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.

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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


Jeff
I took Avalide more than 10 years ago. It caused joint pain and neuropathy after taking it for only 6 months. My feet still tingle. And I have tinitis. It is permanent. I was only 52 at the time. My doctor switched my BP medicine but the damage was permanent.. was never told about the adverse side effects. Looking for a class action suit

Paula
I Took Alavide for a long time one night I was feeling sick to my stomach I vomting all night until I saw green stuff which was bile I was rush to the hospital via Ambulance I was diagnosed with pancreatis and was told I would be place on creon for the rest of my life my stomach looks like I am sic months pregnant and I suffer from acid reflux I was told by my doctor that Alavide has Hct that cause my pancreatis I was taken off that meds a year later I notice Alavide was no longer being sold

Sonny
I can’t believe it. I just found out about any recall of avalide. I have been on avalide for years. avalide 300/12.5 . when my doctor recently increased my avalide to 300/25, we found out it was not available. But no one told me the reason why. I was prescribed avapro and hct instead. But Medco couldn’t even supply that. during the past year, my blood pressure has been all over the place, with accomponied chest pain. My doctor told me, I must not have been takng my bp properly. I am a retired nurse, and i am not supposed to be able to take a proper bp? No one ever notified me, of any recall—–what is going on in this country—————————-I also had a heart catherization, that was not needed. An invasive proceedure that could lead to death.

Suboria
I took Avalide 150-12.5 they would me sick on the stomach and dizzes that i could not get out bed back of neck would get stiff ,cramps in legs.

mozelle
i had been on avalide 150/12.5 for a long time was hospitalized THE doctor asked me what was i taking for my high blood pressure? I TOLD HIM avalide , HE SAID WE WILL GIVE YOU SOMTHING ELSE. I WAS CONCERNED. UPON LEAVING THE HOSPITAL I WA TOLD THAT MEDICATION WAS RECALLED. i confronted my doctor. HE said he had not heard any thing about the recall. But he took me off and replaced it with avapro. SO far so good. incidently i question my doctor about any medication he prescribes for.WE HAVE VERY GOOD REPORE ICAN TALK TO MY DOCTOR ABOUT ANY THING THANK GOD FOR HIM

Sarah
I had no idea the medication had been recalled. My supplier only said my physician needed to order another medication because this one would not be available for a while. I had enough to last until the stated time so I was not worried. There were times my blood pressure went so low that I became unable to function until it came up. I never associated it with the dosage in my pills. Ialso had awful muscle cramps and twitches. I still have them. I started checking my blood pressure before taking my pill. Finally, I started checking the internet and found out what was happening. I took 300/25mg.

Dorothy
I, too, knew nothing about these recalls until my pharmacist sent me a note about the recall. I had severe dizzyness, my ears felt like there was water in them, my eye sight changed and I was seeing flashers all the time, I had joint aches and thought I had severe arthritis in my hips and knees, had dry mouth and cough, muscle aches and never did I think it was due to Avalide. I’d visit the doctor and she kept adjusting the dosage of Avalide and nothing helped these symptoms. She insisted that this was the drug for my hypertension. But I noticed that my blood pressure would go from too low to too high. So I just stopped taking this medication cold turkey after the recall. Today, after reading all these comments, I’m convinced all my symptoms are due to this drug because I’m fine now. But my BP is still high, about 160/86, so I’m going to consult with another physician. Seeing so many comments listing so many side effects makes one wonder if anyone is monitoring these drugs. Thanks goodness for this website for now we all know the truth.

