Denture cleanser problems lead to FDA warning

 

Potential Denture Cream Lawsuits are being reviewed for individuals who have used Fixodent or Super Poligrip and suffered from zinc poisoning problems, which could include:

  • Paralysis
  • Numbness, Tingling or Pain in the Hands or Feet
  • Muscle Weakness or Pain
  • Loss of Balance or Difficulty Walking
  • Loss of Sensation

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Following reports of at least 73 severe reactions to denture cleansers, including one death, the FDA has issued a Public Health Notification and asked the manufacturers to revise the product label and consider changes to the ingredients to reduce the risk of reactions. The denture cleanser problems appear to have been caused by reactions to persulfate, which is a known allergen, and from misuse of the products caused by inadequate warnings from the manufacturers.

>>FDA ALERT: Denture Cleanser Reactions

Denture cleansers, such as Fixodent, Polident and Efferdent, are sold over the counter to help clean and bleach dentures. Most of the cleansers contain the active ingredient pursulfate, which could cause an allergic reaction in some users. The problems could occur soon after use of the denture cleaner begins, or after years of use.

According to the FDA, in addition to the allergic reactions, some of the denture cleanser problems have also been caused by misuse of the product which resulted in patients swallowing the cleanser or gargling it. The warning label does not provide adequate instructions and warnings, which are especially important since many of the users are elderly.  Some of the products even contain mentions that the cleanser contains mouthwash as an ingrediant, however, severe injuries can be caused if the denture cleaner is ingested.

The FDA has asked the makers of Fixodent, Polident, Efferdent and other denture cleansers to modify the product labels to include additional information and warnings about the proper use and to warn about the risks of allergic reactions which could be caused by persulfates. The regulatory agency also asked the manufacturers to consider alternate ingredients to replace persulfate as part of the cleaning and bleaching process.

Symptoms of an allergic reactions to persulfates used in denture cleansers could include:

  • Tissue Damage
  • Rashes, Hies or Irritation
  • Gum Tenderness
  • Breathing Problems
  • Low Blood Pressure

Denture cleanser problems could be caused by the poor instructions and misuse could include:

  • Damage to the esophagus
  • Abdominal Pain
  • Burns
  • Bleaching of tissue
  • Blood in the Urine
  • Internal Bleeding
  • Vomiting
  • Breathing Problems
  • Low Blood Pressure
  • Seizures
  • Death

DENTURE CLEANSER LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. are reviewing the potential for denture cleanser lawsuits for users of Fixodent, Polident, Efferdent or other products, who suffered a severe allergic reaction or injury. If you, a friend or family member have experienced denture cleanser problems, request a free legal consultation.

32 Responses to:

“Denture cleanser problems lead to FDA warning”

  1. Steve Says:

    I have earition in my stomick and head ackes and hard time breathing at times,also have a real bad taste of the denture or fixodent adhesive cream.

  2. Lillian Says:

    Why don’t the efferdent manufactures have ingredients marked on their product? I’ve been having problems with blisters on the tongue. this reaction is the same that I get when I take sulfa or penicillin. I do not know if efferdent is the culprit. The doctor knows of my problem. I never mentioned to him about efferdent for I always felt this was a safe product (it probably is).

  3. karen Says:

    I am the wife of a man who has recently had two anaphylactic episodes due to what I suspect might possibly be persulfates in dental cleansers. I have called numerous labs, asked our newly acquired allergists at Eastern Virginia Medical School, the FDA, our Dentists, local dermatologists, LabCorp, etc, and on and on as to “where” my husband could be patch tested for allergies to persulfates and no one seems to have a clue.

