IN THIS ISSUE:

• Avandia Stirs Debate at Diabetes Meeting
   
• Not All Antioxidants Are Created Equal
   
• FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
   
• Study Results Released On Travel And Blood Clots
   
• Common Preterm Labor Drug Has More Side Effects Than Alternative, Study Finds
   
• Glucosamine Trials Show Little Benefit Against Arthritis
   
• Flaxseed Stunts the Growth of Prostate Tumors

• 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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Avandia Stirs Debate at Diabetes Meeting

Controversy over the popular diabetes drug rosiglitazone maleate (Avandia; GlaxoSmithKline Plc) took center stage on Monday at a meeting of the world's experts on the disease, where researchers debated findings that the drug could boost heart attack risk.
The drug has been under a cloud since an analysis published in The New England Journal of Medicine last month found that Avandia increased the risk of heart attack by 43 percent, along with the risk of death from heart disease by 64 percent.
Study author Steven Nissen, cardiology chief at the Cleveland Clinic, defended his analysis to a packed audience of diabetes experts and other doctors, in a session added at the last minute at the American Diabetes Association's annual meeting in Chicago.
"What was the alternative? Not to know?" Nissen said, addressing concerns that his findings have caused alarm among patients. "The alternative was unacceptable: to keep the scientific community in the dark."


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Not All Antioxidants Are Created Equal

They've been said to stall aging, ward off disease and wage internal war against the harmful free radicals that pummel our bodies every day. But just how well do antioxidants—those all-powerful compounds often found in richly colored fruits and vegetables, such as blueberries, blackberries and red cabbage—actually perform inside the human body?
Eating fruits, like those pictured above, could boost levels of antioxidants in our blood and lead to a lower risk of chronic degenerative disease. (Credit: Photo by Scott Bauer)
Nutritionists with the Agricultural Research Service (ARS), the U.S. Department of Agriculture's chief scientific research agency, recently tackled this question. Their findings appear in the current issue of the Journal of the American College of Nutrition.
Led by Ronald Prior, an ARS chemist who works at the Arkansas Children's Nutrition Center in Little Rock, the researchers investigated how the consumption of different fruits affected volunteers' antioxidant status.
They did this by measuring the plasma (blood) antioxidant capacity (AOC) of volunteers who'd just ingested blueberries, cherries, dried plums, dried-plum juice, grapes, kiwis or strawberries.

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FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

The U.S. Food and Drug Administration (FDA) today approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.
"Letairis represents a valuable addition to the treatment alternatives for this orphan disease," said John Jenkins, M.D., director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."
In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting. About 100,000 people in the United States have pulmonary arterial hypertension.
Letairis, a new drug not previously approved in the United States, was granted a priority review by FDA. A priority review designation is intended for those products that address unmet medical needs. For priority drug applications, FDA sets a target date of six months after the date of receipt for the agency to complete all aspects of a review and to take action.

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Study Results Released On Travel And Blood Clots

WHO today released results from Phase I of the WHO Research Into Global Hazards of Travel (WRIGHT) project. Findings indicate that the risk of developing venous thromboembolism (VTE) approximately doubles after travel lasting four hours or more. However, the study points out that even with this increased risk, the absolute risk of developing VTE, if seated and immobile for more than four hours, remains relatively low at about 1 in 6000.
The two most common manifestations of VTE are deep vein thrombosis and pulmonary embolism. Deep vein thrombosis (DVT) is a condition in which a blood clot, or thrombus, develops in a deep vein - usually in the lower leg. Symptoms of DVT are principally pain, tenderness and swelling of the affected part. DVT can be detected through medical testing and can be treated. It can be life-threatening when associated with thromboembolism.
Thromboembolism occurs when a blood clot (from a deep vein thrombosis) in a leg vein breaks off and travels through the body to the lungs where it becomes lodged and blocks blood flow. This is known as pulmonary embolism, and symptoms include chest pain and breathing difficulties. VTE can be treated, but if it is not, it can lead to death.
The study showed that plane, train, bus or automobile passengers are at higher risk of VTE when they remain seated and immobile on journeys of more than four hours. This is due to a stagnation of blood in the veins caused by prolonged immobility, which can promote blood clot formation in veins.
One study within the project examining flights in particular found that those taking multiple flights over a short period of time are also at higher risk. This is because the risk of VTE does not go away completely after a flight is over, and the risk remains elevated for about four weeks.