Alva
I took Avalide 150/12.5 for over ten years. My blood pressure just went up/down. I suffered tremendous pain diagnosed as trigeminal neuralgia in my right lower jaw. It was excruciating , like a cattle prod. Couldn’t talk, touch my skin, brush my teeth, it would set off the horrific pain. I had gamma knife treatment in Dallas, it didn’t stop hurting for two month, and it came back full force 13 months later. I was still on Avalide. Other pain in my muscles, all over my body was like, “what is going on”? I called to have the prescription refilled, and it was denied down due to a recall. I was changed to another drug Avapro which I am presently taking with a separate drug hydrochlorathyzide for water retention. This “TN” pain is a blood vessel sagging on a nerve in the right side of my brain. Diagnosed by scan and I believe the Avalide drug, in all probable cause , was a contributor of the uncurable condition. There is nothing like it. My dental assistant book, I am a certified dental assistant……quotes, people commit suicide over this pain. My head, neck, ear, nose and throat doctor told me the same thing. I went to several doctors , who specialize in their field, and lost a gold dental bridge, because of the pain. I thought it might help, but that proved not to be the cause. It’s hard to believe it took the pharmaceutical company years to find out the drug was not working. thanks, amc

Clyde
I’ve stopped taking it about 3 months ago. I my blood pressure was elevated. I also began to become depressed (out of nowhere). I accidently found out about the voluntary recall so I stopped taking it. Switching to another medication lowed my pressure and the depression stopped. I contacted the manufacture about an exchange or refund and I was told none was being offered.

Chales
I have been buying Avalde medician in Mexico since Feb. 2011…can’t find the 300/25 but have been doubling the 150/12.5…I wonder if Mexico is still selling the recalled med. It helps same as before and I have no side affects….

tonya
on avalide for several yrs, have suffered severe back pain, overall weakness and scalp condition w/hair loss. my doctor said it was arthritis and old age. but it would come and go depending on if i was taking my meds as prescribed. two mail in pharmacies, mandated by my hmo as a city retiree, never advised me of the recall ! and continued to mail refills. i just found out yesterday of the recall.. i am on other meds for hypertension and have liver and kidneys checked regularly.

rosemary
i been taking avalide 30012.5mg for about 4 yrs now i’m having bad legs cramps they last a few minuite and it hurt so bad you can move until the cramp gones away . i started taking avapro300 mg since march of this year feeling lightheaded all the time so i stop taking them

Jim
Same story —been on Avalide then it disappeared —bp has gone up in 4 months from a constant 120/70 to 165/90 —– Dr changed it again —- don’t want a stroke.

Donnie
I have been aching since July/Augus 2010 or so last year. Right side of my chest and back area has been uncomfortable. Now this has me worried. Had so many test done. I wonder if Avalide was the culprit, I have been taking it for a few years. I hate drug prescriptions!

Theda
I was prescribed Avilide by my primary physician to control my blood pressure. I ache all over and have severe leg aches. I hope this medication is the cause of my complaints. It would be wondeful to feel productive again.

Darrell
I have been taking avalide for about 3 year and every sense i taken it i haven’t been the same . I hurt all the time and have bad cramps all the time I cant even walk 25ft without my leg hurting me . I just dont know what to do. it may have been helping my heart but it hurt me in other places

Nora
I live in Canada. I was taking avalide 150/12.5 mg and was switched to avapro 150mg along withhydrochlorothiazide 12.5 mg. Everything I have read has been about irecall in the in the US. Is it the same here in Canada, or is it still safe to take the avalide?.

FRED
Yes I was on Avalide 300/25 for over 13 years. I tried to renew and they told me it is back ordered.I am now on losartan 100/25. I have hadback problems and stiffness in my joints and ankles while on avalide Dizziness and tired all the time. It is effecting my job. I need to know what everyone is going to do.

David
I have been on Avalide 300/25 since 2006. It was the only BP Medication that kept my blood pressure under control. I was ordering my meds from Express Scripts. They sent me a letter stating the medication was on back order and that I should try something else. I have called Express scripts several times to find out when they may be sending out my script. They just said it was coming in and will be filled at that time. They never mentioned any kind of recall. It has been a couple of weeks now and I called them again. They told me the something and asked me if a local Pharmacy could fill it. I called my local Wal-Mart and they told me they were out and would order it and it would be in tomorrow. So I called the local Walgreens and they said they have not been able to get it and it’s back ordered. I was always so impressed with this medication because it was the only med that would control my BP. I decided to look on line and this was the only time I have read or heard about any recall. I have been taking this med since 2006. I have experienced pain in my sides and kidney areas for awhile now. I sure hope it is not linked to this. This does concern me. I just went to my heart doctor yesterday and he represcribed this medication. I am sure he dose not know about this recall.

