Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions here

Audience: Primary Care, Infectious Disease




ISSUE: Due to continued reports of serious side effects by cchr 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 approved by FDA 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.

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.

New Drug Approved By FDA (First Generic Drug)

Trandolapril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.







Verapamil is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.






The combination of trandolapril and verapamil is used to treat high blood pressure (hypertension).

What is the most important information I should know about trandolapril and verapamil?


Do not use trandolapril and verapamil if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. Do not use salt substitutes or potassium supplements while taking trandolapril and verapamil, unless your doctor has told you to.


Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking trandolapril and verapamil. Drink plenty of water each day while you are taking this medication.






Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.






What should I discuss with my healthcare provider before taking trandolapril and verapamil?


You should not use this medication if you are allergic to trandolapril (Mavik) or verapamil (Calan, Covera, Isoptin, Verelan), or if you have:


certain heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);






a heart rhythm disorder;






low blood pressure; or






if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).






If you have any of these other conditions, you may need a trandolapril and verapamil dose adjustment or special tests:






kidney disease (or if you are on dialysis);






liver disease;






congestive heart failure;






diabetes; or






a nerve-muscle disease such as muscular dystrophy.






 Do not use trandolapril and verapamil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Stop using this medication and tell your doctor right away if you become pregnant. Trandolapril and verapamil can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Trandolapril and verapamil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


Gurbinder Sharma
CCHR.ORG
Investigator