posted
Per hubby's LLMD there are plans to pull quinine from the market.
Hubby had no problem filling his scrip at Walgreens last week. He will be picking up a refill in a couple of days. Walgreens doesn't know anything about any plan to withdraw quinine from the market.
Quinine is the closest thing hubby has found to a miracle drug for babs treatment.
Does anyone know anything about quinine being withdrawn from the market?
Bea Seibert
Posts: 7306 | From Martinsville,VA,USA | Registered: Oct 2004
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Jill E.
Frequent Contributor (1K+ posts)
Member # 9121
posted
Here's the scoop, Bea,
FDA Advances Effort Against Marketed Unapproved Drugs FDA Orders Unapproved Quinine Drugs from the Market and Cautions Consumers About ``Off-Label'' Use of Quinine to Treat Leg Cramps
The Food and Drug Administration (FDA) today ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria, citing serious safety concerns, including deaths, associated with quinine products. There are multiple unapproved products containing quinine currently marketed. However, there is only one quinine product approved by the FDA.
As part of its action, FDA is also cautioning consumers about off-label use of quinine to treat leg cramps. Quinine is approved for treatment of malaria, but is also commonly prescribed to treat leg cramps and similar conditions. Because malaria is life-threatening, the risks associated with quinine use are justified for that condition. But because of the drug's risks, FDA believes it should not be used to prevent or treat leg cramps.
The action posted in a Federal Register notice is part of FDA's continued efforts against unapproved drug products.
``Providing the American public with safe and effective medical products is our core mission,'' said Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs. ``The presence of unapproved drugs on the U.S. market is in stark contrast to our current approach to drug safety because those drugs may not meet modern standards for safety, effectiveness, quality, and labeling. As part of our drug safety efforts, we are committed to ensuring all marketed drugs have required FDA approval.''
One quinine drug product, Mutual Pharmaceutical Company, Inc.'s Qualaquin, is FDA-approved to treat certain types of malaria without complications. Unlike the approved product, many unapproved quinine drug products are marketed without labeling cautioning against use of the product for treatment of leg cramps. The FDA-approved labeling for the product provides extensive warnings regarding serious adverse events associated with use of quinine, potentially serious interactions with other drugs, and conditions under which quinine should not be used. Quinine is a drug with a narrow margin between an effective dose and a toxic dose. The dosing for the approved drug is supported by data to maximize the safety and efficacy of the product. The dosing for the unapproved drugs has not been reviewed and approved by FDA.
Since 1969, FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems), and severe hypersensitivity reactions. There is also the potential for serious interactions between quinine drugs and other drugs, and there are conditions under which quinine should not be used.
Under today's action, previously manufactured unapproved products may still be found on pharmacy shelves for a short period of time, but manufacturing of new product must cease in 60 days. The agency urges consumers who are using quinine products and have questions or concerns to contact their health care provider.
``This summer, when the agency began its aggressive efforts to remove unapproved drugs from the market, we vowed to target the products with the most serious public health risks,'' said Dr. Steven Galson, Director of the FDA's Center for Drug Evaluation and Research (CDER). ``We believe unapproved quinine products represent a serious health risk because of the widespread use of this product for treating leg cramps. Quinine needs to be dosed carefully, and FDA-approved labeling reflects the fact that the risks associated with the use of this drug for treatment of leg cramps outweigh the benefits.''
Jill
-------------------- If laughter is the best medicine, why hasn't stand-up comedy cured me? Posts: 1773 | From San Diego | Registered: Apr 2006
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"FDA has ordered all firms to cease manufacturing unapproved products containing quinine, including quinine sulfate and any other salt of quinine on or after February 13,2007, and to cease shipping such products interstate on or after June 13, 2007."
"FDA has approved one quinine drug product which is manufactured by Mutual Pharmaceutical Co., Inc. (Mutual), of Philadelphia, PA."
"... 324 mg capsules and is sold under the trade name Qualaquin (quinine sulphate) with the following NDC number: 13310-154."
Personally I find this very upsetting. Hubby is allergic to Mepron and could not tolerate the psych side effects from Larium. Took Artemesinin for 15 months with litlle or no improvement.
