Is Benicar Safe?
On July 3, 2013, the Food and Drug Administration (FDA) issued a public warning that Benicar, an antihypertensive medication, may cause a serious intestinal problem identified as SPRUE-LIKE ENTEROPATHY. It also ordered the manufacturer to make the necessary changes in the labels by including a warning of this potential complication.
This order came after a thorough evaluation of the various sources made available to the agency. These include the adverse reports received by the agency’s Adverse Event Reporting System (FAERS), data from published literature, information from the CMS Medicare database, and other relevant data.
A report released by the Mayo Clinic linking Benicar with this serious complication strongly substantiated the findings of the agency. According to Dr. Joseph Murray, the author of the report, 22 patients who were taking Benicar were evaluated for unexplained chronic diarrhea and enteropathy, which were later identified as symptoms of sprue-like enteropathy.
While initially thought as celiac disease, another serious intestinal condition, it was ruled out following blood tests and the failure to improve after following a gluten-free diet. Of significant note, it was found that the patients showed clinical improvements after discontinuing the use of Benicar.
Even before the release of the study linking Benicar to increased risks of sprue-like enteropathy, there were already reports of adverse effects experienced by patients. While the FDA may have taken certain actions regarding these concerns, it maintained its position that the benefits far outweighed the risks.
Complications of Benicar
Medical experts have acknowledged that sprue-like enteropathy is a very serious intestinal condition that may become very critical if left untreated. In fact, majority of the patients evaluated by doctors of Mayo Clinic had to be hospitalized for a considerable period of time.
Symptoms of sprue-like enteropathy include the following:
- Severe and chronic diarrhea
- Extreme weight loss
- Nausea and vomiting
- Inflammation of the intestines.
In addition to the complications associated with sprue-like enteropathy, a patient taking Benicar may also experience the following side effects:
- Back pain
- Influenza-like symptoms
- Severe headache
- Chest pain
- Musculoskeletal ailments
- Skin disorders
What to Do When Injured by Benicar?
Patients taking Benicar are strongly advised to contact immediately their healthcare provider if they experience symptoms that may indicate sprue-like enteropathy – especially severe diarrhea and substantial weight loss.
Your doctor will conduct an examination and a thorough evaluation of the symptoms to ascertain the actual cause. The proper measures may be recommended by your doctor once it has been determined that your condition may be the result of complications associated with your antihypertensive medication.
Similar to other patients, you may have been subjected to serious injuries that resulted to pain and suffering and caused you economic losses by way of medications, consultations, hospitalizations, and loss of income.
These losses can be a burden to you and your family. It may be necessary to take legal actions to protect your rights and be compensated for your losses.
Should you take this course of action, it is important to have the legal assistance of a competent and experienced lawyer who will fight for your rights.
What is Benicar?
Benicar was approved by the Food and Drug Administration (FDA) in April 2002 for the treatment of hypertension, specifically to lower blood pressure in order to reduce the risk of fatal cardiovascular events such as strokes and myocardial infarctions (heart attacks).
Also known by its generic name of olmesartan, Benicar was developed by the Japanese pharmaceutical company Daiichi Sankyo in 1995. This medication is taken orally and comes in the form of 5 mg. to 40 mg tablets. Benicar may be taken independently or together with other antihypertensive agents.
Olmesartan is a part of the class of blood pressure drugs called the angiotensin II receptor antagonist or the ARB. This group of drugs works by preventing blood vessels from constricting and raising blood pressure by blocking the vascular cells’ receptors that angiotensin binds. Angiotensin is a chemical the body produces that may cause the constriction of blood vessels.
With over 10 million prescriptions in 2012, Benicar may be considered as one of the most popular drugs in the market. Records will show that there were 1.9 million patients prescribed with this medication for the same year.
What are the Uses of Benicar?
As an antihypertensive agent, Benicar is indicated for those who may be diagnosed as having elevated blood pressure. These medications are intended to reduce the risks of strokes and heart attacks by lowering blood pressure.
Benicar may be taken by adults and also by those classified as suffering from pediatric hypertension, usually children between the ages of 6 to 16 years. Dosage may be considered individualized, depending on the circumstances of the patient. The healthcare provider would be in the best position to determine the proper dosage after a careful examination and evaluation of the patient.
Children diagnosed with pediatric hypertension may be prescribed tablets if they do not find any difficulty in swallowing. Otherwise, this medication may be given in the form of oral suspension. While instructions in preparing an extemporaneous suspension may be available, the attending physician is also expected to give the needed guidance.