Propylthiouracil (PTU) Side Effects Increase Risk of Liver Injury: FDA Warns
The FDA is alerting health care professionals that side effects of propylthiouracil (PTU), a drug used to combat Graves’ disease, can lead to potentially fatal liver damage.
At least 32 cases of serious liver injury from propylthiouracil, also known as PTU, were identified by the FDA in a warning issued June 3, 2009. Of those adverse event reports, there were 12 deaths and five liver transplants. Ten of the cases involved children, of which six required liver transplants and one died.
PTU is a “second-line” treatment for Graves’ disease, used to treat overactive thyroid glands. It is an alternative treatment to methimazole, which the FDA notes has only been associated with five cases of liver damage.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.
Learn MoreGraves’ disease is an autoimmune disorder that leads to hyperthyroidism. It is estimated to affect 2% of the female population and appears in women at a 5:1 to 10:1 ratio when compared to men. It can cause goiter, disturbed sleep, hypertension, irritability, muscle weakness and increased heartbeat.
“Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease,” said Amy Egan, M.D., from the FDA’s Center for Drug Evaluation and Research. “If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy.”
Symptoms of liver injury from propylthiourail (PTU) could include yellowing of the skin or eyes associated with jaundice, abdominal pain, swelling or tenderness, blood in the stool or urine, brown urine, vomiting, faintness or rapid heart rate.
Patients who are allergic or intolerant of methimazole, or women who are pregnant, are often given PTU instead of methimazole, which has been linked to rare cases of birth defects which are not seen in PTU users. Despite the propylthiouracil liver injury risk, the FDA noted that PTU may still be a better option for pregnant women with Graves’ disease who are in the first trimester.
PTU was approved for marketing in 1947, and it is currently only available as a generic, with no brand names for the drug sold in the United States.
The FDA warning comes after an April 18 public workshop with the American Thyroid Association (ATA) that discussed the PTU liver damage side effects. The FDA said it will continue to monitor PTU side effects and may make changes in labeling. The ATA is planning to update treatment guidelines for Graves’ disease to account for the new findings in upcoming months.
In an editorial published in the April 9, 2009 issue of the New England Journal of Medicine, two doctors warned that the propylthiouracil liver side effects should cause doctors to seek alternative treatments for children with Graves’ disease. The authors estimated that liver failure from propylthiouracil requiring a transplant or resulting in death could occur in between 1 in 2000 and 1 in 400 children treated. However, the number of children who suffer reversible liver injury could be 10 times that number.
Get more articles like this sent directly to your inbox.
"*" indicates required fields
14 Comments
BethDecember 13, 2018 at 5:44 pm
I took PTU for 2 and a half years in 1990. I was careful and dropped the dosage significantly during a pregnancy. My son was born with a deformed kidney and later diagnosed with Blount’s Disease. I never had liver problems but developed joint issues that continue to this day. When I had my son, the GD was reversed and I no longer needed the mediation. I had always struggled with my weight and I di[Show More]I took PTU for 2 and a half years in 1990. I was careful and dropped the dosage significantly during a pregnancy. My son was born with a deformed kidney and later diagnosed with Blount’s Disease. I never had liver problems but developed joint issues that continue to this day. When I had my son, the GD was reversed and I no longer needed the mediation. I had always struggled with my weight and I didn’t want to gain too much weight while I was on it. I took the medicine every other day. I often wonder if this was what reversed my GD. At 61 years old, I have never gone hypothyroid.
