# Librax not FDA approved?



## Guest (Aug 11, 2000)

My doctor gave me a prescription for librax for esophogeal spasms. My insurance won't pay for it. They claim it's not an FDA approved drug. My doctor says it's been used for 30 to 40 years by many people. Do any of you know if Librax is or isn't approved? I can't imagine a drug being around that long and in use and not being approved by the FDA! I don't trust my insurance and I thought I've read that several people on this board have taken it. I'd appreciate if anyone has any info to let me know!Thanks!


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## Clancy Garner (Apr 5, 2000)

Birdie,I took it many years ago so it had to be FDA approved. What they may mean is that it may not be approved for the esophogial spasms. In most cases I know it is an antispasmodic for the colon.


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## Guest (Aug 13, 2000)

My insurance claims that Librax is a DESI Drug- a drug not approved for any use by the FDA. I can't imagine then how could a drug be prescribed when not approved by the FDA. I thought a drug couldn't be on the market unless approved.This all doesn't make any sense to me. I just feel it's another way of Insurance trying to get out off paying for things they should.Thanks for your reply Clancy. If anyone knows about DESI drugs then please let me know!Birdie


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## JeanG (Oct 20, 1999)

Hi Birdie:It's listed both in Medscape and mywebmd.com has available in the US and Canada. Maybe they are confusing it with something else. Can you call your doc on it? This is what webmd says about it, and here is the URL: http://my.webmd.com/content/asset/uspdi.202130 CHLORDIAZEPOXIDE AND CLIDINIUM (Systemic) Brand Names | Category | Description | Before Using This Medicine | Proper Use of This Medicine | Precautions While Using This Medicine Some commonly used brand names are: In the U.S.ï¿½ Clindex Clinoxide Clipoxide Librax Lidox Lidoxide Zebrax Generic name product may be available. In Canadaï¿½ Apo-Chlorax Corium Librax Generic name product may be available in the U.S. Category Anticholinergic-sedative Description Chlordiazepoxide and clidinium (klor-dye-az-e-POX-ide and kli-DI-nee-um ) is a combination of medicines used to relax the digestive system and to reduce stomach acid. It is used to treat stomach and intestinal problems such as ulcers and colitis. Chlordiazepoxide belongs to the group of medicines known as benzodiazepines. It is a central nervous system (CNS) depressant (a medicine that slows down the nervous system). Clidinium belongs to the group of medicines known as anticholinergics. It helps lessen the amount of acid formed in the stomach. Clidinium also helps relieve abdominal or stomach spasms or cramps. This combination is available only with your doctor's prescription, in the following dosage form: Oral Capsules (U.S. and Canada) Before Using This Medicine In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For chlordiazepoxide and clidinium, the following should be considered: Allergiesï¿½Tell your doctor if you have ever had any unusual or allergic reaction to benzodiazepines such as alprazolam [e.g., Xanax], bromazepam [e.g., Lectopam], chlordiazepoxide [e.g., Librium], clonazepam [e.g., Klonopin], clorazepate [e.g., Tranxene], diazepam [e.g., Valium], flurazepam [e.g., Dalmane], halazepam [e.g., Paxipam], ketazolam [e.g., Loftran], lorazepam [e.g., Ativan], midazolam [e.g., Versed], nitrazepam [e.g., Mogadon], oxazepam [e.g., Serax], prazepam [e.g., Centrax], temazepam [e.g., Restoril], or triazolam [e.g., Halcion], or to clidinium or any of the belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancyï¿½Clidinium (contained in this combination) has not been studied in pregnant women. However, clidinium has not been shown to cause birth defects or other problems in animal studies. Chlordiazepoxide  (contained also in this combination) may cause birth defects if taken during the first 3 months of pregnancy. In addition, too much use of this medicine during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Make sure your doctor knows if you are pregnant or if you may become pregnant before taking chlordiazepoxide and clidinium. Breast-feedingï¿½Chlordiazepoxide may pass into the breast milk and cause unwanted effects, such as excessive drowsiness, in nursing babies. Also, because clidinium tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients. Childrenï¿½There is no specific information comparing use of chlordiazepoxide and clidinium in children with use in other age groups. However, children are especially sensitive to the effects of chlordiazepoxide and clidinium. Therefore, this may increase the chance of side effects during treatment. Older adultsï¿½Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement or agitation may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of chlordiazepoxide and clidinium. Other medicinesï¿½Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking chlordiazepoxide and clidinium