FDA Bans Quinine Sulfate (Sort of)

On December 11, 2006, the FDA banned all over the counter products containing quinine sulfate, a drug used for centuries to treat malaria, but which has also been widely used to treat leg cramps and muscle spasms. The ban also applies to all higher strength, prescription-only generic formulations of the drug, but one manufacturer, Mutual Pharmaceutical Company, Inc., will still be allowed to market its name brand product, Qualaquin, which contains 324 mg of quinine sulfate. The sole approved use of the drug will be for the treatment of malaria.

Quinine sulfate is derived from the bark of the Cinchona tree, which according to legend was named after the Countess of Chinchon, the wife of a Peruvian viceroy, who is believed to be the first European cured of malaria using the bark in 1638. The bark had long been used by Peruvian indians for its medicinal qualities, and the active ingredient of the bark was finally isolated by two French scientists, Pierre Joseph Pelletier and Joseph Bienaimé Caventou in 1817, and was named "quinine," possibly in reference to the Cinchona tree or the native Quechua word for the tree, "Quina." The drug has a long history in folk medicine as a treatment for muscles spasms, debility, fever, lumbago and leg cramps. The gin and tonic was invented by officers of the British East India Company who couldn't stand the bitter taste of the quinine-based tonic water they took as a prophylactic against malaria, so they added gin to make it more palatable.

The FDA's granting of exclusive rights for the sale of quinine sulfate in the U.S. to one company has created a serious dilemma for many people in the U.S. who used quinine as a reliable treatment for leg cramps, as there is no other drug on the market that has been approved for the treatment of leg cramps, and the use of quinine itself for cramps was always an off-label, unapproved use. The price of Qualaquin, which now enjoys monopoly status, is over 5 to 6 times more expensive than the previously existing generic formulations of quinine, which are now only available overseas.

It is difficult to fathom the FDA's reasoning for this bizarre prohibition. The FDA states on its website that "Since 1969, FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths, " but compared to many drugs on the market, that is actually a pretty good safety record. Over-the-counter and prescription-only NSAIDs kill over 17,000 Americans every year, but these drugs are still widely available and do not display prominent warning labels that specify their very severe risks. Quinine in prescription strength was previously available over-the-counter but later became prescription-only. "Natural" products containing quinine available over-the-counter generally contained fairly low doses of quinine as well as other ingredients.

If quinine is so dangerous it must be pulled off the market, then why is this company allowed to continue marketing it's quinine sulfate-based product, Qualaquin? At the same time, quinine will still be available in tonic water, which contains 75 mg of quinine on average per liter, and certain energy drinks, such as Howling Monkey. There is no reason to assume that Qualaquin is any more or less toxic than generic quinine sulfate, and the inclusion of a package insert with Qualaquin warning against its use for leg cramps could easily have been mandated for the generics, and is hardly worth a price differential of over 500 percent.

It is also interesting to note that Qualaquin is only available as a 324 mg capsule which is difficult to break apart into a lower dose, but the generics were available in a 260 mg tablet that could easily be broken in half by those seeking to minimize their daily dose of quinine. If the FDA is correct in stating that there is a slim margin between a therapeutic dose and a toxic dose of quinine, then surely there is an advantage to the generics. It should be noted that the usual dosage of quinine for the treatment of malaria, two 324 mg capsules every 8 hours, is six times higher than the usual dose for leg cramps, which was just one 324 mg capsule daily. The FDA states that the more severe adverse reactions that were reported were associated with higher dosages of quinine.

On the surface, it seems that the FDA is doing little more than creating and protecting a monopoly, and allowing a drug company to profiteer off the suffering of millions of quinine users who will now have no choice but to suffer the excruciating pain of chronic leg cramps or pay the piper.