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DRUG A—Adverse Event—Yellow Stripes

Dear Dr. Smith,

Thank you for your inquiry. The following information is provided in response to your question regarding the use of DRUG A® and the incidence of yellow stripes appearing on the skin.

Please note that the information provided is not intended to advocate the use of our product in any manner other than as described in the enclosed full prescribing information.

INDICATION(S)

DRUG A® is indicated for the relief of moderate to severe hiccups in patients 18 years of age or older.1

PRESCRIBING INFORMATION

Please refer to the following sections of the enclosed Full Prescribing Information that are relevant to your inquiry: ADVERSE REACTIONS, WARNINGS, PRECAUTIONS.1

LITERATURE SEARCH RESULTS

A literature search of MEDLINE databases (and other resources) pertaining to the incidence of yellow stripes appearing on the skin associated with the use of DRUG A® was conducted through May 2010.

CLINICAL STUDIES

In phase III efficacy and safety studies of DRUG A® for the relief of moderate to severe hiccups, yellow stripes appearing on patients skin was reported in 7% of patients (see Table: Incidence of Yellow Stripes Appearing on Skin).2

TABLE 1

INCIDENCE OF YELLOW STRIPES APPEARING ON SKIN2

In a 12-month long-term safety study, the incidence of yellow stripes appearing on the skin was evaluated. DRUG A® users reported yellow stripes on their skin with an incidence rate of 9% (see Table: Incidence of Yellow Stripes Appearing on Skin—Long-Term Study).3

TABLE 2

INCIDENCE OF YELLOW STRIPES APPEARING ON SKIN—LONG-TERM STUDY3

Multiple case reports were identified reporting yellow stripes appearing on patient’s skin.

In a report by Jones and associates,4 a 90-year-old woman suffering from severe hiccups reporting yellow stripes appearing on the skin within 4 days of starting treatment. She was treated with DRUG FIX-IT® and her yellow stripes resolved immediately.

In a report by Jones and associates,5 a 20-year-old man suffering from moderate hiccups reported yellow stripes on his skin within 2 minutes of starting treatment. The patient did not seek treatment, continued taking DRUG A®, and the yellow stripes resolved.

ADVERSE EVENT REPORTING

Please see the enclosed Prescribing Information for the complete ...

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