Top Texts from Prescrire International

ADVERSE EFFECTS

Oral peanut desensitisation: excessive adverse effects The results of a systematic review and meta-analysis of clinical trials that evalu- ated oral desensitisation using peanut allergen versus no oral desensitisation in patients with peanut allergy were published in 2019 (1). pain, mouth itching, and 3 cases of eosinophilic oesophagitis, which was probably underdiagnosed), cutaneous and mucosal disorders (urticaria, oe- dema, angioedema), nasal disorders (congestion and rhinitis), and respiratory disorders (asthma). Yet patients in the oral desensitisation groups had better results than those in the other groups in tests of their peanut tolerance, in which they were chal- lenged with increasing standardised oral doses of peanut while supervised in a hospital setting.

Twelve randomised clinical trials were included, in a total of about 1000 patients with a median age of 8.7 years who were followed up for a median of one year (5.8 years in one of the trials).The endpoint was the number of patient-important food allergy events other than in hospital-based allergen provocation tests. Compared with no oral peanut desensitisation, desensitisation therapy increased the risk of allergic reactions, including anaphylaxis (risk tripled from 7% to 21%), and doubled adrenaline use and serious adverse effects (statistically significant differences). The findings were the same regardless of the de- sensitisation protocol used and during both initial and maintenance desensitisation therapy. Various allergy-related adverse effects were also more common with desensitisation, in particular gastrointestinal disorders (vomiting, abdominal

 In practice  In patients with peanut allergy, oral desensitisation increases rather than reduces the risk of subsequent serious allergic reactions, including anaphylaxis. Hospital-based tests of tolerance are not sufficiently reliable. In the absence of a better alternative, the priority is to avoid peanut allergens. ©Prescrire ▶ Translated from Rev Prescrire October 2019 Volume 39 N° 432 • Page 743  Sources  1- Chu DK et al. “Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety” Lancet 2019; 393: 2222-2232.

Prescrire Int • February 2020

SSRI antidepressants: persistent sexual dysfunction In mid-2019, the European Medicines Agency (EMA) recommended adding a warning of persistent sexual dysfunction to the summaries of product characteris- abnormal orgasms including anorgasmia, erectile dysfunction and priapism (4).

Other adverse effects are suggestive of altered endocrine function, such as reversible effects on sperm quality, galactorrhoea, hyperprolactinaemia, and, in children, growth retardation and delayed pubertal development. Studies in young animals have shown a reduction in fertility and delayed sexual maturation.  In practice   Antidepressants carry a risk of many, particularly sexual, adverse effects.The persistence of sexual dysfunction after discontinuation of the antidepressant is a new finding. ©Prescrire ▶ Translated from Rev Prescrire October 2019 Volume 39 N° 432 • Page 743  Sources  1- EMA “PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting” 11 June 2019: 9 pages. 2- EMA “Pharmacovigilance risk assessment committee (PRAC) Minutes of the meeting on 03-06 September 2018” 4 October 2018: 137 pages.  3- Healy D et al. “Enduring sexual dysfunction after treatment with antidepressants, 5 α -reductase inhibitors and isotretinoin: 300 cases” Int J Risk Saf Med 2018; 29 (3-4): 125- 134.  4- ANSM“RCP-Prozac” 16 May 2018: 11 pages.

tics (SPCs) for some antidepressants. Cases of long-lasting sexual dysfunction that persisted despite withdrawal of the antidepressant have been report- ed with the so-called selective serotonin reuptake inhibitors, such as fluoxetine and citalopram, and with serotonin and noradrenaline reuptake inhibitors, such as venlafaxine and duloxetine (1-3). The data come from reports recorded in the European pharmacovigilance database, including 574 cases attributed to duloxetine , and from publi- cations, including a series of 219 observations, in 170 men and 49 women (2,3).The antidepressants most often implicated in this series were escitalo- pram , citalopram and paroxetine .The adverse effects most often reported were erectile dysfunction, loss of libido, genital anaesthesia, difficulty reaching orgasm and emotional blunting (3). Various types of sexual dysfunction are known adverse effects of these antidepressants. For exam- ple, the SPC for one product based on fluoxetine already mentioned reduction or even loss of libido,

Prescrire Int • February 2020

P age 12 • P rescrire I nternational S pecial E dition 2020