A contaminated anticancer drug made by one of China’s largest pharmaceutical companies underscores how quality-control problems continue to plague the Chinese drug industry. There is no sign the tainted leukemia drug was exported. But the case provides a cautionary tale as Western pharmaceutical companies start outsourcing some manufacturing to China. Learn More: Wall Street Journal
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared …
The New York Times is on fire today with great articles about the pharmaceuticals. A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug …
A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs. Chinese drug regulators have accused the manufacturer of the tainted drugs of a …
Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments. If a deal is reached, the fine would be the largest ever paid by a drug …
Some of the nation’s most prominent spine surgeons hailed it as a medical breakthrough. In a study of nearly 240 patients with lower back pain, the doctors said that the Prodisc, an artificial spinal disk, had worked much better than conventional surgery in which patients’ vertebrae were fused… As it turns out, Dr. Zigler had …
The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators. …
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally …
Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or …
The District of Columbia Council voted 7-6 to pass a law requiring pharmaceutical company sales representatives to be licensed. The final bill was stripped of a provision that would have also banned the practice of data mining the prescribing activities of doctors. While New Hampshire, Vermont, and Maine have laws banning or limiting the data …