Have you taken the malaria drug Qualaquin to alleviate night time leg cramps or Restless Leg Syn
drome, only to suffer serious side effects? The off-label use of Qualaquin has been linked to serious blood disorders, according to the U.S. Food & Drug Administration (FDA). If Qualaquin has made you sick, we want to hear from you today.
Reactions linked to the off-label use of Qualaquin include low blood platelets (thrombocytopenia) and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura. In some cases, these reactions proved fatal. If you or a loved one experienced one of these serious, life-threatening Qualaquin side effects while taking it to relieve night time leg cramps or Restless Leg Syndrome, you may be entitled to recover damages for your medical bills, lost wages, and pain and suffering.
Our Qualaquin injury lawyers are investigating potential lawsuits and legal claims related to off-label use of this drug. We are currently providing free lawsuit consultations to victims of Qualaquin-induced blood disorders. We urge you to contact us as soon as possible to protect your legal rights.
Qualaquin Side Effects
According to the FDA, Qualaquin, distributed by AR Scientific, is ONLY approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum. This is a rare infection in the United States which affects only about 1,500 people each year, primarily travelers returning from malaria-endemic areas. In the United States, the majority of Qualaquin prescriptions are written for the treatment or prevention of night time leg cramps, a use NOT approved by the FDA.
Qualaquin use may result in serious and life-threatening blood-related reactions, including serious bleeding due to a severe lowering of blood cells called platelets (thrombocytopenia), and a condition known as hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, these Qualaquin reactions have resulted in hospitalization and death.
According to the FDA, a review of reports submitted to the agency’s adverse-event reporting system from April 2005 to October 1, 2008 found 38 cases of serious adverse events associated with quinine, the active drug in Qualaquin. These included 24 blood-disorder events, four cardiovascular events, and 10 miscellaneous adverse events such as gastrointestinal symptoms, hearing loss, rash, electrolyte imbalance, and drug interaction.
The majority of patients (25) took quinine to prevent or treat leg cramps or Restless Leg Syndrome; only 1 patient was taking quinine for the treatment of malaria. Twenty-one patients were diagnosed with thrombocytopenia, and 18 of those patients required hospitalization. Most of the patients with thrombocytopenia recovered when quinine was discontinued and other therapeutic interventions were initiated. Two deaths were reported among the blood disorder patients, one of which involved thrombotic thrombocytopenic purpura, and another due to hemolysis.
Because of these serious risks, the FDA said the manufacturer of Qualaquin has now developed a risk management plan aimed at educating health care professionals and patients about the potential risks. Patients being prescribed Qualaquin will now be given a medication guide that explains what the product should and shouldn’t be used for, as well as the potential risks of the product. The agency also said AR Scientific would issue a letter to health-care professionals discussing the risks of using Qualaquin off-label. Unfortunately, all of these precautions have come too late for people already injured by Qualaquin.
FDA info for Qualaquin (quinine sulfate)
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy – Risk of serious hematological reactions Audience: Primary Care, Infectious DiseaseISSUE: Due to continued reports of serious side effects in patients using Qualaquin “off-label” for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. 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.
BACKGROUND: Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, 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.
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.
A data summary of adverse event reports received by FDA from April 2005 to October 2008 is provided in the Drug Safety Communication below.
RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin. Patients are encouraged to read the Medication Guide given to them at the pharmacy before starting Qualaquin and each time they get a refill.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Legal Help for Victims of Qualaquin Injuries
If you or a loved one suffered serious, life-threatening side effects while taking Qualaquin off-label to treat Restless Leg Syndrome or night time leg cramps, you may have valuable legal rights. Please fill out our online form, or call 1800 YOURLAWYER (1-800-968-7529) to discuss your case with one of our Qualaquin injury lawyers today.