FDA warns vs 20 unregistered drugs

The Food and Drug Administration (FDA) has ordered the seizure of 20 drugs being sold in the market which did not undergo government evaluation and registration to guarantee their safety and efficacy.

In a recent advisory, the FDA ordered all its field food and drug regulation officers to confiscate the unregistered drug products—mostly antibiotics and antihistamines—from stores and drug establishments.

The agency identified the medicines as Bisacodyl (Delax) 5 mg tablet; Conjugated Estrogens USP ( Conjugase-0.625) 0.625 mg tablet; Bicalutamide 50 mg tablet; Isosorbide dinitrate (Hartsorb Sublingual) 5 mg tablet; Flunarazine (Sobelin) 5 mg capsule; Loratadine (Clatidyne) 10 mg tablet;

Diclofenac Sodium + Misoprostol (Arthrotec 50) 50 mg/200 mcg tablet; Cetirizine 2HCl (Cetrizin) 10 mg tablet; Clindamycin (Clindacap-300) 300 mg tablet; Simvastatin (Zimmex 20) 20 mg tablet; Rosiglitazone maleate (Avandia) 4 mg tablet; Gentamicin sulfate (Gentaderm) 0.1 g/ 100 g cream;

Nystatin (Tystatin) Oral Suspension; Dexamethasone Sodium Phosphate + Neomycin Sulfate (Archidex) eye-ear drops; Lansoprazole 30 mg delayed-release capsule; Ketoconazole (Ninazol) 200 mg tablet; Paracetamol (SaRa) 500 mg tablet;

Amoxicillin + Clavulanate Potassium 400 mg/ 57 mg per 5 ml Oral Suspension; Cefuroxime Axetil (Cefuroxime) 250 mg/ 5 ml Oral Suspension and Cefdinir 250 mg/ 5 ml Oral Suspension.

FDA officer in charge Nicolas Lutero III also asked all local government units and law enforcement agencies to make sure that these products would not be sold in their respective areas of jurisdiction.

At the same time, he warned the public against using any of these unregistered drug products, reminding them to purchase medicines only from establishments or outlets licensed by the FDA.

“Please note that product evaluation and registration is a measure that the government undertakes to ensure the safety and efficacy of health products,” said the FDA official, adding that consumers must always look for the FDA registration number on the label before buying medicines or health products.

Lutero also warned drug establishments and outlets against the importation, distribution or sale of counterfeit drugs, saying they will face sanctions and penalties as stipulated in Republic Act 8203 or the Special Law on Counterfeit Drugs.

Earlier, the FDA warned against the public against buying a brand of Vitamin E capsules, Kirkland Signature Vitamin E 400 IU Softgels, which the agency confirmed was unregistered.

In an earlier interview with reporters, Lutero admitted that the proliferation of “online pharmacies” complicated the country’s fight against counterfeit and unregistered medicines, posing a lot of danger to the health and safety of many Filipino consumers.

“A lot of medicines are being sold or ordered through the Internet, from different websites, so we have difficulty monitoring these,” he said.