    My husband began having a rash on various parts of his body about 9 months ago. About two months ago and the day after a midnight anaphylactic episode, we were in Eastern Virginia Medical School’s Allergy Department beginning the process of testing for the culprit. After another anaphylactic episode followed by my husband’s discovery of a rash on his pallet, I went on line and found that persulfates in Denture Cleansers have recently made the headlines for causing mild to severe reactions in some people. One death has been traced to them. I have read numerous articles about the allergies to persulfates in the Denture Cleansers and have talked to the company of the Denture Cleanser my husband has used ( who admits the persulfates are in their product and that they are soon to put a warning on their Cleanser packaging but even he cannot tell me where my husband can be tested for an allergy to the persulfates)

    The testing done at EVMS turned up that he is allergic to almonds and beef. One might tell my husband to simply stop using the Denture Cleansers, avoid beef and almonds and keep on going. However, since beef is a food that I would like to continue to serve if possible, I would like to rule out the persulfates or “rule in” them since the anaphylactic reaction may have been to a combination of both or persulfates by themselves or whatever. Just avoiding the Dental Cleanser does not bring me peace or satisfaction for many reasons. It is believed also that the persulfates can be absorbed into the dentures so that even avoiding the Cleansers might not solve the problem right away. It is possible that he may need new dentures if he is allergic to persulfates and they have absorbed into the dentures he wears now. We would like to get to the bottom of all this but need to be tested for the persulfates.

  4. Roseann Says:

    I am having stomach issues, headaches, problems breathing and a strange taste in my mouth specically my tongue after using Efferdent denture cleanser. I am allergic to sulfa. I am asssuming now that I have read this I am allergic to it also being a perasulfates. Thank you for the article.

  5. Diana Says:

    My husband broke out in hives just after Thanksgiving. After his tongue started to swell, we went to Emergency. A shot of pred and pills to take for a few days……one week later, same thing, this time his lip swelled and his nostril. We’ve been scratching our heads trying to figure out what he is allergic to and now, thanks to Karen, we are almost 100% sure we’ve found the culprit….Efferdent Cleanser. My husband is extremely allergic to penicillin…this makes total sense. However, I can’t find anything on the package that lists the ingredients and no warning about allergies!

    This could have potentially caused a great deal of harm….we will probably have to buy new dentures…..

  6. M Brophy Says:

    i have usedefferdent for approximately 9 yrs. reecently (last 2 mo0nths) i have had numbness in my right hand including little and index fingers.No idea what can cause this. I am left handed

  7. william Says:

    I have suffered a lot of ailments over the years and could not get an answer from my doctor on what caused my shortness in breathing, swelling in my feet and legs at first it was thought to be arithritis but diagnosis proved otherwise therefore the only thing that could cause these problems were the use of fixodent and efferdent. I have used this product for at least 30 years I have experience rashes and irritation of the skin and have been treated for these sysptoms to no avail.

  8. Emma Says:

    I use the Efferdent Denture Adhesive is there a problem with it? I have been having some muscle pain and have been seen by my doctor for it..Do you think this could cause that along with palpitations, panic attacks,

  9. Bernard Says:

    I experienced swelling and tenderness of the gums,sevre headaches, loss of feelings in my hands,nausea and occasional dizziness until I stopped using polident, a product I believed to have been safe but apparently that is not the case.

  10. Catherine Says:

    i have been having severe stomach problems including IBS, indigestion, cannot digest my food, pains in my stomach that feel like labor pains for the last twenty five to thirty years, i have been using polident denture adhesive power strong hold since i was in my twentys. and i am now fifty four years old. and i just had an endoccospy and i cannot digest my food. I think since 1981 i have been telling my husband that i believe all these stomach problems i have had is because of polident denture adhesive, because i swallowed it as it dissolved because it is like glue.

  11. Mary Says:

    I had all my teeth pulled August 13, 2008 and after I could start using Denture Cream to hold in my Temporary Dentures I had the awfullest taste in my mouth and when I would eat it was horrible leaving such a bad taste that I thought my cooking was bad but my live-in said everything was fine and tasted great. That went on till February 13, 2009 when I recieved my Permanent Dentures and now I don’t have to use Denture Cream and my food taste good again…. So I know for sure that it was the Denture Cream that was causing the awful taste….

