Avalide Recall Issued Due to Risk of Reduced Effectiveness

Bristol-Myers Squibb has issued a recall for Avalide, which impacts about 64 million tablets of the blood pressure medicine due to concerns that they may not release enough of one of the active ingredients.  

The Avalide recall was announced to wholesalers and healthcare professionals through letters sent out by Bristol-Myers Squibb and has not yet been publicly announced. The recall is taking place due to the risk of reduced effectiveness.

Avalide is a combination of hydrochlorothiazide (HCT) and irbesartan, which is sold separately under the brand name of Avapro. Avalide sales brought in $310 million in the first nine months of 2010.

Sports-Betting-Addiction-Lawsuits
Sports-Betting-Addiction-Lawsuits

In July, the FDA launched a safety review of Avapro and similar blood pressure drugs, due to concerns over an increased risk of cancer.

A recall of Avalide is being issued because the irbesartan is less soluble than it should be in certain batches. That means that the pill will not dissolve properly in the stomach and the correct amount of irbesartan may not be released from the pill. The same problem led to a recall of 60 million Avalide tablets in September. In neither case have there been any reports of injury or illness due to the defective pills.

The recall affects 150/12/5 milligram (mg), 300/12/5 mg, and 300/25 mg doses of Avilade. The affected pills were sold in the U.S., Puerto Rico, Canada, Mexico and Argentina.

While Bristol attempts to resolve the problem, production of Avalide will be halted. In the interim, the company is offering vouchers to allow patients to be able to purchase Avapro and HCT as separate drugs. The vouchers will allegedly defray the cost of the HCT.

On the Avalide and Avapro webpage, a pop-up alert warns that there will be a shortage of Avalide and recommends that physicians prescribe Avapro and HCT. However, it does not mention an Avalide recall. The alert claims that, with the voucher, the two medications will cost a total of about $20 a month. Any consumers with questions are advised to call 1-800-332-2056 or 1-800-321-1135.


159 Comments


Rick
I’ve been taking Avlide several years now, just this past hr I went in to renew my perscrition and was told of the recall but no idea of why. they gave me another med to replace it. I’ve also experiance alot of stiffness, dizzyness and swelling in my ankles lately, as if the meds stopped working totally.

Melinda
I have been on Avalide for 5 years, all of a sudden, went for regular checkup in November and my white blood count was low. Went back in six weeks, it was even lower. I was sent to the Cancer Clinic for testing, then to a Rheumatologist today. My test results were showing a positive testing for Lupus but normal blood work for the disease. I have been experiencing lower back, neck, shoulder, and knee pain. I had more blood drawn today to see if the medicine has been the cause of the problems. I did not know about the recall on Avalide, called yesterday to get a refill and the pharmacist said call your doctor, no one has it. The doctor in turn told me to call and find out what is covered under my insurance plan and call him back.

tez
I went to the pharmacy and he said Avalide has been on back order and he didnt know when it was coming in something was wrong. He called my doctor for a new rx and nobody didnt tell me it was a recall on the Avalide when he said its something wrong I said I better look it up. I have pain and I have been on Avalide for years .

Kathy
People are panicky, scared, sue happy animals. There is nothing relating Avalide to your aches and pains just because its been recalled. I have been on avalide for 5 years. Yes was inconvienced more than anything else but not ready to jump on the “sue em ” wagon just yet!! Let them figure it out and in the meantime go get some avapro and hct and shut the hell up

gloria
i was paying 15 dollars a month i been on avalide for almost 3 years. i was wonder why if feel so weak when i wake up in the moringing. i would like to get my money back for all those years i pay. If any promble should happen it should be a law suite.

Mary
I have taken avilide since on the market. I am a cancer surviver from tyroid cancer. Have had back problems, got so tender could not touch spin, couldn’t lie down lean againts anything. Went to Dr in tears. Then neck issues, could turn my head. he had put me on potasium, magnesium, extra D. Have had leg charlie horses, toes feet and hand an fingers cramps. NOW THAT THE TRUTH IS OUT i UNDERSTAND what caused it. PRAYING CANCER doesn’t show up somewhere else now. HAVE not worried bout this til now. SCARRY!!!! Still having some problems. DR JUST CHANGED my meds. TKS TO FD not researching enough before putting on the market. now what can i EXPECT.

