Benicar (olmesartan medoxomil) is an angiotensin II receptor antagonist. It is used to treat high blood pressure in adults and children 6 years and above. By preventing the blood vessels from narrowing, the blood pressure is lowered and blood flow is improved. It may be used alone or in combination with other antihypertensive agents, such as Benicar HCT (olmesartan with hydrochlorothiazide, a diuretic), Azor (olmesartan with amlodipine, a calcium channel blocker), and Tribenzor (olmesartan with hydrochlorothiazide and amlodipine).
Benicar is a blood pressure medication that is prescribed by healthcare providers. This drug is manufactured by Japanese drugmaker Daiichi Sankyo. This drug comes along with the active ingredient olmesartan medoxomil. Hence, the generic name of this drug is olmesartan.
This medication comes with a black box medical warning issued by the U.S. FDA which clearly states that this drug should be avoided during pregnancy. This medication can also cause severely low blood pressure when the body gets dehydrated which could lead to headache, dizziness, and lightheadedness.
Patients taking this medication can also encounter kidney damage if their renin-angiotensin system is activated. This condition develops when there is less fluid in the blood vessel. If a patient continues to use this drug for a longer time it can also lead to long-term diarrhea or weight loss.
Benicar might also interact with other medication, hence before getting it prescribed, the doctor should be well informed about the record, medical history, and other drugs being taken for treatment.
Taking this drug with lithium might lead to an increase in bipolar disorder drugs in the body. If the patient is already having aliskiren, angiotensin receptor blockers (ARBs) like telmisartan and angiotensin-converting enzyme (ACE) inhibitors like lisinopril, then taking Benicar might increase the risk of kidney damage, increase in potassium level in the blood, and low blood pressure. It must be noted that Nonsteroidal anti-inflammatory drug (NSAIDs) interactions may reduce the effect of Benicar.
If we speak of this drug dosage, it depends upon the age and severity of the condition. Children should not swallow a tablet, an oral suspension can be prepared using the tablets.
If patients develop less fluid in their body than normal or are having dialysis for kidney problems, then the dosage will have to be lowered initially. The race and ethnic background of the person also decide the dosage of Benicar.
In the year 2002, Benicar was approved by the U.S. Food and Drug Administration to treat high blood pressure. In 2003, it approved Benicar HCT which is a drug that comprises olmesartan with hydrochlorothiazide, a blood pressure drug from the thiazide diuretic drug class.
In the year 2013, the FDA made a safety announcement with regards to sprue-like enteropathy. The decision came after the development in research by FDA Advent Event Report System (AERS). The reports by the Mayo Clinic case series and data from the Center for Medicare and Medicaid Services (CMS) also played an integral role. The FDA instructed the drug manufacturer to make changes in the labeling of the blood pressure medication to include the essential warning.
As per the premarketing clinical trials, the adverse effects incident reported by Benicar manufacturer, Daiichi Sankyo related to olmesartan can be related to placebo similarity, as the negative aspect linked directly to Benicar with higher frequency superior to the placebo effect. This was reported in the prescribing information as dizziness being the common symptom. Millions of individuals who have been prescribed Benicar over the past few years have reported severe gastrointestinal reactions which are associated with drug usage.
The claim by users has not surfaced until 2012. Within a year time, the FDA ordered the change in warning labels for Benicar and similar drugs that contain olmesartan. Benicar lawsuits have been filed by patients who had suffered injury from sprue-like enteropathy. Benicar’s manufacturer agreed to resort settlement in August 2017 to clear Benicar claims from approximately 2,300 plaintiffs in cases for $300 million.
The U.S. Department of Health & Human Services (DOH) issued a warning letter to the Benicar manufacturer via the DDMAC - Division of Drug Marketing, Advertising & Communications. The letter appealed to Sankyo to immediately stop the promotion of marketing materials that include unsubstantiated effectiveness and false superiority claims. The manufacturers were also ordered to include detailed information on the risks associated with the use of Benicar.
Patients who took Benicar filed lawsuits claiming that they were not informed about serious gastrointestinal problems which this drug can cause. In 2017, Daiichi Sankyo, the manufacturer of Benicar and co-promoter Forest Laboratories agreed to a settlement of $300 million to compensate nearly 2,000 patients for their injuries. Benicar has not yet been withdrawn off the market.
The first federal lawsuit against Benicar was filed in 2014 after the FDA warned that drugs contain the active ingredient olmesartan that could lead to sprue-like enteropathy which is a disease known to cause weight loss and severe diarrhea.
On September 23, 2019, Judge Robert B. Kugler issued an order for a qualified established settlement fund. As of October 15, 2019, a total of 111 Benicar lawsuits are pending in multidistrict litigation (MDL) in New Jersey.
As per the master federal complaint, the Japanese company Daiichi spent $1 B to market Benicar and Benicar HCT between 2002 and 2008. The promotional materials did not mention serious risks, and the drugs became top sellers by misleading healthcare professionals and consumers.
The U.S. Food and Drug Administration warned Sankyo in 2006 that its marketing materials violated federal regulations. At the time, Sankyo was not associated with Daiichi.
According to the lawsuits, the FDA informed Daiichi Sankyo and Forest to stop making false claims that Benicar is superior to other drugs.
As per the terms of the settlement in 2017, Daiichi Sankyo could have stayed away from the entire deal if at least 95 percent of the plaintiffs would have agreed to resort to the matter by settlement.
To the misfortune of Daiichi, only five plaintiffs opted for settlement in August 2018, which meant the deal for negotiation will continue as per further litigation.
Despite Benicar manufacturer agreeing to the multimillion-dollar payout, they denied the fact that plaintiffs suffered injuries due to their drug and stated that "this litigation is without merit.”
Executive Chairman and President of Daiichi Glenn Gormley said in a statement stated their company is committed to the health and safety of consumers having their medications. He further added that the company believes that the settlement is in the best interest of all, and will enable bringing innovation in medicines that will help patients lead a meaningful life.
It must be noted that just over one-half of individuals with high blood pressure is controllable. Seven out of 10 adults with high blood pressure are intaking blood pressure medication. These patients are being prescribed medication like Benicar or medication which comes along with active ingredients like olmesartan.
For patients facing high blood pressure complications, they should have Benicar for control. This medication is said to reduce the risk of heart attack and stroke.
Benicar can also create a problem for fetuses, especially trimesters in the second and third phases. Many of these complications can be fatal to the fetus. Also, the drug is not recommended for children under the age of one, as it can negatively affect kidney growth and development. Other individuals can experience adverse reactions when taking Benicar.
Benicar comes in different prescriptions which are in the tablet form having strengths of 5 milligrams yellow in color, 20 milligrams white in color, and 40 milligrams oval-shaped white color. The intake of this drug can be with or without food, and Benicar can be administered with other antihypertensive medications or diuretics.
The daily recommended dosage of Benicar is 20 mg daily for adults in the earlier stages. If the patient needs more reduction in the blood pressure level, the dosage can be increased to 40 mg once a day. It must be noted that Benicar easily interacts with other drugs, hence be sure to inform the doctor about other medicines which are currently being taken. If Benicar interacts with Aliskiren, NonSteroidal Antiinflammatory Drugs like buprofen (Motrin) or naproxen, angiotensin-converting enzyme inhibitors such as captopril and colesevelam hydrochloride then it can cause kidney problem, excessively reduce blood pressure level or make the functioning of the drug ineffective.