ID :
171193
Mon, 03/28/2011 - 06:16
Auther :
Shortlink :
http://m.oananews.org//node/171193
The shortlink copeid
Thailand imposes strict control on "lenalidomide"
BANGKOK, March 28 (TNA) - Thai Public Health Minister Jurin Laksanawisit has issued an announcement to impose special control on the use of "lenalidomide" medication with local pregnant women, as proposed by Thailand's Food and Drug Administration (FDA), reasoning that it may cause disabilities in infants.
Boonthee Phanichpraphai, Secretary to the Thai Public Health Minister, said on Monday that the announcement is likely to be officially effective at the end of this month, the following day after it is published in the Royal Gazette. Under the regulation, sales of the drugs in Thailand are to be limited only at local hospitals, as studies have found that "lenalidomide" can cause disabilities in infants.
"Lenalidomide" is a new drug used together with dexamethasone to treat people suffering from a cancer of plasma cells known as Multiple Myeloma (MM)--aimed at restoring approximately the normal level of immunity in patients. The Thai FDA said that "lenalidomide" is related in chemical structures with "thalidomide"--which has been under control since June 9, 2007. "Lenalidomide" can cause disabilities in infants such as resulting in babies to be born without a limb. Therefore, it can be harmful if being used with pregnant women.
Thai FDA chief Dr. Pipat Yingseri insisted that the drug needs to be prescribed by licensed practitioners experienced in hematology and concerned operators are required to have measures to protect pregnant and fertile women from the risks of the drug. Besides, the Thai FDA requires licensed distributors to report information related to the safety of the drug every six months.
Meanwhile, public health offices and hospitals across Thailand have already been informed of the new ministerial announcement on the drug control. (TNA)
Boonthee Phanichpraphai, Secretary to the Thai Public Health Minister, said on Monday that the announcement is likely to be officially effective at the end of this month, the following day after it is published in the Royal Gazette. Under the regulation, sales of the drugs in Thailand are to be limited only at local hospitals, as studies have found that "lenalidomide" can cause disabilities in infants.
"Lenalidomide" is a new drug used together with dexamethasone to treat people suffering from a cancer of plasma cells known as Multiple Myeloma (MM)--aimed at restoring approximately the normal level of immunity in patients. The Thai FDA said that "lenalidomide" is related in chemical structures with "thalidomide"--which has been under control since June 9, 2007. "Lenalidomide" can cause disabilities in infants such as resulting in babies to be born without a limb. Therefore, it can be harmful if being used with pregnant women.
Thai FDA chief Dr. Pipat Yingseri insisted that the drug needs to be prescribed by licensed practitioners experienced in hematology and concerned operators are required to have measures to protect pregnant and fertile women from the risks of the drug. Besides, the Thai FDA requires licensed distributors to report information related to the safety of the drug every six months.
Meanwhile, public health offices and hospitals across Thailand have already been informed of the new ministerial announcement on the drug control. (TNA)
