Rapamune Side Effects May Increase Risk of Death After Liver Transplant: FDA

The FDA has issued a warning to transplant doctors that switching their patients to the anti-organ transplant rejection drug Rapamune after a liver transplant may increase the risk of death.

The warning, issued June 11, notified healthcare professionals that a recent study by Rapamune’s manufacturer, Wyeth, revealed a possible increased risk of death among liver transplant patients who were using a calcineurin inhibitor (CNI)-based immunosuppressive treatment, and then switched to Rapamune.

Rapamune (sirolimus) is an immunosuppressant used to prevent the body from rejecting an organ after transplant. The drug generated $376 million in sales in 2008.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

While Rapamune has only been approved by the FDA as a kidney transplant drug, most commonly used in patients with hemolytic-uremic syndrome which can reoccur in a transplanted kidney, many doctors prescribe it off-label to liver transplant patients as well.

Wyeth’s Rapamune study found that the chance of liver rejection was “significantly higher” for stable liver transplant patients who switched from a CNI treatment to Rapamune, than those who continued to use CNI.

The study also revealed that more liver transplant patients discontinued using Rapamune due to adverse events than those who used CNI. The study identified peripheral edema, stomatitis, rash and mouth ulcerations as the most frequent side effects of Rapamune which led to patients discontinuing its use.

The FDA is investigating whether there need to be new labeling requirements for the side effects of Rapamune. The medication already carries a “black box” warning label that advises against using it immediately after a liver transplant.

The agency suggested physicians should continue to use the drug’s label as a guide while it examines the Wyeth study and decides whether other actions are necessary.

According to a different study published last July in the Journal of the American Society of Nephrology, even when the drug is used as directed in kidney transplant patients, Rapamune side effects could increase the risk of diabetes. The study found that when compared to patients who received another anti-rejection drug, the risk of diabetes was increased by 36% to 66%.

11 Comments

  • MarinMarch 7, 2013 at 11:37 pm

    Hope you're still alive. NO rapamune! Is a real killer.Watch The Marin Pitu Story ,video. I refused Rapamune and survived. Watch The Lonnie Shrum Story, he took it, and I also speak in his name. Rapamune killed him, slowly and painfully. Contact me by email, my name (above) no space @yahoo.com

  • ClaudetteJune 5, 2011 at 10:38 pm

    I received a liver transplant in 1997 due to Primary Biliary Cirrhosis. All was great until 6 years ago when my hospital was bought by a larger hospital, and they referred all my care, except for blood work every three months, to my primary care doctor. As I became sicker and sicker, and wound up in another hospital (not part of the hospital chain managing my transplant) it was discovered my kidne[Show More]I received a liver transplant in 1997 due to Primary Biliary Cirrhosis. All was great until 6 years ago when my hospital was bought by a larger hospital, and they referred all my care, except for blood work every three months, to my primary care doctor. As I became sicker and sicker, and wound up in another hospital (not part of the hospital chain managing my transplant) it was discovered my kidneys were shot. At that time, the transplant team decided to pull me off Prograf and put me on Rapamune. I have been on peritoneal dialysis for 16 months, now, feel awful, and the last blood work done by the transplant clinic shows my liver enzymes are up, although they told me everything was normal. It was my nephrologist who looked at the tests and informed me about the high liver enzymes. Of course, the transplant clinic was telling me all my tests were great, when the truth was, they were killing my kidneys with Prograf. I am alarmed that I am on Rapamune, after all the warnings I read on each refill I get.

