FDA warns vs. fake anti-rabies vaccine

By Leilani Junio

April 18, 2018, 7:35 pm

MANILA --The Food and Drug Administration (FDA) on Wednesday warned the public and health professionals against counterfeit anti-rabies vaccines circulating in the market in the midst of dwindling supply of anti-rabies vaccines in the country.

“The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline Philippines, Inc. (GSK), have verified that the above-mentioned sample drug product (Rabipur), is counterfeit,” said FDA in its Advisory No. ‎2018-138.

GSK is the pharmaceutical company that supplies the authentic version of the said human anti-rabies vaccine in the country and other parts of the world.

In the same advisory, FDA reminded also how to examine the fake version of the product labeled also as “Purified Chick Embryo Cell Rabies Vaccine (Inactivated) (Rabipur) 2.5 I.U./mL Lyophilized Powder For Injection (ID/IM)”.

FDA said that the color of the box packaging of the counterfeit product has a more vivid color compared to the warmer color of the authentic or original one.

"The authentic product’s box packaging only had the name and logo of its importer, Novartis Healthcare Inc. at the bottom part as compared to the more detailed content of the counterfeit," FDA said.

It added that label’s pre-printed text in the primary packaging of the authentic and counterfeit has also used different font sizes.

Batch number of the original product is K-388 while the fake one has a batch number of S-164. Syringe and needle batch number of the original is 14F1011 while the fake one is 14M2411.

Meanwhile, with the presence of counterfeit products, FDA warned all healthcare professionals and the general public that said products can pose potential danger or injury to consumers.

It further reminded all establishments and outlets against selling and dispensing verified counterfeit drug products as the importation, selling, or offering for sale of such is in direct violation of Republic Act No. 9711 or the FDA Act of 2009. (PNA)