The FDA panel voted eight to seven that a black box warning was warranted.
The labeling change will not be a so-called black box warning, reserved for lethal side effects.
Bernstein says that in the best-case scenario, Tysabri would get a black box warning--the most serious kind.
The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
FORBES: Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp
Investors are expecting that there will not be a black box warning on the drug, and that any Risk Evaluation and Mitigation Strategy (REMS) plan these are special plans designed to limit who gets a medicine will be relatively lights.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
As previously reported, the Bextra label also includes a "black box" warning--the most serious kind--for a dangerous skin condition called Stevens-Johnson Syndrome.
In its third quarter regulatory filing, the drug giant said these discussions would likely to lead to a 'black box' warning'in which warning language is displayed in bold type on a drug's packaging.
He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.
In a perspective published online Monday night in The New England Journal of Medicine, Nissen lays out his case that drugs such as Ritalin, Concerta and Adderall may cause potential risks to the heart that many patients don't appreciate--and that these risks should be spelled out in a clear, black-box warning for consumers.
In an editorial earlier this year in The Lancet, a medical journal, Topol called for the FDA to put a black box label--its most serious warning--on Vioxx.
Significantly, drug companies can only promote medicines to doctors and patients based on the package inserts approved by the FDA. In the case of the most severe warning, called a black box, the effect on sales can be huge.
At the FDA panel meeting last week, FDA advisers recommended that Celebrex bear the FDA's most stringent warning, known as a black box.
The label for Eloxatin will contain a "black box"--the FDA's most serious--warning of those side effects.
应用推荐