  12. Carol Says:

    I experience soreness and pain in my legs and also in my feet and seemed to have a nervousness in my hands constantly moving them – I have been using polident cream and fixodent cream but they still get loose and each time I eat I must use it but I have noticed these problems. Is there anything that does not have sulfur which I am allergic to? Package does not give warnings out. Half the time I swallow with food which is not good.

  13. domanick Says:

    i have been using efferident glue and cleanor for a very long time and i have been diagnosed with diverticolosis,nuropathy,raynuds, i have had blood in my urine,my legs give out sometimes when i walk,i have had a terrible taste in my mouth that last for 2 or 3 days ,sometimes it feels like someone sticking a knife in me and it can happen any where in my body – seems like we need a support group

  14. Connie Says:

    I just sent the following to both Polident and to Health Canada…this is ridiculous…

    My 82 yr old mother who lives with me as her memory is failing ate one of her polident tablets this evening and then later while complaining about her sore throat told me about it. After panicing for a second i ran for the box and found absolutely no information on what to do if ingested. For a product whose main users are older this is disgraceful. I am quite upset about this after speaking with someone on the poison control hotline and having them tell me i was not the first person to call in about this. Please do something to remedy this ASAP.

  15. John B Says:

    I have been using Polident for over 25 years. For the past 10 years I have had upper respiratory problems. The last 5-7 years I have had problems with dizziness, numbness in my legs and feet and losing blood. I have been in the hospital numerous times for transfusions, treatments for breathing difficulties and testing to find out why I am having these problems. So far none of the doctors have been able to find out what has been causing my problems or how to fix them. I am constantly having to hold onto walls, chairs, etc or use a cane to walk around. At one point the doctors did find blood in my stomach but never did find where it was coming from or what to do to stop it. I have pretty much exhausted all options as to finding the cause until I read about the Polident poisoning. It may very well be what has caused my symptoms.

  16. carrie Says:

    have been using polident about 9 years. the past several months i have had very severe pain in my right arm and my lesgs . have to really work at it to get myself going in the morning. im a waitress and am thankful i have a job, but worry about is this going to get worse or what will happen to me. i have no med insurance.

  17. Connie Says:

    I read the above responses & was shocked to find that I too have experienced the same symptoms & problems, some without explanation, just as others have. I always felt these products were safe to use as I am consistent in keeping my partial clean daily leaving them in container w/cleanser & water overnight. I AM allergic to pennicillin. To name a few: frequent respiratory problems, rash on different parts of my body, nausea, gum tenderness, swollen tongue, (thought I had bitten my tongue in my sleep); blisters on my tongue & inner mouth, problems swallowing food & getting choked, shortness of breath, numbness of legs & arms, severe swelling of legs & feet, being unable to raise right arm to certain height; my children would have to help me get dressed, hands go numb at times, dizziness & severe headaches. I have been given diagnosis on some of these problems but I can’t help but to wonder if using the polident, efferdent & fixodent products could have contributed to my conditions as well. I chose to use them because of the “grip” the super polident had & was pleased to not have my partial sliding out or becoming very loose. I began using these products in 2002 when I had to wear a partial. I am alarmed to hear there is poisining in these products. However I did notice there were no ingredients listed on packaging.

  18. Meg Says:

    After watching a segment on Good Morning America this morning I am convinced that my balance and foot problems might be caused by Polident Denture Cleaner. I have had problems with my gait and balance since I started wearing dentures.

  19. maggie Says:

    I have been using Polident adhesive cream for almost two decades. I have constant pain in my muscles and tissues and constantly drop things and have a loss of coordination. No physician has been able to find any causes for these ailments. I take excellent care of myself, reseaech all before I use or injest anything and I assumed Polident was safe.

  20. Meagon Says:

    After a visit to the dentist for cleaning, I rinsed my mouth with some Listerine then admistered Fixodent on my upper denture before leaving the office, I immediately felt this terrible burning of my gum; quickly removed the denture, washed it and left. When I looked in my mouth the following morning, there were bruises on my gum. It’s a week today and they are still there. I have used salt water, vaseline, ambesol and hydrogen Peroxide – somewhat better, but the larger bruise is still there. I have to work daily and can only remove my dentures at night. if I don’t use the fixodent, they’ll be very loose.