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Common Preterm Labor Drug Has More Side Effects Than Alternative, Study Finds

The drug most commonly used to arrest preterm labor, magnesium sulfate, is more likely than another common treatment to cause mild to serious side effects in pregnant women, according to a study from researchers at Lucile Packard Children’s Hospital and Stanford University School of Medicine. Their findings suggest that, since the effectiveness of the two drugs appears similar, physicians should consider side effects more strongly when choosing which drug to prescribe.
Newborns whose mothers had received magnesium sulfate were also more likely to be admitted to the neonatal intensive care unit than those whose mothers had received the alternative treatment, although the data do not offer an explanation for this finding and more research needs to be conducted to rule out other causes. What is clear is that currently available treatments for preterm labor are far from perfect.
“There is no free lunch with any of these drugs,” said Deirdre Lyell, MD, a specialist in high-risk obstetrics at the hospital’s Johnson Center for Pregnancy and Newborn Services. “But magnesium sulfate has some particularly unpleasant side effects, including vomiting, lethargy and blurry vision. The alternative treatment, nifedipine, often leaves women feeling better.”
Side effects are particularly important for women struggling with the risk of premature birth and the rapid medical decisions that might need to be made about the care of their newborn. Lyell, assistant professor of obstetrics and gynecology at the medical school, and Yasser El-Sayed, MD, associate professor of obstetrics and gynecology at the medical school, are the lead and senior authors respectively of the research, which will be published in the July issue of Obstetrics & Gynecology. The study is the largest multicenter trial that randomized the use of the preterm labor drugs to compare outcome.

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Glucosamine Trials Show Little Benefit Against Arthritis

Although millions of arthritis sufferers buy glucosamine supplements to ease their joint pain, there's still no convincing proof the product works, according to a major new analysis.
In fact, the results of 15 trials of over-the-counter glucosamine vary so widely that industry bias may be a factor influencing the more positive outcomes, concludes a team writing in the July issue of Arthritis & Rheumatism.
"There's a big difference between trials, much more than you would expect by chance," explained lead investigator Dr. Steven Vlad, a fellow in rheumatology at Boston University Medical Center.
But an editorialist in the journal refutes those claims.
Dr. Jean-Yves Reginster, of the World Health Organization's Collaborating Center for Public Health Aspects of Rheumatic Disease, in Liege, Belgium, counters that industry trials are typically more stringent than independent academic research. He also believes that Vlad's group included trials in their analysis that were very unalike in terms of timeframes and methodology, confusing the results.
So, the years-long scientific debate on glucosamine continues. The popular supplement did take a major hit earlier this year, when a major U.S. study published in the New England Journal of Medicine found glucosamine hydrochloride to be of little help for knee osteoarthritis.

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Flaxseed Stunts the Growth of Prostate Tumors

Flaxseed, an edible seed that is rich in omega 3-fatty acids and fiber-related compounds known as lignans, is effective in halting prostate tumor growth, according to a study led by Duke University Medical Center researchers. The seed, which is similar to a sesame seed, may be able to interrupt the chain of events that leads cells to divide irregularly and become cancerous.
"Our previous studies in animals and in humans had shown a correlation between flaxseed supplementation and slowed tumor growth, but the participants in those studies had taken flaxseed in conjunction with a low-fat diet," said Wendy Demark-Wahnefried, Ph.D., a researcher in Duke's School of Nursing and lead investigator on the study. "For this study, we demonstrated that it is flaxseed that primarily offers the protective benefit."
The researchers will present their results on Saturday, June 2, during a news briefing at the annual meeting of the American Society of Clinical Oncology, in Chicago. The multisite study, which was funded by the National Institutes of Health, also involved researchers at the University of Michigan and the University of North Carolina at Chapel Hill.

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Believe It Or Not

Bat virus name offends Malaysian state

The state of Melaka is upset that scientists have named a new bat-borne virus after it, news reports said Sunday.
Australian and Malaysian scientists announced last week they had discovered a new virus likely carried by bats that can cause respiratory illness in humans.
They called it the Melaka virus, using the name of the southern state where it was isolated in early 2006 in a human patient.
Chief Minister Ali Rustam said Saturday the state does not want to be associated with the virus and called the name choice "an insult" to Melaka, which is a popular tourist destination because of its historical sites.
"Melaka is a good state, beautiful and peaceful, not the birthplace of diseases," The Star daily quoted him as saying.
Ali said the state government would lodge a formal protest with Malaysia's health ministry.
A spokesman in Ali's office could not immediately be contacted. Health ministry officials declined to comment.
The virus was detected after the man in Melaka developed high fever and acute respiratory illness last year about a week after a bat entered his home. Two of his children had milder symptoms, and the entire family has since recovered.
Virus samples taken from the man and his children proved similar, and researchers found it was closely related to another virus that was isolated in the late 1990s in fruit bats, also in southern Malaysia.

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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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