FDA is putting a black box warning (the strongest FDA warning) on all drugs containing the pharmaceutical ingredient metoclopramide (Reglan), which is used in the treatment of disorders like heartburn caused by gastroesophageal reflux disease.
The black box label warns consumers about the risk of developing tardive dyskinesia, which causes involuntary repetitive momements (twitches) with long-term, high-dose use of metoclopramide. Symptoms of tardive dyskinesia can persist long after the patient stops using the drug.
Metoclopramide can be found in Reglan tablets, oral disintegrating pills, metoclopramide oral solution and Reglan injections. All of these metoclopramide-containing prescription drugs already contain box warnings, but the seriousness of the risk of developing tardive dyskinesia (involuntary movements) will now be highlighted by the FDA’s strongest available warning.
Any patient taking Reglan or other forms of metoclopramide should have been warned of the risk of tardive dyskinesia by their doctor prior to being prescribed the drug. The risk increases the longer a patient takes metoclopramide, and with higher doses. FDA studies show that around 20 percent of patients who developed drug-induced movement disorders after taking Metoclopramide had taken the drug for more than three months.
The FDA encourages consumers to report adverse events to the FDA’s MedWatch program. You can reach MedWatch by phone at 800-FDA-1088.
If you think you may have developed tardive dyskinesia after taking Regland / metoclopramide contact your doctor immediately. You may also fill out our form via the link below to speak to an attorney about your legal rights.
Symptoms of tardive dyskinesia include repetitive, involuntary, purposeless movements like: Grimacing, sticking your tounge out, lip smacking, puckering, pursing of the lips, rapid movement of arms, legs, fingers or toes, rapid eye blinking and twitches.
Also see this week’s other FDA Black Box Warning for Raptiva.
I was on reglan for 7.5 mths unaware of the side effects it caused i had tremors, twitching, restlessness, akathesia, insomnia, loss of appetite, servere depression with suicidal thoughts, confusion, fatigue, parkonism symptons 2.5 yrs later i am still suffering with depression and sleep problems.
Don’t take this drug is my advice.. i am very lucky not to have developed tardive dykenesia.
I too have been a victim of Reglan. I took Reglan for 3 weeks at which time I found myself so depressed that I stayed in bed all day and did not care about life. I was completely hopeless. Severe depression set in even though I started Wellbutrin 10 days after starting the Reglan. I noticed on the prescription bottle that it said call your doctor immediately if you experience worsening symptoms of sadness, depression etc. So I stopped taking it and said I have to call my doctor to see if this Reglan is causing the problem or if the Wellbutrin just isn’t working for me or causing a weird reaction. I have taken Wellbutrin before and did wonderfully on it so chances are it wasn’t that. I casually thought I would check into Reglan and Depression online and when I did I found so many comments on people who have taken it and ended up feeling just like me. Suicidal. It is a horrible drug. Just knowing that I will get better when all of this is out of my system is like a placebo because I am so happy to know that it wasn’t me that was really feeling like that, it was the drug.
I just heard of these awful side effects last evening, and I am afraid I need to be tested for this horrible discovery. Any advice?
My son was on reglan for about a year and he has a problem with his lips pursing them all of the time and everyone would always ask me why he does that I said I don’t know well know I know it was because of the medicine
my son is 2 years old now and wass on reglan for around 4 months..Should I have him evaluated?
