The World Health Organization, in its latest recommendations on January 13, asked pregnant and breastfeeding women with COVID-19 to consider the use of the drug Paxlovid.
The World Health Organization suggested that pregnant and breastfeeding women consult their physicians to determine the possibility of taking this drug because of its "potential benefits and low harmful side effects."
However, Australian women will have to wait as the Therapeutic Goods Administration does not permit the use of Paxlovid in pregnant and breastfeeding mothers and women of childbearing age.
The Therapeutic Goods Administration allowed the use of the drug in certain categories, provided that these people have specific medical symptoms.
The country's health authorities have not revised their recommendations despite the WHO's updated recommendations.
The Australian Department of Health said that Pfizer did not provide sufficient data on the use of Paxlovid in pregnant women when the TGA approval for its use was initially granted on January 18, 2022.
Therefore, it is not recommended for use in pregnant and breastfeeding women infected with the COVID-19 virus so far.
Australian Department of Health
The Ministry of Health commented on the matter, explaining in a statement, "This is in line with advice provided by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom."
Health guidance from the Western Australian state government advises women who are pregnant or those planning to have a baby not to use Paxlovid.
And the ministry continued in its statement, "Call your doctor immediately if you become pregnant while taking this medication. Paxlovid may affect how birth control pills and other birth control methods work."
"Should you use an alternative method of contraception or an additional method such as a condom while using Paxlovid, talk to your health practitioner about effective methods of birth control," she added.
However, Melbourne-based obstetrician Dr Nisha Kot believes the Australian government will soon update its guidance in line with WHO recommendations and the latest studies in the field.
"Doctors in Australia cannot prescribe Paxlovid or any other drug without approval from the federal government," Cote said.
"This drug will serve as an additional treatment option for pregnant and lactating women. It will also reduce their stress and anxiety when infected with the virus," Kott added.
According to the latest medical data, most recent cases of infection among pregnant and lactating women in Australia are mild.
"This may be due to higher vaccination rates and booster doses. This is why everyone should receive the coronavirus vaccination as soon as possible," Cote said.
A recent study by Johns Hopkins Medicine Research showed that pregnant women with coronavirus can safely take Paxlovid to reduce the risk of developing serious symptoms.
And that study showed that the drug is effective, and there was no data showing an increase in complications affecting parents or their offspring.
The study indicated that "nearly half of all births after treatment with Paxlovid were delivered by caesarean section."
The Australian government said the Therapeutic Goods Administration was aware of limited studies of the effect of the use of the drug Paxlovid in pregnant women and was considering reconsidering its recent recommendations if a new update from Pfizer, which makes the drug, is presented.
Pfizer stated that it does not have data on the safe use of Paxlovid during pregnancy and in newborn infants when breast-feeding.
"Women who wish to become pregnant should avoid becoming pregnant while receiving treatment and up to seven days after stopping Paxlovid," the company said.
Breastfeeding should be discontinued during treatment with Paxlovid and for seven days after the last dose of the drug. There are no data and clinical studies on the effect of Paxlovid on fertility.
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