  21. Frank Says:

    I have been using Polident adhesive for 15 years and have developed hand tremmors with very poor hand writing. I have talked to my doctor for years about this issue and he has no answers. I wonder could the Polident be linked to my tremmors issue?

  22. Ellon Says:

    I have been using efferdent cleaner and fixodent glue and polident cleanser for several years and five years ago I ran a unusual high fever one night and the very next morning I woke up and inside my mouth, tongue, nose, lips and left side of my cheek and chin were numb and still is, I have never gotten my feeling back. I have seen doctor after doctor and have had all kinds of test ran and they cant find anything wrong that could cause it. I had seen this advertisement on t.v and thought maybe this could have been the problem.

  23. maria Says:

    I have incurred wierd silent cough on a daily basis, breathing problems and am sure this has all come to light since my using these products from March 2008.

  24. Madison Says:

    I dont know what to do! my dog ate a few efferdent tablets! wat is guna happen to him!!!

  25. Denise Says:

    My Mother Sharon has been using “Fast-teeth”, “fix-a dent” and efferdent since she was 21 yrs old an had to have all her teeth removed. My mom is now 59 and after suffering from mouth and gum sores for years…She now is in a nursing home suffering from frontal lobe dementia, or Picks disease. Could this horrible disease be from these products? She is allergic to the dyes used for MRI etc,,/are these related to sulfu?

  26. CLETHA Says:

    BEEN USING POLIDENT CLEANER AND EFFERDENT AND FASTEETH FOR 30 YEARS. NOT WITHOUT PROBLEMS ALL DURING THAT TIME. MOST RECENTLY A YEAR AGO I LOST MY SENSE OF SMELL AND TASTE AND HAVE SEVERE RASH ON MY BACK THAT GOES FROM THERE TO MY ARMS,

  27. Hassie Says:

    I have had to have blood transfusions since 95. Started using fixedent. Had lower teeth removed 08, still using fixedent. Just found out about zinc poisoning 2 wks ago. Tested came back positive. I’ve had “all” kinds of problems, from Migrine headaches, stomack surguries, back surgeries, and nerve test. Since before now no Doctor has tested me for zinc poisoning, I have blood transfusions, iron infusions, Vit-B12 shots to keep me going. Also stomack bleeds all time. Hope this will help someone else with their syptoms and don’t let the dr’s make you think it’s all in your head cause it’s not.

  28. Kim Says:

    We just found out about this horrible poison. Unfortunately, for us my dad just died and we had no idea what was causing his demise. After he had his teeth pulled 17 years ago, he used fixodent and poligrip every day. His health started to deterioate. First came the dizzy spells and the Dr. said it was his heart. After a couple of years, he was unable to drive and his license was pulled. The VA claimed he had neropathy and his chin bone started to disentegrate, They said it was osteoperosis. He had kidney and bladder failure, problems with his bowels and had to wear diapers. Within 10 years he was walking with a walker when he did walk. Couldn’t feel nerve endings in lower extermities of his body, couldn’t wear bottom dentures, had siezures and run unexplained fevers and vomiting, persistent cough and breathing problems.He had to use special eating utensils because he couldn’t feel or use his fingers. He became wheelchair bound this 2 past years. The VA and now specialist couldn’t explain what was happening. 2 months ago he had a colostomy put on which come to find out opened up cancer cells in his esophogas and stomach. He passed away choking to death last week. I wish we had found out about this sooner so that we could have had blood tests run. He had every sympton that is listed. My mother kept receipts of the fixodent and poligrip purchases because of the VA. He had no allergies to any medications as this was on his navy records, when he was in the hospital for the last time, he was alergic to just about every medication you can name. They couldn’t even give him morphine to ease his death pain. Are we hurt and upset to see this? You friggin bet.. Attorney says nothing we can do because you have to test blood and the zinc runs out of the blood in 24 hours. If that is so, then why is the damage so extensive and untreatable? Too late now for him, but it may not be for others.

