Connecticut Workers Could Get Additional Workers' Comp Payments
March 27, 2008 09:52

Connecticut is one of several states weighing workers' compensation reform.S.B. 255, now undergoing review by the Office of Legislative Research and Office of Fiscal Analysis, would permit workers' compensation commissioners to award additional benefits to... (Read Article)

Date: Mon, 17 Sep 2007 16:42:22 -0400
From: CDER MedWatch Safety Alerts

There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.

According to an announcement on April 18, 2007 by the UK equivalent of the Food & Drug Administration, Desmopressin nasal spray is no longer approved in the United Kingdom. Desmopressin (DDAVP) and multiple generic versions are used to treat bedwetting.

The UK health authorities were based on reports of serious side effects including water intoxication, low body sodium levels, and convulsions.

Desmopressin still remains approved for bedwetting in the United States although does warn of the possibility of low sodium levels and related water intoxication. Low sodium levels can be dangerous. The concentrations of sodium are equal in the blood and in the fluid between the cells and much lower inside of cells. But if extra cellular sodium levels fall, water will seep into the cells in order to increase the extra cellular sodium levels, making the cells swell. Most symptoms of low body sodium levels will result from brain swelling.

Symptoms of low sodium levels include loss of appetite, nausea, vomiting, headache, restlessness, fatigue, irritability, abnormal mental status, coma, hallucinations, decreased consciousness, confusion, convulsions, muscle weakness, muscle spasms, and cramps.

"A New Jersey jury on Tuesday found that Swiss drugmaker Roche Holding AG failed to adequately warn a patient of the bowel disease risks associated with its potent acne medicine Accutane and awarded him $2.5 million in damages. The jury, during its third day of deliberations, also found that the failure to warn was a major contributing cause of his contracting the bowel disease and awarded the plaintiff an additional $119,000 to cover medical expenses. The trial was the first of about 400 U.S. lawsuits involving Accutane, which has been on the market since 1982."

Reuters, New York Times 5/29/07
http://www.nytimes.com/reuters/business/business-roche-accutane.html

FDA News
FOR IMMEDIATE RELEASE
P07-90
May 23, 2007
Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.

"FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This latest action demonstrates FDA's continuing vigilance about ensuring the safety of drug products once they enter the marketplace."

Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006 . Information on the risks was updated in December.

Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.

NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.

Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.

There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.

Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.

For more information see www.fda.gov/cder/drug/infopage/gcca/default.htm.