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Benicar

The Benicar injury case attorneys at the Drug Law Center are now reviewing and accepting cases involving patients who of suffered harm after taking the antihypertensive medication.

Introduction

Benicar Drug RecallBenicar (olmesartan medoxomil) is a brand-name prescription medication that narrows blood vessels, lowers blood pressure and improves the flow of blood throughout the body. The angiotensin II receptor antagonist medication is also prescribed for the treatment of hypertension (high blood pressure) in adults and children who are six years and older. However, drugs that contain olmesartan medoxomil, including Benicar, as a treatment for hypertension can also produce serious side effects. The medication has been linked to serious side effects, severe health problems and adverse reactions including sprue-like enteropathy. The FDA has issued warnings that the medication might cause intestinal issues. Many injured patients have filed Benicar lawsuits against the drug maker Daiichi Sankyo for producing, marketing and selling the defective medicine.

The History of Benicar

The Japanese pharmaceutical giant Daiichi Sankyo developed the generic version of the angiotensin II receptor antagonist Benicar, olmesartan medoxomil, in 1995. Since the company received approval for Benicar in 2002 by the FDA, the hypersensitive medication as generated billions of dollars in annual global sales. The lucrative Benicar patent held by the drug maker expired in 2016.

In 2013, the US FDA (Food and Drug Administration) issued a warning to consumers that Benicar (olmesartan medoxomil) can produce severe health problems including substantial weight loss and chronic diarrhea. Many in the health care industry have criticized the medication because it can produce a severe gastrointestinal side effect. Even though the drug produces dangerous side effects and no other medicines in the same class produce sprue-like enteropathy like Benicar, the pharmaceutical company continues to promote medication as though it is safe.

Who Should Avoid Taking Benicar?

While Benicar can provide health benefits to patients including lowering blood pressure, some people should avoid taking the medication due to its contraindications. Before taking Benicar (olmesartan), it is important for patients to discuss potential health risks and side effects if they have any of the following:

  • Low bloodstream sodium levels (hyponatremia)
  • High bloodstream potassium levels (hypercalcemia)
  • Type II diabetes myelitis
  • Renal impairment
  • Renal artery stenosis
  • Diarrhea caused by intestinal malabsorption
  • Decreased blood volume
  • Pregnancy
  • Severe congestive heart failure
  • Giant hives

Additionally, an individual that is allergic to olmesartan ARB-angiotensin II receptor antagonist should avoid taking the medication.

Benicar Side Effects

Benicar (olmesartan), like most prescription medications and over-the-counter drugs, can produce mild to severe side effects and adverse reactions. The most common minor Benicar side effects include:

  • Nausea
  • Diarrhea
  • Dizziness
  • Lightheadedness
  • Skin rash
  • Itching
  • Headaches
  • Overall weakness
  • Stomach, muscle, or joint pain
  • Flu like symptoms
  • Sinus infection
  • Gross hematuria (blood in the urine)

Potentially severe Benicar side effects include:

  • Rhabdomyolysis (breakdown of muscle tissue)
  • Hypercalcemia (elevated bloodstream potassium levels)
  • Vertigo (spinning or whirling sensation)
  • Abnormally low blood pressure
  • Throat irritation
  • Bladder pain
  • Stiffness, swelling or painful joints
  • Irregular, pounding or fast pulse or heartbeat
  • Difficulty urinating
  • Painful or burning urination
  • Acute renal failure
  • Coughing
  • Indigestion
  • Intense abdominal pain
  • Chest pain
  • Difficulty in swallowing or breathing
  • Renal failure
  • Upper respiratory tract infections
  • Bronchitis
  • Vomiting
  • Puffy face and swollen hands, arms, feet or legs caused by water retention
  • High bloodstream uric acid levels

 Benicar and the Food and Drug Administration

  • July 2013 – The U.S. FDA issued a warning to consumers that drugs containing olmesartan medoxomil to treat blood pressure have the potential of causing serious intestinal problems including sprue-like enteropathy. These medical products are marketed as Benicar, Benicar HCT, Tribenzor, Azor, and their respective generic versions. The Food and Drug Administration mandated that the drug makers of these products update approve label changes to keep the public informed.The Safety Announcement published in July 2013 defined olmesartan medoxomil as an ARB (angiotensin II receptor blocker) that received approval by the FDA to treat high blood pressure. The product can be used alone or concomitantly with other anti-hypersensitive agents. Federal agency officials stated that the drug was approved to lower blood pressure while reducing the potential risk of non-fatal and fatal cardiovascular events including heart attacks and strokes. The federal agency revealed that there were no other ARB medications that produce sprue-like enteropathy other than olmesartan.The FDA released prescription data revealing that in 2012, more than 10.5 million prescriptions had been written by doctors to nearly two million patients who were dispensed olmesartan-containing drugs in the United States.
  • June 2014 – The Food and Drug Administration published its findings in a Safety Review revealing that no clear evidence of an increased potential risk of cardiovascular events was found at the conclusion of the study. The study involved diabetic patients taking olmesartan, a blood pressure medication.The safety review was a part of a clinical trial that examined the outcome of type II diabetic patients taking olmesartan medoxomil products to see if the medication delays kidney damage. Clinical trial researchers identified an unexpected result involving the olmesartan medication taking group but there was an increased risk of cardiovascular death when compared to the group taking sugar pills (placebos). However, the findings also revealed a lower potential risk of non-fatal heart attacks compared to those taking the blood pressure reducing medication.
  • March 2012 – The Food and Drug Administration issued a fetotoxicity warning involving mothers taking Benicar (olmesartan) to treat hypertension and lower blood pressure. The Benicar Black box warning label indicated that “when pregnancy is detected, discontinue Benicar soon as possible. Drugs that act directly on the renin-angiotensin II system can cause injury and death to the developing fetus.”
    Additional warnings and precautions issued by the FDA for pregnant women taking Benicar include:

    • “Avoid fetal (in utero exposure.
    • Children [less than 1] year of age must not receive Benicar for hypertension.
    • Observe for signs and symptoms of hypotension in volume or salt-depleted patients with treatment initiation.
    • Monitor for worsening renal function in patients with renal impairment.”