Ben
Discovered ,just today, that there was a recall on this medication. About three weeks ago I was advised by my employer’s mail order pharmacy that the medication was on back order, not on recall. Today, when I inquired about the fact that I had not received my medication, I was then told that there had been a recall and given the option of taking the two ingredients as two separate pills. Avalide has worked extremely well fro me. The only dishearting thing is that the Pharmacy seem to have forgotten the fact that they need to immediately inform their customers of any problems with medications. As customers, we should not have to ask for this information.

Cynthia
I got a refill LAST WEEK on Avalide. They only gave me a weeks worth because they were ‘out’ of them so yesterday when I went to pick up the remainder I was told there was a recall. I have been on Avalide for many years with no issues and this past week I have felt like I was having BP issues so I made an appt with my Dr. I guess this recall could explain why I feel like my BP is high and my legs have been swelling. Good to know before my appt this afternoon! Not interested in suing, just want to get my BP back on track.

C. Cochran
I have been taking Avalide for several years now with no problems other than the current shortage. No other drug has worked for me effectively like Avalide.

Nellie
I went to have my perscription refilled at my Walmart pharmacy January 20, 2011 and was told they were out and was referred to another Walmart that had my medication in stock. Today February 26, 2011 I went for a refill and was told this medication was recalled and they could not refill the perscription without explanation. I was taking Avalide 150/12.5 forever and then suddenly my pressure spiked and did not come down so my doctor bumped me up to Avalide 300/25 and now my pressure is up again. It is the weekend so I am unable yo see my doctor. I too like some of the other comments have been having pain in my hip joint and down the side of my leg. My eyes feel like I have sand in them for the past week. I just do not want any complications from this medicaton not doing what it is supposed to do. And why take Avapro if it too has been recalled in the past. Why weren’t Avalide customers notified of this recall? All patients really should be reimbursed the copay of this drug. There is a history of stroke in my family so I need something reliable but what can we trust if not our drug companies and I understand thing happen.

Donna
I have been on avalide for 7 yrs. now and have not felt well. Headaches body aches. was told fibromialga was the prob. or thyroid. Now Im extremely worried Its something else.

ernestine
I went to have my prescription refilled found out it’s been recalled, asked why nobody could answer the question. I’m reading comments regarding this medicine. In the past year I have lost weight without trying, always have stomach problem vomiting nausea and migraines. I also have a vitamin deficiency is this all due to taking Avalide

Jim
I just went to my local pharmacy and they advised me of the Avalide recall and were awaiting a fax from my insurance company to approve Avapro and HCT as a replacement. Needless to say I was concerned, but my pharmacist advised me that that Avapro and HCT are the two ingredients in Avalide, plus it would save me $70.00 per month on my prescription plan if I did not mind taking two pills instead of one a day. I’m a happy camper, the avalide worked fine for me and I expect the Avapro and HCT to do just as well, if not, I’ll see my doctor *S*.

Dave
I had to switch BP meds from Avalide because of this recall. I was taking Avalide for about 2+ years. The last year and a half I have had severe ankle pain that could not be corrected. I spent numerous times going to a podiatrist and other doctors, spending money on orthodics, and they couldn’t give me a straight answer what was wrong. Now that I have been off of avalide for about 1.5 weeks, I have to admit the ankle pain seems to be going away. Knock on wood. However, if Avalide was the reason, I can’t stress how much this hurt my life over the last 1.5 years. I’ve gained a lot of weight do to not being able to walk and exercise. I couldn’t teach my daughter ride her bike any more or do anything active with my kids. I felt like I was criple. If step 1 was to get off Avalide, then that is what I had to do. But, I can’t stress how much this pill has hurt my life over the last 1.5 years if this is what was responsible for it.

