MANILA, PHILIPPINES – With summer upon us, so are allergies, infections, and hot weather-diseases that often spoil our vacation plans. But don’t go rushing to the shelves of drugstores to stock upon those handy anti-allergy medications and antibiotics just yet.
Unscrupulous elements have apparently taken advantage of the dry season to release certain brands of these basic medications that are seasonally in demand without the prior clearance from the Food and Drug Administration.
They have not undergone FDA inspection and their efficacy and safety are, therefore, unverified.
[pq]…the FDA has found 20 drug products being sold in the market without having undergone government evaluation and registration that would guarantee their safety and efficacy.[/pq]
In an advisory, the FDA ordered all its field food and drug regulation officers to confiscate the unregistered drug products, most of which were 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 ordered all local government units and law-enforcement agencies to be on a tight watch to ensure that these products do not get sold in their respective areas of jurisdiction.
Lutero also warned consumers against the use of these unregistered drug products, reminding them to only purchase medicines 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.
He also warned drug establishments and outlets against the importation, distribution or sale of counterfeit drugs or they shall face sanctions and penalties as stipulated in the Republic Act 8203 or the Special Law on Counterfeit Drugs.
– DFF, Medical Observer