IN THIS ISSUE:

• American Diabetes Association Strongly Advises Patients Using Rosiglitazone To See Their Doctor
   
• Drug Slows And May Halt Parkinson's Disease
   
• Experts Call For Urgent Research Into Antiepileptic Drugs Given To Children After Significant Rise In Prescribing
   
• In Mice, Drug Protects against Diabetes and Atherosclerosis
   
• Extensively Drug-Resistant Tuberculosis (XDR TB) Overview
   
• Girl Dies After Using Excess Of Muscle Cream
   
• Prostate Cancer Treatment Can Speed Heart Attacks

• 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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American Diabetes Association Strongly Advises Patients Using Rosiglitazone To See Their Doctor

On June 5, 2007, the New England Journal of Medicine published results of an interim analysis of the cardiovascular safety trial of rosiglitazone (brand name, Avandia). The article was accompanied by three editorials. Although the findings from RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) found no significant increase in heart attack or cardiac death, but an increased risk of heart failure, this interim analysis did not have the statistical power to reach a definitive answer as to all the potential cardiovascular risks that may be associated with rosiglitazone. As one of the accompanying editorials stated, the RECORD study demonstrated a trend toward increased cardiovascular events and, when combined with recently published data and an analysis released by the company, there is still concern about cardiovascular side effects related to this drug.
As a result of all of this information, the American Diabetes Association strongly encourages patients taking this medication to consult with their physician as to its benefits and risks. The Association also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health care provider.
The most life-threatening consequences of diabetes are heart disease and stroke, which strike people with diabetes more than twice as often as they do others. If you have diabetes, it is very important to control your blood glucose, blood pressure and cholesterol levels.


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Drug Slows And May Halt Parkinson's Disease

Northwestern University researchers have discovered a drug that slows -- and may even halt -- the progression of Parkinson's disease. The drug rejuvenates aging dopamine cells, whose death in the brain causes the symptoms of this devastating and widespread disease.
D. James Surmeier, the Nathan Smith Davis Professor and chair of physiology at Northwestern University's Feinberg School of Medicine, and his team of researchers have found that isradipine, a drug widely used for hypertension and stroke, restores stressed-out dopamine neurons to their vigorous younger selves. The study is described in a feature article in the international journal Nature, which will be published on-line June 10.
Dopamine is a critical chemical messenger in the brain that affects a person's ability to direct his movements. In Parkinson's disease, the neurons that release dopamine die, causing movement to become more and more difficult.
Ultimately, a person loses the ability to walk, talk or pick up a glass of water. The illness is the second most common neurodegenenerative disease in the country, affecting about 1 million people. The incidence of Parkinson's disease increases with age, soaring after age 60.
"Our hope is that this drug will protect dopamine neurons, so that if you began taking it early enough, you won't get Parkinson's disease, even if you were at risk. " said Surmeier, who heads the Morris K. Udall Center of Excellence for Parkinson's Disease Research at Northwestern. "It would be like taking a baby aspirin everyday to protect your heart."

For more information CLICK HERE

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Experts Call For Urgent Research Into Antiepileptic Drugs Given To Children After Significant Rise In Prescribing

Researchers have called for urgent studies into the long-term safety of newer antiepileptic drugs after discovering that the number given to children has increased significantly over recent years, reports the June issue of British Journal of Clinical Pharmacology.
When the UK team studied antiepileptic drugs (AEDs) given to nearly 8,000 children over a 13-year period, they discovered that overall prescribing had risen by 19 per cent and there had been a five-fold increase in prescribing of newer AEDs.
The results follow a report by the European Medicines Agency (EMEA) which called for greater research into paediatric drugs for epilepsy.
“EMEA recommended further research into 21 antiepileptic drugs for children but didn’t indicate which ones should be prioritised” explains Professor Ian Wong from the Centre for Paediatric Pharmacy Research, a collaborative project run by the School of Pharmacy at the University of London, the UCL Institute of Child Health and Great Ormond Street Hospital.
“Our research has narrowed that list down to three drugs that have seen a massive rise in UK prescribing since 1993 – lamotrigine, topiramate and levetiracetam. The uptake of these drugs has been rapid, yet their long-term safety has not been established and further research must now be seen as a priority.”
Worldwide concern has been expressed about the need to reform regulations and develop better research structures for paediatric medicines, says Professor Wong, who is also a member of TEDDY - the Task-force of European Drug Development for the Young.

