2019 Update: Daiichi Sankyo agreed to pay $358 million in 2017 to settle over 2,000 lawsuits. Some plaintiffs opted out of the global settlement but the vast majority of these cases settled in the global resolution. The warning label on Benicar has been update to include sprue-like enteropathy since 2013.
Benicar, marketed as Benicar, Benicar HCT, Azor, Tribenzor, and in the generic form as olmesartan medoxomil, is a commonly prescribed drug used to treat hypertension or high blood pressure. This drug is now the subject of a new FDA investigation into its role in producing sprue-like enteropathy.
Sprue-like enteropathy is a disorder which mimics the symptoms of celiac disease such as chronic diarrhea, substantial weight loss, vomiting, dehydration and related cardiovascular problems. That sounds, on some level, like not a huge deal. So let's be more clear: this condition is dire and can cause serious injury and death.
The difference between celiac disease and Benicar induced sprue-like enteropathy is that patients with celiac disease can largely control their symptoms by eliminating gluten from their diet. Patients with Benicar induced sprue-like enteropathy will see no improvement from a gluten-free diet. Their symptoms will only subside if the drug is entirely discontinued.Symptoms of Enteropathy from Benicar
The symptoms are:
- Weight loss
- Enlarged gallbladder
- Cardiovascular problems
- Elevated white-blood-cell count
- Colon perforation
The last one on that list, colon perforation, is the latest concern. Case Reports in Gastrointestinal Medicine published a study this year that raised a lot of eyebrows. A woman had severe sprue-like enteropathy and went to the emergency room complaining of severe abdominal pain and nausea. She had a cardiac arrest and was found to have a colon perforation. Thankfully, she did not need surgery and her symptoms resolved. Her doctor first step to healing her? It was getting her off Benicar.
Is this a big deal? Time will tell.Studies on Benicar
Even before the FDA warning about Benicar’s side effects, these effects had been documented by those in the medical community. The Mayo Clinic in Rochester, Minnesota reported that a study of 22 patients on Benicar who were hospitalized with celiac disease-like symptoms showed that they were unable to control those symptoms with a gluten-free diet. Suspecting a direct link between Benicar and the abdominal symptoms, the clinic asked the patients to fully discontinue their use of the drug.
The big question is what happened to these patients after they stopped taking the drug? After all, maybe their sprue-like enteropathy was from something other than Benicar. Well, the patients’ symptoms improved dramatically, including an average reported weight gain of 27 pounds! This tells us something, doesn't it? In fact, that is part of how the problem was solved. People were going off Benicar and seeing the symptoms resolve only to go back on it again and they return. The big question: why couldn't they figure this out during the clinical trial of the drug?
Since the results from the Mayo Clinic were released, an additional 40 cases of Benicar induced sprue-like enteropathy have been reported. That number should increase as patients and doctors become aware of Benicar’s potentially severe abdominal effects.
This has all led the FDA last year on July 4, 2013, to issue a warning stating the obvious: sprue-like enteropathy. According to the FDA warning, symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The FDA approved changes to the labels of Benicar to include this concern. This is now on the drug's label. It should have been there a lot sooner than it was. Clearly, doctors need to know Benicar can be a cause of this severe diarrhea and the injuries that ensue.
A new 2014 study sheds further light. The Journal of Pharmacy Practice took a look at the mounting evidence linking the use of Benicar and symptoms similar to celiac disease. These symptoms include unexplained chronic diarrhea, weight loss, and enteropathy. The study included data used for prior studies from 1965 through November 2013, as well as information obtained from the FDA. Researchers additionally evaluated data from 22 cases where patients with Celiac disease like symptoms improved after being taken off Benicar (Olmesartan).
The study confirmed what other studies before it did, “There is growing evidence supporting the association between olmesartan and sprue-like symptoms…” adding however, “further research is warranted.” Sure, you could always use further evidence. But how much more do you need to conclude that the overwhelming likelihood is that there is a connection?What is the Settlement Value of Benicar Lawsuits?
2019 Update: These cases resolved for $358 million as we mentioned above. Below is our speculation. We were not far off.
Now we enter the world of pure speculation. These cases are just now getting off the ground. Plaintiffs' lawyers have not even sought an MDL class action yet because there are not enough cases to warrant a consolidated action. But the smart money says that this will change quickly given that these injuries do not appear to be all that uncommon.
You can expect the settlement range of these cases to vary more wildly than most mass tort claims because the injuries are going to range from very small cases where the award might be as little as a few thousand dollars and a death or permanent injury case where a settlement could be in the millions. This is true in any mass tort settlement because the injuries always vary. But it holds particular force in these Benicar lawsuits.Do You Have a Benicar Claim?
If you are currently on Benicar and have experienced celiac disease-like symptoms, you should see your prescribing doctor right away and ask if discontinuing use of the medication is the right option for you.
The Benicar lawsuits argued that the drug company Daiichi Sankyo failed to warn doctors and patients about the connection between Benicar and sprue-like enteropathy. If they had, many of the sufferings that has occurred would not have happened. Now there is a warning that makes the risk of these problems clear.Can Filing a Lawsuit Help Me?
We are unaware of any lawyers who are still taking Benicar lawsuits. Why? Because the warning label now adequately warns of these problems.