If you’ve been using Qualaquin (quinine sulfate) to prevent leg cramps, treat leg cramps or for restless leg syndrome, you need to know that two people using Qualaquin and 36 others have experienced serious life threatening side effects between April and October 2008. This link was discovered after the FDA reviewed its Adverse Event Reporting System for the April through October time period. It is not clear how many others since October 2008 have experienced life threatening side effects or death from Qualaquin use. It is also important to know that Qualaquin is not FDA-approved to prevent or treat night time leg cramps.
The problem with the drug seems to be linked to the active ingredient called quinine. The serious side effects listed in the report, include:
- Low blood platelet levels (thrombocytopenia)
- Hemolytic uremic syndrome
- Thrombotic thrombocytopenic purpura which is a blood disorder resulting small blood vessel clots and possibly kidney impairment
- Permanent kidney impairment
- Heart and blood vessel (cardiovascular) problems
- Hearing loss
- Electrolyte imbalance
- Internal bleeding
Consequently, the FDA has demanded that the manufacturer sent a warning letter out to physicians letting them know about the risk of serious and life threatening blood disorder reactions. The FDA has warned that Qualaquin is only approved for the treatment of malaria caused by the Plasmodium falciparum parasite. This type of malaria is associated with foreign countries, but US citizens traveling to other countries may return to the U.S. with this form of malaria.
If you are using Qualaquin, you should stop taking the medication and report to your physician if any of the following conditions is applicable.
- Using the drug for leg cramps
- Inappropriate bruising
- Nose bleeds
- Blood in urine or stool
- Bleeding gums
- Purple, red, brown discoloration of the skin.
If you or a loved one has suffered injury because of a drug, contact Burton Padove, Indiana personal injury lawyer, for a free consultation at (219) 836 2200.