2023-12-14 18:31:21
These are medications that have been on the market for years, some of which everyone is talking about and sometimes available without a prescription in pharmacies. However, they are “more dangerous than useful”, according to the medical journal Prescribewhich recommends excluding them from therapeutic uses.
105 drugs “to be discarded for better treatment”, including 88 marketed in France, make up this ” blacklist “ whose “benefit-risk balance is unfavorable in all the indications of the marketing authorization”.
There we find Toplexil cough syrup, which “exposes people to disproportionate adverse effects” or Maxilase, “an enzyme with no demonstrated effectiveness beyond the placebo effect” which “exposes people to sometimes serious skin or allergic disorders” .
Smecta, used in the treatment of intestinal disorders, contains “natural lead pollution”. And Voltarene, which is used in the treatment of pain and inflammation, exposes us to “an increase in cardiovascular adverse effects and deaths of cardiovascular origin”.
Oral or nasal decongestants are also part of the black list, because they “expose people to serious or even fatal cardiovascular disorders, ischemic colitis and ischemic optic neuropathies”. “There is no valid reason for these drugs, which are more dangerous than useful, to remain authorized,” judges the editorial staff of Prescrire.
A complex scientific and regulatory evaluation process
How can we explain that they continue to be marketed? Most drugs have been on this list, published for the 12th time, for years. The National Agency for the Safety of Medicines and Health Products (ANSM) itself recommends avoiding oral vasoconstrictor medications in the event of a cold, without banning them.
However, it is the ANSM, or the European Commission, which can decide to suspend the marketing authorization of a medicine, recalls the Ministry of Health. But in reality, it is not that simple. “Health policy decisions [suspension de mise sur le marché, de fabrication, de distribution, de restriction d’utilisation, NDLR] constitute strong legal acts: they result from a scientific and regulatory evaluation process aimed at guaranteeing the proportionality of the measure to the health risk”, explains the ANSM on its site.
“Today, the ANSM is part of a European network which does not allow a marketing authorization to be withdrawn without negotiation between several national agencies. We must therefore wait until French demand is negotiated in this network,” sociologist Etienne Nouguez also explained at the end of October on France Culture. The evaluation of new safety data relating to vasoconstrictors in oral form, carried out at the request of the ANSM by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, thus led to the only recommendation to add new contraindications and warnings to the instructions for these medications.
Authorizations withdrawn in dribs and drabs
“Market withdrawals due to adverse reactions imposed by agencies rely less and less on spontaneous reporting alone, and are more often supported by epidemiological studies and clinical trial results. Which implies an extension of the period before a possible withdrawal from the market”, also notes the magazine Prescrire. In this context, the journal’s list is mainly intended to inform patients and to put pressure on health professionals and authorities.
Every year, drugs disappear from the list. This year, this is the case of pholcodine, an antitussive syrup, whose marketing authorization was withdrawn in September 2022 due to a “risk of cross allergy with curares”, an anesthetic product. . The product was on Prescrire’s blacklist precisely for this reason. Another missing, tixocortol oral spray, combined with chlorhexidine, which was associated with severe allergic reactions. The drug remains available as a nasal spray and by prescription only.
In 2022, it was cimetidine, recommended in cases of gastric reflux, which was removed from the list after a worldwide recall. And in 2021, it was the Esmya treatment (ulipristal) against the symptoms of uterine fibroids, whose marketing authorization had been suspended by the ANSM in March 2020 because “the benefit/risk ratio of its use is unfavorable.
A “global transparency effort to be made”
This Thursday, the Minister of Health Aurélien Rousseau recognized that there was a “global transparency effort to be made”, particularly on the side effects of certain medications. He also indicated that he complied with “all instructions given by the Medicines Safety Agency”.
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