July 13, 2010: FDA Risk Management Plan Regarding Qualaquin
FDA
released a statement on July 8, 2010 regarding Qualaquin (quinine sulfate) and
the risk of serious hematological reactions . Due to continued reports of
serious side effects in patients using Qualaquin "off-label" for
night time leg cramps, FDA approved a risk management plan to warn against the
use of this drug for such unapproved uses.
The risk
management plan (REMS) 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. In addition, the REMS requires that the manufacturer issue a
Dear Health Care Provider Letter warning of the risk of serious and
life-threatening hematologic reactions.
Qualaquin
is the only FDA-approved for the treatment of uncomplicated malaria caused by
the parasite
Plasmodium falciparum. Most users are travelers returning from malaria-endemic
areas, but the majority of Qualaquin's use in the United States is for the
treatment or prevention of night time leg cramps.
The
product labeling states that the risks associated with the use of Qualaquin in
the absence of evidence of its effectiveness for treatment or prevention of
nocturnal leg cramps outweigh any potential benefits.
FDA says
that Qualaquin should not be used for night time leg cramps because Qualaquin
use may result in serious and life-threatening hematological reactions,
including serious bleeding due to thrombocytopenia, and hemolytic- uremic syndrome/ thrombotic
thrombocytopenic purpura, which in some cases may result in permanent
kidney damage. In some patients,
adverse reactions result in hospitalization and death.
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