EU tetrazepam suspension
April 16, 2013
The European Medicines
Agency has recommended the
suspension of medicines containing
tetrazepam, after a review showed
that side effects, particularly skin
reactions, were occurring at a
higher rate in comparison with
other benzodiazepines.
The French medicines agency
cited very serious reactions incl
toxic epidermal necrosis, erythema
multiforme and other syndromes.
The EMA’s Pharmacovigilance
Risk Assessment Committee has
concluded that tetrazepam is
associated with a low but increased
risk of serious skin reactions, and
that in the light of this the data
on its effectiveness was “not
sufficiently robust to support its use
in the authorised indications”.
MEANWHILE the EMA committee
also recommended restrictions
in the use of strontium ranelate
(Protelos/Osseor), based on the
outcome of a “routine benefit-risk
assessment of the medicine”.
Data from clinical studies showed
there was an increased risk of a
heart attack in post-menopausal
women taking the medication
compared to placebo.
A further review has proposed
changes to the prescribing info for
Protelos/Osseor, including that it
not be used in patients with current
or past history of heart disease or
those with inadequately controlled
blood pressure.
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