EliseDecember 17, 2015 at 4:43 am
The CLUELESS Mainstream Medical Doctors, Here In This Small Texas Town, IGNORE Too, And THINK THEY Know IT ALL About THEIR Patients, AND THEIR Patients BODIES, But THEY DON'T! (One SIZE FITS ALL, Now, GO HOME, And TOX OUT On The BIG PHARMA DRUGS, IF YOU CHOOSE To, OR NOT, And Just WAIT TO DIE, IS Basically WHAT DRUG PUSHING Mainstream Medical Doctors, ARE SAYING To YOU ALL! (Sometimes The DIS EASE[Show More]The CLUELESS Mainstream Medical Doctors, Here In This Small Texas Town, IGNORE Too, And THINK THEY Know IT ALL About THEIR Patients, AND THEIR Patients BODIES, But THEY DON'T! (One SIZE FITS ALL, Now, GO HOME, And TOX OUT On The BIG PHARMA DRUGS, IF YOU CHOOSE To, OR NOT, And Just WAIT TO DIE, IS Basically WHAT DRUG PUSHING Mainstream Medical Doctors, ARE SAYING To YOU ALL! (Sometimes The DIS EASE, IS BETTER Than The "CURE".) (Do I WANT THIS DIS EASE Called GRAVES?!) (NO!) But I'm NOT So SURE About These EXTRA HEALTH PROBLEMS With These BIG PHARMA Graves DIS EASE DRUGS, EITHER! Most DIS EASE Comes From Being DISSATISFIED In Life, FEELING CORNERED By The INTRUSIVENESS Of OTHER People Around Us, Both Of Which I AM FEELING, For OVER Three Or So Years Now! (and yes, I HAVE LOST TONS Of WEIGHT Too, And THAT SCARED ME All Summer Here In Greenville, Texas, Right Into Winter Now, And Everyone/Everybody Around ME, HAS Been WAY Too INSENSITIVE, And PUSHY, Assuming That I'm NOT EATING, Because I Have Very Real Swallowing Problems, INCLUDING The CLUELESS AND PUSHY Mainstream Medical Doctors, AND My Family Too, TREATING ME VERY POORLY, And Basically Said Something VERY RUDE To ME All Summer, Into Now: AT LEAST YOU LOST LOTS OF WEIGHT, AND AREN'T FAT ANYMORE, BUT NOW YOU MUST START "EATING" AGAIN, To ME! My Own Twin Sibling, SHE CALLED ME AN ANOREXIC NERVOSA, When SHE HAS The SAME GRAVES DISEASE HEALTH PROBLEM, And I NEVER SAID THAT To HER, When SHE STARTED GETTING POOR THYROID/GLAND PROBLEMS, NOT EVER! My Family CAN BE RUDE To Me AND One Another OFTEN! VERY DEPRESSING, I FEEL ALL ALONE WITH THIS HEALTH PROBLEM, AND ALL I GET, IS THIS GARBAGE FROM My Family AND The CLUELESS DOCTORS Too, And YOU WONDER WHY PATIENTS Such As ME, DON'T WANT TO FOLLOW THE MEDICAL/DOCTOR'S PLANS?!?! THE DISRESPECTFUL ATTITUDES FROM OTHER PEOPLE, IS WHY! I Am Age 43, And Went From Basically 200 Pounds, To Now Basically 130, With A 160 Pound DIFFERENCE, THIS HOT Summer, Here In Texas, AND A WET MOLDY, MILDEW Y Spring, Which I THINK KICK STARTED THIS! (I AM Hypersensitive To TOXINS In The Environment, Or Whatever) And Then 140 Somewhere Along The Excessive Weight Loss Health Problem Of Graves DIS EASE Too, And I HAVE'T Been Past 130 Pounds Since, And I'm SCARED, Of BOTH The TOXIC DRUGS, AND The DIS EASE ITSELF!
robin d.November 2, 2012 at 6:57 pm
i was diagnosed with anca vasculitis with membranous glomerulonephritis(kidney disease).i went into kidney failure& was sent to a nephrologist for treatment. i found out that all of this was brought on by taking PTU. apparently there are many others being treated for the same thing from the dr. treating me. people need to be aware that this drug is very dangerous!! anyone out there with this[Show More]i was diagnosed with anca vasculitis with membranous glomerulonephritis(kidney disease).i went into kidney failure& was sent to a nephrologist for treatment. i found out that all of this was brought on by taking PTU. apparently there are many others being treated for the same thing from the dr. treating me. people need to be aware that this drug is very dangerous!! anyone out there with this same problem... i'm considering a lawsuit but don't know about starting a class-action suit??
Nicole B.August 30, 2012 at 1:50 pm
I was diagnosed with GD after having my oldest child (rapid weight loss, bulging eyes),I was then started on PTU! After having a second child, I continued taking PTU. Around 10mts later i went into acute liver failure and had to receive a liver transplant. I was in the hospital for almost two months and missed my child begin to walk. I would like to file a lawsuit against this drug company, does a[Show More]I was diagnosed with GD after having my oldest child (rapid weight loss, bulging eyes),I was then started on PTU! After having a second child, I continued taking PTU. Around 10mts later i went into acute liver failure and had to receive a liver transplant. I was in the hospital for almost two months and missed my child begin to walk. I would like to file a lawsuit against this drug company, does anyone know of an attorney handling this type of case?
