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Drugs to avoid

in the name of better patient care - 2022 update


The result of a reliable, rigourous and independent methodology 

 

Drugs to avoid: main changes in the 2022 update

Drugs to avoid What are the main differences between the 2021 and 2022 versions? Learn more...


Prescrire updates its review of drugs to avoid every year. As a result of this analysis, some drugs are added to the list, while others are removed, either because the pharmaceutical company or a health authority decided to withdraw the drug from the market, or pending the outcome of our reassessment of the drug's harm-benefit balance, which may change if new data become available in the course of our analysis.

Main differences between the 2021 and 2022 lists of drugs to avoidDrugs to avoid

Gaspard BilanOne more drug to avoid: fenfluramine

Fenfluramine, an old amphetamine, has now been authorised for use in Dravet syndrome, a rare and serious form of infantile epilepsy, but it increases the incidence of convulsive status epilepticus and exposes patients to a risk of serious cardiovascular harms in the long term (Prescrire Int n° 233).

Gaspard BilanThe gliflozins, ciclosporin eye drops and cimetidine removed from the list of drugs to avoid

A few drugs have been removed from Prescrire's list of drugs to avoid, despite their burdensome adverse effect profiles, due to the emergence of efficacy data showing improvements in clinical outcomes.

  • The gliflozins, or sodium-glucose cotransporter-2 (SGLT2) inhibitors, are authorised for use in various situations: type 1 or type 2 diabetes, heart failure and chronic kidney disease. Four gliflozins are authorised in the European Union: canagliflozin (alone or combined with metformin), dapagliflozin (alone or combined with metformin or saxagliptin), empagliflozin (alone or combined with metformin or linagliptin), and ertugliflozin (alone or combined with metformin or sitagliptin).

    All the gliflozins have an unfavourable harm-benefit balance in the prevention of the complications of type 1 or type 2 diabetes. However, limited data have shown a reduction in all-cause mortality with dapagliflozin in patients with moderate or severe kidney disease, most of whom had diabetes; or a reduced risk of progression to end-stage kidney disease after 3 years of treatment with canagliflozin in patients with diabetic nephropathy, but a substantial increase in the risk of ketoacidosis (Prescrire Int n° 231). In certain heart failure patients, with or without diabetes, whose physical activity remains limited despite optimised treatment, dapagliflozin reduced the incidence of the serious complications of heart failure, although robust evidence of a reduction in mortality is lacking (Prescrire Int n° 232).

    All the gliflozins share a burdensome adverse effect profile, which includes urogenital infections, serious skin infections affecting the perineum, ketoacidosis, and possibly an increased risk of toe amputation. We removed gliflozins from our list of drugs to avoid in late 2021, but it is still not clear which patients are likely to derive a real benefit.
     
  • Ciclosporin eye drops were initially authorised for the treatment of dry eye disease with severe keratitis. In this situation, they have no proven efficacy beyond that of a placebo, but they expose patients to disproportionate risks: eye pain and irritation are common, they have immunosuppressive effects and possibly cause ocular or periocular cancer (Prescrire Int n° 181). They therefore featured in our list of drugs to avoid in 2021. Ciclosporin eye drops have now also been authorised, under a different brand name, for severe forms of vernal keratoconjunctivitis, a rare form of severe seasonal allergy. In this situation, they are sometimes an option when continued use of corticosteroid eye drops is not advisable (Prescrire Int n° 226).
     
  • Cimetidine is a histamine H2-antagonist authorised for use in various gastroesophageal disorders. It inhibits numerous cytochrome P450 isoenzymes. As a result, its concomitant use with many other drugs can cause these drugs to accumulate in the body, enhancing their dose-dependent adverse effects. Its harm-benefit balance is unfavourable compared with other H2-receptor antagonists that do not expose patients to these drug interactions (Interactions Médicamenteuses Prescrire). However, as of late 2021, as ranitidine is unavailable in France, cimetidine is the only histamine H2-antagonist marketed in a form suitable for use by infants with gastroesophageal reflux disease complicated by œsophagitis. It constitutes an alternative to omeprazole.
Gaspard BilanSee : A reliable, rigorous and independent methodology > HERE

Three drugs removed from the list due to their market withdrawal

The three following drugs have an unfavourable harm-benefit balance in all the situations for which they are authorised, but we have removed them from the list of drugs to avoid because they are no longer available in France, Belgium or Switzerland as of late 2021.

  • Attapulgite, a medicinal clay used in various intestinal disorders, should be avoided because it is naturally contaminated with lead (Prescrire Int n° 203; Rev Prescrire n° 430).
     
  • The fixed-dose combination of conjugated equine œstrogens + bazedoxifene, which contains œstrogen and an œstrogen receptor agonist-antagonist, has an unfavourable harm-benefit balance in the treatment of menopausal symptoms, because the risks of thrombosis and hormone-dependent cancers have not been adequately evaluated (Prescrire Int n° 184).
     
  • Topical prednisolone + dipropylene glycol salicylate has an unfavourable harm-benefit balance in the treatment of pain associated with a sprain or tendinitis, because it exposes patients to the adverse effects of corticosteroids and to the risk of salicylate hypersensitivity reactions (Rev Prescrire n° 338, 452).

Reintroduction of ulipristal 5 mg: once again authorised, but best avoided in all circumstances

Ulipristal 5 mg (Esmya°), an antagonist and partial agonist of progesterone receptors, authorised for use in uterine fibroids, has an unfavourable harm-benefit balance because it can cause serious liver injury, sometimes requiring liver transplantation. Esmya°'s marketing authorisation was suspended in the European Union in March 2020, and we removed it from our list of drugs to avoid because it was no longer available in the European Union. However, ulipristal 5 mg has once again been authorised and is marketed in Belgium, and is therefore back on our list of drugs to avoid.

Drugs to avoid  > FREE PDF  "Towards better patient care: drugs to avoid in 2022" Prescrire Int 2022; 31 (234): 50-1 - 50-10.

For more about this year's update:

  • Drugs to avoid in the name of better patient care: 2022 update > HERE
     
  • Drugs to avoid: a reliable, rigorous and independent methodology > HERE
©Prescrire 1 February 2022

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