Is currently treating babs for the 3rd time and having significant improvement with low-dose quinine and tetracycline. Also taking very low dose Tindamax and IV Heparin as well.
The thing that strikes me as suspicious about this FDA action is that I know there was a new drug approved in the last year or two for restless leg syndrome. The Australia article mentioned that there were basically no effective drugs besides quinine for leg cramps in late 2004.
The second "coincidence" is that the only approved drug was approved in August, 2005. Haven't priced that yet, but I bet it is not considered a generic but is a brand name with a brand name price to match.
Just hoping the Cryptolepsis herb I got in the mail today can knock out the babs for good in combo with the quinine.
Bea Seibert
Posts: 7306 | From Martinsville,VA,USA | Registered: Oct 2004
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Jill E.
Frequent Contributor (1K+ posts)
Member # 9121
posted
Bea,
I haven't done Babs treatment yet - Bartonella is currently a huge issue for me - but I, too, had heard rumors about quinine and had been trying to keep an ear open for news for future reference.
Hmmm, I never thought about the fact that Requip was recently introduced for RLS, and now the FDA wants to take quinine off the market for RLS. I have known parents of friends, etc., who have used quinine from the health food store for their restless legs.
I'm glad to hear that there are a few medications at least that are helping your hubby!
Take care, Jill
-------------------- If laughter is the best medicine, why hasn't stand-up comedy cured me? Posts: 1773 | From San Diego | Registered: Apr 2006
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posted
Whoa! I guess I'd better see if I can get mine refilled quick!
Glad I saw this - thanks everyone for the research and information.
I had not hear a thing about this.
I also think that it is quite "fishy" that a new drug comes out and all of a sudden an old one is pulled.
hmmmmmmmm................
of course, we all know the FDA and drug companies and research go hand in hand
-------------------- here's hoping today is better than yesterday and tomorrow is even better! Posts: 239 | From Evansville, IN | Registered: Oct 2000
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minoucat
Frequent Contributor (1K+ posts)
Member # 5175
posted
The therapeutic class for Quinine sulfate is listed as "Anti-Infective Agent", sub class is antiprotozoal, so it seems that it will still be available as an approved tx for babesia, although I wonder about cost increases and time it takes to get it if the market for it is shrinking so drastically.
I'm going by Costco to stock up -- Costco sells it for $44 for 180 pills, as opposed to $140 at Safeway for the same number of pills (324 mg)
Bea -- my hubby is also having good results with quinine (so far -- 2 weeks into this new tx) -- his babesia has resisted everything else we've tried. And he's much less fogbrained on quinine than he was on Mepron. He's doing the clindamyacin/quinine combo now.
Chloroquine/primaquine didn't work for him either, although others have had luck with that one (at least in the short term, dunno about long term follow up).
I'd like to know how the cryptolepsis works out for you -- I'm nervous about adding in one more thing to the hubby's current protocol but it looks promising.
It's such a weird deal -- mepron/zith/art worked great for me after 7 months, and I treated my small relapse with Malarone and haven't had any babesia problems in almost 2 years. The hubby, on the same tx and more, just can't shake it.
BTW, one pharmacist told me that quinine was going to be completely "off the shelf" and that the pharmacy (Safeway) would not be replacing stocks when they were sold out. So there's a very mixed message going out about availability of quinine for approved vs unapproved uses.
-------------------- ********************* RECIDITE, PLEBES! Gero rem imperialem! (Stand aside plebians! I am on imperial business.)
posted
So, is Quinine only available by prescription?
Posts: 582 | From midwest | Registered: Nov 2006
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klutzo
Frequent Contributor (1K+ posts)
Member # 5701
posted
I just want to present the other side of this issue. I almost died from taking over the counter Q-Vel for restless legs. I found out the hard way that Quinine makes me stop breathing.
My Cardiologist also told me it can cause heart arrhythmias, so anyone doing the Cowden Protocol should be very careful with the dosage of Quina, which is pure quinine.
Klutzo
Posts: 1269 | From Clearwater, Florida, USA | Registered: May 2004
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