Seven medicines used in France withdrawn over irregularities
Dozens more may be withdrawn over next two years, as effectiveness of drugs was not accurately evaluated in studies
Patients who still have stocks of the drug at home can continue to use them
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France is set to immediately withdraw seven drugs from the market, after their efficiency was called into question by a European medical review.
The drugs, spanning from pain relief to diabetes medicine, are to be withdrawn immediately, said officials at the Agence nationale de sécurité du médicament (ANSM).
The drugs that are being withdrawn are:
Olanzapine (three different versions of the drug), an anti-schizophrenia drug
Nevirapine, an HIV medication
Metformin, an anti-diabetes medicine
Tramadol, a pain-relief
Patients using these drugs will see treatments replaced by alternatives, which the ANSM has promised will not reduce the effectiveness of treatment programmes.
The recall only concerns medicines currently stocked in pharmacies – people who have a stock of these drugs at home do not need to return them, and can continue to take them until they run out.
The efficacy of the drugs is potentially due to poor evaluations, meaning producers have needed to re-submit proof of the medicine’s effectiveness.
It does not mean that the drugs are necessarily ineffective altogether.
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Dozens of other medicines are to be withdrawn in the next two years for the same reasons - however to prevent further shortages of more effective treatments they are not being pulled immediately.
“An immediate suspension of these medicines would have created a critical situation, given their indications and the lack of therapeutic alternatives available,” said the ANSM.
The EU Commission asked member states in May to analyse the effectiveness of around 400 medicines, of which 70 were deemed by the French authorities to not be of a satisfactory level.
Out of these, around 40 will be withdrawn over the next two years, and 20 were deemed effective enough after submitting new test results.
The 40 medicines that may be withdrawn – and the seven currently being pulled from shelves – will be able to remain or return to the market if producers can provide new studies proving their effectiveness.
