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07/11/10   |   By

FDA WARNING: Qualaquin unapproved for use for night leg cramps due to serious side effects | DC Metro Area Medical Malpractice L

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The FDA issued a warning this week due to continued reports of serious side effects in patients using Qualaquin “off-label” for night time leg cramps. This medication is not intended to be used to treat leg cramps, and the FDA has not approved it for this purpose. However, the majority of the use of Qualaquin in America is to relieve night time leg cramps instead of its approved use (to treat malaria caused by Plasmodiumfalciparum, which is rare).

The use of Qualaquin can result in “serious and life-threatening blood-related (hematological) reactions” which in some cases may result in permanent kidney damage, hospitalization, or death. Symptoms of related adverse reactions include easy bruising, severe nose bleeds, blood in urine or stool, or purple, brown, or red spots on the skin.

The FDA has created a risk management plan which “requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug.” The manufacturer is also required to inform healthcare providers that prescribing Qualaquin to treat conditions for which it is not approved exposes patients to risk for serious adverse events. The FDA recommends healthcare providers never prescribe any medication to treat conditions for which the medication is not approved.

Medication should only be used to treat the condition(s) for which it is approved by the FDA; always follow the directions included with prescriptions to avoid medication complications.

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