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FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)

This is a discussion on FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate) within the FDA News forum, part of the Industry News and Updates category; [07-08-2010] Due to continued reports of serious side effects in patients using Qualaquin "off-label" (a ...


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Old 07-08-2010, 11:47 AM
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Default FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)

[07-08-2010] Due to continued reports of serious side effects in patients using Qualaquin "off-label" (a non-FDA-approved use) for night time leg cramps, the U.S. Food and Drug Administration (FDA) has approved a risk management plan to warn against the use of this drug for such unapproved uses.

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