Benicar (olmesartan medoxomil) is a prescription drug that can cause serious, sometimes deadly, side effects and complications. The most notable adverse reactions include fetal toxicity, resulting in injuries and/or death to fetuses if taken during pregnancy, and sprue-like enteropathy, resulting in severe gastrointestinal symptoms most commonly associated with celiac disease.
Benicar, a popular high blood-pressure medicine, has been linked to several very serious side effects, including one with severe gastrointestinal symptoms.
The complication triggers diarrhea so severe that it can cause substantial weight loss and malnutrition, as well as permanent damage to the small intestine. More than 2,000 people who developed these side effects filed Benicar lawsuits.
Benicar’s label also has a black box warning for fetal toxicity. The drug is not recommended during pregnancy because of potentially serious and often fatal conditions in fetuses. Even if the fetus survives to birth, the medication’s adverse effects can cause severe health complications for infants that can persist into adulthood.
Research has linked olmesartan, the active ingredient in Benicar, to fetal toxicity, especially when taken during the second and third trimesters of pregnancy. The drug’s label contains a black box warning that states that drugs, such as Benicar, that act directly on the renin-angiotensin system “can cause injury and death to the developing fetus.”
Benicar can also cause disease for children 1 and under. The drug has been found to have certain effects on the development of immature kidneys.
A fetus’ kidneys start to grow during the first month of pregnancy. An ultrasound can allow a doctor to see the baby’s internal organs, including the kidneys, prior to birth, usually starting in the second trimester. This test can also detect abnormalities in the developing kidneys and urinary tract. In general, one in about 500 births has some abnormality occur in the development of the kidneys or urinary tract, according to the National Kidney Foundation.
Problems with kidneys can lead to complications after birth. Kidneys are essential to urine production and the maintenance of electrolyte levels and fluids in the body. Kidney dysplasia, also referred to as multicystic dysplastic kidney, is a condition in which the internal structures of one or both of the fetus’ kidneys do not develop normally.
In this fetal condition, the kidneys have tubules (these tiny structures collect urine while the fetus is in the womb) that fail to completely branch out. The urine that would normally go into the tubules has nowhere to go and instead collects inside the affected kidney. This results in the formation of fluid-filled sacs called cysts, which replace normal kidney tissue preventing the kidney from functioning properly.
Kidney dysplasia, or underdevelopment, can affect one or both kidneys. When the condition is severe, babies typically will not survive birth. Those who do survive require immediate treatment, including dialysis (to filter the blood) and a kidney transplant. Treatment is postponed or not needed in babies with mild dysplasia, or in those with dysplasia affecting only one kidney.
There is no cure for multicystic dysplastic kidney, but it is a fairly common occurrence, with scientists estimating that it affects about one in 4,000 babies. About half of babies diagnosed with the condition are also diagnosed with other urinary tract defects. One such defect is anuria, which occurs when the kidneys stop producing urine.
Urination is important to remove wastes and excess fluids from the body. The kidneys produce about one to two quarts of urine each day, and filter about 120 to 150 quarts of blood. Children produce less urine than adults. When a person does not urinate, wastes, fluids and electrolytes can build up in the body, complicating health problems and possibly resulting in death.
Some babies may not show any signs or symptoms of kidney dysplasia if only one kidney is affected. Sometimes the affected kidney may be enlarged at birth or cause the infant pain. Complications associated with kidney dysplasia can lead to permanent damage to one or both kidneys, which can progress to chronic kidney disease and possibly lead to kidney failure and/or death.
When kidney dysplasia is limited to one kidney and the baby is not experiencing any symptoms, treatment is likely not necessary. When the condition is more severe, or affecting both kidneys, patients may eventually need dialysis or surgery, including a kidney transplant. Regular check-ups will be needed regardless of an infant’s overall health.
When only affecting one kidney, babies with kidney dysplasia have a good long-term outlook. The affected kidney may shrink as the child grows, becoming unable to be seen on X-ray or ultrasound by about age 10. This results in the child living with a solitary kidney, or just one working kidney, with few, if any, health complications. If urinary tract problems are present, kidney failure of the solitary kidney may result, requiring dialysis or a transplant operation.
When both kidneys are affected, children are more likely to develop chronic kidney disease. Patients will need to be seen by a pediatric nephrologist, who is a doctor that specializes in the care of children with kidney disease. Dialysis and a kidney transplant may eventually be needed.
In 2013, the FDA issued a safety announcement that the blood pressure drug Benicar (olmesartan medoxomil), as well as similar drugs such as Benicar HCT, Azor, Tribenzor and generic versions, can cause severe intestinal complications with side effects collectively known as sprue-like enteropathy. Patients experiencing olmesartan-induced sprue-like enteropathy exhibit signs and symptoms similar to individuals suffering from celiac disease.
This condition can develop months or even years after the patient first starts taking Benicar or other medications containing olmesartan. In severe cases, patients can end up hospitalized and/or suffer from permanent intestinal damage, or villous atrophy (the destruction of intestinal villa that helps with the absorption of nutrients from food). The condition usually resolves once the offending drug is discontinued.
Most often, when patients take prescription medications that cause diarrhea, such as Benicar, the side effect occurs without permanent damage to the intestines. But when villous involvement and malabsorption are present, the resulting damage to the intestines is called sprue-like enteropathy. This condition is typically associated with celiac disease due to gluten exposure. However, drug-induced enteropathy can occur independent of gluten intake.
Villous atrophy occurs when the intestinal villi (microscopic, finger-like projections) erode away, causing the walls of the small intestine to essentially become a flat surface. The villi help absorb nutrients from the foods we eat. If they are destroyed, resulting in villous atrophy, patients can experience serious nutritional deficiencies.
The only way to detect and diagnose villous atrophy is to look directly at the walls inside the small intestine. This can be done through a procedure called an endoscopy, which uses a camera on the tip of a small medical instrument. The instrument is threaded down the throat, through the stomach and into the small intestine.
Drug-induced diarrhea can occur for any number of reasons. Its cause is uncertain in patients taking Benicar. Due to its lag time in patients taking the high blood-pressure medication, developing months to years after the start of treatment, most researchers believe it is a hypersensitivity (allergic) response.
Please seek the advice of a medical professional before making health care decisions.
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