Pamela
I wasn’t told about the recall of Avalide and only found out after I ordered through Medco. After ordering Avalide , I received a notice that my Losartan/hctz 100/25 was being shipped. I was confused and said that is not what I ordered. When I contacted Medco, they told me that Avalide was not available, but they never mentioned a recall. They only said it wasn’t available. I called my doctor’s office to see what the deal was and if the dosage was sufficient, they said it was. Nobody ever said it was recalled. As a result, I’m taking this Losartan/hctz and my blood pressure is elevated. I will be calling my doctor about this!!

Dave
I’ve been off of Avalide for 2 weeks now. I’ve been prescribed Losartan-HCTZ as a replacement. I’m wondering if the withdrawal from Avalide or the ineffectiveness of Losartan is causing a very noticable increase in my BP (FROM 125/80 TO 165/90). I am also experiencing a tingling sensation in my brain and heat flashes. Does Bristol-Myers Squibb have anything to say about this, or do they pass on the responsibility to the patient and his doctor?

Darris
WOW, i say dont take the medicine, it may cause more symtoms to come about.

Debbie
I found out there was a shortage, but not a recall until today. My doctor changed me to something else (Clonadine). On March 9 was admitted to the emergency room with blood pressure of 248/130. I was told I was about to have a stroke. I had to go to a cardiologist to find out I should be on Avapro.

Retha
I too, found out about the recall through my Walmart pharmacist. My doctor did not know anything about it until I called him. About November 2010, I started to experience headaches so I went to see my doctor. My BP was quite elevated. So he put me on Bystolic to help the avalide. I did felt a little better. By December I was just not feeling good at all sort of a general feeling of malaise. January 2011, I went to see another doctor thinking I needed another opinion. I got off the avalide and within a week I was feeling more like myself again. But of course now I take two pills (avapro 300mg and HCT 25 mg.) I do not take the Bystolic any longer. My question is why didn’t informatin go out through the news media?

Gloria
I learned from my pharmacy that Avalide was recalled, when I tried to refill my perscription. They said they would contact my doctor to see what he would use in it’s place. When I got home, I noticed that I was given the same perscription, one that is listed on the recall list.

Nancy
when I went on Avalide it was because my Medicare Part D would not cover Hyzar that I had been on for years. Avalide was the drug of choice and I was told I would have to switch. In January I had bronchitis in February It returned and in March it came back as Bronicle Asthma. I have been on a nebulizer and an Inhaler. Maby this was caused from taking the Avalid I’m going to speak with my doctor and see.

Virgil
I started taking Avalide about 3 years ago after other BP meds did not seem to work. Avalide got my BP within normal limits in about two weeks. I have recently found it is not working that well and I have began to have severe foot and leg cramps as well as headaches and a sharp abdominal pain at times. Not sure how much of this is related to Avalide, but it fits in with complaints others are making…

LloydB
Like all the above, I too went to refill my scrip and was told Avalide was not available and to come back tomorrow where I would get two medicines to make up for what is in Avalide. Nothing about a recall. Thank goodness for the internet. Typed in Avalide and one of the hits was the Wall Street Journal that mentioned a recall. To read more I had to subscribe. Went back and typed in Avalide recall and got this sight. Before I pick up any new meds I plan to stop by the doctor’s office to let him know about the recall and what should I be taking in place of Avalide.

