Prescrire International Special Edition 2015/Volume 24 N°158
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In conjunction with its annual Prescrire Awards, the independent
French medical journal Prescrire publishes an annually updated list of
drugs that ought to be avoided, most often in favour of better options.
Free download available at:
english.prescrire.org > Topics > Annual Prescrire Awards >
Drugs to avoid: 2015 update
Prescrire Int • March 2015
Prescrire Int • January 2015
In 2014 the indications of
stron-
tium ranelate
were further restricted in
the European Union, and the French
pharmacoeconomic committee has
finally judged strontium ranelate to
have “insufficient medical benefit”.
S
trontium ranelate (Protelos° -
Servier), a drug authorised in
the European Union for severe
osteoporosis, has at best only modest
efficacy in secondary prevention of ver-
tebral fractures (1). In stark contrast, it
carries a risk of disproportionate adverse
effects, including myocardial infarction,
embolism, vein thrombosis, hypersensiti-
vity reactions (including Lyell’s syndrome
and Dress (drug reaction with eosinophi-
lia and systemic symptoms)), impaired
consciousness, seizures, hepatitis and
cytopenia (1-4). Ocular disorders (loss
of visual acuity and inflammation) have
also been reported (5).
In early 2014, as part of a European
reassessment, the European Pharma-
covigilance Risk Assessment Commit-
tee (PRAC) recommended suspending
marketing authorisation for products
containing strontium ranelate in the
European Union (
a
)(1).
The European Committee for Medi-
cinal Products for Human Use (CHMP)
considered that “the cardiovascular risk
in patients taking Protelos can be man-
aged by restricting its use to patients
with no history of heart and circu-
latory problems (…). In addition, patients
(...) should be screened and monitored
regularly, every 6 to 12 months” (6,7).
Ten Member States, including France,
disagreed with this conclusion (7).
In April 2014, the European Commis-
sion approved the CHMP recommenda-
tion and allowed strontium ranelate to
remain on the market (8). This decision
is binding on all EU Member States. The
French health products agency (ANSM)
which had advised against starting treat-
ment with strontium ranelate pending the
European Commission’s decision, had
to inform healthcare professionals of the
new instructions for strontium ranelate,
which notably include last-resort use only,
and regular cardiovascular monitoring
(1,7). In July, the French pharmacoeco-
nomic committee considered that stron-
tium ranelate still had “insufficient medical
benefit” under these new conditions (9).
Once again, the CHMP, followed by
the European Commission, favours
drug companies over patients’ health.
In practice, it is best to follow the advice
of PRAC: this drug should have been
discarded long ago.
©Prescrire
a-
In early 2014 Servier withdrew an application in the
European Union to extend the indications of Protelos°
to osteoarthritis of the hip and knee, the CHMP having
underlined the weak efficacy and uncertain long-term
benefits in view of the known risk of serious adverse effects
(ref 10). The company also withdrew its EU application
for a fixed-dose combination of cholecalciferol + strontium
ranelate in osteoporosis, the CHMP having detected prob-
lems with the manufacturing dossier (ref 11).
Translated from
Rev Prescrire
October 2014; 34 (372): 743
Strontium
still authorised despite an unfavourable opinion
of the European pharmacovigilance committee
Towards better patient care: drugs to avoid in 2015
Selected references from Prescrire’s literature
search.
1-
Prescrire Rédaction “Strontium: le Comité
européen de pharmacovigilance contre le main-
tien des AMM”
Rev Prescrire
2014;
34
(365): 185.
2-
Prescrire Rédaction “Strontium: comment justi-
fier tous ces risques ?”
Rev Prescrire
2013;
33
(361):
820 + 34 (365): 162.
3-
Prescrire Rédaction “20-2. Patients ayant une
ostéoporose”
Rev Prescrire
2013;
33
(362 suppl.
interactions médicamenteuses).
4-
EMA “Protelos and Osseor. Strontium ranelate.
CHMP scientific conclusions and PRACassessment
report of the review under article 20 of regulation
(EC) n° 726/2004” 28 February 2014: 29 pages.
5-
EMA “PRAC minutes of the meeting on 2-5
December 2013” 9 January 2014: 58 pages.
6-
EMA “European medicines agency recom-
mends that Protelos/Osseor remain available but
with further restrictions” 21 February 2014: 3
pages.
7-
ANSM “Point d’information - Le CHMP recom-
mande le maintien sur le marché de Protelos
(ranélate de strontium) en restreignant de nou-
veau ses indications” 27 February 2014 + “Lettre
aux professionnels de santé - Protelos (…): nou-
velles restrictions d’indication” 24 March 2014:
5 pages.
8-
European Commission “Commission imple-
menting decision (…) amending modifiant the
marketing autorisation for “Protelos - strontium
ranelate” (…)” + “Annexes” 15 April 2014:
46 pages.
9-
HAS - Commission de la transparence “Avis de
la Commission - Protelos” 9 July 2014: 23 pages.
10-
EMA “Questions and answers. Withdrawal
of the applications for a change to the marketing
authorisation of Protelos” 23 May 2014: 2 pages.
11-
EMA “Questions and answers. Withdrawal of
the marketing authorisation applications for Dite-
los and Issarlos” 25 April 2014: 2 pages.
