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DRUG A—Adverse Event—Yellow Stripes

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Dear Dr. Smith,

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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.

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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.

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

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

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LITERATURE SEARCH RESULTS
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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.

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CLINICAL STUDIES
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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

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Table Graphic Jump Location
TABLE 1

INCIDENCE OF YELLOW STRIPES APPEARING ON SKIN2

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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

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Table Graphic Jump Location
TABLE 2

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

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

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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.

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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.

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ADVERSE EVENT REPORTING
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Please see the enclosed Prescribing Information for the complete ...

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