Sanofi-Aventis Korea said it would recall three types of hypertension treatments containing irbesartan due to impurity concerns raised in other countries.
The three products sold 16.9 billion won ($14.7 million) in Korea in the first half. However, the recall could dent second-half sales of Handok and Hanmi Pharmaceutical that manufacture the three, industry watchers said.
On Friday, Sanofi-Aventis Korea said it would retrieve Aprovel, CoAprovel, and Rovelito tablets manufactured before January in Korea. The three drugs all contain irbesartan, which was recently related to detecting azido impurity in other countries.
The recall in Korea is to prevent any safety issue, Sanofi said.
Azido impurity is a potentially carcinogenic substance. On April 29, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that azido impurity was a new mutagenic substance. In addition, the Canadian health authorities recently recalled sartan-class medicines that showed excessive levels of azido impurity. In Korea, the Ministry of Food and Drug Safety is investigating the matter.
“Our company is managing azido impurity in finished products manufactured after January 2021 below the tolerated level,” an official at Sanofi-Aventis Korea said. “We have yet to derive results for azido impurity in finished goods manufactured before January 2021.”
Although the company has yet to detect an excessive level of azido impurity, it expects that it would take a long time to derive test results. Thus, it decided to retrieve irbesartan preemptively, the company official said.
The official added that the company would fully cooperate with the MFDS and make every effort to promote the safety and health of patients.
Handok and Hanmi, manufacturing Sanofi’s irbesartan medicines, are likely to face a setback. Handok produces Aprovel and CoAprovel, and Hanmi, Rovelito, for the domestic market.
Sanofi-Aventis Korea handles domestic sales and marketing.
UBIST data showed that Aprovel, manufactured by Handok, sold 14 billion won in 2020 and 6 billion won in the first half of 2021. CoAprovel sold 6.9 billion won in 2020 and 3.9 billion won in the first half of 2021.
Rovelito, manufactured by Hanmi, sold 18 billion won in 2020 and 7.7 billion won in the first half of 2021.
An official at Handok said the company is an authorized manufacturer of the finished products of Aprovel and CoAprovel and that Sanofi-Aventis Korea is in charge of marketing, sales, and recall.
An official at Hanmi Pharmaceutical said the company was recalling the product promptly. “We are closely working with Sanofi-Aventis Korea to speed up the recall, as well as in local marketing and sales.”
The Korean ministry said there would be no significant safety issue regarding the recall of the three products.
“If there is a safety issue, we will take additional measures. But the latest was not the case, so we don’t recommend patients to switch drugs arbitrarily without a doctor’s advice,” a ministry official.
Upon the recall decision, hospitals, clinics, pharmacies, and wholesalers must return the three hypertension drugs manufactured before January 2021 to the purchase site.