Benicar

The drug olmesartan medoxomil , marketed under the brand name Benicar, found FDA approval in the year 2002.  Since then the drug has been prescribed to thousands of men in an effort to reduce their blood pressure.  Marketed as a “fast acting” blood pressure medication, the drug does work quickly; helping to lower blood pressure in as little as 7 days.

The drug, while not the most popular blood pressure drug on the market, ranks high on the list.  In fact, during 2013, the drug managed to sell over $800 million worth.  Compared to many popular drugs that never come close to the $1 billion mark, this is impressive.

The pharmaceutical company that makes Benicar, Daiichi Sankyo, has been around for over a century.  Founded and headquartered in Japan, the company was made famous with the discovery of epinephrine, a drug that has been credited to saving many lives of those suffering from acute allergic reactions.  The company has a market cap of nearly $12.5 billion.

There are two primary methods of controlling blood pressure with the help of medication.  They seek to block, or synthesize the receptors that cause hypertension.

When angiotensin II hormones bind to AT receptors in the smooth muscles surrounding blood vessels, they muscles contract and the vein constricts.  This process is completely natural, and is normally regulated subconsciously.  When the binding occurs too often, the veins remain constricted and blood pressure increases.

Some hypertension treatments seek to synthesize more angiotensin II hormones in effort to overrun the binding process.  Since some of the hormones will bind, there will still be an abundance of unbound hormones.

Benicar works to block the binding process in the first place.  Instead of producing more angiotensin II, the drug inhibits the binding.  The veins never constrict in the first place, and the individual will be left with lower blood pressure.

Scientists that work for Daiichi Sankyo, a pharmaceutical giant that is based in Tokyo Japan, began working on their newest drug in the early 1990’s.  For several years they developed olmesartan medoxomil (now marketed under the name Benicar).  This angiotensin II receptor antagonist is an ester prodrug that goes to work much more quickly than some of the other high blood pressure medications on the market.

By working with this drug the scientists discovered that as the ester prodrug was hydrolyzed it helped to loosen the constriction of the patient’s blood vessels.  When the blood vessels dilate, or loosen, they allow the blood to flow more freely and reduce strain on the heart.

Throughout the late 1990’s Daiichi Sankyo tested their drug to make sure that the benefits of lowering blood pressure would outweigh the severe side effects that may occur.  Throughout their testing they should have seen all the side effects and been able to properly include warnings when marketing the drug.

In 2002 the FDA granted approval for the drug to be sold in the US (it is also sold in Japan, much of Europe, Canada, India, and Egypt).  Their initial approval made no mention of the requirement for warning language to include the possibility of spruelike enteropathy.

From 2008 to 2011 the Mayo Clinic saw a number of people come through the doors from multiple states with severe gastrointestinal problems.  It was discovered that 22 patients were experiencing symptoms similar to those caused by celiac disease, yet they were not responding to traditional celiac treatments.  14 of those patients had lost so much weight that they required hospitalization.  Upon further study it was found that they all were suffering from enteropathy (inflammation of the small intestines), and discontinuing the use of Benicar showed drastic improvement in all the patients.  The clinic concluded that Benicar was causing an adverse reaction in the small intestines that mimicked celiac disease.  They published the results of their study in 2012.

In 2013 the FDA took these results into consideration and updated the required warnings for Benicar to include the risk of spruelike eneteropathy.

When Benicar first came on the market in 2002, it saw immediate success in the US.  It worked well, and the side effects were thought to be minimal.  This drug worked differently than other drugs that help to treat high blood pressure.  The drug works to block the binding of angiotensin II, by doing so it prevents the blood vessels from constricting.  Other drugs produce excess angiotensin II, essentially doing the same thing by allowing more of these receptors than can be bound.

Use of the drug has declined slightly in the past three years; however, increased prices have allowed profits to increase.  In the first quarter of 2011, there were 1.65 million units of Benicar sold in the US.  This helped the company see sales of $174 million.  By the fourth quarter 2013, the sales in terms of units had dropped to 1.35 million units.  However, sales had grown to $203 million.

Despite the fact that the Mayo Clinic published a study in 2012 that showed a link between taking Benicar and developing severe gastrointestinal problems, the drug has remained popular.  Even after the FDA issued new warning language for the Benicar label in 2013, sales in terms of units did not decline much.  The drug continues to make hundreds of millions of dollars for the manufacturer Daiichi Sankyo.

Benicar, like all drugs, has a host of side effects that may occur.  Nearly all men will experience some of them while their body adjusts to the drug, and some men may start to experience some of the side effects as the drug stays in their system.  They range from mild and annoying to severe and life threatening.

Mild side effects:

• Dry Cough
• Headache
• Dizziness or Spinning Sensation
• Joint and Stomach Pain
• Diarrhea

While these mild side effects are discomforting, they do not represent a serious problem and will often go away with time.  Some of the more severe side effects, however, can cause lasting problems if left untreated.

