New Diabetic Drug Similar to Byetta, Victoza Approved, Despite Cancer Risks
Federal drug regulators have approved a new weekly incretin mimetic diabetes injection, which works similar to the existing drugs Byetta and Victoza. However, the medication will be introduced with a black box warning about the potential risk of thyroid cancer, and comes amid continuing concerns about the potential risk of pancreatic cancer associated with the entire class of diabetes drugs.
Eli Lilly’s Trulicity (dulaglutide) was approved by the FDA on September 18, as a weekly subcutaneous injection designed to help diabetics control blood sugar levels.
It is part of a class of medications known as incretin mimetics, which also include the blockbuster diabetes injections Byetta and Victoza, as well as popular oral versions like Januvia and Janumet.
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Learn MoreThe approval comes after only six clinical trials involving just 3,342 patients, and as many experts question the safety of incretin mimetics and whether the potential risk of pancreatic cancer and severe pancreatitis outweigh the benefits provided over other available diabetes treatments.
Trulicity will carry a black box warning at the time it is introduced, which is the strongest warning the FDA can require for a prescription medication, indicating that use of the medication may be linked to the development of thyroid c-cell tumors.
The agency also only agreed to release the drug with a Risk Evaluation and Mitigation Strategy (REMS), which involves a communication plan to ensure that doctors are fully informed about the risk of Trulicity side effects.
FDA officials determined that approval of the medication was justified, due to the diabetes epidemic in the U.S.
Eli Lilly will be required to conduct a number of post-marketing studies to be conducted, including tests for cardiovascular risks, a pediatric safety study, a thyroid cancer study, a study on reproductive side effects and a study involving patients with kidney problems.
Diabetes Drug Cancer Lawsuits
Trulicity will be introduced as a growing number of Byetta lawsuits, Victoza lawsuits, Januvia lawsuits and Janumet lawsuits continue to be filed against the makers of the other members of this same class of medications.
In the federal court system, more than 500 cases filed on behalf of individuals nationwide diagnosed with pancreatic cancer after using the medications are consolidated as part of an incretin mimetic diabetes drug litigation, which is centralized for pretrial proceedings before U.S. District Judge Anthony Battaglia in the Southern District of California as part of an MDL, or multidistrict litigation.
Incretin mimetics work by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin following a meal.
Side effects of the diabetes drugs have previously been linked to a risk of severe pancreatitis, which some reports suggest may lead to the development of pancreatic cancer for some users.
As part of the coordinated pretrial proceedings before Judge Battaglia, it is expected that a series of early trial dates will be scheduled in the MDL involving each of the different medications, to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes are not binding in other cases, it may help the parties reach additional agreements to settle Byetta and Januvia cases.
On September 16, parties involved in the cases participated in a telephone case management conference to discuss moving the cases forward toward resolution. The next status conference is scheduled for October 9, and
The parties are dealing with a number of disputes over the discovery process, where both sides turn over documents and interview witnesses relevant to the claims and allegations. The next status conference is scheduled for October 9, and it is possible that the first trial dates may begin in late 2015.
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15 Comments
ElizabethApril 7, 2020 at 10:29 am
I took my first and last injection of Trulicity on March 22, 2020 and 2 weeks later I am still experiencing awful side effects. The first week I was forcing myself to eat here and there, had zero appetite, nausea, feeling like I wanted to vomit, dizziness, severe heartburn/acid reflux, stomach pain, gastroparesis, and suddenly I got dry mouth as well. The stomach pains were so bad they’d wake me u[Show More]I took my first and last injection of Trulicity on March 22, 2020 and 2 weeks later I am still experiencing awful side effects. The first week I was forcing myself to eat here and there, had zero appetite, nausea, feeling like I wanted to vomit, dizziness, severe heartburn/acid reflux, stomach pain, gastroparesis, and suddenly I got dry mouth as well. The stomach pains were so bad they’d wake me up and I wanted to cry. every time pain started in a different area, my anxiety would go way up thinking it was appendicitis or heart trouble. It’s horrible that I’m not able to sleep and that the symptoms are still occurring over 2 weeks after I stopped taking it. Tonight I felt like someone was burning me with matches from the inside of my chest and I slept hardly at all. I cannot believe the FDA approved this torture drug.