Benicar Recall

To date, the FDA nor Daiichi Sankyo, the maker of low blood pressure treatment medication, has yet to recall Benicar due to its link with causing sprue-like enteropathy. However, the Food and Drug Administration has recommended that the drug manufacturer update label changes to inform the drug’s consumers of the serious potential side effects the drug can cause including intestinal problems.

Benicar Lawsuits

In 2015, Daiichi Sankyo, the pharmaceutical company that developed, manufacturers and markets the prescription blood lowering medication reached a $39 million Benicar settlement with the United States federal government. The lawsuit plaintiffs had alleged the drug maker paid kickbacks to doctors in exchange for prescribing its medications including Tribenzor, Azor, Benicar HCT, and Benicar.

  • Drug Makers Facing Another Benicar Lawsuit Filed by an Ohio PlaintiffJanuary 2015 – An Ohio man has filed a Benicar lawsuit in an Ohio Federal courthouse against Daiichi Sankyo, Inc. and Forest Laboratories Inc. The plaintiff is seeking financial recompense from the drug makers after he developed colonic issues and severe intestinal problems involving sprue-like enteropathy, microscopic colitis, intestinal malabsorption, colitis, and collagenous colitis.The plaintiff’s attorneys are claiming that their client suffered Benicar side effects after taking the medication including dehydration, malnutrition, vomiting, nausea, acute renal failure, rapid weight loss, and chronic diarrhea. As a result of ongoing suffering from the side effects, the plaintiff also developed severe weakness and anemia requiring hospitalization on numerous occasions. His doctors continue to monitor’s health problems.
  • New York Woman Files Benicar Lawsuit against Drug Makers after Suffering Painful Side EffectsMarch 2015 – The makers of Benicar are in a legal battle with a New York woman who claims she suffered injuries caused by the blood pressure medication. The plaintiff is alleging that Benicar caused her to develop sprue-like enteropathy and other serious intestinal harm.Lawsuit documents reveal that her doctors prescribed Benicar as a treatment for arrived blood pressure. Even though the drug worked as directed, the plaintiff was simultaneously suffering painful side effects and embarrassment from her intestinal difficulties. Soon afterward, the plaintiff began experiencing serious Benicar side effects including weight loss, dehydration, and diarrhea.The New York plaintiff claims that Daiichi Sankyo, Inc. and Forest Laboratories Inc., makers of Benicar, failed to provide adequate warning in their Black box warning label. Her attorneys have built a financial compensation claim against the drug makers stating that they were responsible for warning her, her doctors and other patients who were taking the medication. The lawsuit is based on numerous factors including the companies’ failures that involved false advertising, negligence, product misrepresentation and concealing safety information.
  • Benicar Wrongful Death Lawsuit Filed by New Jersey Widow against Two Major Pharmaceutical Companies
    December 2014 – A New Jersey widow has filed a Benicar lawsuit alleging that her husband died after taking the popular hypertension treatment medication. The woman’s case joins seven other lawsuits that have been consolidated in a New Jersey federal court.Lawsuit documents reveal that the plaintiff’s husband had been prescribed Benicar by his doctors as an effective solution for treating his hypertension and managing elevated blood pressure levels. However, the wrongful death lawsuit makes claims that before the husband passed away he had developed severe side effects from the medication including a gastrointestinal disease and sprue-like enteropathy that causes uncontrollable diarrhea. The widow has made claims that her deceased husband needed to be hospitalized because he was suffering greatly from the side effects including uncontrollable diarrhea that resulted in sustaining severe gastrointestinal tract damage and excessive weight loss.

This is hardly the first time that Daiichi Sankyo, Inc. and Forest Laboratories Inc., the makers of the blood lowering medication, have faced injured patients and surviving family members. The number of lawsuits filed against the two pharmaceutical giants has created the need to consolidate many existing cases into a Benicar class action lawsuit.

What to Do If You Been Injured

The Benicar injury case attorneys at the Drug Law Center are now in discussion with patients who have suffered chronic diarrhea, vomiting, excessive weight loss, and other serious gastrointestinal side effects after they took Benicar, olmesartan or other brands of the blood pressure medication. Our attorneys are investigating, evaluating, and determining which victims are eligible to file a Benicar lawsuit against the drug maker.

If you have suffered an injury, or lost a loved one, due to the side effects and adverse reactions caused by taking Benicar, contact us today so we can begin the process of obtaining your financial compensation award from the drug maker. To minimize the financial burden for you and your family during the litigation process, we are currently postponing payment of our legal services until after we have successfully resolved your case. This could happen through a jury trial award or negotiated out-of-court settlement.

We provide free initial consultations to discuss the merits of your case. All information you share with our law offices remains confidential.

Sources:

http://www.mayoclinic.org/drugs-supplements/olmesartan-oral-route/description/drg-20065169

http://bmjopen.bmj.com/content/5/11/e010077

http://www.cleveland.com/healthfit/index.ssf/2010/06/uh_cardiologists_research_warn.html

 

 

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