I was given both Reglan and another drug prior in a hospital that both caused the same terrible reaction. Within 5-8 minutes of injection into my I.V., my mouth started to twist, my jaw went into complete spasm, and it progressed until the first time, my sister dragged me back into the ER who gave me the drug DROPERIDOL. The doctor seemed amused and said a comment like “I have seen peoples heads twist around, kinda funny”????? I was givwen 50 mg of Benadryl and had to stay in the ER another hr until they were sure it had stopped and I was released. The second time, I didn’t even need the drug, and a nurse at St. Peter’s Hospital, in New Brunswick, NJ, gave me Reglan. She shot it into my iv so fast and I asked her what was that, and she said “for nausea”. I was NOT NAUSUA’S AT ALL!! By the time they brought me to my room, I was having a full blown diskonsea reation, and screamed for the ER doc, and ended up being given 70 mg of Benadryl to stop it this time. This is a VERY DANDEROUS DRUG AND SHOULD NOT BE USED IN ANY WAY SHAPE, OR FORM. I AM MORE THAN WILLING TO SUE DUE TO THE HORRIBLE POST TRAMATIC SYNDROME I HAVE NOW.
I have been prescibed Reglan after having an endoscopy. I have not taken the medicine because I am concerned re: the side effects and so far everything that I have read. My husband told me about the recall and he was concerned– so we called the pharmacy and she told me not to worry about it and to go ahead and take it. She said these are long term effects but from what I am reading not everyone that had these side effects were from long term usage. I am very nervous about taking this. Please help with any advice. I am already taking Nexium and Carafate (suspension). Neither are helping. I will be having additional testing done soon. (upper G I ) Thank you.
I took this drug for slow stomach emptying and possible gastroparesis. This drug worked ok for about 3 months. By the 4 month I was noticing unusual fatigue and lack of motivation. As I reached the 7.5 month I was knocked off my feet. I entered into deep depression, severe anxiety, unable to eat, unable to experience joy, akathasia, anhedonia, insomnia, and liver problems. Never had any of these problems prior to Reglan. Reglan crosses the blood brain barrier and can re-wire your brain. Do not take this drug. I have been off Reglan for 5 months. Can’t take an antidepresssant as all of them seem to amplify my symptoms. My anxiety is better, but still dealing with depression, lack of motivation, and lack of joy. Any advice on how to hasten recovery from Reglan?
I took the generic version of Reglan for a month and stopped because it made me incredibly drowsy. At the time I started having symptoms that I didn’t think where related to this drug and that I still experience to this day, symptoms such as involuntary shakings and movements of the face, fingers, hands, toes and arms, lack of coordination, and confusion. I never knew this drug could cause this, until I saw it on TV and I put the 2 things together. Please, don’t risk it, don’t take this drug.
my mom has been on this medication for months after a back surgery she had she became paraylized so reglan was given to her to promote digestion. just about two weeks ago she had heard there was a recall on the medication and stopped taking the medicine. then last friday they told her to start taking it again cause there was no recall after all and now my mother is in ICU fighting for her life. she is in a coma, having seizures over and over, and have severe brain damage. we are still unsure of the reason behind this. drs have ran every test under the sun and everything comes back clear. the only thing i can think of is this medication. please do not take this medication.
I have a daughter who is now 6months,when she was about 3 months she was diagnosed from her pediatrician and from the hospital as having “acid reflux” she would have bad attacks (as i call them) where she would slightly loose her breath and gag until she got herself together,she always seems real fussy,on edge and her arms,head and her eyes weren’t functioning the way they should of at her age so after MANY trips to the doctor and hospital the doctors had me give her Reglan for her problem,she took it for about 3months, i always knew something wasnt right about her using the drug because it didn’t seem to help her and her attacks got worse so i took it upon myself to stop giving it to her, Im so glad i did,a few days ago i saw a t.v commercial about a recall for reglan and i talked to a lawyer.Now her new pediatrician wants her to be seen by a neurologist to see why her motor skills are lacking.Im very hopeful that they will treat her and give her proper care.Ive had ALOT of sleepless nights and constant worry about her so i advise anyone who is using reglan to stop and seek care i would hate for someone like me to go though what my daughter and me have went through.
