Ono Pharma Korea received a warning from the Ministry of Food and Drug Safety for late reporting of adverse reactions during the Opdivo clinical trials, a medication to treat cancer.
A patient participating in the Opdivo clinical trials, “ONO-4538,” was hospitalized due to a urinary tract infection and pneumonia. The pharmaceutical firm didn’t report the hospitalization for two days.
The ministry issued the warning to the drugmaker for breaching Article 34 of the Pharmaceutical Affairs Act. The Pharmaceutical Affairs Act stipulates that in the case of a serious and unexpected drug adverse reaction, a test client must promptly report it to the clinical trial assessment committee within 15 days of learning it.
An adverse event occurs when the participant in a clinical trial receiving a pharmaceutical product experiences an untoward event within the trial, such as injury, which could result in extended hospital stay, disability or death. In the Opdivo clinical trials, the adverse event wasn’t reported until much later.
A primary source of information used by the FDA for providing safety information on drug labels is gathered from adverse drug event reports. Reports are sent by health care professionals, consumers and drug manufacturers to the FDA, where they are organized in a database called the Adverse Event Reporting System (AERS), previously known as the Spontaneous Reporting System.
According to an American Medical Association (AMA) study, the FDA’s Adverse Event Reporting System is the main database used to collect information to identify safety problems with marketed drugs. Submitted and properly investigated reports allow the identification of serious adverse events that are added to the product labeling information and warn future patients.
In rare instances, additional regulations, including market removal, have been required. Limitations of the system include underreporting, differential reporting and uneven quality.
Opdivo, also known as nivolumab, is a cancer-treating medication for inoperable or metastatic melanoma, squamous non-small cell lung cancer, and renal cell carcinoma. It is a monoclonal antibody that works as a checkpoint inhibitor, blocking a signal that prevents activated T cells from attacking cancer. This act allows the immune system to clear cancer on its own.
Opdivo was developed by Medarex and Ono Pharmaceutical and brought to market by Bristol-Myers Squibb and Ono Pharmaceuticals. Dr. Tasuka Honjo, the creator of Opdivo, won a Nobel Prize in 2018.
Side effects include severe immune-related inflammation of the lungs, colon, liver, kidneys, and thyroid, and there are effects on the skin, central nervous system, the heart, and the digestive system. Opdivo has also been associated with eye problems, specifically retinal detachment.
Ono Pharmaceutical Korea is currently conducting the phase-3 Opdivo clinical trials to confirm its impact on various carcinomas, including metastatic urothelial carcinoma, metastatic squamous cell esophageal cancer, non-squamous non-small cell lung cancer, gastric cancer, recurrent or metastatic head, and neck squamous cell carcinoma and hepatocellular carcinoma.
Ono Pharmaceutical Company is headquartered in Japan and has roots leading all the way back to 1717 as an apothecary by Ichibei Fushimiya in Doshomachi, Osaka. Ono markets an array of pharmaceutical drugs, many of them treat cancer among other diseases such as asthma, osteoporosis and Alzheimer’s disease.