doctor before stopping the medicine.
It also requested that healthcare facilities and pharmacies stop providing the drugs in these batches and cooperate with Sanofi Taiwan’s drug recall process.
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