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For the ninth consecutive year, the magazine To prescribe publishes the blacklist of marketing authorization medicines (AMMs). Let’s see what has changed since the article we wrote the year before.
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We will not go back to the prerequisites for marketing a drug or the concept of risk / benefit ratio. If you want to know more, the first part of our previous article below talks about it briefly. End of 2019, before the year 2020 and the pandemic from COVID-19 did not start, there were 92 drugs on the magazine’s blacklist To prescribe. Among them, three had theirs ADM. Ten new drugs have been added this year’s list.
Three drugs withdrawn from the market
This is theulipristal (a antagonist is agonist partial receptors of the progesterone), of nifuroxazide (an intestinal anti-infective), e nintédanib (an inhibitor of tyrosine kinase with antiangiogenic effect). Why were they withdrawn?
The former no longer has Alzheimer’s due to the severe liver damage it can cause. The second is no longer sold in France due to the lack of clinical evidence coming to attest to its effectiveness. The third, because the risk / benefit ratio was evaluated by the journal To prescribe, as this medicine has been used to treat two new conditions: lung diseases chronic fibrosing diffuse interstitials with a phenotype progressive, associated with systemic scleroderma. For the latter, the risk-benefit ratio is positive. however, the nintédanib it should be avoided in the context of others pathologies. These three drugs are still blacklisted by the magazine To prescribe.
Ten new drugs to avoid
This is the case with gliflozines (a class of hypoglycemic drugs used in diabetes type 1 and 2), finasteride (an anti-androgen), piracetam (a vasodilator), L ‘detection (a anesthetic), the pimecrolimus (a immunomodulateur), the romosozumab (an antibody monoclonal) and the méloxicam (a anti-inflammatory non-steroidal). For the former, they have long been on the magazine’s blacklist To prescribe. They were already present last year, but were withdrawn later in the year to evaluate the effectiveness of one of the drugs in this class type 1 diabetes. This turned out to be negative. The others joined the list due to their disproportionate negative effects compared to the benefits they confer, aside from the last one, which was only forgotten on the 2019 list.
What you need to remember
- A drug is a chemical that aims to treat or provide a benefit in one or more given conditions.
- It is generally assessed by measuring the risk / benefit ratio, i.e. with the certainty that it entails more benefits than risks compared to no treatment or a treatment of similar effectiveness. Subsequently, it obtains a marketing authorization issued by the pharmaceutical agency.
- According to the review To prescribe, 112 drugs marketed in Europe have the characteristics of therapies that should not have a marketing authorization.
Drugs to Avoid: The Prescribe Journal Blacklist
Article by Julien Hernandez, published on 11/29/19
Like every year for eight years, the independent magazine To prescribe publishes its blacklist of drugs on the market. It brings together several drugs that all have one thing in common: having a risk-benefit balance that clearly tends to risk.
So thata drug is marketed and therefore issued by the National Agency for the Safety of Medicines (ANSM) a marketing authorization (Marketing Authorization), it must provide evidence of its effectiveness in one or more given conditions, but it is also necessary that the potential side effects it causes do not put patients at greater risk than the benefit it should confer. We call it the risk / benefit ratio.
What is the risk / benefit ratio?
Let’s take a concrete example. For someone with a bacterial infection, antibiotic treatment prevents patient death and can cause some digestive disorders or rashes most of the time (only very common side effects are mentioned here). It is easy to understand that in this situation the risk / benefit ratio is positive. On the other hand, we remember the file mediator scandal. While this file is complex, it is a typical example of a drug with a strongly negative benefit-risk ratio. In other words, this drug, supposed antidiabetic, but actually quite anorexic, it turned out heart valve disease in a considerable number of patients and caused the death of many of them. But the risk / benefit balance is not found only in the medical field. We can also cross it in the field ofagriculture or in the energy sector, to cite just these two examples.
About 92 drugs are expected to be banned
No exceptions as regards the medical disciplines: they all pass there. Of the cancerology to psychiatry Pneumology, Gastroenterology,urology, etc. There are drugs that do not provide real benefits but carry serious and frequent risks or that are as effective as similar therapy side effects More.
In this 2020 review, twelve drugs were added, only one withdrawn after the reassessment (but which includes, according to the journal To prescribe, a still uncertain risk-benefit ratio). The twelve new drugs were listed because ” the undesirable effects to which they are exposed are disproportionate to their low efficacy or the benignity of the clinical situation in which they are authorized. ” These are alpha-amylases in sore throat, Ginkgo biloba in cognitive impairment in elderly patients, naphthidrofuril in syndrome from Urinary bladder pain, pentoxiverine in cough, tenoxicam, a non-steroidal anti-inflammatory drug, xylometazoline, nasopharyngeal decongestant available in Belgium, Switzerland and elsewhere. There are also several medications to avoid due to contaminations of to conduct of the clays medicated. This is the case of the very famous Smecta.
Finally, it is possible to find the exhaustive list of the 105 drugs concerned, classified by discipline, in the newspaper report To prescribe to speak to your healthcare team if you or someone in your family is being treated with any of these medicines.
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