  • SondraMay 14, 2011 at 3:31 pm

    Acute liver failure (for no apparent reason) December 2008; liver transplant 2008. First drugs: Prograf and Cellcept. Prograf was toxic to me; could not stay on it. Affected my cognitive function, neuromuscular, vision, nightmares, hallucinations - I would have rather died than stay on Prograf. Told doctors to either switch me to Rapamune or write me up a medical retirement. I got the Rapamun[Show More]Acute liver failure (for no apparent reason) December 2008; liver transplant 2008. First drugs: Prograf and Cellcept. Prograf was toxic to me; could not stay on it. Affected my cognitive function, neuromuscular, vision, nightmares, hallucinations - I would have rather died than stay on Prograf. Told doctors to either switch me to Rapamune or write me up a medical retirement. I got the Rapamune in February 2009. Took it with Cellcept until Celcept lost its patent and went generic. Now I take Rapamue with Myfortic. My side effects are fewer and much more minor Biggest problem is acne and cholesterol. Yes, my resting glucose has increased slightly but I am not diabetic. What is important to remember about immunosuppressants is that no one drug will work for everyone. All of them are horrible to take and as I tell people they rot you from the inside out. Almost makes the transplant not worth it at all. But with Rapamune, studies have shown that patients have a better chance at having blood sugar levels return to normal than on the other drugs of choice. We also have the best chance of our bone loss reversing itself. The "death" warnings are for taking Rapamune and Prograf together or Rapamune and Cyclosporine together. After my transplant, my liver enzymes would not decrease until after I stopped Prograf and began Rapamune. As I also went into kidney failure at that time, my kidneys didn't fully recover until I was switched to Rapamune. I have had no infections outside of a cold and I've had no rejection episodes. And the tremors - which is a rofound understatement - disappeared within 4 hours of beginning Rapamune. I prefer the Rapamune.

  • DonDecember 24, 2010 at 8:34 pm

    I had a Liver transplant Labor day 2004 . I was on Prograf for about a 9 months. My Dr. switched me to Rapamune to reduce the risk on the kidneys. I am now on 2mg a day. I have had absolutly no problems except for acne. My liver function test are great and as long as I drink plenty of water my kidney function test are fine. No sores or any rejection yet. Blood sugar is fine.

  • JimNovember 12, 2010 at 8:12 pm

    Anyone who has had a transplant for any number of years, I say this: DO NOT ALLOW YOUR DOCTOR TO PLACE YOU ON RAPPAMUNE!! I nearly died after being on rappamune for 1 year back in 2007. I had my transplant on June 2, 1994 and only had a few episodes of rejection along the way. I have been on tacro adn cellcept for many years and was doing fine. My docs felt I could reduce the meds by going on rapp[Show More]Anyone who has had a transplant for any number of years, I say this: DO NOT ALLOW YOUR DOCTOR TO PLACE YOU ON RAPPAMUNE!! I nearly died after being on rappamune for 1 year back in 2007. I had my transplant on June 2, 1994 and only had a few episodes of rejection along the way. I have been on tacro adn cellcept for many years and was doing fine. My docs felt I could reduce the meds by going on rappamune and this would also help with my failing kidney functions. Big mistake. I had muscle fatique, sores in my mouth, joint pain.....you name the possible side effects and I had them. I'm much better now that I'm off of rappamune!! I still have some lingering pains in my back since I've taken the med.. Not sure if this is due to rappamune or not!

  • RodneyOctober 26, 2010 at 10:01 pm

    I had my liver transplant in December 2002. I was on Prograf for about 7 years, but Prograf can lead to kidney failure. I was placed on Rappamune (@ 2 milligrams per day) and I too suffered from mouth ulcers. I found that if I drink a glass of water when I take the Rappamunre that this helps tremendously. Don't hold the pills in your hand and then take either. Have the glass of water ready, pop t[Show More]I had my liver transplant in December 2002. I was on Prograf for about 7 years, but Prograf can lead to kidney failure. I was placed on Rappamune (@ 2 milligrams per day) and I too suffered from mouth ulcers. I found that if I drink a glass of water when I take the Rappamunre that this helps tremendously. Don't hold the pills in your hand and then take either. Have the glass of water ready, pop the pills right out of the bottle and into your mouth and then drink the water immediatly. If I( do this I don't have problems. Maybe this will help someone else.

  • SandraOctober 12, 2010 at 3:34 pm

    I had my liver transplant new years eve 2006, and was placed on Prograf and Cellcept at that time. A few months later they started me on Rapamune and continuing the Cellcept. So far this has worked, but I'm concerned about the diabetes and my kidneys. If anyone has any information about these two issues please let me know. My blood sugar has been climbing for several months now, and I think it[Show More]I had my liver transplant new years eve 2006, and was placed on Prograf and Cellcept at that time. A few months later they started me on Rapamune and continuing the Cellcept. So far this has worked, but I'm concerned about the diabetes and my kidneys. If anyone has any information about these two issues please let me know. My blood sugar has been climbing for several months now, and I think it may have something to do with the Cellcept, but maybe not. The medicare system now requires you to take the generic Cellcept, and I have had issues with it for almost a year. I beleive that Mycophenolate 500 mg (generic brand for Cellcept) is causing some of my issues, but it maybe the rapamune. I would love to hear from any transplant patient if possible.

