Italy bans 7 APIs from compounding pharmacies after off-label abuse
The decree affects “abuses” of the following active pharmaceutical ingredients:
- TRIAC/tiratricol for thyroid problems and weight loss;
- the antidepressants fluoxetine and bupropion;
- clorazepate, a benzodiazepine;
- furosemide, a diuretic;
- metformin, for diabetes;
- and the anticonvulsant topiramate.
The ban, backed by the Italian Drug Agency (AIFA), comes after some compounding pharmacies created unregistered slimming drugs from combinations of APIs not intended for weight control.
Patients reported adverse reactions to the country’s pharmacovigilance network, and AIFA said such drugs “have an extremely unfavourable risk-benefit ratio and can be dangerous for those who use them.”
The risk of adverse reactions goes up with the number of APIs in the drug preparation, the Ministry of Health added, saying the ingredients on its banned list can cause psychiatric and cardiovascular reactions.
“Additionally, these combinations have never been tested in regular clinical trials, and lack the leaflet and information sheet to which the patient can refer to learn about the product. The documentation available on the individual API does not guarantee its safety when administered in combination with another”
The move follows two other decrees adopted by AIFA and the Health Minister in May and July which banned phenylpropanolamine/norephedrine and pseudoephedrine in diet drugs.