Dec 26, Colombo: Sri Lanka's Cosmetic Devices and Drugs Regulatory Authority (CDDRA) of the Ministry of Health has issued an order to withhold the injectable contraceptive Depotone following the death of a young mother in Puttalam district.
The CDDRA has issued the order to immediately withhold the Medroxyprogesterone Acetate Injection 150mg from use as a preliminary precaution.
The 21-year old mother of one from Kalpitiya was administered the contraceptive at a private clinic on December 23, six weeks after giving birth to her first child.
Following a serious adverse event to the drug soon after administration, the patient was admitted to the Puttalam District General Hospital. The woman later died due to anaphylactic shock to the contraceptive.
The event is under investigation and the Department of General Health Services (DGHS) has approved withholding the product from use with immediate effect, until investigations are completed, the CDDRA said.
As such, the market authorization holder has been instructed to withhold Depotone from use, immediately, as a preliminary precaution and furnish the department with consignment details including details of batches and manufacture’s explanation within two weeks.
Following the death, the Health authorities have assigned a team of special medical practitioners, including the Deputy Director of the CDDRA, pharmacologists, officials from the Family Health Bureau, specialists from the National Drug Quality Assurance Laboratory to investigate the death.
CDDRA Director Dr. Hemantha Benaragama told media that the injectable Depotone is not administered in government hospitals and people who are using family planning at government hospitals need not to be concerned about the withholding.