The Main Pharmaceutical Inspectorate informed in two decisions about withdrawing from the market all series of Monural and Uromaste drugs. The active ingredient of these drugs is fosfomycin. The reason for the withdrawal is the negative benefit-risk balance of taking these drugs.
Monural and Uromaste withdrawn from the market
The Main Pharmaceutical Inspectorate first presented a decision to withdraw all series of Monural and Uromaste drugs from the market, and then another to prohibit their placing on the market in Poland.
The decisions were issued on the basis of the request of the President of the Office for Registration of Medicinal Products in connection with the receipt of information on the occurrence of a threat to public health. Monural and Uromaste are drugs that contain fosfomycin. On June 9, the European Commission issued a decision to suspend the marketing authorizations for drugs containing: fosfomycin calcium, fosfomycin disodium, fosfomycin sodium and fosfomycin trometamol.
The justification stated that the use of drugs with these active substances carries a risk that is greater than the clinical effect.
As a consequence, the following were withdrawn from the market:
- Monural (Fosfomycinum), granules for oral solution, 2 g – all series. Marketing Authorization Holder ZAMBON SpA Italy
- Uromaste (Fosfomycinum), granules for oral solution, 2 g – all series. Marketing Authorization Holder Labiana Pharmaceuticals SLU Spain
Drugs with fosfomycin
Fosfomycin is an antibiotic belonging to the derivatives of phosponic acid. It is classified as an antibiotic with a bactericidal effect. The antibiotic is used to treat bacterial urinary tract infections. It is indicated in the treatment of acute uncomplicated bacterial cystitis, the treatment of asymptomatic bacteriuria and the prevention of urinary tract infections associated with surgery and transurethral diagnostic procedures.
The decision of the Main Pharmaceutical Inspectorate to withdraw these drugs from the market is immediate. Both drugs were available by prescription.
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