Among them, Tramadol…
Concerns about the efficacy and safety of generic drugs had long been raised in France, but they could resurface. The French National Agency for Medicines (ANSM) announced in a press release dated July 3, 2024, the suspension of marketing authorizations (MA) for certain generic drugs whose bioequivalence studies were carried out in India by the company Synapse Labs. Bioequivalence guarantees the identical efficacy and safety of a generic drug to those of the original drug, regardless of its differences in presentation.
India is one of the world’s largest suppliers of generic drugs, including to France. However, an inspection by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in late 2023 at Synapse Labs, a company that tests generic drugs before they are sent to Europe, revealed “irregularities” And “raised serious concerns about the data from the bioequivalence studies conducted” reports theEMA. “For the majority of drugs tested, supporting data were missing or insufficient to demonstrate bioequivalence.” In light of these shortcomings, the EMA recommended on 21 March 2024 to suspend or not grant marketing authorisations for a number of generic drugs tested by Synapse Labs. Among them, 72 are marketed in France.
L’ANSM announces that it will withdraw 7 from the French market as of July 3, 2024. Immediately. All batches present in pharmacies as of this date are also recalled. The suspension of these drugs “does not create a critical situation” argues the marketing authorisation. Which is not the case for 41 other drugs that remain on the market for the moment: “We are granting a postponement of the suspension of marketing authorization, because the cessation of marketing would create a critical situation for the continuity of patient care” justifies the authority. These are drugs indicated in cardiology, oncology, hematology, diabetology, gastroenterology and in the treatment of HIV “which do not have sufficient quantities of therapeutic alternatives. The suspension of the marketing authorisations for these drugs is postponed for up to 24 months, pending new bioequivalence studies.” For 22 other drugs, new bioequivalence studies were conducted “allowing the marketing authorizations of these drugs not to be suspended”. Finally, two other drugs should have been withdrawn from the market but their marketing authorization has lapsed due to non-marketing for at least 3 years.
List of 7 drugs whose marketing authorizations are suspended from July 3, 2024:
- Olanzapine Arrow 5 mg tablet (Arrow Generics) – antipsychotic (schizophrenia, bipolar)
- Olanzapine Arrow 7.5 mg tablet (Arrow Generics)
- Olanzapine Arrow 10 mg tablet (Arrow Generics)
- Nevirapine Arrow LP 400 mg prolonged-release tablet (Arrow Generics) – antiretroviral (HIV)
- Metformin Almus 500 mg, film-coated tablet (Almus France) – antidiabetic
- Tramadol Almus 50 mg, capsule (Almus France) – painkiller
- Ibuprofen Liderlens 400 mg, soft capsule (Nutra Essential OTC SL) – anti-inflammatory suspended but no batch recall
The Medicines Agency specifies that: “To date, no reports of safety or loss of efficacy have been reported for these drugs.” Do not stop or change your treatment if you have boxes of medications whose marketing authorisation has been suspended. You do not need to return your boxes to the pharmacy. If you renew your treatment, if it no longer has a marketing authorisation, the pharmacist will give you a box of another medication (marketed by another laboratory). “Batch recalls at the pharmacy level should not have an impact on your care as several similar medicines can be used as an alternative and are available in sufficient quantities” concludes the French health authority.