Counterfeit anti-rabies vaccine used in hospital made in PH - FDA


Posted at Jan 31 2019 01:48 PM

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MANILA - The counterfeit and unregistered anti-rabies vaccine used by a local hospital was manufactured inside the Philippines, an initial investigation by the Food and Drug Administration found.

The Medical City in Pasig City earlier admitted that it had injected fake anti-rabies vaccine to some of its patients last year, but that it has since coordinated with the FDA and the Department of Health (DOH) to have the batch tested.

The FDA has since confirmed that the Verorab vaccine, with batch number H1833, was indeed counterfeit, said Michelle Lapuz, director of the agency's legal support service center. 

"Ang source is talagang dito sa Philippines. 'Yan ang tinutumbok ng aming investigation at operation," she told radio DZMM. 

(The source was here in the Philippines. That is where our investigation and operation is heading.)

Lapuz declined to give "critical information" since the probe is ongoing but said the agency has identified the distributor and manufacturer of the drug.

The company may face administrative and criminal charges, which would carry fines and penalties up to imprisonment, if proven that there was negligence or intention to release the counterfeit drug, she said.

The medicine was distributed to 42 other hospitals apart from The Medical City, and was pulled out in 3. Unfortunately, the drug was administered to patients in 2 of the hospitals, said Lapuz.

"Patuloy ang FDA and DOH to make sure ang distribution ng counterfeit vaccines na ito ay maitigil," said Lapuz.

(Efforts of the FDA and the DOH continue to make sure we stop the distributoin of these counterfeit vaccines.)

She warned that the inoculation of counterfeit vaccine bears health risks and negative effects as it may contain harmful ingredients that may react with a patient's other medications.

She appealed for sobriety, however, reminding the public not to fear vaccination after the fresh discovery of a defective vaccine. 

The controversy surrounding dengue vaccine Dengvaxia had triggered a vaccination scare, with immunization coverage dropping in 2018. 

Dengvaxia makers had warned in late 2017 that it may cause more severe dengue symptoms if administered on one yet to be afflicted with the mosquito-borne disease. 

The FDA published a list of legitimately registered medicines on its website, she said.

"Hindi naman lahat ng vaccine or lahat ng gamot ay delikado. Puwede nating i-administer, puwedeng i-take 'yung mga registered sa Food and Drug Administration dahil nakakasiguro tayo na dumaan ito sa proper testing and evaluation," she said.

(Not all vaccines or medicine are dangerous. We can administer or take those that are registered with the Food and Drug Administration because we can be assured that it went through proper testing and evaluation.)