IN THIS ISSUE:

• Novel Anti-oxidant And Anti-inflammatory Agent Shows Effectiveness On Key Endpoints In Trial
   
• Breastfeeding Alone Cuts HIV Risk
   
• FDA Panel Backs Prostate Cancer Vaccine
   
• Omega-3 Fatty Acid May Protect Heart
   
• Hospitals Wage Battle Against Drug Diversion
   
• FDA Announces Voluntary Withdrawal of Pergolide Products
   
• FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

• Believe It Or Not

• News From MedWatch

• Research Update

• Recently Approved Drugs/Indications

• FDA Recalls and Safety Alerts in the Past 60 Days

• Drug Shortages

• Recommend Edmund's Newsletter

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Novel Anti-oxidant And Anti-inflammatory Agent Shows Effectiveness On Key Endpoints In Trial

Heart attacks are caused by a build-up and instability of plaque in the coronary arteries, which is often a result of chronic inflammation of the blood vessel walls. A study presented at the American College of Cardiology's 56th Annual Scientific Session assessed whether adding a novel agent with antioxidant and anti-inflammatory properties to optimal medical therapy would reduce coronary events and death among patients with heart disease. ACC.07 is the premier cardiovascular medical meeting, bringing together more than 30,000 cardiologists to further breakthroughs in cardiovascular medicine.
While the trial results did not demonstrate a difference with the use of succinobucol (AGI-1067) versus placebo on the primary endpoint of a composite of major adverse cardiovascular events, the study did achieve a number of other important predefined endpoints, including a reduction in the composite of "hard" atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction (heart attack) and stroke with a relative risk reduction of 19 % (p=0.028); as well as an improvement in several key diabetes parameters, including fewer patients developing diabetes with a relative risk reduction of 64 % (p<0.0001), and better glycemic control (reduction of HbA1c of 0.5% at twelve months, p<0.0001) in patients randomized to succinobucol.

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Breastfeeding Alone Cuts HIV Risk

Exclusively breastfeeding until a baby is six-months old can significantly reduce the risk of mother-to-child HIV transmission, an African study says.
The South African researchers compared solely breastfed babies with those also given formula or solid foods.
They say breastfeeding carries a low transmission risk, but protects against potentially fatal conditions such as diarrhoea and pneumonia.
They say it is the best option for most women in the developing world.

For more information CLICK HERE

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FDA Panel Backs Prostate Cancer Vaccine

A U.S. Food and Drug Administration advisory panel voted Thursday to support approval of Provenge, a vaccine aimed at extending survival for patients with deadly metastatic prostate cancer.
The FDA panel voted unanimously that the vaccine was "reasonably safe," noting that while it failed to meet some study endpoints, it did extend patient survival, according to published reports.
The panel then voted 13-to-4 to say there was substantial evidence to show the vaccine was effective for treating advanced prostate cancer that no longer responds to standard hormone treatment.
The FDA does not have to follow the advice of its advisory panels, but it typically does. The agency is expected to make its final decision by May 15.

For more information CLICK HERE

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Omega-3 Fatty Acid May Protect Heart

An omega-3 fatty acid found in fish oil may help prevent nonfatal heart problems in some people with high cholesterol, a Japanese study shows.
The omega-3 fatty acid is called EPA (eicosapentaenoic acid). It's found in fish such as salmon and mackerel, along with another fatty acid called DHA (docosahexaenoic acid).
The Japanese study looked at more than 18,600 adults with high cholesterol, including 3,660 people with a history of coronary artery disease.
The coronary arteries supply blood to heart muscle. Unhealthy coronary arteries make heart attacks more likely, and high cholesterol is a risk factor for coronary artery disease.
Study participants were followed for more than four years, on average. During that time, they all took cholesterol-lowering statin drugs.

For more information CLICK HERE

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Hospitals Wage Battle Against Drug Diversion

Recently, a former nurse who worked at the Veterans Administration Medical Center in Bedford, the Somerville Hospital, and the Metro West Medical Center-Framingham—all in Massachusetts—was sentenced because she stole numerous controlled substances, including codeine, oxycodone, and fentanyl, from these facilities. She had falsely stated on medication administration records that she was administering the medications to patients, all the while keeping the medications for herself.
Drug Topics contacted the hospitals involved to find out what measures they have put in place to prevent such thefts in the future, but all three declined to comment.
Diversion of controlled substances and other pharmaceutical products is recognized as a critical problem in the United States. Many hospitals are fighting back, however, by utilizing medication monitoring devices, such as Pyxis machines from Cardinal Health, and tighter medication distribution security to assist them in preventing drug diversion.
The Pyxis machine has a series of drawers and pockets to hold various medications. Narcotics and controlled substances are stored in a carousel drawer that keeps track of amounts dispensed. "Technology helps a lot. There are statistical programs that we can use to look at the medications that have been withdrawn from the Pyxis machines. If more medication than normal is withdrawn, it sends us an alert," stated Timothy Lesar, Pharm.D., director of pharmacy at Albany Medical Center in New York State.
Drug diversion by patients or by individuals posing as patients may result in harm to the people themselves or to other people around them. Healthcare professionals have easy access to controlled substances, and some will divert and abuse medications to relieve stress or enhance alertness and performance. According to the National Council of State Boards of Nursing, approximately 15% of healthcare professionals struggle with drug dependence at some point in their career. Drug diversion can result in substandard care by, and ultimately the death of, the healthcare provider.

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FDA Announces Voluntary Withdrawal of Pergolide Products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.
The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.
In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.
There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

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FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.
Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.
FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

For more information CLICK HERE

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Believe It Or Not

Dog performs 'Heimlich' on choking owner

Toby, a 2-year-old golden retriever, saw his owner choking on a piece of fruit and began jumping up and down on the woman's chest. The dog's owner believes the dog was trying to perform the Heimlich maneuver and saved her life.
Debbie Parkhurst, 45, of Calvert told the Cecil Whig she was eating an apple at her home Friday when a piece lodged in her throat. She attempted to perform the Heimlich maneuver on herself but it didn't work. After she began beating on her chest, she said Toby noticed and got involved.
"The next think I know, Toby's up on his hind feet and he's got his front paws on my shoulders," she recalled. "He pushed me to the ground, and once I was on my back, he began jumping up and down on my chest."
That's when the apple dislodged and Toby started licking her face to keep her from passing out, she said.
"I literally have pawprint-shaped bruises on my chest. I'm still a little hoarse, but otherwise, I'm OK," Parkhurst said.
"The doctor said I probably wouldnt be here without Toby," said Parkhurst, a jewelry artist. "I keep looking at him and saying 'Youre amazing.'"

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A political cartoon that has nothing to do with the content of this publication. (but I think it is funny and maybe accurate)

What Would Georg W. Bush Do?

News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICK HERE

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Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs CLICK HERE

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FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

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Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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