The Drug Administration of Vietnam (DAV) is closely examining information on a type of birth control pills suspected to have killed several Canadian women in order to make a timely decision on whether to recall those being used in Vietnam.
The announcement from the department under the Ministry of Health was published on the government website on Friday, amid concerns over the safety of Yaz and Yasmin, produced by Canadian-owned Bayer and licensed for circulation in Vietnam.
Vietnamese health authorities licensed Yaz and Yasmin in 2012 and 2010, respectively, Truong Thi Nguyet, who is in charge of managing drug information and advertising under the department, was quoted as saying.
Last September, labels for Yaz and Yasmin being sold in Vietnam were updated to include information about the increased risks of blood clots following other countries’ warnings, Nguyet said.
At that time DAV also asked local health departments and hospitals under the Ministry of Health to tighten their monitoring of possible adverse reactions to the pills, and report them to the DAV, she said.
In late 2011, the U. Food and Drug Administration said the pills both contained a hormone called Drospirenone that could increase risks of blood clots compared other oral contraceptives, according to the government website’s report.
Previously, on June 7 that same year Health Canada announced that it would start reviewing the safety of birth control pills containing Drospirenone.
The review was completed on December 5 last year with conclusions that Yaz and Yasmin carry higher risks of blood clots – 1.5 to 3 times – than some other birth control pills.
On June 6 this year, Health Canada issued a summary on the adverse reactions to the pills in Canada from 1965 to 2013.
It found nine deaths were linked to Yaz and 18 related to Yasmin, but it did not give details about the connection between the deaths and the patients’ use of the pills, DAV said in the report.
A report on Canada’s CBC News quoted Health Canada’s summary as saying that Canadian doctors and pharmacists have reported 600 adverse reactions and 23 related deaths between 2007 and February 2013.
It said more than half of the reported deaths were women under 26 with the youngest being 14-years-old.
Meanwhile, Bayer is scheduled to appear in court in Ontario this September 4 for a class-action lawsuit brought against the manufacturer by hundreds of women in the Canadian province over the birth control pills.
The Ontario lawsuit is one of 13 class-action lawsuits Bayer is facing over the pills, according to the Toronto Star newspaper.
The company admitted that it has already paid over US$1 billion to settle thousands of lawsuits in the U.S.
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