well what ive been through for 6 yrs and never knew till now. i started reglan 6 yrs ago. after i had my large intestine removed cause it died. i was given reglan in order to eat cause i would bloat. well after 6 months i would awke to look in mirror and see my right side of face twitching and my right eye drooping and twitching my husband noticed and i thought i was just sleeping too hard i didnt know what was happening to me. i just let it go. well then i noticed in my left arm it became very weak i couldnt lift my newborns sons legs to put diaper under him or even open jars cause my arms and hands became too wek i again just thought i was outta shape let it go also. them my legs began to hurt something fierce over the years. i thought i just had fobro myalgia like my mom and just let it go and was given pain meds which didnt work so i just through them out. well i lived in montana this went on for 3 years. well i moved to nevada 3 years ago this conituned to get worse. still on reglan. this last 3 threes so make it a total of 6 yrs. i started to have trouble swallowing food getting stuck. my legs giving out falling. im only 41. i thought i was having a heart attack i called amulance cause my left arm and leg went numb and my chest hurt was rushed to hospital twice had all heart tests and everything was ok i stayed in hospital the heart doc said it isnt heart something else is causeing this. my eyesight has gone downhill so badly i never wore glasses ever over last 3 yrs i can see a thing and my eyes need a diff scrpt every six months. i know was rushed to hospital with involuntary movements of face and jaw and have twitching in face legs and numbs legs and feet. i went to hospital was diagnosed with dystonia. he said due to reglan i stopped it immediately a month ago. im still having all these symptoms still. i called the attorneys i never saw the tv commercial but my 14 year old daughter said mom i saw on tv about reglan and it sounds just like you. plus ive been lactating for 6 yrs. and to my surprise i finally went searching on the internet! there it was reglan makes woman lactate. finally got that answer! and all the others too! well im glad i called the attornies all i have gone thru even suicide attempts and manis insomia all these years has to do with the reglan i never knew till now. i see a neurologist on the 17th if he finds nothing in my brain like a tumor or anything this proves that reglan has been the culprit of all my issues for years. i take benydryl daily just so the twitches dont start they are exhausting needless to say embarrassing in public. im sure some or alot may be permanant 6 years is along time and i was on 40 milagrams a day. they checked my pharmacys and ive always took the generic form of reglan for day one thats the one that causes the damage. if i only know i got tired rushing to er cause i do have bipolar and they never found anything and i thought they thought i was nuts! well now i know im not i was thinking it too! i hope i get compensated well. cause ive been through hell and back for 6 yrs and nothing was found. i felt i was going crazy. i wanted to die the pain was so bad and every day just got more symptoms over the yrs and i just couldnt take it no more. well im glad im going to go see a neuro doc in 2 weeks to finally get his opinion wish me luck there! at least i sent in my paper work to the attornies that deal with the reglans cases. theres so many thing that drug does i was so amazed! plus all the injections i got in the stays at the hospital too so i got my fill of the drug ill tell ya. wish all others luck with this its a nasty drug and take it from me it does cause damage.
My daughter is 5 moths old and was given Reglan 1 month ago for reflux and slowed digestive system. I didn’t know about know about the recalls and her doctors never told me of any side effects. I’ve still had problem with my daughters health since. What should I have them test for and or look for just recently she’s started getting shivers, and sticking out her tounge, but I’m not sure if some of this is her age.
PLEASE HELP I NEED FEED BACK
My 2 year old son has been loosely diagnosed with GERD. He’s had an upper GI that came back clear, and Prevacid the so called miracle drug does nothing for him. He gags at the thought, smell or touch of most foods. He eats a diet of soup, toast and potatoes mostly. He want to eat other foods, yet he gags so bad he can’t. The gagging causes bad vomiting spells. He has seen our family GP, the pediatrician, and the gastroenterolgist. About 6 weeks ago he was put on 2.5ml of Metoclopramide 4 times a day. it has stopped the vomiting, not the gagging. He’s a big 2 year old at 19.8 kg (43lbs) and 93 cm. He’s proportionate and does not appear fat. We just got home for the latest appt with the gastroenterologist, and he ants him to contiune the prevacid which is a joke, and the metoclopramide for 6 more months and then he’ll re evaluate. I asked him if it’s safe for him to be on this medication that long and he assured me YES. I would just like to know from anyone what dosage they were on and for how long. He’s only 2 and this drug makes me nervous…please feel free to contact me if you would, I would greatly appreciate it sindi_lee@yahoo.ca
I took Reglan while pregnant for about four months. I was wondering the effects it could have had on the baby.
