The drugs are used in the treatment of diabetes, HIV, certain psychiatric disorders or as painkillers. However, there are alternatives, specifies the National Agency for the Safety of Medicines.
- The French National Agency for the Safety of Medicines (ANSM) banned the sale of seven generic drugs on Wednesday 3 July at the request of the European Union: a tramadol reference, treatments for diabetes (metformin), HIV (nevirapine) and bipolar disorders and schizophrenia (olanzapine).
- The decision follows irregularities, highlighted during a European inspection, in bioequivalence studies conducted by the Indian company Synapse Labs. In this case, the efficacy tests of the drugs did not comply with EU standards.
- “These recalls should not have an impact on patient care as several comparable medicines can be used as an alternative.”
They will no longer be found in pharmacies.National Agency for the Safety of Medicines (ANSM) banned the sale of seven generic drugs on Wednesday, July 3, at the request of the European Union.
Among these treatments, there is a reference for tramadol, a powerful painkiller commonly prescribed by doctors, but also generic drugs for diabetes (metformin), HIV (nevirapine) or even bipolar disorders and schizophrenia (olanzapine).
Irregularities in drug efficacy testing
However, all seven treatments have equivalents on the market. “These recalls are not expected to impact patient care as several comparable medicines can be used as alternatives and are available in sufficient quantities to treat patients.”assures the ANSM in a communicated. The French drug regulator specifies that if you have a prescription for one of these treatments, your pharmacist will give you another generic instead. And that if you have already obtained one of these drugs, you can continue to use it without risk, “no reports of safety or loss of efficacy have been reported.”
On May 24, the European Commission ordered member states to temporarily suspend the marketing authorizations of nearly 400 generic drugs marketed in the EU, including 72 in France. This decision follows irregularities, highlighted during an inspection, in the bioequivalence studies conducted by the Indian company Synapse Labs. In this case, the drug efficacy tests did not comply with current European standards. The authorities had set a deadline of one month to redo them and thus get back on track.
Other generic drugs against cancer or diabetes still in the sights
In France, of the 72 drugs concerned, about twenty have successfully passed new tests, and seven must therefore be withdrawn as of Wednesday. On the other hand, the ANSM has granted an additional two-year period to the 41 other generics still targeted in this affair, in order to carry out new bioequivalence studies. And for good reason, these drugs against cancer, diabetes or cardiovascular diseases, crucial for patients, have today “no therapeutic alternatives in sufficient quantity”.