it is especially important that your health care professional know if you are taking any of the following: Antacids or Diarrhea medicine containing kaolin or attapulgiteï¿½These medicines may reduce the blood levels of chlordiazepoxide and clidinium, which may decrease their effects; they should be taken at least 2 to 3 hours before or after the chlordiazepoxide and clidinium combination Central nervous system (CNS) depressants (medicines that cause drowsiness) or Other anticholinergics (medicines for abdominal or stomach spasms or cramps)ï¿½Use with chlordiazepoxide and clidinium may increase the side effects of either medicine Ketoconazole (e.g., Nizoral)ï¿½Chlordiazepoxide and clidinium may reduce the blood level of ketoconazole, which may decrease its effects; therefore, chlordiazepoxide and clidinium should be taken at least 2 hours after ketoconazole Potassium chloride (e.g., Kay Ciel)ï¿½Use of chlordiazepoxide and clidinium may worsen or cause sores of the stomach or intestine Other medical problemsï¿½The presence of other medical problems may affect the use of chlordiazepoxide and clidinium. Make sure you tell your doctor if you have any other medical problems, especially: Difficult urination or Dryness of mouth (severe and continuing) or Emphysema, asthma, bronchitis, or other chronic lung disease or Enlarged prostate or Glaucoma or Hiatal hernia or High blood pressure (hypertension) or Intestinal blockage or Mental depression or Mental illness (severe) or Myasthenia gravis or Ulcerative colitis (severe)ï¿½Use of chlordiazepoxide and clidinium may make these conditions worse Drug abuse or dependenceï¿½Taking chlordiazepoxide (contained in this combination) may become habit-forming, causing mental or physical dependence Kidney disease or Liver diseaseï¿½Higher blood levels of chlordiazepoxide and clidinium may result, possibly increasing the chance of side effects Overactive thyroidï¿½Use of chlordiazepoxide and clidinium may further increase the heart rate Proper Use Take this medicine about 1/2 to 1 hour before meals unless otherwise directed by your doctor. Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. Dosingï¿½The dose of chlordiazepoxide and clidinium combination will be different for different people. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of this combination medicine. If your dose is different, do not change it unless your doctor tells you to do so. For oral dosage form (capsules) To relax the digestive system and to reduce stomach acid: Adultsï¿½1 or 2 capsules one to four times a day, thirty to sixty minutes before meals or food. Your doctor may change the dose if needed. However, most people usually will not take more than 8 capsules a day. Childrenï¿½Dose must be determined by your doctor. Older adultsï¿½To start, 1 capsule two times a day. Your doctor may change the dose if needed. Missed doseï¿½If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storageï¿½To store this medicine: Keep out of the reach of children. Store away from heat and direct light. Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children. Precautions If you will be taking this medicine regularly for a long time your doctor should check your progress at regular visits. Do not take this medicine within an hour of taking medicine for diarrhea. Taking them too close together will make this medicine less effective. This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well . This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine and also for a few days after you stop taking it . This medicine will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine as this could possibly result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. Your mouth, nose, and throat may feel very dry while you are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections. Check with your doctor if you develop intestinal problems such as constipation . This is especially important if you are taking other medicine while you are taking chlordiazepoxide and clidinium. If these problems are not corrected, serious complications may result. If you will be taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur: Less common or rare Constipation; eye pain; mental depression; skin rash or hives; slow heartbeat, shortness of breath, or troubled breathing; sore throat and fever; trouble in sleeping; unusual excitement, nervousness, or irritability; yellow eyes or skin Symptoms of overdose Confusion; difficult urination; drowsiness (severe); dryness of mouth, nose, or throat (severe); fast heartbeat; unusual warmth, dryness, and flushing of skin Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome: More common Bloated feeling; decreased sweating; dizziness; drowsiness; dryness of mouth; headache Less common Blurred vision; decreased sexual ability; loss of memory; nausea; unusual tiredness or weakness After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects: Convulsions (seizures); muscle cramps; nausea or vomiting; stomach cramps; trembling Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.