I have taken generic reglan for years w/ no side effects; it has helped greatly w/ reflux. But I am now weaning myself from it and hope never to take it again.
I have been on reglan for almost a month to increase my breast milk supply. It has helped, and I have had no side effects. I recently saw ads for reglan lawsuits and the drugs link to Tardive dyskinesia. While I have suffered no ill effects, my 6 month old daughter just recently started smacking her lips and sticking out her tongue. Should I be worried? Can she get tardive dyskinesia from the reminants of the drug in my breast milk? Is this just something 6 month olds do? I am worried. Any advice would be welcome.
i took reglan when i was breat feeding to increase my milk supply now my son is 9 months old and has been in the hospital twice due to spasms or whatever they have no clue what they are not i see this on t.v. about reglan i am freaking out my sons head goes towards his right shoulder and tenses up and he like kind jerks or twitches sometimes all i am gonna say is dont take this medicine when i was on it i had alot of depression i felt like i was going crazy i couldnt sit still i thought my mind was going 1000 miles a hour its not a good drug!
I have been on the generic brand of Reglan for a little less than a year with the symptoms of fatigue, insomnia, depression and others. Im using this drug for my gastroparesis but the only thing I know it helped was always feeling like I needed to throwup to unload my stomach. I am always tired and always feeling depressed. Does anybody know whatelse I can take?
I was taking reglan for about 2 years. I have been in 7 different mental hospitals and I have also been to the emergency room at least once every month. It wasn’t until I seen the commercial that I stoped taking it but it was too late I am suffering from akathasia and TD. It is the worst thing i have every been through I have almost lost my family and haven’t worked in 2 years.Please dont take this medication. I have gastroparesis and the best thing I can do is to control my diet but I know this I wont trust anymore meds.
04/30/09 Iwas in the Hospital for heart surgerie .ON THAT DAY I GOT 10MG OF REGALN 2 times that day.FOR 7MORE DAYS 20MG ADAY.NOW pain in left leg 24/7 .DRYmouth headache restlessness.DEPRESSION muscle movements in arms legs and faice.SHORTNESS OF BREATH increased sweating decreased energy.LIKE iwas jumping out of my skin . REGLAN FOR ME IS THE DRUG FROM HELL.
I too took reglan for my gastroparesis. What a ride. I am diagnosed bi-polar and was never told of the side effect of severe depression or TD. I was taking for a few months and noticed my depression was returning. I was put on remeron but didn’t seem to do the trick like before. I was on this all summer but again still did not feel right. After taking Reglan for a year, In Dec. 2009, it seemed like the ceiling fell on me and again supposedly was my bi-polarism. I was put on Remeron and then Wellbutrin but again did nothing. I heard on the tv about TD and starting checking on it. I couldn’t believe when one of the side effects was severe depression. I stopped taking it in Jan. 2010 and have been thru He__. Of course my Dr. wouldn’t attribute the depression on reglan but I have read too many stories not to believe it had something to do with it. When I asked my psychiatrist if he ever treated someone that was taking reglan for their depression, he really didn’t give me an answer. I know Drs. dispense alot of drugs, but why don’t they check into them more thoroughly. I am so angry at the prescribing Dr. that he didn’t tell me of the side effects since he too knew I was bipolar and of course didn’t tell me of the TD. Why must we be experiments? I can’t believe what we have been put thru. How can we fix this situation since big business controls the meds. Hopefully people will read this and not take REGLAN. It did help my stomach but really messed with my mind.
