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FDA Cautions on Use of Quinine Products

In February 2007, the Food and Drug Adminstration (FDA) banned all over-the-counter quinine products and ordered all prescription-only generic formulations of the drug off the market, leaving Mutual Pharmaceutical’s Qualaquin as the only FDA-approved prescription quinine product left on the market. In addition, it warned doctors and consumers about the dangers of using quinine “off-label” to treat leg cramps and cautioned against such use.

This decision was derived from the 665 reports the FDA received between 1969 and 2006, citing adverse events with serious outcomes associated with quinine use, including 93 deaths.

About Quinine

Quinine is an ancient therapeutic agent that was originally used in the prevention and treatment of malaria. Today, however, companies have taken its active ingredients and promoted it for other uses. In particular, it has commonly been used to treat leg cramps and muscle spasms.

Serious side effects associated with quinine include:

  • Heart attack
  • Stroke
  • Cardiac arrhythmias
  • Blood conditions (hemorrhaging or clotting)
  • Renal (kidney) failure
  • Blindness
  • Liver failure
  • Death

If you or your loved one has suffered a Quinine injury, contact us today. Submit the form to the right and we’ll let you know if you have a case and if we can represent you.