Prevacid

[Lansoprazole]

Postmarketing On-going Safety Surveillance:

Additional adverse experiences have been reported since lansoprazole has been marketed. The majority of these cases are foreign-sourced and a relationship to lansoprazole has not been established. Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole -

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anaphylactoid-like reaction;

Digestive System -

hepatotoxicity, pancreatitis, vomiting;

Hemic and Lymphatic System -

agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura;

Skin and Appendages –

severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal);

Special Senses -

speech disorder;

Urogenital System -

urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with PREVACID, amoxicillin, or clarithromycin.

Triple Therapy:

PREVACID/ amoxicillin/ clarithromycin

The most frequently reported adverse events for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse events between the 10-and 14-day triple therapy regimens. No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

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