When Benicar was first approved by the U.S. Food and Drug Administration for treating high blood pressure in 2002, it was hailed as a superior treatment option to existing drugs at the time.
In the years since, countless people have suffered from adverse and unexpected side effects while taking Benicar. These side effects include serious pregnancy-related risks like fetal toxicity and intestinal problems like sprue-like enteropathy.
Thousands have filed lawsuits against the makers of Benicar over claims that the companies failed to disclose risks. This resulted in Daiichi Sankyo and Forest Laboratories agreeing to a $300 million settlement if 95 percent of plaintiffs enrolled in the settlement program.
What is Benicar?
Benicar is the brand name of a drug with the active ingredient olmesartan medoxomil. It is part of a class of medications known as angiotensin II receptor antagonists, which are used to treat high blood pressure.
Benicar works by getting absorbed into the blood and releasing olmesartan. Olmesartan stops a chemical called angiotensin II from binding to receptors. Angiotensin II normally tightens and narrows blood vessels. However, when the chemical is blocked, blood vessels relax and widen, according to Daiichi Sankyo1.
The drug ultimately blocks natural chemicals in the body that cause high blood pressure to help treat hypertension.
Drugs Containing Olmesartan Medoxomil
These are the drugs containing olmesartan medoxomil from Daiichi Sankyo. Generics are also available.
- Benicar HCT
History of Benicar
Benicar was first developed by Japanese pharmaceutical company Sankyo in 1995. However, it wasn’t approved for use in the United States until April 2002 when the FDA granted it approval for the treatment of hypertension in adults. Sankyo partnered with Forest Laboratories to promote the drug.
“We’re very enthusiastic about Benicar,” John Alexander, president of the Sankyo’s development division at the time, said in a press release2. “Clinical trials clearly establish the efficacy and safety of Benicar and demonstrate that it offers healthcare providers who treat hypertensive patients, a new viable option for controlling high blood pressure.”
Between 2002 and 2008, Daiichi Sankyo was thought to have spent $1 billion in promotional spending on Benicar3. The marketing paid off as the Benicar products brought in billions in sales for the company.
In 2012, around 10.6 million prescriptions were given for Benicar. The drug also reportedly brought in $3.1 billion in 2013 and $2.4 billion in 2014.
The revenue generated by Benicar has dropped precipitously since 2016, the year Daiichi Sankyo lost its patent on the drug and cheaper generic alternatives became available.
Common Benicar Side Effects
Patients who take Benicar may experience common side effects4, such as:
- Back pain
- Stomach pain
- Flu-like symptoms
- Blood in the urine
- Joint pain
Serious Benicar Side Effects
Benicar is also linked to more serious side effect, including:
- Chest pain
- Breathing difficulties
- Hair loss
- Muscle tissue breakdown
- Kidney failure
- Allergic reactions
- High cholesterol
Benicar Connected with Severe Complications
Since its inception, Benicar has been linked to severe complications. One of the most serious risks Benicar poses to patients taking the drug is fetal toxicity.
Studies have shown that women who take Benicar during pregnancy, especially during the second and third trimesters, may put the fetus at risk of fetal kidney failure and other complications.
This is why Benicar carries a black-box warning5 — the strongest warning on a drug label — that says, “Drugs that act directly on the renin-angiotensin system can cause injury
and death to the developing fetus.”
Other dangers Benicar may pose to the fetus include skeletal deformations, skull hypoplasia, anuria, low blood pressure, and death.
FDA Adds Intestinal Warning to Benicar Labels
In 2013, the FDA issued a safety announcement warning that medications containing olmesartan medoxomil could cause intestinal problems known as sprue-like enteropathy6. Symptoms of sprue-like enteropathy include severe, chronic diarrhea and weight loss.
During its evaluation of adverse effects reported via its Adverse Event Reporting System, the FDA found 23 serious cases that looked like late-onset diarrhea with weight loss. Researchers at the Mayo Clinic also found 22 patients taking olmesartan medoxomil who exhibited the same symptoms.
The FDA announced that it was making changes to the label of all drugs containing olmesartan medoxomil to reflect the risks of developing sprue-like enteropathy.
FDA Accuses Sankyo of Misleading Benicar Marketing
As early as 2006, drugmaker Sankyo has been accused of misleading marketing tactics that violated FDA regulations. A warning letter sent to the company that year called an ad misleading “because it contains unsubstantiated effectiveness and superiority claims, and omits and minimizes information on the risks associated with Benicar and Benicar HCT.”
The letter detailed how the ad made false claims that it was better than competitors and highly effective while downplaying the risks associated with fetal renal failure when taken during pregnancy.
The FDA sent another letter with similar claims that the Benicar marketing campaign was misleading in 20137.
Daiichi Sankyo Settles Kickback Allegations with Government
Then, in 2015, Daiichi Sankyo agreed to pay $39 million to the United States and state Medicaid programs after it was accused of paying kickbacks to doctors in order to boost sales for drugs like Benicar8.
The lawsuit was brought by whistleblower Kathy Fragoules, who was a former sales representative of Daiichi. She received $6.1 million for her role in shedding light on the company’s violations of the False Claims Act.
Thousands File Benicar Lawsuits
The federal government wasn’t the only one to take on the makers of Benicar. Thousands of people who took Benicar for hypertension and suffered unexpected side effects have filed lawsuits against Daiichi Sankyo and Forest Laboratories over claims that the companies falsely marketing the drug and downplayed risks.
Injuries mentioned in the lawsuits include intestinal problems stemming from sprue-like enteropathy, such as diarrhea and cramping.
In one of the earliest lawsuits, plaintiff George Williams claimed to have been hospitalized for more than 100 days over the course of four years after taking Benicar and suffering from chronic diarrhea. He suffered a compression fracture in his back and developed cataracts in both eyes. He now requires a feeding tube, according to Law3609.
Daiichi Sankyo Agrees to $300 Million Benicar Settlement
The number of lawsuits against Daiichi and Forest Labs grew exponentially after they were consolidated into an MDL. Cases were moving toward a trial date before the companies reached an agreement with thousands of plaintiffs to the tune of about $300 million in August 2017.
The proposed settlement would cover more than 2,000 cases pending in federal and state courts10. In order for the settlement to be finalized, 95 percent of all claimants must opt into the settlement before the deadline.
Benicar Settlement Amounts
The award for each participant in the settlement depends on the extent and severity of their injury. According to the settlement documents11, the levels of injury range from one through four. The highest amount a claimant may receive for the highest level — a Level VI injury — is capped at $10,000.
If the threshold of 95 percent of claimants opting into the settlement has not been met by the deadline, Daiichi and Forest Labs may pull out of the settlement.