FDA Warns Against Use Of Two Unregistered Drug Products

The Food and Drug Administration (FDA) on Monday warned the public about the presence of two unregistered drug products in the market.

In an FDA Advisory No. 2016-001, the public is being warned against use of Deksametason (Dexahersen) 0.5mg Tablet and Cyproheptadine HCl (Prociny 4) Film-Coated Caplet.

“All establishments and outlets are hereby warned against selling and/or selling or dispensing above-identified products. Anyone found to be selling said product will be penalized,” said Ma. Lourdes C. Santiago, FDA Officer-in-charge Director General.

Santiago added that the above-mentioned drug products posed potential harm to the consuming public and violates Republic Act No. 9711 or the FDA Act of 2009.

Santiago added that products evaluation, registration, and testing were measures that the government undertook to ensure the quality, safety, and efficacy of health products.

Aside from not undergoing the required checking in the country, the FDA noted that the misuse of Dexamethasone, a steroid, and Cyproheptadine, an antihistamine, pose potential danger or injury to the consuming public.

Misuse and/or chronic use of steroids like Dexamethasone may lead to serious adverse reactions such as gastrointestinal bleeding and ulcers, osteoporosis, muscle weakness, obesity, dyslipidemia, increase risk for infection, poor wound healing, and withdrawal signs and symptoms such as hypotension, shock and coma, if stopped abruptly.

On the other hand, chronic use of Cyproheptadine may lead to the adverse reactions like confusion, seizure, tinnitus, increased appetite, hypotension, tachycardia, difficulty urinating, and jaundice.

She added that they already ordered their Officers of the Field Regulatory Operation Office (FROO) to seize the unregistered drug products found in the market.

The FDA added that all government units and law enforcement agencies have been requested to ensure that these products are not sold or offered for sale in their localities or area of jurisdiction.

She repeated the call to consumers to only purchase their medications from FDA licensed establishments.

She also reminded that it is important to look at FDA Registration number when checking if a product is registered and not fake.

She said that drug products registered in the Philippines bear in their labels information in English or Filipinos for the understanding of the consumers. (PNA) RMA/LSJ