November 28, 2021
Valsartan (English: valsartan) is one of the angiotensin II receptor blockers mainly used for the treatment of hypertension. Synthesized in 1989, approved in Japan in 2000, and marketed by Novartis under the trade name Diovan.
Angiotensin has the greatest effect on human blood pressure as a pressor substance. Angiotensin I is converted to angiotensin II by angiotensin converting enzyme, and angiotensin II binds to the receptor and acts on the heart / blood vessels and adrenal glands. Valsartan binds to the angiotensin II receptor as a competitive inhibitor and lowers blood pressure.
Serious side effects
As a serious side effect in the package insert,
Angioedema, hepatitis, renal failure (less than 0.1%), hyperkalemia (less than 0.1%),
Shock, fainting, loss of consciousness (less than 0.1%),
Agranulocytosis, leukopenia, thrombocytopenia (less than 0.1%),
Interstitial pneumonia, hypoglycemia, rhabdomyolysis (less than 0.1%),
Toxic epidermal necrolysis, mucocutaneous ocular syndrome (Stevens-Johnson syndrome), erythema multiforme, pemphigus, and pemphigoid are mentioned.
Injustice in clinical research
A clinical study conducted in Japan revealed tampering with data on antihypertensive and organ-protecting effects, and a series of related papers were withdrawn. In addition, it was revealed that Novartis employees were involved in clinical research as statistical analysts, hiding their identities. By June 11, 2014, the Tokyo District Public Prosecutor's Office had arrested a former Novartis employee, 63, for violating the hype of the Pharmaceutical Affairs Law. On March 16, 2017, the Tokyo District Court ruled that the former employee was not guilty.
July 6, 2018 --Recalled that the raw material of "Valsartan Tablets AA" manufactured by Aska Pharmaceutical (-2017) contains N-nitrosodimethylamine, a nitroso compound that is said to be carcinogenic. Start. The cause of the contamination lies in the raw materials manufactured by Zhejiang Huahai Pharmaceutical Industry in the People's Republic of China, and manufacturers in 22 countries that used the raw materials for pharmaceuticals also recalled during July.
February 8, 2019-In response to the above, each pharmaceutical company was investigating and found that it was manufactured at the API manufacturing plant in India in a specific production lot of the Amvalo combination tablet "Pfizer" manufactured by Pfizer. It was decided to voluntarily recover N-nitrosodimethylamine from the drug substance valsartan of the product because it was contaminated.
Novartis Pharma Co., Ltd.
Kyoto Prefectural University of Medicine: About the establishment of a special site "Important Notice Regarding Research Misconduct"