Table 1: Summary of reports
of suspected pancreatitis associated with alendronate submitted to the
CADRMP between December 1995 and Aug. 31, 2001
|
Case
|
Reported reaction*
|
Age/ sex
|
Daily dose, mg
|
Time to
onset
|
Findings†
|
Medical history
|
Concomitant
drugs
|
Outcomes‡
|
|
| 1 |
Pancreatitis |
68/F
|
10
|
7 mo
|
Epigastric
pain, vomiting, dehydration. Serum amylase level 372 U/L, WBC count 18
x 109/L |
Osteoporosis |
MS
Contin§ |
Hospital
admission, discontinuation of alendronate; recovered |
| 2 |
Pancreatitis,
acute |
76/F
|
10
|
48 d
|
Serum
amylase level 3490 U/L, serum lipase level 7110 U/L |
Osteoporosis,
type 2 diabetes, stroke, cardiac insufficiency, hypertension |
Diabeta,
Entrophen,§ Glucophage, K-Dur, Lasix,§
Vasotec§ |
Hospital
admission,
discontinuation of
all drugs; not recovered |
| 3 |
Pancreatitis,
acute |
77/F
|
10
|
13 d
|
Acute
epigastric pain. Serum amylase level 4339 U/L, WBC count 12.1 x 109/L |
Osteoporosis,
previously well, nondrinker, no gallstones |
None |
Discontinuation
of alendronate; recovered |
| 4 |
Pancreatitis |
NA/F
|
NA
|
NA
|
NA |
NA |
NA |
Death
(may be drug related) |
| 5 |
Pancreatitis |
NA
|
NA
|
NA
|
NA |
NA |
NA |
NA |
| 6 |
Pancreatitis,
acute |
NA/F
|
NA
|
"Several
years" |
NA |
Osteoporosis,
ulcer history |
Prinivil,§
Thyroxine |
Hospital
admission, discontinuation of alendronate |
Note:
CADRMP = Canadian Adverse Drug Reaction Monitoring Program, NA = not available, WBC = white blood cells.
*Based on the "preferred term" of the World Health Organization Adverse Reaction Dictionary (WHOART).
†Normal ranges vary among laboratories; typical reference values are: serum amylase 0-130 U/L, serum
lipase 0-160 U/L, WBC count 3.2-9.8 x 109/L.
‡At the time of reporting, as indicated by the reporter.
§Drugs for which an association with pancreatitis has been suggested.2,
3
|