JanetMay 4, 2018 at 8:01 am
I was prescribed Trulicity. About 3 days after the first shot I went to urgent Care for lump in throat. I was told gargle with salt water. The next day I went to doctor office as my throat was swelling and feeling aweful. I was given antibiotic and was told to get plenty of rest and drink lots of water. The next day I was in emergency as my throat was swollen more. I was then sent to las Vegas hos[Show More]I was prescribed Trulicity. About 3 days after the first shot I went to urgent Care for lump in throat. I was told gargle with salt water. The next day I went to doctor office as my throat was swelling and feeling aweful. I was given antibiotic and was told to get plenty of rest and drink lots of water. The next day I was in emergency as my throat was swollen more. I was then sent to las Vegas hospital and was admitted there . They were looking at taking out my tonsils. I was on iv antibiotics and was told I was dehydrated. I was then told I could go home. They did not see any thing wrong with tonsils. I was told I could take the shot of Trulicity. I was only allowed short acting insulin and pain meds. About Wednesday of that week I was feeling sick again my throat swelled again. I drank lots of ice water. Sunday I took my 3 shot of Trulicity. By Wednesday again I started getting swollen neck again and my coworkers seen the ad for trulicity and told me that the side effects sounded like what I was having. I went to ER again and was treated for allergic reaction to Trulicity. I was taking benydral for over a week. Stopped taking Trulicity and have not had any problems with my neck swelling or feeling sick like I did.
ElaineDecember 23, 2017 at 1:47 am
After reading the other comments on Trulicity, I realize I dodged a major bullet. No abdominal pain or pancreatitis, but I did end up in the ER twice with extreme faintness, which was attributed to dehydration. The first time (September 2016), I had donated blood, so I assumed it was an after-effect from that (and maybe it was). I did not completely pass out that time, but could not make the short[Show More]After reading the other comments on Trulicity, I realize I dodged a major bullet. No abdominal pain or pancreatitis, but I did end up in the ER twice with extreme faintness, which was attributed to dehydration. The first time (September 2016), I had donated blood, so I assumed it was an after-effect from that (and maybe it was). I did not completely pass out that time, but could not make the shortness of breath and faintness go away, so my husband called an ambulance for me. I was given IV fluids in the hospital and went home feeling tired but better, a few hours later. 2-3 months later (December 2016), I passed out completely at work and went home once I could drive. It was a quiet day and nobody noticed me unconscious at my desk. I must have been out only a minute or less. A few months after that (March 2017), I felt faint again and attempted to drive home (I live close to my job). However, I became very faint and had to pull over into a parking lot. I did not completely black out but did lose control of my bladder. Went home; felt better gradually. Finally in May of this year, I felt faint again. I had talked to my endo about this; she said I just needed to do a better job of controlling my bg. I had requested referrals to a cardiologist and a neurologist, but none were forthcoming. So I decided that if I had these faintness symptoms again, I would just go to the ER and have them sort it out. That's what I did. A coworker took me to the ER and watched me pass out cold in a wheelchair for a couple of minutes. When I came to, I started vomiting. Admittedly, there are plenty of gray areas here. At the time, I was not "behaving" well as a Type 2 diabetic. I was drinking too little water and too much alcohol and not staying on top of the medication doses. I was strongly resisting transitioning to regular doses of insulin. So there are plenty of other possible reasons for the fainting. But in both September and May, I was diagnosed with acute dehydration by the ER physicians, and I was taking Trulicity once a week. I only stopped taking the Trulicity shortly after that May ER visit because the price went way up. I had been getting it at Costco for $25 a 4-dose box, and it suddenly went up to over $80 just after my stay in the hospital. So I declined to refill the prescription, because I hadn't noticed any significant benefit from taking it. The only thing I liked about Trulicity was that it was easy to inject, virtually painless. Several months later (October 2017), I visited my endo again. She urged me to get back on Trulicity because it is an appetite suppressant (supposedly). I declined, due to the cost. That very day I was watching TV and saw a Trulicity commercial. That was the first time I noticed the warning about dehydration. It occurred to me that all four times I'd fainted, I'd been taking Trulicity. I took it for approximately one year. My endocrinologist did not mention anything about dehydration when urging me to take Trulicity, both in February of 2016 (before I started using it) and October of 2017 (after I had stopped). I have not had any fainting symptoms since June of 2017 (I had weakness after donating blood again and have simply decided to stop donating). I am doing a much better job of staying hydrated; alcohol consumption is much lower, and I'm taking Humalog and my oral meds regularly. But I believe the Trulicity aggravated the dehydration to the point of losing consciousness. I had never been a big water-drinker before this series of episodes, but had not experienced faintness until an 8-month stretch that, coincidentally or no, fell within the year that I was taking Trulicity.
