Roughly 70 million Americans are living with high blood pressure. When diet and exercise aren’t enough, doctors often prescribe antihypertensive medications to treat their patients. One popular drug to treat high blood pressure came under fire in recent years after it was linked to a serious gastrointestinal disorder. Now lawsuits are piling up against the drug’s manufacturer as patients harmed by the drug attempt to seek justice for their suffering.
What is Benicar and what is it used to treat?
Benicar is a popular medication indicated to treat high blood pressure in adults and children aged six to 16. The main ingredient in Benicar, olmesartan, belongs to a family of drugs called angiotensin receptor blockers, or ARBs. About 7 in 10 U.S. adults with high blood pressure take some form of medication, including ARBs, to treat their condition.
High blood pressure, or hypertension, is a condition where the force of blood pushing against the walls of the arteries is too high. Arteries carry blood away from the heart to other parts of the body. High blood pressure can eventually damage the heart and lead to other health problems. It is often called the “silent killer,” because many people do not know they have high blood pressure but the condition could lead to serious, even deadly medical emergencies if left untreated. Those emergencies include heart attacks, stroke and kidney failure.
About 1 in 3 American adults have high blood pressure, a condition called hypertension, and another one-third of adults have pre-hypertension. High blood pressure costs the nation roughly $46 billion each year in health care services, medications and missed days of work, according to the Centers for Disease Control.
How does Benicar work?
Olmesartan, the active ingredient in Benicar, belongs to a class of drugs called angiotensin receptor blockers. Like the name suggests, ARBs work to lower blood pressure by blocking the activation of angiotensin II AT1 receptors in the body. Blocking these receptors causes blood vessels to widen, which causes blood to flow through more easily and reduces blood pressure.
Blocking the AT1 receptors also reduces the amount of vasopressin and aldosterone released in the body. Vasopressin is an antidiuretic hormone that retains water in the body and constricts blood vessels; aldosterone is a steroid hormone that plays a key role in regulating blood pressure.
Other olmesartan-containing drugs include Benicar HCT, Azor and Tribenzor.
Who makes Benicar?
Benicar is manufactured by Japan-based Daiichi Sankyo, a powerhouse pharmaceutical company employing more than 32,000 people worldwide.
In 2014, Daiichi Sankyo made over $8.5 billion in revenue, to which Benicar contributed a mere fraction. The former blockbuster drug brought in well over a billion dollars each year between 2009 and 2011, but sales of Benicar have been dropping steadily since 2012. Thanks in part to competition from generic versions of similar drugs, the most recent data show Benicar’s North American sales at $700 million in 2014, down more than 37 percent from 2011.
When was Benicar approved by the FDA?
The Food and Drug Administration (FDA) approved Benicar on April 25, 2002, making it the seventh drug of its kind on the market. After its approval, Benicar became one of the top-selling drugs in its class in the U.S.
What are the side effects of Benicar?
Benicar, like all prescription medications, has potential side effects which can range from mild to severe. The most common side effects of Benicar are:
- Upper respiratory tract infections
- Too much uric acid in the blood
Other more serious side effects are also possible with Benicar. These include:
- Low blood pressure (hypotension)
- Kidney problems
- Chronic diarrhea with significant weight loss (sprue-like enteropathy)
What is sprue-like enteropathy?
Since its approval, Benicar has also been plagued by ongoing safety reviews by the FDA. Roughly three years ago, the FDA announced it was investigating a potential gastrointestinal side effect of Benicar called sprue-like enteropathy.
Sprue-like enteropathy is a condition that affects the small intestine and causes severe, chronic diarrhea and substantial weight loss. The gastrointestinal condition can occur several months to several years after a person starts taking Benicar. In some cases, it is severe enough to require hospitalization. Symptoms typically subside about a week after a person stops taking the drug.
The symptoms of sprue-like enteropathy mimic those of Celiac disease, and oftentimes Benicar patients are misdiagnosed or their diagnosis is delayed. Celiac disease is a hypersensitivity to gluten, which causes inflammation and damage to the small intestine. Patients with Celiac disease benefit from a gluten-free diet. Patients with sprue-like enteropathy caused by Benicar, on the other hand, do not benefit from a gluten-free diet. Instead, their symptoms subside only when they stop taking Benicar.
Sprue-like enteropathy can also lead to another condition called villous atrophy, which causes the finger-like projections in the small intestine to erode away. These projections, called the villi, are responsible for absorbing nutrients from food to be used by the body.
After reviewing studies and other data sources that linked Benicar use to sprue-like enteropathy, the FDA required Daiichi Sankyo to include a warning on the drug’s label.
What are the symptoms of sprue-like enteropathy?
The most common symptom of sprue-like enteropathy is chronic diarrhea with weight loss, but patients with the condition can also suffer from the following symptoms:
- Nausea and vomiting
- Abdominal pain
In some cases, patients suffering from sprue-like enteropathy had symptoms severe enough to require hospitalization, even stays in the intensive care unit.
Severe symptoms that required hospitalization included:
- Severe dehydration
- Electrolyte imbalance
- Acute renal failure (kidney failure)
- Need for parenteral nutrition (feeding a person intravenously).
How does Benicar cause sprue-like enteropathy?
It is unclear exactly how Benicar can cause sprue-like enteropathy in some patients. Researchers suggest that because it usually takes a while for the symptoms of sprue-like enteropathy to appear, the condition could be caused by a delayed hypersensitivity to the drug.
The inhibitory effects of Benicar on a certain protein in the body called the transforming growth factor beta (TGF-beta) may also cause sprue-like enteropathy, since TGF-beta is an important mediator of gut homeostasis.