  • tiffanySeptember 2, 2010 at 8:53 pm

    i too had many many painful ulcers after telling my doctors about it they decided to lower my rappamunes by quite a bit and it worked the ulcers completely went away they also had to increase my other anti rejection meds i was fine with that as long as the ulcers were gone and stayed gone good luck i know youre pain

  • AnitaApril 27, 2010 at 5:21 pm

    I had a liver transplant on February 18, 2004. At first I was given tacolimus but after about a year I was taken off of it, I forgot why, then put on cyclosporine, cellcept was tried but I threw up the first time I took that. Finally I was put on rapamune. I have been on this drug for about 2-3 years. For the past 6 months I have been having so many mouth ulcers that I am in constant pain. I [Show More]I had a liver transplant on February 18, 2004. At first I was given tacolimus but after about a year I was taken off of it, I forgot why, then put on cyclosporine, cellcept was tried but I threw up the first time I took that. Finally I was put on rapamune. I have been on this drug for about 2-3 years. For the past 6 months I have been having so many mouth ulcers that I am in constant pain. I thought it was because I was drinking too much caffeine. Finally I told my PCP she said it was the rapamune causing the mouth ulcers. She prescribed triamcin/orabas 0.1%. This stops the pain for a little while, but when the medicine wears off the pain is back. I have been in pain for months on a daily bases. I discovered this website searching for other symptoms related to rapamune. So I decided to post my comment. I just put some mouth medicine on the ulcers about 10 minutes ago, and already my mouth is starting to hurt all over again.

  • LaceyJune 22, 2009 at 10:22 pm

    Please please please don't go on rapamune! my father is a recent liver transplant patient, he was doing great too and then they put him on the drug back in feb and he got horribly bad. he started shaking all the time, tremors constantly, then we haven't been able to keep him our of the hospital for longer than a week. he swells up so bad that he goes into respitory arrest (five times to be exact s[Show More]Please please please don't go on rapamune! my father is a recent liver transplant patient, he was doing great too and then they put him on the drug back in feb and he got horribly bad. he started shaking all the time, tremors constantly, then we haven't been able to keep him our of the hospital for longer than a week. he swells up so bad that he goes into respitory arrest (five times to be exact since feb), he gains 60-80 pounds in three days and then goes to hosp and they get it off and then goes home and it comes back...it is a very vicous cycle. He was on prograp first too and they took him off rapemune after 15 days, FINALLY listening to us that it was the rapamune. they believe that now it has ruined the new graph, but yet its getting covered up and nobody will talk to us about it. they just keep letting him go through all the pain and the craziness. we are going somewhere to get a second opinion. they are even refusing to do his 6 month liver biopsy cause they know it will prove that his liver was ruined.

  • NIcholasJune 17, 2009 at 6:00 pm

    I am a recent liver transplant recipient who is doing very well. My labs are all normal, and I am really getting back in good shape, I went to hepatologist on annual visit and he has indicated to me in 3mo. I will be put on Rapumane. We all know how toxic these immunosuppressants are to other organs, but what needs to be done is to figure out which ones are the most fatal. I currently tRx Prograf1[Show More]I am a recent liver transplant recipient who is doing very well. My labs are all normal, and I am really getting back in good shape, I went to hepatologist on annual visit and he has indicated to me in 3mo. I will be put on Rapumane. We all know how toxic these immunosuppressants are to other organs, but what needs to be done is to figure out which ones are the most fatal. I currently tRx Prograf1+1mg. + Myfortic 360+360mgp/day.

Share Your Comments

I authorize the above comments be posted on this page*

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

Baby Food Injury Lawyers Appointed To Leadership Roles in Autism, ADHD Lawsuits Over Heavy Metal Contamination
Baby Food Injury Lawyers Appointed To Leadership Roles in Autism, ADHD Lawsuits Over Heavy Metal Contamination (Posted today)

A group of 19 plaintiffs' lawyers have been appointed to serve in various leadership position during the consolidated pretrial proceedings for all baby food injury lawsuits, taking actions that benefit all families pursuing claims for children diagnosed with autism, ADHD or other developmental problems from toxic heavy metals found in many popular products sold in recent years.

Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024
Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024 (Posted 3 days ago)

A federal judge is allowing plaintiffs to file large numbers of Suboxone tooth decay lawsuits in one bundled complaint, to meet a potential two-year statute of limitations deadline, with the ability to flesh those claims out in more detail at a later date.