SPC changes
Abilify
The summary of product characteristics for Abilify (aripiprazole; Bristol-Myers
Squibb/Otsuka) has been updated. The special warnings section of the
SPC now includes the following: “The occurrence of suicidal behaviour
is inherent in psychotic illnesses and in some cases has been reported
early after initiation or switch of antipsychotic therapy, including
treatment with aripiprazole. Close supervision of high-risk patients
should accompany antipsychotic therapy.” In the undesirable effects
(post marketing) section, the following has been added: “Cases
of suicide attempt, suicidal ideation, and completed suicide have been
reported post marketing”. See SPC.
Flomaxtra XL
The summary of product characteristics for Flomaxtra XL (tamsulosin;
Astellas) tablets has been updated. The special warnings section now
includes information on the observation of intraoperative floppy iris
syndrome during cataract surgery in some patients on or previously
treated with tamsulosin. Some guidance is given to prescribers (initiation,
discontinuation of tamsulosin therapy in relation to cataract surgery),
cataract surgeons and ophthalmic teams (assessment before cataract
surgery). The undesirable effects section of the SPC has been updated
accordingly. See SPC.
Replagal
The summary of product characteristics for Replagal (agalsidase alfa;
Shire) has been updated with new information on the use of Replagal
for paediatric patients. The SPC now says: “Limited clinical
data in children (7–18 years) do not permit to recommend an optimal
dosage regimen presently. Because no unexpected safety issues were
encountered in the 6-month study with Replagal administered at 0.2mg/kg
in this population, this dose regimen is suggested for children between
7–18 years of age.” See SPC.
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