FDA: Sanofi Pasteur did not disclose negative effects of Dengvaxia if administered prior to dengue infection

admin   •   February 27, 2018   •   4308

FILE PHOTO: A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. CREDIT: REUTERS/CHRISTIAN HARTMANN

MANILA, Philippines — The Food and Drugs Administration (FDA) said that the French pharmaceutical company, Sanofi Pasteur did not initially disclose the negative effects of Dengvaxia vaccine on people who have not had dengue infection.

“We visited some of the documents of Singapore recently. With their publication, they already announced that it is not to be used for patients who haven’t had dengue,” said FDA Director General Nel Acharade Puno.

“This means they should have had known about it since December 22, 2015, and they should have told the Philippine government that this anti-dengue vaccine cannot be injected to children without prior dengue infection,” added the official.

This has also been the claim of former President Benigno Aquino III in his first appearance in the inquiry of the Lower House on the controversial anti-dengue vaccine.

Aquino explained that he approved the use of the Dengvaxia due to the information he received from Sanofi that the anti-dengue vaccine was safe and approved by the FDA.

The former chief executive sent his condolences to the families of the children whose deaths are being linked to Dengvaxia.

Nevertheless, Aquino said he and his former officials should not be blamed for the incident.

“Dito may dumating na impormasyon noong November 2017. Baliktad sa hinarap sa aming impormasyon noong kami ay nagdedesisyon ,” said Aquino.

(In this case, an information came in November of 2017. It was opposite of the information presented to us when we decided on its approval.)

Aquino also made insinuations about an unnamed individual who, he said, was pretending to be a health expert while examining the alleged victims of Dengvaxia.

“Lalo na po yung isang maingay na ang certification ay tila isang antas lang ang lamang sa nabibiling diploma sa Recto ,” said the former president.

(Especially this one who is too loud, but whose certification seems to be just one rank above a diploma that can be bought in Recto.)

Although the former president did not give a name, Public Attorney’s Office (PAO) chief Persida Acosta defended her forensic expert Dr. Edwin Erfe.

“Siya po ay forensic and medical evidence analysis forensic examiner. May certificate po siya sa Harvard. Hindi naman po mabibili yan talagang paghihirapan mo po yan,” said Acosta.

(He is a forensic and medical evidence analysis forensic examiner. He has a certificate from Harvard that can’t be bought, you must work hard for it.)

In the House inquiry, Department of Health (DOH) Sec. Janette Garin insisted anew that they allowed the use of the Dengvaxia anti-dengue vaccine under the Aquino administration due to the rising number of dengue cases in Regions III, IV-A and National Capital Region (NCR).

“Layunin po ng progama na ito na hindi lang pigilan ang mga namamatay at patuloy na namamatay sa dengue kundi pigilan ang pagkakasit ng dengue,” said Garin.

(This program aims not just at preventing deaths due to dengue but also at stopping stopping dengue fever.)

Incumbent Health Sec. Francisco Duque III meantime seeks for the immediate conclusion of the House inquiry, noting it only created fear among the public against other vaccination programs of the agency.

“Are we ready to have outbreaks of measles, of diphtheria, pertussis, hepatitis, of HPV? I think we have to be mindful of the implications of a very prolonged investigation,” said Duque. — Grace Casin | UNTV News & Rescue

FDA warns online shops that put prescription drugs on sale

Maris Federez   •   December 12, 2019

MANILA, Philippines — The Food and Drugs Administration (FDA) has warned online shops that sell medicines and put prescription drugs on sale, especially this holiday season.

DOH spokesperson and FDA officer-in-charge Usec. Eric Domingo said that the agency has already penalized three online selling platforms for such infraction.

“It’s very rampant. At itong ibang na fine natin nakita na natin yan. Winarningan na natin. Tapos mawawala ng dalawa, tatlong araw iyong mga produkto tapos after a while babalik na naman. And then we have to remind them again na bawal. And we urge them na that they have to police their own ranks,” Domingo said.

The official also advised pharmacies to apply for separate license to operate and certificate of product registration from the FDA should they decide to also venture into online selling.

“Unang – una ang ating mga drug stores allowed lang kayo to sell the products within the premises of the store.  Kung gusto niyong tumanggap ng online orders you can apply for it as an extra activity with the FDA. But even then, may limitations iyon,” he added.

Domingo said the limitation is basically applicable to prescription medicines.

“Maaring mag- online, mag-order online ng isang kliyente nila pero kapag kukunin na iyong gamot kailangan pa rin niyang kunin sa pharmacy kung saan naka- store nang tama at ma- check ang reseta bago ibigay sa kaniya,” the official explained.

The FDA is still verifying several reports against online shops that openly sell medicines at a much cheaper price.

They shall be meted out with fines and corresponding charges. — (from the report of Aiko Miguel) /mbmf

Food and Drug Action Center announces half-day work on Dec. 13

Marje Pelayo   •   December 10, 2019

MANILA, Philippines –  The Food and Drug Administration (FDA) announces half-day work suspension at the Food and Drug Action Center (FDAC) on Friday (December 13).

The half-day suspension is to provide our employees the opportunity to participate in the FDA wide event on the said date.

Thus, office work at FDAC will be suspended from 12:00 noon onwards, the FDA advised its clients.

“Applicants with confirmed schedule to appear on the said date will be accommodated during regular office hours,” the advisory said.

DOH: No recorded case of dengue transmission through sexual intercourse in Phl

Maris Federez   •   November 11, 2019

MANILA, Philippines – The Department of Health (DOH) said there are no clear expert studies yet on the supposed recorded case in Spain of dengue transmission through sexual intercourse.

Based on a report, a male tested positive of dengue after having sexual intercourse with his partner who has dengue.

The health department said it was an isolated case.

“E kasi ito naman hindi siya the usual, this is very atypical. So, the chances of its spreading via that route are very low,” Health Secretary Francisco Duque III said.

Sec. Duque said the DOH is rather concerned over unprotected sex which causes an increase in the number of HIV-AIDS cases in the country.

He added that the alleged transmission of dengue virus through sexual intercourse will remain theoretical or mere speculation.

 He underscored that the Philippines has yet to record a similar case of dengue transmission.

The department, he said, is pushing for safe sex and clean living, especially this year when the country is recording an average of 35 individuals who are HIV positive daily.

“I will not be worried that there can be an epidemic of dengue via that route because there already is with mosquitoes. So, I would be worried for lack of protection primarily because we don’t want anymore HIV-AIDS cases as much as possible. So incidental lang iyong isa e to the main issue of unprotected sex. It’s a (very) collateral issue,” Duque said. (from the report of Aiko Miguel) /mbmf


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