Hi i am 24 yrs old and I have taken Reglan on and off since i was about 15-16yrs old!!! I was put on it because i have acid reflex. At that point i was put on zoloft, which i figure was normal since i have a strong family history of depression. But as time has gone on i have noticed extreme in depression. And not all my family member have had to take medicine to control their depression. I started twitching at night when i go to sleep since 17-18 yrs old. Now its every time i go to sleep and when i am nervous in public my head shakes and i cant control it. I HATE that feeling. I was in a car accident 4 years ago and have injuries. But Does anyone know if the pain i still have is related to the Reglan or the accident. All my injuies are on my left side of my body and its soft tissue damage. so my muscles stay tight and it pulls my bones in my neck out and my left side of hip out of place. but so far they have not found any nerve damage and my hip structure is fine it just gets pulled out of place. I am is extreme pain all the time. I cant take a whole shower standing up, i have to sit down in it. My body feels fatigue when i bearly do anything. HELP I NEED ANSWERS. Is it the Reglan thats causeing me to still suffer or is it the car accident and its just all tied in together. Thank you.
****Regarding ?blair on December 15th, 2009 5:33 am
STOP STOP STOP USING THAT DRUG AND CONTACT A LAYWER AND SUE. DO NOT TAKE ANY MORE REGLAN AND PUMP ALL THAT MILK OUT UNTIL THE DRUG IS OUT OF YOUR SYSTEM. I WOULD GET YOUR BABY CHECKED OUT THAT DOES NOT SOUND GOOD AT ALL
I was given Reglan to help produce more breastmilk after both boys. i was also taking it for morning sickness during both pregnancies. my first son was fine, but my 2nd was in NICU for the first 12 days of his life. Long story short, he was diagnosed with GERD and now, at 9 months old, is experiencing no control of eye muscles occassionally. we are hAving to see specialists, etc. i don’t know if the reglan being present during pregnancy and while breastfeeding has anything to do with it, but i think i will be asking a lot of questions to find out.
i was on reglan for about a month for acid reflux and in that time i experienced constant eye twitching its really embarassing this is the worse drug ever!!!!
I was on Reglan for 6 YEARS before it was black listed. I have not had any symptoms yet, but my new GI doc (I moved), has switched me to Domperdone. It is a generic drug available in Canada (you can order it in the US with a prescription from your doc). It does the same job as reglan, but has ZERO side effects. According to my doc, the only reason the FDA doesn’t approve it, is because it is a generic, no name brand version available.
25 year old male, 1 year of reglan use.
Hi, I was only reglan for one year. I have developed minor twitching and jerkiness in my hands and finger and some very minor twitching of the tongue.
It’s been 40 days since I have been off the drug and the symptoms are still present. I am pretty scared that I’ll be stuck with this for the rest of my life. My fingers are pretty stiff and rigid at times.
Is there anything we can do help our bodies heal? So far all the lawyers i’ve talked too don’t want to take my case unless it’s tardive dyskinsea. Right now my condition could simply be called reglan induced essential tremor.
I have seen a neurologist and my family doc and the believe the symptons may eventually go away.
I’m taking massive doses of b vitamins, coq-10, vitamin e, herbs such as skullcap and oatstraw, exercising twice a day and practicing meditation, yoga and relaxation techniques.
Nothing seems to help, and some days the symptoms seem worse, other times they may seem slightly better. In the morning when I wake up after a good night of sleep the symptoms are worse. They may ease slightly as I’m a going on through the day.
I’m really curious, has anyone with reglan induced tremors gotten better? I’m 25 and I should have never been prescribed this. I had a mild acid reflux caused by smoking. When i quit smoking my acid reflux went away. I’m so angry the doctor never warned me. Please, somebody out there help us.