Severe side effects:

• Vision Problems
• Chest Pain and Shortness of Breath
• Jaundice
• Rapid Weight Gain
• Fainting or Seizure
• Spruelike Enteropathy

The manufacturer of the drug did extensive testing and has acknowledged, and warned the public, about most of these severe side effects.  However, a study that was published in 2012 has raised awareness that the company could have done more to warn about one side effect that is being found to be much more common.

The FDA updated the warning requirements for Benicar in July 2013.  The drug, however, had already been on the market for over 11 years.  During this time it caused gastrointestinal problems in many individuals, requiring numerous to be hospitalized.  This disregard for public safety has caused lawsuits to be filed against Daiichi Sankyo, the manufacturer of the drug.

George Williams took Benicar for several years as a treatment for his high blood pressure.  During that time Williams felt he was getting sick, and could not understand why suddenly he was having chronic diarrhea, vomiting, dehydration, and severe weight loss.  During the course of four years he was in the hospital 10 times racking up 100 total days of hospitalization.

Williams required that a feeding peg be inserted into his stomach which he still uses to eat.  His lawsuit alleges that taking Benicar did permanent damage to his intestines, and the medical problems that he suffered for 4 years caused him to develop cataracts in his eyes and a compression fracture in his spine.  His case was filed in March 2013 and is currently under investigation.

Between the years 2008 and 2011 the Mayo Clinic in Minnesota treated 22 patients for spruelike enteropathy.  These patients, who ranged in age from 47 to 81 years old and included 13 females and 9 males, all were taking Benicar.  None of the patients responded to traditional methods of treating celiac disease.

The entire study group suffered from chronic diarrhea and weight loss with nearly 2/3 of the patients requiring hospitalization because their weight loss was so severe.  Biopsies showed that the patients were suffering from inflammation of the small intestines (enteropathy).

Initial treatment was to switch the patient to a gluten free diet.  However, none of the 22 patients studied responded positively to this treatment.  Out of the original 22 patients, there were 18 who came back later for follow up biopsies.  After discontinuing the use of Benicar, all 18 patients saw improvement in their intestines, and all 22 patients saw weight gain after discontinuing the drug.

The conclusion that was reached by the clinic is that Benicar can cause some rare, hard to detect side effects that closely mimic celiac disease.  Discontinuing the drug leads to improvement.

Benicar was developed in the mid and late 1990’s.  Scientists at Daiichi Sankyo, a pharmaceutical company based in Tokyo Japan, oversaw its development.  It has been marketed around the world, and it has brought the company billions of dollars over the years.

The FDA approved Benicar for sale in the US in 2002.  Over the course of the next decade the drug surged into popularity with millions of units sold each year.  In 2013 Benicar sold over $800 million worth of medication.  But there were bumps along the way.

The FDA issued a warning against Daiichi Sankyo in 2006 for some of the literature it was using as marketing material.  In their advertisements the drug company claimed that the drug Benicar was superior to some of its competitors.  However, when reviewing the research cited in the advertisement, the FDA found that these claims were unsubstantiated.

In 2010 and 2011 the FDA followed up on complaints that Benicar caused major kidney failure, and adverse cardiovascular events.   Upon investigation the FDA concluded that there was evidence for these issues, however the benefits of taking Benicar still outweighed the risks of these side effects.

In 2013 the FDA responded to a study done by the Mayo Clinic. It was found that Benicar was causing inflammation of their small intestine leading to chronic diarrhea and severe weight loss.  The FDA updated the required warning language on the Benicar label.

Despite all the negative consequences that are the result of taking Benicar, the FDA still insists that the benefits of taking the drug outweigh the negative consequences.  However, for those who have suffered from severe side effects, side effects they were never warned about, the drug is entirely not safe to be used.

After its US debut in 2002, Benicar saw a rapid rise to popularity.  The drug worked well, and the side effects were often just inconvenience. The drug, which currently costs around $80 for a one month supply, is still protected with a patent.  This means there is no generic available, and the manufacturer can still reap the huge profits associated with sales.

Those huge profits are some of the largest in the industry.  The year 2012 saw US sales of Benicar topping $727 million.  Those profits continued to grow to $807 million in 2013 despite the report that came out that showed a link between taking Benicar and developing spruelike enteropathy.  It was not until July 2013 that the FDA updated the warning requirements to include a warning about the risk of developing intestinal problems.

The manufacturing company Daiichi Sankyo is profiting tremendously from these sales as well.  With a market cap of nearly $12.5 billion this global company sees profits from around world.  The revenues brought by the sale of Benicar only help add to this massive corporation’s bottom line.

But those sales come at quite the price to many people taking the drug.  A study published by the Mayo Clinic in 2012 showed that taking Benicar may cause gastrointestinal problems, and those problems may be misdiagnosed as celiac disease.  The outcome is that patients do not respond to a gluten free diet, have chronic diarrhea and severe weight loss.  In the study that looked at 22 people, one patient lost 125 pounds before it was discovered that Benicar was the culprit and not another malady.