Sunday, August 19, 2007

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.

7 comments:

Anonymous said...

I have taken quinine sulfate for many yrs. for leg and foot cramps in the night. It always works, and has no side affect, other than ringing in ears if I took too much! I could buy a yr.'s supply for around $15.00 OTC.

Later it had to be a prescribed by my Dr.. The only side afect if I took too much was ringing in the ears!

Since it was taken off the market, I have suffered with leg cramps, and plan to mail-order from some place! The Co-pay Prescription for it is around $38.00 per mo.

Please make it and OTC again!

Anonymous said...

In the year 1978. I was given anecdotal information that some people had used Quinine in the treatment of leg cramps, which I had suffered from approximately all my walking life. I proceeded to try some vile pills, that if swallowed gave me a pain free nights sleep. Then I found CAPSULES and the world was good.
When the US government made them a prescription med. I got my regular physician to prescribe and on my occasional visit to my Canadian Grandchildren where I could still buy over the counter. The cost of travel did increase and the Canadian government also made them prescription, so this plan was abandoned and I was forced back into the system. All went well until I was notified my pharmacy would only give me a seven (7) day supply at the same cost as my previous 30 day supply. That meant my co-pay instead of being $20 a month is $20 a week, plus the 3 more trips to the pharmacy! and the cost of fuel it really adds up. I know at my age (78) I won’t need them too much longer, but I’d really like to live out my life pain free and out of debtors prison.

Old Jack said...

In the year 1978. I was given anecdotal information that some people had used Quinine in the treatment of leg cramps, which I had suffered from approximately all my walking life. I proceeded to try some vile pills, that if swallowed gave me a pain free nights sleep. Then I found CAPSULES and the world was good.
When the US government made them a prescription med. I got my regular physician to prescribe and on my occasional visit to my Canadian Grandchildren where I could still buy over the counter. The cost of travel did increase and the Canadian government also made them prescription, so this plan was abandoned and I was forced back into the system. All went well until I was notified my pharmacy would only give me a seven (7) day supply at the same cost as my previous 30 day supply. That meant my co-pay instead of being $20 a month is $20 a week, plus the 3 more trips to the pharmacy! and the cost of fuel it really adds up. I know at my age (78) I won’t need them too much longer, but I’d really like to live out my life pain free and out of debtors prison.

Bill said...

I have taken Quinine Sulfate for the last 45 years for myotonia congenita. I now have to buy it from Canada (300mg instead of the USA 325mg doasage). My doctor gives me a prescription and I fax it to Canada. The only rub is that I have to pay for all of it, since my copay won't work in this case. The good news is that I'm not getting ripped off by the high price of the USA monopoly version.

Anonymous said...

In 2010 after a few years of testing (so starting about 2006), Advair obtained FDA approval to market a very low dose (20 mg) of Dextromethorphan Hbr (available for pennies OTC as Robutussin) mixed with a very very low dose (10 mg) of quinine sulfate (until 2006 available for pennies OTC) as "Nuedexta" to treat pseudo bulbar palsy (involuntary emotional outbursts suffered by those with traumatic brain injuries and ALS). The catch? Thanks to making quinine sulfate prescription only in 2006, "Nuedexta" is prescription only at the bargain price of $500 per month. The Iraq and Afghanistan wars have created a lot of traumatic brain injuries, a gravy train of government paid medical benefits for injured soldiers, and lots of companies with government contract connections and good lobbyists waiting in line to feed off the pork. Follow the money train folks. Not much mystery as to why quinine sulfate was "mysteriously" made prescription only in 2006 despite its safety record over several hundred years. Making Robitussin prescription only would have been too obvious and generated an uproar. But few enough people were buying OTC quinine sulfate for leg cramps for the scheme to work. $500 a month per injured soldier for drugs that cost pennies...follow the money train...

SuperMIssive said...

I took quinine sulfate generic by prescription, for sudden, severe leg cramps, usually "charlie horse" thigh cramps,and foot and hand cramps and back spasms, formany years as needed only, or sometimes one capsule at bedtime when I could feel cramps coming on. I was plagued for years with debilitating leg cramps, multiple times at night.
hen the FDA took it off te=he market, I asked, and neither my doctor nor my pharmacist had ever heard of the problems th FDA claimed people were having. Both told me that there was a new drug coming out that had no generic, and they couldn't sell it because of the cheaper generic quinine sulfate being available.
I sure m,iss it, because I could take one when I had a cramp or spasm, and it would be gone in just a few minutes and not come back.I now have to take Soma by prescription, starting out taking one nightly before bed, whether I needed it or not. The cramps and spasms have now gotten worse and more frequent, causing me to have to take more of the Soma throughout the day. The warnings on Soma are even more sever than what the FDA warned about quinine sulfate, but Soma is approved for that use.
I have, however, lately, on the advice of a local football coach who is of Amish descent, begun to drink pickle juice (eating a dill pickle works pretty good, too) when I feel a cramp coming on or have one hit suddenly. It is an old Amish remedy, and it does work pretty well -and fast. However, it does not help the back spasms much. A "Dixie Cup" amount or a pickle juice ice cube (seal the tray in a bag!!). When the pickles are gone from a gallon jar of dill pickles (regular or Kosher either one)pout the juice into a smalled jar and store in fridge- it keeps forever.
I think the FDA move was all about money, because the Soma costs 20 time what the quinine did.

SuperMIssive said...

I have also learned that there were hundreds of thousands of vets coming back from Iraq and Afghanistan in the early 2000's with bad leg cramps of unknown cause and with malaria due to the malarial drugs either not working or having such bad side effects that the troops threw them away and took their chances with water filters only, or even raw water in the field.
The FDA quinalone change came out at "just about this same time" (coincidence, of course.
Whether "malaria" or the "unknown causes", the VA prescribes quinalone for the problem, and ONLY the VA is allowed to do so. The company allegedly cgarges the govt about twice (now) what it used to before the ban.

And of tonic water--you have to drink enough of it to take a bath in to do any good, and the "energy drinks" have now been banned as well.