But Quinine Makes My Leg Cramps Disappear

Many unscrupulous companies are taking advantage of our belief that herbal and natural drugs can supplement or fill in the blanks when traditional medicine and science do not have all the answers. Firms are raking in profits through the illegal marketing of dangerous drugs whose safety and effectiveness has not been approved by the FDA.

This week the FDA took aggressive action against multiple companies that are flouting the law by marketing unapproved products containing quinine. Products containing quinine have been proven effective in treating malaria. However, the gap between a safe dose of quinine to treat malaria and a toxic dose of quinine is razor thin. Since 1969, the FDA has been notified of 665 adverse events involving quinine including 93 deaths. Other serious side effects are cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reactions.

There is only one FDA-approved product containing quinine on the market. Mutual Pharmaceutical Company’s product Qualaquin is approved to treat malaria. Rogue manufacturers are promoting the use of quinine for the off-label use of treating leg cramps and other similar conditions. The labeling on these unapproved quinine products does not warn consumers about the serious side effects associated with quinine.

The FDA has many shortcomings, but one thing it is doing right is making efforts to save lives by ridding the market of unapproved drugs. The FDA initiative has gained steam since June 2006 when it published new guides in the effort to combat those companies selling such drugs. Consumers can educate themselves by checking out the FDA’s Unapproved Drugs Web Page.