  29. Carol Says:

    I was told to use Efferdent or something similar (for a retainer), by a nice orthodontist, who probably had no idea of what the ingredients really are, in Efferdent. How could he know, since NO INGREDIENTS ARE LISTED ON THE BOXES OF EFFERDENT, AT SUPERMARKETS, ETC.?!

    I googled “Efferdent”, and found that Johnson & Johnson makes Efferdent. Their phone number is 1-800-223-0182. I called & spoke with a pleasant lady, who FIRST said to me, that there are NO ACTIVE INGREDIENTS in Efferdent.

    Golly. I wonder how Efferdent can kill germs (bacteria) if there are no active ingredients. I think Johnson & Johnson likes to call the ingredients “inactive” to protect themselves from potential law suits, due to bad effects from one or more of the ingredients in Efferdent, etc.

    Due to possible allergies, plus the obvious toxic (poisonous) nature of some of the ingredients, the FDA should REQUIRE manufacturers to list ALL the ingredients on the box, and tell why each ingredient is in there!

    Here is what the lady told me are the ingredients of Efferdent (original formulation):

    Various dyes, called “Blue Blend” (FDC blue #2, green #3, yellow #10 lake, blue #2 lake…)

    EDTA (Ethylene Di-amine Tetra Acetic Acid)–sounds like maybe started out as vinegar (vinegar is a mild solution–watered down acetic acid), but who knows what EDTA really is, after chemically reacting with acetic acid, and adding the “ethylene di-amine” molecules!

    Potassium Mono Per Sulfate (don’t know why this is in there, and I don’t know what it does–will have to google–and apparently from this website’s patient comments, it can be harmful to some.

    Sodium Bicarbonate (NaHCO3), which is baking soda, which contains sodium (heart patients & high blood pressure patients, take note). Also, I’ve decided to forget about buying the Efferdent, and I’ll use baking soda plus water, to gently soak & brush my retainer. I already juse just baking soda, instead of toothpaste, anyway, and rinse with plain well water.

    Sodium lauryl sulfyl acetate–probably a detergent (cleaning agent), as it looks similar to ingredients in other various detergents.

    Sodium per borate mono hydrate (I’m leery of anything containing borate–I think it’s toxic/poisonous)–will have to google, to find out what this stuff does, and how toxic it is.

    Sodium Saccharine (artificial sweetener that can cause cancer)

    Sodium sulfate (NaSO4)

    Tri Sodium Poly Phosphate (have no idea yet, what this stuff is, or why it’s in Efferdent)

    Spearmint flavor (mints, if swallowed, can worsen gastric reflux)

    Teflon (yes, you read that right!). Teflon is TOXIC, and shouldn’t be in one’s mouth!

    Well, now I know WHY J & J won’t list all of this on Efferdent boxes! Looks to me like they are HIDING the identity of all these nasty ingredients!!

  30. Becky Says:

    I’m the wife of a husband that has been using these denture cleaners for some time now. He has and still is experiencing muscle pains in the legs to the point of having his Doctor change his meds. thinking possibly the pains were being caused from them. Also having very bad cracking in the knee and pain in the hand.

  31. Gail Says:

    have been using efferdent cream for several years, Having some numbness in hands and feet as well as arms with some tingling , has anyone had problems with hair loss? Lots of mussle loss

  32. Thomas Says:

    I have been using “Polident” in water for years as an overnight soak for my plates. Beginning about 5 years ago I began experiencing soreness in my lower legs & soreness & burning of the feet.Six months ago I noticed my feet & ankles were quite swollen after a day’s activity. I now wear elasticised stockings which do a pretty good job of rectifying that.Walking is a problem for me now as I seem to be somewhat jerky in my gait & my toes are stiff. Doctors I have consulted can’t come up with any answers.I think it best to stop using the Polident & see results.

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