Jean
Last month CVS called to let me know that my automatic refill was available. Since I did not have any medications needing refills I was curious and went to check it out. They had prescriptions filled for Avapro and HCT. I told them I was not on these meds and I had not seen my MD recently. They said they would look into it. A few weeks later while picking up another prescription they again tried to give me the Avapro and HCT. I would not accept them and they did not give any explanation except they would look into it. Now last week I called in my refill for AVALAIDE. When I went to pick it up I was told there was a delay in the delivery and would be ready next Wed. (yesterday). Well I went to pick the script up yesterday and was told that they still did not have the medication and no other pharmacy nearby had any either. I then asked about the Avapro and HCT and was told that those were the two ingredients in Avalaide. So that is what was filled. I was given no explanation except that there was a delivery issue from the manufacturer. I learned about the recall today by researching myself on line. WHAT IS THE DEAL-WHY IS IT A SECRET FROM THE PEOPLE TAKING THE MEDICATION – THE ONES WHO ARE GOING TO SUFFER. I was allowed to continue to take the medication with the risk of reduced effect because it was a secret.

T. Thomas
****PLEASE READ**** BRISTOL MYERS REPLACED THE 4TIME RECALLED MEDICINE AVALIDE…… WITH AVAPRO. NOW, GOOGLE AVAPRO RECALL. YOU’LL BE SHOCKED TO LEARN THAT AVAPRO TOO HAS BEEN RECALLED IN THE PAST.

Dale
Avilide has always worked for me (8 years). People are really quick to want to file a lawsuit is what I think. Always wanting somrthing for nothing. Hopefully the Dr. will come up with something equally as good.

Scott
I have been taking it for about a week and I cannot get rid of a cough. No aches no pains no temperture. Just a very dry cough.

Michele
I have been on Avalide for probably 9 years. All of the other BP meds my doctors tried always had some side effect that I couldn’t tolerate. Avalide has been wonderful!! My BP is perfect and no side effects. I hope the manufacturers solve any problems and get it back on the market.

Michael
For all you “so called” health professionals or self inflicted “why didn’t you do…” folks not taking this medication…. I’d ask YOU. Why didn’t the doctors know of a recall? Why didn’t the dispensers of the drug know of a recall? Why didn’t the drug companies COMMUNICATE? Each and every one of these parties are CULPABLE, and I for one will gladly join a class action law suit. Why is the onus on the consumer to TRUST these people who write prescriptions and dispense FDA regulated pharmaceuticals, if not to do the job they’re entrusted to perform? I’m going to sue their ass until Tuesday. I’ve had rashes on my neck for over 3 months (thought it was stress related), and it comes and goes. My prescribing doctor just wants an appointment to get more $$ out of me. They’re going to give the same ol bs I already know. Time for a change, and someone will pay. Hope your malpractice insurance premiums are current … doctors, pharma companies and dispensers.

Nancy
I noticed months ago on my refill that the pills looked different (slightly off in color) and the texture of them felt different. I joked to my mother at that time that I hoped the pharmacy hadn’t started selling “knock-off” (fake) drugs to make more money. Shortly thereafter, I noticed that Avalide didn’t seem to be working for me anymore. My BP had crept up and remained at a high level (sometimes 30 points higher than normal.) Every time I had to go to a doctor or clinic where they checked my BP, they always told me it was too high, but since I was taking my BP medicine faithfully, I thought the high readings were from “white coat syndrome.” However, my readings even at home became quite high for me. When I was informed by my pharmacy of a “shortage” of Avalide, I made the arrangements that they suggested (new prescriptions from my doctor for Avapro and water pill.) During the night, I awoke with the thought that there was something wrong with that Avalide. I got on the internet and for the first time learned that there had been recalls without any notification to me. Even my pharmacist had seemed clueless, saying that a “shortage” seemed strange. Even though I had one more week of the Avalide, I started taking the Avapro that I had picked up. Within one day, my BP levels were back to the normal 30 points lower!!! I am so upset that I essentially wasn’t on any blood pressure medicine since the Avalide wasn’t working. I wouldn’t go ONE DAY without my BP med to avoid risk of stroke, but because they didn’t notify me of the problem, I was taking med that wasn’t even controlling my BP levels. This is wrong!!! I was AvaLIED to!!!

