Daiichi Sankyo is a large global pharmaceutical company and the second largest drug maker in Japan. Headquartered in Tokyo, this company has been around only since a 2005 merger between Dankyo Company, Limited, and Daiichi Pharmaceutical Company, Limited. Daiichi Sankyo also owns several smaller companies around the world, including Plexxikon in the U.S.
The company has developed and produced a number of drugs over the years, both as the merged company, and earlier by the two original companies. Many of these have been successful and helped patients, but there have also been issues. One product that has caused a lot of harm is the blood pressure medication Benicar. Daiichi Sankyo faces a number of lawsuits over the serious gastrointestinal side effects that some patients using Benicar have experienced.
Daiichi Sankyo – Overview
Although Daiichi Sankyo is headquartered in Japan, it is a truly global pharmaceutical company. It provides medications for humans and animals, medical tools, equipment, food, and agrochemicals to more than 20 countries. Although the current company has only existed since 2005, the two that merged have been around for over 100 years, developing and designing drugs and technologies.
Daiichi Sankyo is a large company with several different units. These include a U.S. unit headquartered in Parsippany, New Jersey. Other units focus on vaccine research, non-prescription medications, non-drug medical products, and generic drug manufacturing. Some are in japan, while others are in Europe or the U.S.
One of the company’s most successful drugs has been Benicar for high blood pressure. It is one the company’s best-selling prescription medication in the U.S. Other drugs made by Daiichi Sankyo include Mevalotin, for lowering cholesterol, Loxonin, a painkiller, and Cravit, an antibiotic. In spite of its successes, Daiichi Sankyo has also faced setbacks, including harmful products and allegations of providing kickbacks.
The history of Daiichi Sankyo begins with the founding of Sankyo Company, Limited in 1899. The business began with a digestive enzyme and an adrenalin product. An early success for the company was the discovery of vitamin B1 in 1910. Daiichi Pharmaceuticals Company, Limited was founded in 1915. Daiichi’s early products included drugs for treating syphilis and asthma.
Over decades of research and development the two companies separately came up with many different medications. They made the first antibiotics produced in Japan. They both developed diabetes drugs and blood pressure-lowering drugs. Sankyo developed Zantac, the popular antacid, as well as Benicar.
Sankyo and Daiichi merged in 2005 and jointly worked on a flu vaccine, Effient, an antiplatelet agent, Memary for the treatment of Alzheimer’s disease, and Nexium in partnership with AstraZeneca. Over the years the companies have also acquired a number of other, smaller companies, like Zepharma, Ranbaxy, and U3 Pharma.
Sankyo developed Benicar, which is the generic drug olmesartan, and got it approved by the U.S. Food and Drug Administration (FDA) in 2002. Benicar is indicated for the treatment of high blood pressure in adults and children older than six. It is a type of drug belonging to the class of angiotensin II receptor blockers and it is supposed to be used along with lifestyle changes to lower blood pressure.
Only after Benicar was on the market for several years did serious side effects come to light. Some patients are affected by severe gastrointestinal symptoms when taking Benicar. Symptoms include pain and abdominal cramping, and diarrhea that is severe and dangerous, leading to unhealthy weight loss. This set of symptoms is known as a condition called sprue-like enteropathy.
The FDA discovered the connection between Benicar and sprue-like enteropathy after several reports were made to the agency’s adverse events reporting system. The FDA announced in 2013 that Benicar could cause this condition and the severe and dangerous symptoms. The agency recommended that anyone developing the symptoms should stop taking the medication immediately.
The FDA also issued a warning to Daiichi Sankyo, stating that the company had aggressively marketed the drug, knowing the problems that could arise with gastrointestinal symptoms. The company was accused of being misleading about the benefits and risks of Benicar.
Another big controversy that Daiichi Sankyo has faced is over kickbacks related to Benicar and other drugs. According to the U.S. Department of Justice (DOJ), the company held a series of Physician Organization and Discussion programs, or PODs, between 2005 and 2011. Physicians were paid speaker fees for the PODs, even when they didn’t really give a talk, or only spoke to their own staff. They were also given lavish dinners that exceeded Daiichi Sankyo’s own imposed limits on spending.
The spending on speaker fees and dinners were considered to be kickbacks to entice or reward physicians for buying or prescribing the company’s drugs. The DOJ considered this particular kickback scheme to be a way of cheating Medicare and Medicaid, federal health care programs.
Because the company was found to be in violation of the False Claims Act and the Anti-Kickback Statute, it was forced into a settlement agreement. In addition to fines in the millions as a settlement, Daiichi Sankyo also agreed to work with the Department of Health and Human Services – Office of the Inspector General. This partnership is supposed to force the company to make substantial internal reforms.
Daiichi Sankyo was found to have been misleading with the aggressive marketing of Benicar and for providing kickbacks. The company was charged under the False Claims Act by the U.S. Department of Justice, and had to pay $39 million in fines. Individuals have also filed lawsuits against the company over Benicar. Some of these plaintiffs cite diarrhea so severe that they experienced ten to twenty bouts per day and that they lost up to 100 pounds and became dangerously malnourished.
Cases against Daiichi Sankyo for Benicar side effects are ongoing, but the company is expected to face thousands of plaintiffs and to end up paying millions or billions in settlements when all cases have been completed. If you were harmed or made ill by Benicar, you may be able to get in on the cases or start your own lawsuit against the makers of this medication. The long-term results of taking Benicar can be serious and if you have experienced them, you may be entitled to compensation