FDA warns vs. 20 ‘unregistered drugs’ in the market

The Food and Drug Administration has warned the public against using 20 "unregistered" drug products. 

 

The FDA identified the following products in its advisory dated Feb. 20: ()

* 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

* Cefdinir 250 mg/ 5 mL Oral Suspension.

 

It also ordered its field officers to confiscate them should they be found in the market, and called on local governments and law enforcement agencies "to ensure that these products are not sold or offered for sale" in their areas.

 

Consumers were also advised "to purchase their medications only from FDA-licensed establishments."

 

"Please note that product evaluations and registration is a measure that the government undertakes to ensure the safety and efficacy of health products," the FDA said. "Please look for the FDA Registration Number on the product label."

 

The importation, distribution, or sale of such products are "subject to sanctions and penalties" from RA No. 3720, as amended by RA No. 9711, or the "Food and Drug Administration ACt of 2009," as well as RA No. 8203, or the "Special Law on Counterfeit Drugs."

 

To report continuous sale or distribution of "unregistered health products," people may reach the FDA via report@fda.gov.ph or (02) 807-8275. —Rose-An Jessica Dioquino/NB, GMA News