NicoleMarch 17, 2011 at 8:40 pm
Shortly after having my first child I was diagnosed with GD, and started taking PTU. After taking it for 2yrs I went into acute liver failure and had to have a liver transplant. If you are taking it please have your doctor follow your liver enzyme levels very closely!
RosemarieFebruary 21, 2011 at 8:48 pm
I have had GD since 2008 which was left untreated until my eyes were lliterally buldging out of my head by december 2009. When I went to my thyroid doctor on an emergency basis she said "let me check you for whats called "graves disease"... my reply was you know I have GD you have the blood test results for that.. Her reply well I don't treat that and now I need to send you to another specialist t[Show More]I have had GD since 2008 which was left untreated until my eyes were lliterally buldging out of my head by december 2009. When I went to my thyroid doctor on an emergency basis she said "let me check you for whats called "graves disease"... my reply was you know I have GD you have the blood test results for that.. Her reply well I don't treat that and now I need to send you to another specialist that can deal with it and your eye issues! Wow... after steroid treatments directly into my eyes, eye plugs in my tear ducts and radiation to both eyes(none of those treatments worked) I got a brain hemorage in June of 2010. I just underwent a craniotomy in January and my recovery time is 3 to 6 months. I have to have eye surgery on both eyes consisting of eye decompression surgery and eyelid retraction surgery. I have been out of work for almost a year now and needless to say this has ruined me financially. If anyone knows anyone who has this disease do not take it lightly it is very serious and make sure you get a good doctor as soon as possible. I thought I had a great doctor and reported all of my symptoms to her immediatly unfortunetly she ignored them!
SylviaFebruary 16, 2011 at 4:08 am
Hello, just want to share my experience with PTU. I was diagnosed with GD in May '07 and was prescribed ptu right away...I took it until OCt. 2010. Within the first 6 months of taking ptu I started having minor joint problems, and with time it got worse. SOOO bad that sometimes I could not sleep at night due to the pains..It was swealing of the joints, at not specific place,..knee, wrist, shoul[Show More]Hello, just want to share my experience with PTU. I was diagnosed with GD in May '07 and was prescribed ptu right away...I took it until OCt. 2010. Within the first 6 months of taking ptu I started having minor joint problems, and with time it got worse. SOOO bad that sometimes I could not sleep at night due to the pains..It was swealing of the joints, at not specific place,..knee, wrist, shoulder, elbow,,it would sweal up and be hot to the touch. I stopped taking PTU in Oct 2010 and my joint problems started getting better,...ever since December I could tell that the problem was gone... Please check your blood levels,..liver levels..and good luck..for now my thyroid levels are normal..
shicaDecember 28, 2010 at 7:11 pm
I have been on ptu cuz of GD n have had two clott thrown, liver issue, sever pain on left side n twitching has anyone else had this issue or other issues.
kisvisSeptember 27, 2010 at 12:51 pm
I have been on PTU for over 2 years now, it has stopped working and at my next doctors visit we are talking about RAI, I am starting to have abdominal pain and was wondering if this could be from PTU use. NO yellowing of skin or any other symptoms besides fatigue. Anyone else have ab pain with PTU it has only started in the last month or so. I am not going to be one of the lucky ones to go into re[Show More]I have been on PTU for over 2 years now, it has stopped working and at my next doctors visit we are talking about RAI, I am starting to have abdominal pain and was wondering if this could be from PTU use. NO yellowing of skin or any other symptoms besides fatigue. Anyone else have ab pain with PTU it has only started in the last month or so. I am not going to be one of the lucky ones to go into remission and the only upside is i can get off this med soon.