The first study to report on the effects of Benicar on sprue-like enteropathy by Rubio-Tapia et al. also suggested the presence of HLA-DQ2 in the body may predispose a person to sprue-like enteropathy while taking Benicar. HLA-DQ2 is one of the major risk factors for Celiac disease.
Do all ARBs cause sprue-like enteropathy?
The FDA analyzed data to see whether or not other ARB drugs were causing sprue-like enteropathy in some patients. According to the agency, people taking olmesartan (Benicar) had a higher rate of Celiac disease diagnoses than people taking other ARBs. The agency concluded the increased risk of sprue-like enteropathy was most likely not a class effect – meaning it was specific to olmesartan-containing drugs and not all ARBs.
Has the FDA issued any warnings about Benicar?
The FDA has issued several warnings about Benicar, including two “black box” warnings, since the drug was approved in 2002. Black box warnings are the agency’s strictest warnings and are reserved for products with serious potential risks.
“Black Box” Warnings
In 2012, the FDA added a black box warning to the label of Benicar telling women to avoid its use during pregnancy. Benicar has the potential to cause injury or death to developing fetuses and women should stop taking Benicar as soon as they know they are pregnant, the warning states.
In 2013, the FDA added the potential risk of sprue-like enteropathy to the labels of Benicar and other olmesartan-containing drugs, including Benicar HCT. The warning indicated the drugs have the potential to cause severe, chronic diarrhea with substantial weight loss months to years after taking Benicar. It also said many patients who developed sprue-like enteropathy also developed villous atrophy.
In 2011, the FDA required Daiichi Sankyo to update the Benicar label with a warning about the use of NSAIDs with the antihypertensive medication. The new requirement warned that taking Benicar with NSAIDs (non-steroidal anti-inflammatory agents), like ibuprofen and aspirin, could weaken the effects of Benicar.
In elderly patients or those with decreased kidney functions, using NSAIDs with Benicar could result in deterioration of kidney function, including acute kidney failure.
Has Benicar been recalled?
Neither the FDA nor Daiichi Sankyo has initiated a recall of Benicar due to the possible gastrointestinal side effects associated with the drug. Daiichi Sankyo did voluntarily recall certain batches of Benicar and Benicar HCT in 2014 because they were not stored at the proper temperature while being shipped.
Are there alternatives to Benicar on the market?
There are several other drugs in the same class as Benicar, as well as medications in different drug classes, that treat hypertension. These drugs may work differently in different people, and should not be considered as substitutes or replacements for Benicar, nor are these drugs equivalents to Benicar.
Angiotensin receptor blockers currently on the market include:
- Cozaar (losartan)
- Atacand (candesartan)
- Diovan (valsartan)
- Avapro (irbesartan)
- Micardis (telmisartan)
- Teveten (eprosartan)
- Edarbi (azilsartan)
Two other classes of drugs that treat hypertension include ACE (angiotensin-converting-enzyme) inhibitors and beta blockers. These drugs also help treat hypertension but work in different ways than ARBs.
Is Benicar expensive?
The price of Benicar may differ depending on a patient’s particular situation, including whether or not he or she has insurance that covers the expense of prescription medication. According to Drugs.com, Benicar costs about $3 to $7 per pill without insurance, depending on the dosage.
Some patients may be eligible for patient assistance programs, discount cards or other coupons. Daiichi Sankyo offers a savings card for some Benicar patients, as well.
Is there a generic version available?
There are no generic equivalents of Benicar available — yet. Daiichi Sankyo is set to lose exclusivity rights over Benicar in October 2016, when the patent for drug’s main ingredient expires. When drugs go “off-patent,” other pharmaceutical companies can start making generic equivalents, which are generally cheaper than their name-brand counterparts.
The generic name of Benicar is olmesartan, the same as its active ingredient.
How do you take Benicar?
Benicar is available in 5 mg, 20 mg, and 40 mg once-daily tablets. Benicar dosages are individualized for each patient. The recommended starting dose for adults is usually 20 mg once a day, according to the drug’s label. After two weeks, the dosage can be increased to 40 mg if blood pressure needs to be lowered further. Benicar can be taken with or without food
It is possible to overdose on Benicar. Seek emergency medical help or call Poison Control at 1-800-222-1222 if an overdose occurs.
Symptoms of a Benicar overdose can include:
- Extreme dizziness
- Fast or slow heartbeat
Are there lawsuits against the makers of Benicar?
After the FDA’s 2013 warning about the risk of sprue-like enteropathy and Benicar, hundreds of patients harmed by the drug filed lawsuits against its maker.
There are nearly 1,300 lawsuits pending in federal court against Daiichi Sankyo, the manufacturer of Benicar and Benicar HCT. The lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey. U.S. District Judge Robert B. Kugler is presiding over the MDL.
The lawsuits allege Daiichi Sankyo failed to adequately warn patients about the potential risk of gastrointestinal disorders while taking Benicar.
Daiichi Sankyo is no stranger to lawsuits. In 2015, the pharmaceutical company settled a lawsuit filed by the U.S. Department of Justice for $39 million. The lawsuit claimed Daiichi Sankyo provided illegal kickbacks to doctors who prescribed Benicar. A former Daiichi Sankyo representative blew the whistle on the company’s illegal operations and received more than $6 million from the settlement.
I developed sprue-like enteropathy after taking Benicar. Can I file a lawsuit?
If you took Benicar, Benicar HTC, Azor or Tribenzor and developed sprue-like enteropathy or villous atrophy, you may be entitled to compensation. With lawsuit already pending in federal court, it is important that you act now. Contact the Hood National Law Group today for a free case evaluation by calling 1-800-214-1010 or use the form on the right-hand side of the screen.