MANILA, Philippines – The Food and Drug Administration (FDA) has warned the public to exercise caution when purchasing over-the-counter (OTC) medicines after it discovered counterfeit versions of commonly used drugs manufactured by a local pharmaceutical company.
In two advisories dated May 17, but issued only recently, FDA Director General Samuel Zacate reported that they found counterfeit versions of Kremil S, Alaxan FR, Biogesic, Medicol Advance, Bioflu and Tuseran Forte, all manufactured by Unilab.
Kremil-S (Aluminum Hydroxide + Magnesium Hydroxide + Simethicone) is used to relieve stomach pain due to hyperacidity.
On the other hand, Alaxan FR (Ibuprofen + Paracetamol), Biogesic (Paracetamol) and Medicol Advance (Ibuprofen) are taken for headaches and body aches.
Bioflu (Phenylephrine Hydrochloride + Chlorphenamine Maleate + Paracetamol) and Tuseran Forte (Dextromethorphan Hydrobromide + Phenylpropanolamine Hydrochloride + Paracetamol) are used to treat coughs, colds, fever and other flu symptoms.
READ: FDA warns against rise in counterfeit versions of popular drugs
Only licensed stores
“All health care professionals and the general public are alerted to the availability of these counterfeit drug products on the market, which pose a potential risk or harm to consumers. Consumers are also reminded to purchase drug products only from FDA-licensed establishments,” the FDA said.
READ: FDA intensifies crackdown on fake drugs sold online
The sale of fake drugs is punished according to Republic Law No. 9711, or the FDA Act of 2009, and RA 8203, or the Counterfeit Drugs Special Act. Those who possess counterfeit medicines can be sentenced to imprisonment of not less than six months and one day.
Unilab also issued a warning on Monday against fake medicines and vitamins, saying they may contain dangerous substances such as chalk, corn starch, flour, pollen, rat poison, arsenic or cement as a substitute for the active ingredients of medicines.
“Since most fake medications try to pass [for] original products, patients who try to eat them may be at risk [of] failure to obtain desired effects such as managing a symptom or treating a disease,” the company said in a post on its official Facebook page.
“[They may also] swallow the toxic ingredients … that if done [over] a long period of time, can [result in] serious health conditions and can lead to hospitalization or death,” he added.
READ: FDA Warns Against Unregistered Vitabears Supplements
How to spot fakes
To identify fake medical products, Unilab asked consumers to be alert for colors that may be too light, too dark or unusual compared to the real thing. Counterfeit medicines may also be a different size or shape, have an unusual smell, or have mold or dirt on them.
Other things to look out for are misspelled words or grammatical errors on packaging or missing expiry dates and lot numbers. The packaging and security seal may also be dirty, messed up, damaged or printed using substandard materials.
In an earlier interview with Unilab officials, they said that law enforcement agencies found the counterfeit drugs being sold in retail stores, which usually do not have a license to sell drugs from the FDA.
In 2022, the Department of the Interior and Local Government ordered local governments — which are responsible for issuing business licenses to retail stores — to pass ordinances banning the sale of drugs in such establishments nationwide.
This came after the FDA received a total of 185 reports in just one month about retail stores caught selling drugs illegally. Of the number, nine shops were selling fake medicines, including medicines for COVID-19.
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