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06-14-07, - 11:32 AM
HIV drug being recalled
http://www.thenassauguardian.com/national_local/353151179754494.php
By JIMENITA SWAIN, Guardian Senior Reporter
jimenita@nasguard.com
Viracept, an antiretroviral medicine used to treat HIV in infected adults, adolescents and children three years and older is under quarantine by the Ministry of Health after its parent company Roche issued an immediate recall of the drug on June 5. According to information from the press office of the European Medicines Agency, viracept was recalled after there was an indication of contamination in some batches.
"Roche has identified the presence of an unexpected contaminant ethyl mesylate (also known as methane sulfonic acid ethylester in some batches of viracept," the release stated. Ethyl mesylate, is a known genotoxic that is harmful to DNA and if taken by a pregnant woman can cause harm to a child in the womb. The company who makes viracept investigated complaints by patients who said the tablets they had taken smelled unusual.
Chief Medical officer (CMO) in the Ministry of Health, Dr Merceline Dahl-Regis, told The Guardian yesterday that viracept is used locally. Further, she said, an investigation has been launched by Dr Perry Gomez, the National HIV/AIDS Program co-ordinator. The CMO explained that for the time being HIV patients will be placed on another antiretroviral medication.
"We are following the WHO (World Health Organization) recommendations to quarantine the drug," she said.
The Ministry received notification for the recall on June 8, three days after Roche issued their recall in Europe. Viracept, has an active substance nelfinavir, which blocks the enzyme protease that is involved in the reproduction of HIV. Once the enzyme is blocked, the virus does not reproduce normally and is slowed down in its spread through the body.
Persons who are presently taking the drug are advised to contact their doctor immediately as they will need to change their antiretroviral medication. The remaining packages of medication should also be returned to their health care provider as it is now under quarantine.
The Guardian made several attempts to contact Dr Gomez for further comment on the impact of the recall, but up to press time they proved fruitless.
http://www.thenassauguardian.com/national_local/353151179754494.php
By JIMENITA SWAIN, Guardian Senior Reporter
jimenita@nasguard.com
Viracept, an antiretroviral medicine used to treat HIV in infected adults, adolescents and children three years and older is under quarantine by the Ministry of Health after its parent company Roche issued an immediate recall of the drug on June 5. According to information from the press office of the European Medicines Agency, viracept was recalled after there was an indication of contamination in some batches.
"Roche has identified the presence of an unexpected contaminant ethyl mesylate (also known as methane sulfonic acid ethylester in some batches of viracept," the release stated. Ethyl mesylate, is a known genotoxic that is harmful to DNA and if taken by a pregnant woman can cause harm to a child in the womb. The company who makes viracept investigated complaints by patients who said the tablets they had taken smelled unusual.
Chief Medical officer (CMO) in the Ministry of Health, Dr Merceline Dahl-Regis, told The Guardian yesterday that viracept is used locally. Further, she said, an investigation has been launched by Dr Perry Gomez, the National HIV/AIDS Program co-ordinator. The CMO explained that for the time being HIV patients will be placed on another antiretroviral medication.
"We are following the WHO (World Health Organization) recommendations to quarantine the drug," she said.
The Ministry received notification for the recall on June 8, three days after Roche issued their recall in Europe. Viracept, has an active substance nelfinavir, which blocks the enzyme protease that is involved in the reproduction of HIV. Once the enzyme is blocked, the virus does not reproduce normally and is slowed down in its spread through the body.
Persons who are presently taking the drug are advised to contact their doctor immediately as they will need to change their antiretroviral medication. The remaining packages of medication should also be returned to their health care provider as it is now under quarantine.
The Guardian made several attempts to contact Dr Gomez for further comment on the impact of the recall, but up to press time they proved fruitless.