wade
bp went crazy since avalide ran out tried 2 diff. meds have not worked. had stroke 2 wks. ago doing ok but still bp not controlled on third diff. med. bp benn off couple months guess med dose waS MESSED UP

mishael
I had been having body aches an muscle aches an have been on this medicine for over 10 yrs the only high blood pressure meds I have been on an back aches an heachaches I too wonder if all of it is due to this medicine I know I had to take something for my bp but sometimes I wonder if the meds are worse for u in the long run.I found out about it when I went to the doc today an was also complainin of other things an he had just found out but wasnt sure why it was recalled yet said he was goin to check into it.When I went to urgent care 3 days ago an the guy looked up the meds i was on an what he was givin me for any reactions he never said anything about it being recalled an that was thur they med thing online kinda scarey!!

rosemary c
i have been taking avalide for over a year now and never had anny symptoms thank god, but what my concern is now is that in january i had my rx refilled for the avalide and the pharmact refilled it! and all this was way after the recall.. now im really worried and upset and wondere if anyone else had this happen to them what to do next for me is the question,,,

Karen
Have been on Avalide for over 10 yrs now. The only side effects I have had recently have been sore muscles in my legs (which, by the way, is listed as a side effect) I took this medication to take the strain off my kidneys, which lose to much protein…My protein levels have been very high…

Jenn
I called my pharmacy today for a refill of Avalide, which I have been on for 5+ years. She told me they were on back order, and that did not make sense to me.Something made me ask her if it was a recall, she then said yes, but a recall only on the professional level of doctors and pharmacists,that hasn’t reached the consumer yet….and not to worry, take Avapro combined with the lasik. Made less sense. Went to research and found out about not only a recall,but that this is the second one! For the last two years my legs, feet, shoulders have been in extreme pain. The pain makes walking difficult. And recently my legs get stiff and at night I suffer with charley horses in my calves. All this time I thought it was my shoes, or dehydration. Haven’t worn heels in years. Was just going for blood work and tests to find out why all this chronic pain, and its the Avalide- I am very concerned about the long term effects of this medication, I want to know why when the consumer is at risk and suffering, this information was kept at the professional level. God be with us.

T. Thomas
BRIAN (On 02/17) I totally agree with you in regards to the drug company not wanting this to get out. I feel there is alot more to this story that we consumers are NOT hearing about thid 4 time recalled drug. After having a STROKE due to hypertension while taking this medicine, I feel the world should know of the possible dangers with this drug. For the life of me, I have no understanding why the drug company would allow us to keep taking this none effective medicine. NOTE TO BRISTOL MYERS: ALLOW THE CONSUMER TO KNOW BY EXPOSING THIS TO THE GENERAL PUBLIC.

Chad
I am 30 years old and I have been taking Avalide for about 3 years now. I have had alot of pain in my shoulders and neck. I have also had way more stomach problems then what I had before taking this med. I wonder if this pill can cause these symptoms.

Phyllis
Also when I went to pick up my avalide refill I was told it was on back order. When I asked the pharmacist when it will come in, she said there was a recall. My Doctor had to put me on something else. The funny thing is, I have been on the same pill for 13 years and last year I had to have a partial hysterectomy for a over size fibroid. I am wondering if there is any connection by reading these posts about cancer.

Raymond
I was running out of Avalide 300/25, so called in another prescription to Giant Food Store. To my surprise, I was told that Avalide had been recalled (news to me). I was given equal dosages of Avapro (300mg)and Hydralazine (25mg) tablets instead. I have been taking the drug since November 2010. Whether of not I am experiencing any unusual side effects is unknown.

