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By Elizabeth Merab
The Department of Health warned counties to stop prescribing an HIV drug related to conbad malformations in HIV-positive women.
Through Director of Medical Services Jackson Kioko to ensure that pregnant and badfeeding women to whom a first-line drug, dolutegravir (DTG), has been prescribed, continue their current prescription until the next day. that they stop badfeeding.
But those between the ages of 15 and 49, who are In a note addressed to county health directors, Dr. Kioko said that the drug, launched on the Kenyan market last year, was Was not recommended for pregnant and lactating women. "Due to limited safety data"
INJECT DRUGS
He however added that through a circular in June 2017, the Ministry had recommended the use of DTG in an alternative regime for people living with HIV. It has been recommended to be part of the third line of medication for patients.
Dr. Kioko's memo comes just three weeks after the Nation pointed out that two international drug regulators had warned that a generic version of an antiretroviral drug could cause birth defects .
He also noted that according to the 2017 circular, adolescents and adult men receiving first-line antiretrovirals will be treated with DTG.
MEDICATION REACTIONS
"Ministry Encourages All Healthcare Providers to Last Month, International Regulators, the US Food and Drugs Administration and the European Medicines Agency warned that new studies indicated that HIV-positive women were taking the drug at the time of taking antiretroviral medications.At the time of conception or during the first trimester of pregnancy, the risk of giving birth to babies with neural tube defects is more
Neural tube defects are birth defects Women of childbearing age who choose to take a diet containing dolutegravir should routinely use an effective means of contraception (contraception) during pregnancy and pregnancy. childbirth. "
The drug was approved for the first time less than four years ago. World Health Organization advises against the use of this drug during pregnancy or badfeeding due to inadequate safety and antiretroviral treatment. GSK said it was informing doctors about the issue and working with health authorities to better understand the potential risk.
Dolutegravir (DTG or Tivicay) is manufactured by the British pharmaceutical giant GlaxoSmithKline (GSK) was made available to patients through a partnership between the Ministry of Health and Unitaid, based in Geneva. [19659020] Dolutegravir was licensed in the United States in 2013 and in the European Union in 2014.
NEWER MEDICAMENT The drug works by blocking an HIV enzyme to prevent the multiplication of the virus, thereby reducing the amount of virus in the body.
Since it was a new drug, with high costs, it is largely unavailable in low- and middle-income countries, until partnerships are established. innovative, negotiated an agreement between the Government of Botswana (2016) and Kenya (2017) part of the national health program.
The generic version sold under the Tivicay brand costs around Sh403 ($ 4) for a 30-day pack. Prior to the current introduction, patients were paying Sh 5.045 -Sh6054 ($ 50-60) for a package.
The 2016 agreement in Botswana was the first time that dolutegravir was available on the front line as part of a national program. health program in sub-Saharan Africa
BABY DEFECTS "There is no known mechanism linking dolutegravir to these types of conbad malformations and there are no relevant findings in preclinical studies", said GSK in a statement
. "Animal models are generally predictive of drug-induced conbad malformations and it is very unusual to see an effect in humans if no evidence is observed in animal models."
The two regulators stated that they were badessing evidence of the link between dolutegravir and birth. The trip at the end of May followed preliminary data from a study in Botswana that revealed four cases of neural tube defects, such as spina bifida, in infants and mothers who became pregnant while taking the drug
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