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.

According to a new study published in the New England Journal of Medicine (NEJM), the popular type-2 diabetes drug Avandia has been linked to heart attacks, heart risk, and death.

Actos, another drug used to treat type-2 diabetes was not part of the NEJM study. Its risks are being debated.

The study analyzed 42 clinical trials of patients who took Avandia to treat type-2 diabetes. Of these trials, 15,560 patients were randomly assigned to take Avandia and 12,283 were taking placebos or alternative diabetes drugs. The average age for patients was 56.

Of those patients taking Avandia - 87 suffered heart attacks, compared to 72 patients taking other drugs or a placebo. Hence, the conclusion was that there was enough of an increase in the risk of death from cardiovascular causes.

Approved in 1999, Avandia is manufactured by GlaxoSmithKline. Last year, more than 11.3 million prescriptions were written by U.S. pharmacies at an estimated retail cost to consumers of over $1.6 billion.
The Food and Drug Administration (FDA) has known for several years that both Avandia and Actos can cause heart failure. The NEJM's analysis brings forth the new finding of heart attacks linked to AVANDIA.

Heart failure and heart attacks are two different, but related, conditions. Heart failure occurs when the heart can no longer pump enough blood to the other organs in the body.
A heart attack is the death of heart muscle due to the sudden blockage of a coronary artery that supplies that muscle with blood and oxygen. Heart muscle death is irreversible, and the dead heart muscle is replaced by scar tissue.

The percentages of heart attacks and deaths have been small. In addition to the risk of heart attack and death, the fact that AVANDIA has not been shown to benefit the health of diabetes patients in a clinically meaningful way should be examined when considering this drug.

Are you a woman taking Avandia for type-2 diabetes? If yes, then not only could you be at risk for heart failure or heart attack but you could also be at risk for fractures. Earlier this year the FDA issues warnings about the increased risk of foot, hand, and upper arm fractures for women taking Avandia. Older diabetes drugs do not cause that problem.

Women had twice as many fractures with Avandia than with Glucophag, Glynase, or Micronase which are also less expensive but not anybody is advertising those in every magazine. As for Actos, women had a two in 100 chance vs. a one in 100 chance compared with other similar diabetic drugs.

Consumer protection groups like the Public Citizen have warned that Avandia and Actos are marginally effective and cause serious side effects. Other side effects include weight gain, fluid retention, liver toxicity, anemia, and vision disturbances.

Men were not similarly impacted.

China Issues Death Penalty For Mistakes Made by Head Drug Minister SUMMARY In the USA we don't hold those in the FDA accountable for their mistakes. We allow the injuries to occur to those taking dangerous drugs, leaving lawsuits as recourse. BODY Head of FDA China Executed for Accepting Pharmaceutical Drug Bribes The penalty in China is death, in America its business as usual. Zheng Xiaoyu, the former head of China's FDA, was sentenced to death for accepting $832,000 in drug company bribes and for dereliction of duty. Like China, our country is in the middle of a drug and food safety crisis. Why is FDA Commissioner Andrew von Eschenbach, M.D. getting a free pass? Why did the Senate just pass legislation (S.1082) that gives von Eschenbach power to do whatever he pleases? Most of us would be shocked to know that drug safety or food supply safety is not the top FDA management priority. Preserving the profits of drug companies and furthering the myth that drugs are the answer to our health problems, is the FDA�s priority. The timing couldn't be worse for the FDA. On June 6, 2007, Henry Waxman (D-CA), Chairman of the House Committee on Oversight and Government Reform will haul in Andrew von Eschenbach to testify on why the FDA failed to warn Americans of the extreme cardiovascular danger and increased risk of death from taking Avandia, a $3 billion blockbuster diabetes drug made by GlaxoSmithKline. Statistics that were primarily obtained from GlaxoSmithKline's own research data predict that 35,000 people needlessly died taking Avandia last year and the FDA was fully aware of the risks and chose to ignore them. Then there is the Trasylol scandal, a very expensive cardiovascular bypass drug that needlessly may have sentenced as many as 15,000 Americans per year to premature death within the next 5 years, according to statistics in the study published by the New England Journal of Medicine in January 2006. That study, by Dr. Mangano and colleagues, revelead that Trasylol � (generic name aprotinin) increases the risk of kidney failure following heart surgery by more than 2 � times (259%). . When Bayer was caught directly lying to the FDA regarding Trasylol's dangers, von Eschenbach deflected legal liability for Bayer by doing virtually nothing and leaving the drug on the market. These are just a few examples, there are unfortunately many more. As a result, the only recourse we have in the USA is to sue the manufacturer for damages. It is sad that there is no way to prevent these injuries under the way that the FDA currently operates. Instead, we leave it to the consumers to be injured and for the injured patients to then seek legal redress in the form of monetary damage lawsuits. While this does eventually lead manufacturers to correct mistakes in the drugs they produced, it is only after the biggest expense has been paid in the lives of those injured. Source: http://www.americanchronicle.com/articles/viewArticle.asp?articleID=28383 KEYWORDS fda,trasylol,aprotinin,lawyers,lawsuits,drug,heart,surgery,cardiac

- Health Professional Communication
- GlaxoSmithKline Inc.
A New England Journal of Medicine article raised concern about increased risk of heart attack and cardiovascular death in diabetic patients. The conclusions reached require confirmation.

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/index_e.html

"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.