FDA accepts weakened antidepressant warning

Epidural steroid warning controversy still dogging FDA.

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health...

Anesthesia and Developing Brains - Implications of the FDA Warning.

through pregnant women to fetuses with developing brains — has been a subject of concern and considerable research interest. The topic has been the focus of three public hearings by the Food and Drug Administration (FDA) since 2007, including an FDA Science Board meeting in November 2014, to better inform the public and practitioners about this potential problem and to foster a discussion betwe...

McLachlan Accepts Tulane Post

-In view of the relatively poor prognosis for patients after surgery for locally invasive colorectal cancer a trial of repeated systemic infusions of Corynebacterium parvum (CP) has been carried out. It is in this group of patients, with a high risk of recurrence from small residues of cancer left by the surgeon, that immunotherapy should have its optimum chance of success. A total of 92 patien...

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.   Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...

Looking Beyond FDA Warning Letters to Explore Unforeseen Trouble Spots in eDTCA: A Response to Recent Commentaries