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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,
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