Barbara
I tried to fill my Avalide prescription and found out it was not being made anymore. I went to the Dr’s office and they are spppose to prescribe something else. But after reading the commnets regarding Avalide, it is all sgtaring to make sense. For some time now, i have been experiencing headaches, shortness of breath, constant ache in my joints, and panic attacks. Just a couple of nights ago I woke up in a panic because it felt like I was dying and I couldn’t breathe. I have dizzy spells and Ihave had substantial weight gain. My blood pressure did not go down and my veins were popping out of my arms and legs. If this drug has caused me irrrepreable damage, i want this company sued.

connie
Do you people read the long list of possible side effects listed on every medicine you take? This looks like everyone has jumped on bandwagon that all their aches and pains are from this medicine. That is not what the recall was for. Are you overweight, do you smoke, do you exercize, do you take care of your teeth, is your immune system working like it should, are you over the age of 30? If so, you can bet you will be getting aches and pains that don’t have anything to do with a blood pressure medicine. The worst we are looking at from this is blood pressure not remaining under control with batches of the medicine that have not dissolved properly. If you have high blood pressure you should be checking it regularly at home anyway and should have already known this wasn’t working for you.

brian
i have been taking avalide for about 8 years now. i am very concerned about this meds because it seem that my highblood pressure has been getting worst. such as frequent hospitalization. how funny when you called the pharmicist they only tell there is a back order. its so obvouis the drug company does not want to get the word out there that avalide is being recalled

Maria J
I have taken Avalide / irbesartan for years. Yesterday i went to my doctor to get another prescription my doctor check my BP and he was suprised that my BP is very high he says what happen? When I visited the doctor’s office last two months my BP is normal 120/80. He did prescribe me the same Avalide and I went to Shoppers Drug Mart to get the prescription but they told me that there is no stock. They will call my doctor to change the prescription to a different medication. Without realizing that Avalide is a recall and I do hope there is no side effect overall when I’m taken this medication.

pegi
My mom has been taking Avalide and recently began having severe cramps in her legs at night. For the last four weeks she has been getting very little sleep at night. Diarrhea, some slight dizziness (doesn’t last long), dry mouth…when the drugstore said they couldn’t get any more Avalide (nothing about a recall) she began doing more research and discovered her symptons were side affects from the drug. We are concerned what she can take for her blood pressure, will the side affects leave once she is off or have they caused permanent damage.

Marilyn
Just found out the drug was recalled from a CVS. I first went to my local Walgreen to fill, they were unable to do so. At that time they had me call to do a mail order for the prescription. I decline because I was not comfortable with mail order. The pharmacy tech tells me I can only fill the script at the CVS store, I found that strange. I have always fill at Walgreen’s. However I go to the Local CVS the pharmacist there informed me that Avalide was recalled. This pharmacist offer other subs.(he took a pro active approach). How many others will. Who is responsible? My question is why didn’t the drug company inform, doctors, patience and all pharmacy’s. I think or I know there is a break down in communications from the Drug Company to the Doctors. Some bodies making money at the expense of the health of millions of American. Let this be an eye opener to all of us. We should take control of our health and become informed about the Drug we put into our bodies. Change our eating habits, increase our exercise we all have a choice to live a health lifestyle. Do not let the Drug Companies win. Take care of the Body God gave you.

T. Thomas
I have been taking Avalide & another high blood pressure medicine for almost 5 years now. I recently (01/11) had a stroke due to high blood pressure and i’m only 54 yrs old. I never knew of any Avalide side effects until reading these comments, and it’s like you are describing me. I DO PLAN TO FILE A LAWSUIT against the makers and this will probably end up being a class-action suit. WILL KEEP YOU POSTED.

Bunmi
I have been taking Avalide for several years – and I did not know of any recall until my Walmart pharmacist callled to say that it’s on recall. My doctor did not informed me of this. Who do we turn to in situation like this. I am concern about this drug being linked to increase risk of cancer.

