72 medications used in France suspended due to ‘irregularities’
There is no suggestion that the drugs - which all are generics - are harmful to patients
A generic drug is one that uses the same active ingredient as a ‘branded’ drug that is already on the market
Ulf Wittrock/Shutterstock
Health authorities in Europe have suspended the sale of 400 generic medications - including 72 sold in France - due to doubt over their ‘reliability’.
The European Medicines Agency (EMA) confirmed the temporary suspension of the drugs, due to what it called “insufficient evidence on the reliability of test data”.
The EMA made the announcement after it emerged that an independent Indian company called Synapse Labs had tested all of them before they went on the market. The methods and reliability of this testing company have now been called into question.
Doubts about the company emerged after a Spanish medicines safety inspector reported “irregularities” during a check in 2020 on studies the company conducted for the EMA between 2009-2019. Another inspection in 2022 appeared to confirm the suspicions.
The Spanish healthcare watchdog made a formal report to the EMA on June 27, 2023.
The European Commission decided to take on the EMA’s recommendations having conducted its own reviews and investigations, issuing an injunction against the company on May 24, 2024.
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What is a generic drug, and which are affected?
A generic drug is one that uses the same active ingredient as a ‘branded’ drug that is already on the market. Usually, generic drugs are much cheaper than their original due to lower production costs.
A generic drug must undergo testing to prove that it is ‘bioequivalent’ to the branded drug, which means that it must have the same effects in patients.
The EMA has said that the studies done by Synapse Labs are “erroneous”.
Among the 72 drugs concerned in France are generics made by pharmaceutical companies Viatris, EG Labo, Sandoz, Biogaran, Teva, and Arrow.
The number of medications affected in France is ‘technically’ 98, but in reality, the number is 72, as the 98 figure includes the same active molecule in different forms (e.g. pill, gel, powder).
The drugs suspended in France include:
Several antiretrovirals used in the treatment of HIV/AIDS
Anti-diabetics (metformin, sitagliptin, vildagliptin)
Anti-cancer drugs targeting breast, pancreatic and blood cancers
Anti-epileptics (topiramate, lacosamide)
Anti-bipolar and schizophrenia drug olanzapine
Anti-dizziness drug betahistine
Hospital anaesthetic propofol
Erectile dysfunction drug tadalafil
The suspension has impacted several counties, in particular Germany (208 drugs), the Netherlands (188), and Portugal (112).
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Are these drugs dangerous?
No. The national drug safety agency (l’Agence nationale de sécurité du médicament, ANSM) has been quick to point out that "there is no evidence that the medications concerned are harmful or ineffective".
Similarly, the drugs will not be withdrawn from sale completely if no alternative exists for patients. Health authorities can delay the suspension of a drug for up to two years in order to ensure that patients who use it are not suddenly left without treatment.
However, generic drugs must be positively evaluated by a separate research organisation before they can be marketed (as opposed to studied in clinical trials). Any doubt about the reliability of this research organisation - in this case, Synapse Labs - necessarily calls into question the reliability of the studies.
Synapse Labs “is ultimately not considered reliable”, said the ANSM, meaning that new studies must be completed.
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‘Case-by-case’ studies
The ANSM must review each drug on a case-by-case basis to see if it is safe for sale. Any that do not make the cut could be withdrawn from the market definitively. A verdict on the drugs is expected by June 24.
“We have a period of one month following publication [of the injunction] to implement the decision,” ANSM told Les Echos.
“We are in contact with the various pharmaceutical companies,” it said.
Several laboratories that manufacture the drugs affected by the suspensions have already submitted studies of their safety, effectiveness and equivalence relative to the ‘branded’ versions of the drugs.
This includes the lab Biogaran, which has said it is "confident" that its generic drugs will pass the new tests. “The new assessments have been carried out, demonstrate their bioequivalence, and are in the process of being filed,” it has stated.