Diane
I went to have a prescription refilled and when I went to pick it up I was told it was recalled. This was in February 2011. I told the pharmacist at that time my husband was also taking Avalide and how did this recall effect him. I was told only the ones on the shelf was pulled and everything else that was out there was okay. Today 03/16/2011, I dropped off my husbands bottle for a refill and was told they would have to get in contact with his doctor due to the fact Avalide was recalled. I was completely out at the time I was trying to refill mine in February but, Should the phamarcy have contacted his doctor at the time I told them so he could discontinue taking his.

Luana
I found out about the recall when my husband went to see the doctor and his blood pressure was sky high one day and very very low the next so he went to get checked by his doctor and that’s when we got the news about the recall.Now he’s going to have blood tests done to see what’s going onwith his pressure.Good job BRISTOL -MYERS…

debboe
II can’t believe no one told me about this issue. I went to 5 walgreen locations and they just told me they were out. Finally someone was honest enough to tell me about the recall. Nothing like Toyota. I always had great success with availed, now I wonder if this explains my aches and fatigue the past few months? I want a refund of all prescriptions since September. Any suggestions?

Lee
I was doing fine on Avalide. Now I’m taking Losartan-HCTZ 50-12.5 and I feel terrible. I’m having leg cramps, chest pains, I’m tired and now back pain. Yes, I have been checking my BP and I am making an appointment with a cardiologist.

Brandi
My dad has taken Avalide for as long as i can remember. He has a laundry list of food and drug allergies and fortunatly he can take Avalide. But now that it is being recalled he has to take the smaller dose of Avalide. As of right now he is not showing a reaction to the smaller dose. But does anybody know when they will re-“issue” the 300-25 dosage?? I would love to find out for him.

Judi
I have taken Avalide for many years now (believe me, I will be checking with my doctor to determine just how many years…). And, during the course of that time, there were several instances, where for one reason or another, I was not able to get a refill quickly. And, I would be out of the medicine for several days. And, I never experienced ANY side effects from being off the drug. Then, at the beginning of Decemvber 2010, I was waiting for my yearly physical appointment at the end of the month, to obtain a new prescription for Avalide. And, inadvertently ran out of Avalide before my Dr’s appointment. So, I figured, no big deal. I’ve run out of the drug before, and never experienced any problems. Even when being off of the drug for a week. ++ But, this time, after being off the drug for 5 days, I started experiencing severe shortness of breath, with any type of exertion. It scared me badly…..I went to my Doctor immediately, and while in the Doctor’s office, my oxygen saturation level was so low, while just walking around, they sent me to the hospital via amublance. They thought I might be having a heart attack, or an embolism. My blood pressure was never severely high during all of this, by the way. ++ At the hospital, It was determined I had not had a heart attack. A heart catherization was done, and it was also determined I did not have a embolism, or any blockage. A 3d echo with stress test indicated I did have a mitral valve prolapse, but they did not bellive the mitral valve prolapse was severe enough to cause the shortness of breath problem. I, of course, began taking the Avalide again while in the hospital, and within 2 days, was back to normal with no shortness of breath. I was sent home with the recommendation to have a sleep study down, to see if I had a problem with OSD/sleep apnea. + I had the sleep study done, and found out I did have severe sleep apnea. So, I am now using a CPAP. Anyway, long story short, I just now found out about the Avalide recall, due to the risk of reduced effectiveness. And, wow, …..I wonder how long the risk of reduced effectiveness problem has been around, and maybe I have heart/lung damage, that has given me the mitral valve prolapse, and the sleep apnea problem??….hmmmmm

Nancy
I read over a year ago that these drugs were being tested because of increased incidence of cancer/lung cancer especially. This is very concerning to me. It could be a cover up. We need to stay vigilant. Have been using Avalide for 4 years.