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In Mice, Drug Protects against Diabetes and Atherosclerosis

Blocking a single protein with an experimental drug prevented and treated both type 2 diabetes and atherosclerosis in laboratory mice that had been fed unhealthy diets and were genetically predisposed to these common killers, according to an article published online at Nature on June 6, 2007. The team was led by senior author Gökhan Hotamisligil, chair of the Department of Genetics and Complex Diseases at the Harvard School of Public Health (HSPH). Lead author was Masato Furuhashi, research fellow in the department.
In earlier studies, Hotamisligil’s lab members researched mice lacking two lipid-binding proteins, aP2 and mal1. When these mice were fed a high-cholesterol or high-fat diet, the expected signs of metabolic diseases such as atherosclerosis, type 2 diabetes, and fatty liver disease never developed. Recently, researchers in Hotamisligil’s lab and at the Garvan Institute of Medical Research in Australia also demonstrated that these genes were critical in the development of asthma, another disease associated with obesity.
In this new paper, researchers from HSPH, Bristol-Myers Squibb, and elsewhere describe how a designer compound mimics many of these protective effects in mice, conferring substantial immunity to diabetes, heart disease, and other metabolic problems. This immunity takes place even if the animals are severely obese or have high amounts of cholesterol and consume dangerously fatty foods. Use of the compound not only appears to prevent the development of these diseases, but also to reverse the symptoms of these illnesses in mice.
“To have this chemical in hand and to replicate the effects of genetic manipulation is a huge milestone and an incredible source of excitement,” said Hotamisligil, Professor of Genetics and Complex Diseases. “This drug is very effective in treating diabetes and heart disease in mice at the same time, and we believe it may turn out to be protective against asthma and other metabolic disorders as well.”

For more information CLICK HERE

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Extensively Drug-Resistant Tuberculosis (XDR TB) Overview

Extensively drug-resistant tuberculosis (XDR TB) is a relatively rare type of multidrug-resistant tuberculosis (MDR TB). It is resistant to almost all drugs used to treat TB, including the two best first-line drugs: isoniazid and rifampin. XDR TB is also resistant to the best second-line medications: fluoroquinolones and at least one of three injectable drugs (i.e., amikacin, kanamycin, or capreomycin).
Because XDR TB is resistant to the most powerful first-line and second-line drugs, patients are left with treatment options that are much less effective and often have worse treatment outcomes.
XDR TB is of special concern for persons with HIV infection or other conditions that can weaken the immune system. These persons are more likely to develop TB disease once they are infected, and also have a higher risk of death once they develop TB disease.
The risk of acquiring XDR TB in the United States appears to be relatively low. However, it is important to acknowledge the ease at which TB can spread. As long as XDR TB exists, the United States is at risk and must address the threat.

For more information CLICK HERE

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Girl Dies After Using Excess Of Muscle Cream

Arielle Newman was the captain of the track team at Notre Dame Academy in Staten Island, N.Y.
"She was a good kid, an overall good kid, following the rules, just trying to do the best she could in school, in track," said Alice Newman, Arielle's mother.
The award-winning cross country runner, who was popular with friends and teachers alike, was found dead by her mother on April 3.
"I went upstairs to her room and found her on the floor," Newman said. "I tried to do mouth-to-mouth. I tried to do chest compressions, but I could tell that she'd been gone for a while."
Arielle's death came as a shock to family and friends. But, nothing could prepare them for the apparent cause of this tragedy -- an overdose of muscle-pain-relieving creams.
Millions of consumers use such over-the-counter products to relieve pain from aching muscles. But doctors say they contain a substance known as methyl salicylate, which if used in excess can prove harmful.

For more information CLICK HERE

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Prostate Cancer Treatment Can Speed Heart Attacks

The male hormone-suppressing treatment used against aggressive prostate cancer may help bring on earlier heart attacks in older men, new research suggests.
"The new finding is that in men who have risk factors for heart attack, even six months of androgen-suppression therapy [and] maybe as little as three months, can cause a heart attack to occur sooner by about 2.5 years," said lead researcher Dr. Anthony D'Amico, chief of genitourinary radiation oncology at the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston.
That finding, which comes from analysis of pooled data of studies in the United States, Australia and New Zealand, does not mean that such men should not be treated to suppress the activity of androgens -- male sex hormones that spur the growth of prostate cancer cells, D'Amico said.
Instead, "the implication is that a man who needs hormonal therapy to avoid dying from cancer but also has risk factors for heart attack should be sent to a cardiologist for assessment and possible treatment of heart disease before starting hormonal therapy," he said.

For more information CLICK HERE

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Believe It Or Not

NYC man blames health drink for erection that wouldn't go away

A man has sued the maker of the health drink Boost Plus, claiming the vitamin-enriched beverage gave him an erection that would not subside and caused him to be hospitalized.
The lawsuit filed by Christopher Woods of New York said he bought the nutrition beverage made by the pharmaceutical company Novartis AG at a drugstore on June 5, 2004, and drank it.
Woods' court papers say he woke up the next morning "with an erection that would not subside" and sought treatment that day for the condition, called severe priapism.
They say Woods, 29, underwent surgery for implantation of a Winter shunt, which moves blood from one area to another.
The lawsuit, filed late Monday, says Woods later had problems that required a hospital visit and penile artery embolization, a way of closing blood vessels. Closing off some blood flow prevents engorgement and lessens the likelihood of an erection.
Woods' lawsuit, which seeks unspecified damages, names Novartis Consumer Health Inc. as a defendant. A spokeswoman for the company, Brandi Robinson, said Tuesday the company was aware of the lawsuit but does not comment on pending litigation.
Woods' lawyer did not return telephone calls for comment Tuesday.
Novartis' Boost Plus Web site describes the drink as "a great tasting, high calorie, nutritionally complete oral supplement for people who require extra energy and protein in a limited volume," in vanilla, chocolate and strawberry.

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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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