PaulOctober 26, 2017 at 5:53 pm
Was on this for less then a month fourth week shot got bad pain in stomach area.after four days went to hospital they said had pancreatitis could have died if ignored pain.nasty drug still not doing great don't recommend it at all.
JaimeOctober 24, 2017 at 2:26 am
One day after taking my first injection I had the worst abdominal pain and vomiting I had ever had in my life. At first I thought I had caught a nasty stomach virus because one of my daughter was also ill. Hers went away after a day and mine continued for 4 more. I started to feel half way better and by that time I was ready to inject for week 2. That very evening I took the injection I began vomi[Show More]One day after taking my first injection I had the worst abdominal pain and vomiting I had ever had in my life. At first I thought I had caught a nasty stomach virus because one of my daughter was also ill. Hers went away after a day and mine continued for 4 more. I started to feel half way better and by that time I was ready to inject for week 2. That very evening I took the injection I began vomiting and having stomach cramps. I ended up in my physicians office the next morning getting 2 liters of saline a blood draw and a CT with contrast to make sure I didn't have pancreatitis. This was the worst side effects I have ever had with any drug. It should be taken off the market.
jamesOctober 10, 2017 at 7:14 pm
I was taking trulicity for 4 weeks the 4th week I had a stoke on the medicine I need a lawyer am in nc does any one know a good one
AlexSeptember 12, 2017 at 1:46 pm
After being prescribed trulicity I researched it and did not like any of the side effects I saw. It took my doctor several months to convince me to fill the prescription. After the first shot I was having abdominal pains and feeling like crap for the first couple of days after taking each of the five shots I took over the course of five weeks. After the 5th shot I ended up in the emergency room du[Show More]After being prescribed trulicity I researched it and did not like any of the side effects I saw. It took my doctor several months to convince me to fill the prescription. After the first shot I was having abdominal pains and feeling like crap for the first couple of days after taking each of the five shots I took over the course of five weeks. After the 5th shot I ended up in the emergency room during the middle of a hurricane in October of 2016. My wife and daughter had to drive me in Hurricane conditions for an hour to get to an emergency room that was 5 minutes away. The worst part about this is that not a single person in the emergency room or in the building had ever heard of trulicity. They treated me at first for kidney stones even after I told them that I believed it was an allergic reaction to trulicity. I had all the information on trulicity and they had no interest in educating themselves on it to make sure they treated me correctly. Turns out the trulicity gave me pancreatitis. I suffered immensely from this. Next visit to the emergency room was a few weeks later because my GI tract was still giving me trouble from the trulicity. My doctor instructed me to go back to the emergency room to see about being admitted into the hospital. Once again not a single person in a different emergency room had ever heard of trulicity. So obviously I was again concerned since the doctor nor the nurse nor the tech knew what Trulicity was. After being there an hour and a half I was told by the emergency room doctor that he could write me a prescription for a stool softener and that he didn't know why I was there that I really needed to be seeing my regular GI doctor. In other words he didn't have a clue what to do so he just shoved me out the door. It's been a year now I still have all kinds of problems that I attributed to trulicity I've lost so much weight that I can't even gain back I have no strength no stamina. Do not take this drug it could and will kill you if given the chance.
