Swissmedic Vigilance News
Edition 31 – November 2023
Edition 31 – November 2023
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Results<br />
Between January 2022 and June 2023, RPVC Geneva<br />
received a total of 798 reports of adverse drug reactions,<br />
including 11 reports of suspected drug-induced<br />
pancreatitis. The majority of cases concerned<br />
women (n=7, 64%), and the average age was 55<br />
(min-max: 27–92 years).<br />
At the time of the report to the pharmacovigilance<br />
centre (the investigations were still in progress for<br />
several of the cases), drug causality was assessed<br />
as probable in two cases and as possible in nine<br />
cases (Table 1). We reviewed all these cases remotely<br />
for follow-up. In view of the additional investigations<br />
and dechallenge results, we were able to<br />
update the causality assessment. Thus, drug causality<br />
could be ruled out (unlikely) in four cases, remained<br />
possible for four cases and was probable<br />
for three cases.<br />
Table 1: Characteristics of pancreatitis individual<br />
case safety reports (n=11) processed by RPVC Geneva<br />
between January 2022 and June 2023.<br />
The reasons stated for reclassifying the cases as unlikely<br />
after follow-up were as follows:<br />
• a negative rechallenge (enalapril) was observed,<br />
and an unknown aetiology with underlying<br />
biliary lesions after a cholecystectomy<br />
was suggested.<br />
• a recurrence of pancreatitis despite the discontinuation<br />
of the suspected drugs (valsartan/hydrochlorothiazide).<br />
Moreover, this patient<br />
was known to be a regular consumer of<br />
alcohol and had a history of several episodes<br />
of pancreatitis (four episodes in all).<br />
• a positive resolution despite the continuation<br />
of the suspected drug (azathioprine) with the<br />
presence of polyps in the gall bladder.<br />
• a positive resolution despite the continuation<br />
of the suspected drugs (sitagliptin, metformin<br />
and dapagliflozin) in a patient with a<br />
history of pancreatitis and cholecystectomy.<br />
Number<br />
Age (years) ≥ 80 1<br />
50-79 6<br />
30-49 2<br />
We are not aware of any positive rechallenge for<br />
the 11 reports of pancreatitis in our centre. The<br />
characteristics of the other cases (causality possible<br />
or probable after follow-up) are detailed in Table 2.<br />
0-29 2<br />
Sex Female 7<br />
Male 4<br />
Causality assessment<br />
at declaration<br />
Causality assessment<br />
after follow-up<br />
Probable 2<br />
Possible 9<br />
Probable 3<br />
Possible 4<br />
Unlikely 4<br />
<strong>Swissmedic</strong> <strong>Vigilance</strong> <strong>News</strong> | Edition 31 – November 2023<br />
9
Change language