FDA clarifies Lianhua Qingwen not registered for Covid treatement

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The Department of Health (DOH) and the Food and Drug Administration (FDA) on Monday clarified that Lianhua Qingwen is registered but not as a medication against coronavirus disease 2019 (Covid-19).

In a joint statement, the DOH and the FDA said the traditional Chinese drug Lianhua Qingwen is a prescription medicine approved by FDA but “not registered as a Covid-19 medication”.

The FDA said Lianhua Qingweng’s manufacturer was able to acquire FDA registration in August 2020.

“But for purposes of being used as a traditional herbal product that helps remove ‘heat-toxin invasion of the lungs, including symptoms such as fever, aversion to cold, muscle soreness, stuffy and runny nose’. Additionally, the use of Lianhua Qingwen is only allowed with a doctor’s prescription,” it said.

Under Republic Act (RA) 3720, the role of the FDA is to license, monitor, and regulate medicines like Lianhua Qingwen for the safety of Filipinos.

The FDA said any food or medicinal products not registered in the Philippines should not be sold and are subject to seizure or confiscation.

It advised the public to always check if a drug product has been registered with the FDA before purchasing it.

The FDA also warned the public against the purchase and use of Ivermectin veterinary products against Covid-19.

In an advisory, it said Ivermectin products are registered in the country for veterinary use only and are allowed for the treatment of internal and external parasites as well as prevention of heartworm disease in animals.

Local pharmaceutical company Lloyd Laboratories Inc. has applied for a certificate of product registration on March 31, which the FDA is currently processing.

In a Facebook post of a group promoting the use of Ivermectin, a certain congressman said his office will launch an initiative where Quezon City residents especially the senior citizens would have access to Ivermectin.

The FDA noted that studies from the Philippine Covid-19 Living CPG Reviewers of a systematic review of six randomized controlled trials showed that:

-Ivermectin did not significantly reduce the risk of mortality among patients with mild to severe Covid-19 cases;

-Ivermectin was not associated with a definite benefit of other clinically important outcomes such as clinical improvement at Day 6-10, clinical deterioration, and need for mechanical ventilation;

-Ivermectin did not significantly reduce the duration of hospitalization and the time to resolution of symptoms; and

-The rate of hospitalization discharge did not differ significantly between the ivermectin group and the placebo group.

The DOH agreed with the Covid-19 Living CPG reviewers based on the current evidence from randomized controlled trials.

It said it does not recommend the use of Ivermectin for the treatment of Covid-19.

“Dr. Rabindra Abeyasinghe, World Health Organization (WHO) Representative to the Philippines, has stated that there is no evidence that supports the use of ivermectin to treat Covid-19, even as a preventive measure. The use of ivermectin for Covid-19 has to be evaluated through clinical trials,” the DOH added.

While the DOH and FDA are open to allowing pharmacies for compounding Ivermectin, both agencies emphasized they put the safety of Filipinos first before allowing unproven and uncertified medicines in the country. 

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