Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2009 : 1 | 30 | 60 | 90

In the June issue of Prescrire International:
adverse effects of sitagliptin, corticosteroids and mydriatic eye drops

FREE DOWNLOADMydratic eyedrops can cause severe adverse effects in children and the elderly. Corticosteroids, whether they are inhaled, injected or taken orally, have neuropsychiatric adverse effects. And the EMEA, at the express request of Prescrire, released a review of the allergic adverse effects of the blood glucose-lowering agent sitagliptin.
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Mydriatic eye drops : Severe adverse effects in children (Summary)

  • France's Health Products Safety Agency (Afssaps) released the results of a national pharmacovigilance survey focusing on the systemic adverse effects of atropinic mydriatic eye drops based on atropine, cyclopentolate or tropicamide in children and the elderly.
  • The report listed 150 cases, observed up to 13 March 2007, in 133 children and 17 patients aged over 75. There were a total of 277 systemic adverse effects. Nine cases were life-threatening, 7 of which involved infants under one year of age.
  • The dose must be carefully tailored to the patient’s age, and the patient (or parents) must be informed of warning signs.

    Corticosteroids: Neuropsychiatric effects (Summary)
  • Whether they are inhaled, injected or taken orally, corticosteroids have known neuropsychiatric adverse effects, including euphoria, insomnia, excitation, confusion, manic episodes, depression and seizures.
  • The Toulouse Regional Pharmacovigilance Centre and the French Association of Pharmacovigilance Centres identified 95 spontaneous reports in the French Pharmacovigilance Database.
  • These reports described 136 neuropsychiatric adverse effects observed in children and adolescents between January 1994 and March 2007 (2). Fifteen cases were considered serious.
  • These cases serve as a reminder to use the minimum effective dose of corticosteroids, even when inhaled.

    Sitagliptin: Serious allergies (Summary)
  • In October 2008, at the express request of Prescrire, the European Medicines Agency (EMEA) released a review of the allergic adverse effects of sitagliptin, a blood glucose-lowering agent indicated in type 2 diabetes.
  • The EMEA had been notified of hypersensitivity reactions that included anaphylaxis, angioedema and skin reactions, occurring during the first 3 months of sitagliptin therapy. Some cases occurred after the first dose.