LeannaJune 13, 2017 at 4:01 am
In November 2016 I suffered extreme pain in my abdomen, non stop diarrhea and vomiting that was mostly blood. I was taken to the ER and coded there due to loss of blood. I had an Xray which showed that an stem of the aortic which supplied the duodenal head and pancreas burst (Abdominal Aneurysm), filling my abdomen with blood (what was dx as AAA) I had been given an emergency surgery to put a[Show More]In November 2016 I suffered extreme pain in my abdomen, non stop diarrhea and vomiting that was mostly blood. I was taken to the ER and coded there due to loss of blood. I had an Xray which showed that an stem of the aortic which supplied the duodenal head and pancreas burst (Abdominal Aneurysm), filling my abdomen with blood (what was dx as AAA) I had been given an emergency surgery to put a stent in the artery to stop the blood loss. I just discovered this board while researching the drug Trulicity since I was given this for my diabetes 2, I was on for several months and went off of it due to the stomach pain. I wonder if this is what made this happen to me?
VirginiaApril 28, 2017 at 9:50 pm
I started taking Trulicity about 4 months ago. At first I had no problem, but now I have a lot of pain in my abdomen and my back. Also, diarrhea and extreme fatigue. I've also broken out with bumps on my scalp, which may be unrelated, but I've never had that in my life. (81)
YvonneSeptember 20, 2016 at 7:01 pm
I started taking injections of Trulicity the latter part of March and a week later, I experience pain in the lower left abdominal area and back. The pain became progressively worseI over the past 4 months. I have been in and out of emergency rooms, after-hour care facilities and different doctor's office. I have had CAT scans and x-rays, and change in medications to include high powered pain[Show More]I started taking injections of Trulicity the latter part of March and a week later, I experience pain in the lower left abdominal area and back. The pain became progressively worseI over the past 4 months. I have been in and out of emergency rooms, after-hour care facilities and different doctor's office. I have had CAT scans and x-rays, and change in medications to include high powered pain medications. My appetite has decreased immensely in spite of taking insulin shots. Can't go far from home due to pain due to the IBS. WILL NEVER TAKE THIS MEDICATION AGAIN!!!!
PatriciaApril 7, 2016 at 4:34 pm
After 1 week of taking the low dose Trulicty I started getting sick and having pain. At 2 months I had pancreatitis and severe GERD. 5 weeks later I'm still eating soups and very small meals that include crackers because of the acid stomach and pain in my side. The medication worked well on my diabetes but I have been so sick since I started this drug in January. Had an EGD yesterday and I'm fina[Show More]After 1 week of taking the low dose Trulicty I started getting sick and having pain. At 2 months I had pancreatitis and severe GERD. 5 weeks later I'm still eating soups and very small meals that include crackers because of the acid stomach and pain in my side. The medication worked well on my diabetes but I have been so sick since I started this drug in January. Had an EGD yesterday and I'm finally starting to heal.
kathyMarch 23, 2016 at 11:20 pm
After taking Trulicity I developed, horrible abdomen pain, nausea, dizziness, etc and was just diagnosed with acute pancreatitis and 4 pseudo cysts on pancreas. Don't take this drug.
loriMarch 4, 2016 at 5:34 am
After taking Trulicity i ended up with pancretitis sick for weeks. this drug is nasty!!! Still cannot eat much food.. still on soups and soft stuff.. Was not fun being sick daily and in pain... :( beware of this drug.. NOT GOOD!!!
BettyNovember 29, 2015 at 8:13 pm
After taking Trulicity I ended up in the hospital with a kidney infection, was out of work and lost my job, now have large lumps on my neck and throat. I have endured 7 biopsies and several doctors cannot determine what is wrong with me? I believe it is due to the Trulicity? Are there any other facts to correlate this?
kendallNovember 6, 2015 at 11:56 pm
This drug is poison, do not be fooled by big pharma, they only care about profit magins.