Pharmaceutical Litigation


Pharmaceutical Litigation

after taking

If you suffered potentially
life-threatening gastrointestinal
problems as a result of taking
Benicar®, our Patient Advocates at
Pharma Suits can help.

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Side Effects Associated with Benicar

Benicar Side Effects

Besides severe, chronic diarrhea, there are other side effects associated with the use of Benicar or Benicar HCT to treat high blood pressure or hypertension.

Remember, the class of drugs Benicar falls into is known as angiotensin receptor blockers or ARBs. The medications work by disabling the pairing of angiotensin 2, a hormone, with a receptor where it most effectively does its job of constricting blood vessels. Benicar, and other ARBs, interfere with that joining which serves to relax constricted blood vessels, reduce the increase of salt and water retention, the stiffening of the heart and the promotion of heart cell growth. Essentially, the blood vessels can relax and blood pressure is reduced.

A report published in the British Medical Journal found nearly all of patients on an antihypertensive medication had suffered some side effects.

Even though the U.S. Food and Drug Administration believes Benicar and safe and its upside outweighs its potential risks, there are still warnings against its use for women who are pregnant. Scientific literature indicates a fetus can suffer malformation in the womb.

A 2011 published report noted seven babies were born in German hospitals with a partially severe fetopathy. The mother had taken an ARB during her pregnancy and at different times during their pregnancy. Many of the babies suffered a malformed kidney. Four of the seven babies did not survive and one recovered full renal function. Two other babies suffered renal impairment and had to undergo dialysis.

Also noted among newborns was a failure of the cranium to close and a partial paralysis of hands and feet with some hearing loss. The researchers note that the general recognition of this risk is underestimated.

The warning label for Benicar and Benicar HCT specifically warns not to take the medications during pregnancy. Nursing mothers should discontinue the drug according to the Instructions for Use that come with the medication. It is not known if the drug passes into breast milk.

Japanese drug maker Daiichi Sankyo has agreed to work with the Food and Drug Administration to further explore this and other safety risks, specifically a cardiovascular concern.

In 2010, the agency noted two clinical trials showed patients with type-2 diabetes taking Benicar had a higher rate of death from heart attack when compared to the control group. The data was surprising. The studies were looking to see if Benicar was effective in slowing the progression of kidney disease in patients with type-2 diabetes. In both trials, an unexpected finding was that there were more deaths from heart attack or stroke among diabetic patients taking Benicar than among those on the placebo.

The U.S. Food and Drug Administration still insists the benefits of Benicar outweigh the cardiovascular risk.

If Benicar lowers blood pressure too much, a patient can experience dizziness. Benicar and other drugs in this class, have also been linked to swelling in the face, lips and tongue, which can restrict breathing. This may be a sign of an allergic reaction and patients should contact their doctor immediately if this happens.

Some patients prescribed ARBs can undergo changes to the kidney function causing an increase in potassium. Those patients may want to reduce their use of sodium and avoid taking Benicar with other supplements or salt substitutes that contain potassium that may also increase potassium in the blood.

Benicar is also contraindicated for patients with biliary obstruction, that is, obstruction of the biliary tract, the liver, bile ducts and gall bladder which store and secrete bile. Bile is then secreted by the liver when it then ends up in the small intestine and the process of digestion begins. Those with kidney or liver problems should let their doctor know about their medical condition because Benicar can worsen the disease.

Elevations of liver enzymes are considered rare but were observed in clinical trials. Five patients who were given Benicar were withdrawn because their liver chemistries came back abnormal.

Among the problems, three patients had elevated enzyme transaminases, which was blamed on alcohol use. The enzyme is important in the synthesis of amino acids in the body.

One had an elevated bilirubin value. Since new blood cells replace older ones every day, bilirubin is what’s left when the older cells are gone. The liver is supposed to break it down but a high level of bilirubin can lead to jaundice.

Side effects of drinking alcohol with Benicar could result in lower blood pressure that can cause dizziness or cause a patient to faint.

Additional side effects of Benicar and Benicar HCT (Benicar and hydrochlorothiazide) include an allergic reaction, dry mouth, weakness, sleepiness, restlessness, confusion, seizures, muscle pains or cramps, fainting, having no or little urine output, a rapid heartbeat, nausea and or vomiting. Because Benicar HCT contains a thiazide diuretic, vision loss can result from eye problems.

Back pain has been reported as has joint pain, flu-like symptoms, a skin rash, headaches, blood in the urine as well a sinus infections. Impotence has also been reported with Benicar use.

Upper respiratory tract infections have been associated with the medications. Some older patients may be more sensitive to olmesartan medoxmil, though that has not been tested. Only one study suggests that children from age one through sixteen may suffer the same side effects as adults, but generally do as well.

Some patients taking Benicar may experience difficulty swallowing or breathing, have chest pain, a cough, abdominal pain, vertigo, gastroenteritis or a heart rhythm disorder.

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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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