My mom was on reglan for years for her stomach they said her stomach was emptying to slow it didnt work for her and i would tell them and we would stop it but they would prescribe it agai she is deseased now they say from blood cancer she had really bad tremors of her hands and neck she was tested for parkerson disease didnt have it only the symptons of it shortly after her death they had the recall on reglan im sure that is why she sufferered from the tremors but to late to help her now or the hurt of all of her children seeing her in that shape
I was prescribed the substitute for reglan a few months back for my morning sickness when i first found out i was pregnant. I took it only one time, but thats all it took. I ended up passing out and getting sick while at work from taking this drug. I immediatley stopped taking the drug, and i was fine. I am now 6 months pregnant and see all this stuff about the reglan being recalled. What do i do? I need to know if anyone has a number to call, the lady i did speek with told me she couldnt help me due to the fact i was only taking it for a short while. If anyone has a number or anything please let me know i need to get this taken care of so i know that my son will come out healthy and alright.
The doctors put me on Reglan for 6 months of my pregnancy before they knew it caused this side effect. I developed Tardive Dyskinesia. My left leg drives me insane twitching. My right leg twitches also just not like my left.. I worry about my daughter who I was pregnant with at the time.
I been on reglan for a long time and i do have legs and arm twitching. I woke up one day and now i have vertigo benign paromysmal. Which now I can’t contol my balance an my head keeps spinning all the time.I feel like a walking drunk and can’t contol it.I’M SO MISABLE. The only meds i’m on is reglan and previd for my acid reflux.My doctor said he don’t no what cause this I’M just wondering if this is another side affect to taken reglan if anyone else has what I got post it on here.
I’m so glad I read all this. I was on reglan/metaclopramide for the past 20 years and wasn’t sure if all the things I am expereincing are just age or the Reglan. Now I know. I was taken off reglan a couple of years ago because my gastrointerologist noticed I was having some nerve problems. Shakeing, twitching, jaw clenching, teeth grinding, muscle weakness and severe lethargy and depression. All this has progressively gotten worse since. Now I have no feeling in my abdomen. Can’t tell if I’m hungry or full or if I need to urinate or deficate. I recomend that anyone given Reglan see a neurologist and also always ask your Doctor and Pharmacist about side affects of any drug you are given before taking it. Don’t just trust that they know what’s best for you. This drug has caused me so much damage I wish I would die and this would all be over. Please don’t take this drug no matter how much your Doctor says you need it. I am so sorry for anyone who has been damaged by this drug. I think they should take it off the market.
I was prescribed reglan to keep me from throwing up when I was pregnant I was wondering has anyone reported birth defects or infant loss after taking reglan? I had a miscarriage when I was 19 weeks and not sure if reglan could have been the cause of my baby’s health problems that caused her to pass away…
i was on reglan foe 10 yrs after I was diagnosed with GERD and I know have a large hiatal hernia i suffered from depression to severe anxiety and uncontrolable diarrea i after about 2 yrs I was diagnosed with type 2 diabetes and am having a lot of problems with my stomach i have severe pains and cramping around the stomach area i belch all the time my daughter does not like the way i eat cause she says i smack my lips awful i cant help i my bowels are out of control one day i am constipated and the next day i have bowel movements with realizing i went in my pants it is very embarrassing when people tell you that you stink and you realize that your underware is filled with bm what do i do no one believes how much i suffer
Hi.My name is Wally and if your child is doing better that\’s great.i see He still has some problems hope they go soon.i am responding to you because my wife got Parkinsons from Reglan so i would keep a very keen eye on the boy if you see any symptoms at all report to your Dr. or emergency room rite away i would stop it for any reason,but you have a different situation i suppose.i only wish i had known about the possible side effects sooner my wife may be better today.She is a Master Educated Woman that dedicated her time to be a School Teacher,but now is a shell of the person She was from Reglan.please be very careful with this drug.and i am not against needed drugs,but we are the final end of the meds.processes.believe me when i say watch what is going on you care more than any Dr.that\’s just the way it is.good luck and kids are the best part of life wish i could do it all again.