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## Guest (Aug 13, 2000)

Birdie,You might try: http://www.verity.fda.gov/search97cgi/s97_...ax&Collection=a ll&SearchUrl=http%3A%2F%2Fwww%2Everity%2Efda%2Egov%2Fsearch97cgi%2Fs97%5Fcgi%2Eeslvhat


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## Guest (Aug 13, 2000)

Birdie,Not all of the web site address took so you will get an error message, but if you have the will to type it all out you will get to the FDA approval update page which contains some terminology changes to Librax which is listed as a previously approved drug. Hope this helps.


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## Guest (Aug 13, 2000)

Thanks so much for your help & info, JeanG and slvhat.I did try retyping the entire web address slvhat but still reached an error that way. I'll try connecting to the FDA another way to check.You found a lot of info on the drug Jean.Thanks!Maybe this will give me some substantial proof for Insurance and I will tell my doctor too.Thanks again!Birdie[This message has been edited by Birdie (edited 08-13-2000).]


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## flux (Dec 13, 1998)

In the days old (prior to 1962), drugs were approved even if they didn't help. Librax was apparently one of these drugs. As a result, it is given what is called DESI status. This means that the manufacturer must come up with proof that the drug is effective otherwise it would have to be discontinued. From what I can tell, Librax is still listed as DESI on some FDA web pages, but the web page mentioned by slvhat seems to indicate that at least one form from one manufacturer has been (re-)approved.


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## NancyCat (Jul 16, 1999)

I just filled an RX for librax around 2 weeks ago. I think that my insurance (BC/BC)paid but I'm not positive because it was a small amount and its not terribly expensive (generic)anyway. However if you are taking say 100 a month (3 x day) it would definately add up. To the best of my memory from what I had read in an older PDR librax was never found to be "effective" in treating "spastic colon" but it was found to be "possibly effective", and insurance always paid too I think. It seems to me that you and your DR would have a pretty good case for your insurance to pay for it on appeal as your DR can indicate how hard it is to find an effective medication for IBS (a perplexing medical condition wherein no one medication will be effective for every patient), how he/she thinks librax is indicated for you and how it has been around for over 30 years. I hope that you have good luck with the librax (can you pay for the initial RX and get a refund from insurance if they deceide to pay?) and that your insurance will pay for it too.







------------------Nancy


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## Guest (Aug 13, 2000)

I have United Healthcare Insurance and I take Librax twice a day and my insurance pays for it. It only costs me $10 for one month supply (60 tablets). Your insurance should be paying for this medication. I hope you and your physician can convince your insurance company to cooperate. Good luck!


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## Guest (Aug 14, 2000)

Thanks Flux, NancyCat & jlt-Flux thanks once again for explaining things to me- Desi drugs and why it might not be approved or reapproved. That makes sense. But I will try to further find out if the once Rx I have was from the manufacturer that is approved.NancyCat- I liked the way you described how to explain to my insurance the reason why Librax was prescribed. It's hard sometimes telling people why you need certain medications in away that's effective.I can afford to pay for the intial RX. It doesn't cost much but after awhile all those Rx's that my insurance decides not cover inventially adds up. I'm a person of principal and that's why I'm on a quest to get insurance to cover medication that they should be paying. Insurance has already given me the run around so much that I soon figured out it was on purpose so as to deter me or anyone from getting the medication we need. I ended up having to call my husband's HR dept at his company who deal with benefits. She said our Rx plan was giving out wrong information and called them personally. I was told by the Rx plan that there was no way to get a medication that was not on the list. Next time I called the plan they told me had to call my husband's company & HR decided if I could get the medication covered. All that info was wrong! The plan was supposed to contact my doctor and find out the reason why I need it and make a decision, HR was NOT to be involved at all. I thought that was odd to begin with, why would an HR person who has no medcial degree be making decision as wether or not I need a medication!Anyway, my med is still not covered but I need to follow up with the info everyone has given me & I see my doctor in a few weeks again.Thanks everyone!Birdie [This message has been edited by Birdie (edited 08-14-2000).]


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