Merrill
I’ve taking Avalid for seveal years…over the last year or so I’ve been getting dizzy and have suffered from dry mouth…I didn’t connect these to the Avalid but when my wife went to refill my prescription we found out about the recall. i then looked on line and saw articles which show the side effects. Both the dizzyness and the dry mouth have been getting worse .

Linda
I take avalide and did not know about the recall – that is wrong – if we depend on a drug, we should know from our pharmacist if there has been a recall. As far as the drug itself, it has worked well for me. My doctor, the best heart doctor in this area, swears by it. I hope it works out and the drugmaker fixes the problem. It sounds like they only have to make it dissolve better. I will continue to take what I have left of my prescription, and go with the flow here – PS Quit Complaining People – be glad to be alive. Don’t be lawsuit crazy!!!!

millie
well, they just told me so i guess i will just go to the doctor tomorrow i havent noticed any symptoms yet. i know i dont want to take 2 pills everyday. and i hope my pressure dont go up worrying about this before tomorrrow

Lani
I have been taking Avalide since Feb. of 2007. It has done nothing for my BP. I have extreme back pain that takes your breath away. Muscle pains in my arms and legs and am having trouble breathing when I walk. Can’t go out when it is windy as it takes my breath away. Learned of the recall when I googled it after the pharmacist said it was not longer available. Now I have been put on HCT and Avapro and wonder what this medication will do to my body.

Andy
I was surprised that I was not informed by my physician nor pharmacy about the recall of AVALIDE. I am annoyed that the date of the recall was Jan. 11 and just got the letter from my health care provider today (2/15). I have had absolutely NO SIDE EFFECTS from this medication and it has been doing its job for several years. I used to take AVAPRO and had no problems with it either. Has anyone taken a substitute with any success?

Muriel
After reading the comments – i realized i have been experiencing the same trend of symptoms – but – did not have reason to attribute them to my Avalide : The back aches, the headaches, the fatugyue and the leg cramps and occasional dizzines. My doctor is over 120 miles away and I have not secured a doctor in my new area – and finding out my medication was on recall came as quite a shock and has given rise to great concern as to what other concerns should I have.

gina
you people need to get off these drugs and start eating right and excercising….. they cause more harm than good!!!!! its a great way for your doctor to schedule appointments for you!!

Charles
I found out that the drug was recalled when I tried to renew my prescription. A substitute was ordered by my doctor but I would like to know how I can get reimbursed for the 75 days of Avalide that I cannot use!

Jennifer
Why is everyone going off half cocked about side effects and listing all the horrid symptoms that they’re having?? The medication was recalled because it wasn’t disolving correctly. The only symptom you MIGHT have had, IF you had taken drug that was affected by this problem is that your blood pressure MIGHT have been elevated. All of these other ridiculous complaints are completely unrelated to this recall. Are you folks having a problem reading? Again, not related to the drug. I’m an RN, and I have to say, thank the Universe that I’m not working in patient care. I would hate to have to deal with all this hysteria. Take a breath. Stop reading the Internet. See a physician. Don’t try to diagnose yourselves – you’re not doing a good job.

Pamela
I just recently found out about the avalide recall. I had been having too low of Blood pressures, so many times I only took half the prescrbed dose. I was surprised to see all the comments posted about pain, as I have had flu-like symptoms for some time.

susan
This has been a great medicine for me and has kept my blood pressure within normal reanges. Nor have I had all the little side effects that I had when I tried a number of generics. I hope Bristol-Meyes Squibb can correct the glitches with this medicaiton.

Theresa
GREAT. I just found out today that Avalide is off the market when I went to go refill it. I have taken this medicine since 2004. Why did they wait until all the Avalide was gone before letting us know it was recalled? How stupid! I will sue the pharamceutical company if I have any adverse side effects from this.

Share Your Comments

This field is hidden when viewing the form
I authorize the above comments be posted on this page
Post Comment
Weekly Digest Opt-In

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

MORE TOP STORIES

Lawsuits over gambling addictions are being brought against DraftKings, as regulators and health experts warn the platform’s push into micro-betting could heighten risks for vulnerable users.