Sheron
I have been taking Avalide since 2006 and had no problems until 2008 when my legs and back would spasm all day and all night. On top of that I would experience dizziness in the morning. This last year I lost 20 pounds and started cutting back on my medication. Which stopped the leg and back spasms. I started only taking the avalide when my pressure started to go up. I would only take it for one or two days to get my pressure back to normal. I have always thought that doctors leave us on some medications to long. They do not go back and re-evalutate the situation. In my case I was under a lot of stress when the medicine was prescribed now that my stress level is less I find that my pressure is normal most of the time. So I take my pressure everyday and medicate when needed. Since finding out about the recall my doctor has precribed somehting else. I am going to check that out on the internet before taking that. I do have headaches neck and shoulder pain which has occured recently . If their is a lawsuit I will definitely join because of the deceit involved and for the possible problems that may arise.

Shirley
I have been on Avalide for probably 5 years. I take several other meds for my high blood pressure, However, since mid-December 2010, I have been to the ER, and to my family physician, my cardiologist and my diabetic doctor trying to find out why I was having weak, warm/flushed episodes which would last approximately 3-4 hours and would cause my BP to go very high.. My cardiologist changed some of my BP meds, gave me two new ones trying to get my BP down. Also they thought it might be anxiety and I was put on Ativan. I tried to get my prescription for Avalide refilled the first of March at Fred’s Pharmacy and was told they couldn’t get it right now and he gave me Avapro and HCT. The Avapro was rather expensive and I told him I would just wait on getting it. I was not told Avalide had been recalled and didn’t know that until I called a CVC Pharmacy to see if they had Avalide and was told that it had been recalled. Don’t know if that has been the cause of my ‘strange’ episodes since Dec. or not but guess it is possible. Can’t believe I am just finding out about the recall that apparently happened several months ago.

Ken
I have been on Avalide 300-12.5 for quite a long time and have experienced lots of different side affects, i feel like i have sand in my eyes all the time, i have had painful cramps in my feet, legs, arms, hands and chest. i have been dizzy , and back pain. i just got word from CVS that my meds were on a large backlog and no other explaination. i called my doctor and got I DONT KNOW. I Am SCARED TO TAKE ANYMORE MEDS FROM THESE LIARS. WHAT ARE WE TO DO NOW…..AFTER ALL THIS TIME OF FEELING LIKE CRAP I GUESS IT ONLY GETS WORSE. DAMN IT.

Andrea
I found out about the recall here recently when I tried to refill my prescription and the pharmacist informed of the recall. Bristol Myers should put the information out on the news and in the newspaper. Sense this impacted 64 million tablets and afftected pill that were sold in the US, Puerto Rico, Canada, Mexico and Argentina. I guess thier not feeling any obligation to the public sense Avalide sales brought in $310 million in the first nine months of 2010 – Their own words. I will be sharing the informatio on my facebook page.

Diana
I went to ER three times complaining of chest pain and found out my potassium levels were very low because I was taking Avalide. My doctor switched me to Avapro…which never kept my blood pressure at normal levels. While on Avapro, I have severe unsteadiness, always feeling like I had to hold on to something to keep from falling. I started having breathing problems and was put on Asmanex because the doctor said I was slightly asthmatic. I had to start taking heartburn medication. I took generic for Prilosec, which depleted my Vitamin B-12 and my iron stores dropped. From just one medication: Avalide/Avapro, my Potassium, B-12, Iron dropped to very low levels and I have difficulty breathing. This has nothing to do with the recall, but, it has everything to do with the drug. I can’t stand without having to hold on to something all the time. My husband demanded today that I stop taking Avapro. I’m going to call the doctor and get a different medication. My life has been hell for 5 years now.