PertreceJune 26, 2010 at 1:22 am
I was taking PTU during the 2nd month of my pregnancy in 2008. Sadly, I lost that pregnancy late in 2008 due to my GD. I did not start taking care of it until I found out I was pregnant. Afterwards, I was still taking PTU and had no liver problems. My next step was to take the RAI in april 2009. I wanted to try and get pregnant right away, safely after the doc. appoved of course. After treatment, [Show More]I was taking PTU during the 2nd month of my pregnancy in 2008. Sadly, I lost that pregnancy late in 2008 due to my GD. I did not start taking care of it until I found out I was pregnant. Afterwards, I was still taking PTU and had no liver problems. My next step was to take the RAI in april 2009. I wanted to try and get pregnant right away, safely after the doc. appoved of course. After treatment, I was put on methimazole for a year. I still have not went under active nor noral. Now, in 2010, I am pregnant and my doc switched me to ptu, again. Lately i havent been feeling myself. I swell up whenever I do any activites. I reported it o my doc, she anted to wait cause it only has been 3 weeks after the switch. Now, my liver enzymes have spiked upwards to 50. My doc had me to comepletely stop taking the meds, now that i have gone under. I dont know what is going on and i think that waiting 4-6 weeks to test blood is way too long .I am knida scared for my health and my unborn chlds health...Anyone in a similar situation?
MichelleJune 17, 2010 at 3:38 pm
been on ptu 3 years now. I get tested every 6 weeks anyway for my lups for liver damage. My liver is fine. I would advise Helen who just started ptu to make sure her doctor tests her right away for liver damage and get tested every month for the next 6 months. If not planning on having kids in the next 2 years should ask doctor about switching to Methimazole, but this causes birth defects if p[Show More]been on ptu 3 years now. I get tested every 6 weeks anyway for my lups for liver damage. My liver is fine. I would advise Helen who just started ptu to make sure her doctor tests her right away for liver damage and get tested every month for the next 6 months. If not planning on having kids in the next 2 years should ask doctor about switching to Methimazole, but this causes birth defects if planning a pregnancy stick to ptu. Talk to your doctor about these options. Your family is right to worry since you just started the ptu and you need to know how it is affecting your liver. Mine was not affected for 3 years, but you should have liver checked since you just started ptu. As far as GD once the ptu or methimazole treatment is underway you will feel much more in control. Also, please learn to not stress out, get stress under control asap because my stress after having gd lead to lupus after my stepfather and father passed away 2 months apart. Stress is very bad for people with autoimmune diseases. Learn to destress with exercise, perhaps start with walking. I run 5 miles a day now that my gd is under control and I run ultra marathons. It helps with my lupus joint pains, which ar nonexistent now. And my resting pulse rate never goes over 59 now. I am at my best health ever and I feel wonderful now that I am stress free.
kimJune 4, 2010 at 9:43 am
been on ptu 2 years now. besides weight gain and retaining water. no side effects to speak of.
helenJune 2, 2010 at 8:39 pm
I have just recently been diagnosed with GD & am shattered to learn of the potential side effcets of PTU which I have been taking for less that a month now. It would be really comforting to be reassured that my life was not in danger from taking this medication. This is quite alarming & my family are very concerned about me. Regards Helen
BrendaDecember 8, 2009 at 6:36 am
I have known I had GD for 2 yrs now. I'm 53 now. I started with rapid heartbeats, insomina and anxiety and finally snapping peoples head off. I am not a good candidate for removal surgery because they have to give you meds to shrink your blook vessels. I can't do this because 6 yrs ago I had 2 brain aneuysms and 3 surgies to correct them. I refused RAI because it increases my risk for throat cance[Show More]I have known I had GD for 2 yrs now. I'm 53 now. I started with rapid heartbeats, insomina and anxiety and finally snapping peoples head off. I am not a good candidate for removal surgery because they have to give you meds to shrink your blook vessels. I can't do this because 6 yrs ago I had 2 brain aneuysms and 3 surgies to correct them. I refused RAI because it increases my risk for throat cancer and I already have skin cancer so that's out. Then I read about inhaling food grade Hydrogen peroxide and my anxiety and rapid heartbeat literally disappeared. So I asked my doc to retest me and he said my hormones were still too low and I explained about the not feeling the sypmtoms anymore, but he insisted I start taking Inderal and then gave me PTU, 50 mgs every 8 hours. 3 months later my test came back a little better but I now have to take 100 mgs every 8 hours cuz he wants it up more. I don't have the side effects of GD anymore and still inhale the food Grade 3% HP 2 or 3 times a day. I recently read in a June 09 article that PTU could be quite dangerous causing cancers and I want to quit taking it, ease off and go back to a natural health practictioner. Anyone have any experience with my situation and can you advise?