Ian
I have been on Avalide for a few years. My Pharmacist did not know about the recall. She got me 25 of 30 and told me there seem to be a problem as the suppliers are not responding to requests for the drug. My blood pressure seem to have worked using Avalide. Of all the comments I have read, the one that seems to be the most similar to my experience is Freeman who said he is a techincian. I have been having excruciating pain on my right shoulder and legs. The shoulder pain has been for about 2 years. My doctor tried several ways to relieve me of the pain. I the end, I decided I would have to live with it. Then I started having pain from thighs down. Now, most of the pain is in my heels. I never connected any of it with taking Avalide. Reading other peoples comments is making me to wonder!

wade
taken this drug for several got where b p has been running to high.came time to refill could not get Dr. tried something else didn’t work , had a mild stroke. changed again in hosp. new med working some better but still fighting effects of stroke dr. blames on high b p & diabetes & high cholestrol that has not been high for last six years. no mention of being on wrong dosage of meds. or of recall. found that out on my own

Cheryl
Been taking Avalide for over 10 years with no apparent problems. Pst 6 months have had on & off back pain I attributed to “sleeping funny.” Just refilled my prescription at Walgreens. Listed as Backordered. And replaced with Avapro and Hydrochlorthiazide. Asked if the other medication will become available. Pharmacist insists that there isn’t any reason he knows of as to why the backorder. Googled today to find out about the recall. Glad to see that the FDA is doing it’s job!

De'borah
I just picked up my replacement prescription yesterday from Publix Pharmacy (Avapro and Hydrochlorthiazide) and I paid a total of 33.33 for both. One was $30 (Avapro), and the other was $3.33

Minerva
It’s unfortunately that we need to find out when a medication is recalled is when we need to refill out prescription. My pharmacy did not explained why it was taken of the market. Bristol Myers shold put an ad in the paper letting everyone know. I’ve been taken Avalide for approximately six years and have not experienced any of the symptoms that everyone is claiming. It has however controlled my HBP plus I walk ten miles a day. I’m 62 years old. I hope that everyone that has made a comment has passed the word around.

frank
I have the same comments the reaction for me is my systolic preasure has been on the rise. I now take another drug to reduce the systolic. As to othere affects, I do not believe there are any.

R. Kelly
I suggest that they consider taking some reality medication. I have been taking Avaide for many years. The current price for 90 tables of 300/25 is $316.00 from Walgreens. They suggest that seperately the Avapro and Hydrochlorthiazide shoud cost $20.00. Does this mean I (we) are overpaying about $90.00 a month????????

Thomas
As with other consumers of avalide my wife and I have taken this medication for years. In January when my wife’s prescription could not be refilled I didn’t think much about it since I use mail order and had enough I thought until she could get hers. Now my mail order company informed me last week about the drug is longer available and I am being prescribed another drug. When will we ever get it that the pharmacuteical companys are in it for the money along with their buddies the FDA. The FDA cannot continue being in bed with these drug companies and not expect similar lawsuits to rain down upon the officials who are there to protect us from such dim-witted oversights when millions of people trust their doctors and pharamictists to be on the square with the patient. When will we ever learn. Now onto the next classaction lawsuit awaiting to happen. I just been diagnosed with diverticulitis and going in for diagnostic tests. I wonder is this all related?

Roseanna
I have been on Avalide about 3 years. It really worked in the beginning, then about 6 months ago, my blood pressure started getting higher. Recently, when I went to the doctor, he said it was very high, and wants me to check it every day for a week. I did, and the numbers kept getting higher. When I went to refill my prescription for Avalide, I was told it is not available indefinitely. My doctor put me on Benicar and Norvasc. I’m a type 2 diabetic, and it’s essential my bp is under control. I paid over $500.00 for my prescriptions since last August, and at this point a voucher isn’t going to cut it. I’m not in the “sue” mode, but certainly would like my money back!

Annie
I have been taking Avalide for a number of years, I tried to get my prescription refilled in January 2010 I was told there was a back order and they could’nt fill it at that time but they had a few pills on hand (3) so I took those. I found out the drug was recalled when I went to pick up my diebetis medication that Avalide was recalled. I to have been having a lot of almost unbearable pain, I can hardly get out of bed in the morning the right side of my body is in extreme pain from my hip down my leg and my toes this didn’t start until I could’t get the medication. Avalide use must be the cause of this pain.

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