IN THIS ISSUE:

• Unique Blood Disorder Drug, Eculizumab, Approved By FDA
   
• Medical Bills Soaring For American Pets
   
• Euthanasia Doctor Given Suspended Sentence
   
• Testing Adult Stem Cells For Heart Damage Repair
   
• Soy Study Opens More Questions Than Answers
   
• FDA Requests Label Change for All Sleep Disorder Drug Products
   
• Want to Live Longer? Reach Past That O.J. for Some Grape Juice

• 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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Unique Blood Disorder Drug, Eculizumab, Approved By FDA

Soliris (eculizumab), an Orphan Drug, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a very rare blood disorder, has been approved by the US Food and Drug Administration. PNH can lead to disability and premature death. Solaris is a new molecular entity containing an active ingredient never previously marketed in the USA.
Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research, FDA, said "This product is important in that it offers a treatment other than blood transfusion that may help this small population of patients who are often very ill. This approval is one of multiple examples of how the orphan products program can benefit the public health with urgently needed products that would otherwise not be commercially available."
PNH is a disease which generally develops during adulthood. The red blood cells develop abnormally. Once these abnormal cells are present in the bloodstream, naturally occurring proteins designed to destroy bacteria and other organisms break these cells down. This leads to darkened urine and causes anemia. Depending on how serious a patient's disorder is, they can experience varying degrees of pain, fatigue and debilitating weakness - they may require frequent blood transfusions, experience blood clots, strokes, heart failure and intestinal disease. Soliris treats the breakdown of red blood cells.

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Medical Bills Soaring For American Pets

Americans increasingly are medicating their companion animals, even mortgaging their homes to do so.
With aging, it has become a routine faithfully endured by the Guffords. Each day starts with a blood-sugar test and a shot of insulin. Then a couple of pills, maybe mashed into a bowl of tuna and canned carrots. Mixed with dry chow.
All for their 12-year-old dog.
Brownie takes more drugs than his human companions put together. He has been medicated in recent months for diabetes, infections, high blood pressure and his finicky gut, which rebels at red meat. Since 2005, he has also taken drugs for anemia and a spider bite.
"He's our baby, he's a family member, I would want somebody to do that for me," Ann Gufford says.
She estimates expenses of $5,000 over the last two years on medicine for the mixed beagle-cocker spaniel. He has lost a couple of steps on the squirrels outside their little home near Goldsboro, N.C. His hearing is failing. Still, without some of the drugs, he'd probably be gone.
"You cannot put a price on that," Gufford says.
"And I don't want to," adds her husband, Ben.

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Euthanasia Doctor Given Suspended Sentence

Doctor Laurence Tramois was given a one-year suspended prison sentence on Thursday for poisoning Paulette Druais, a terminally ill woman. Chantal Chanel, the nurse who administered the injection, was acquitted by the court.
Druais's husband and son testified during the trial that they were grateful to Tramois and Chanel for their actions and insisted that Druais had asked to end her life.
But her son Laurent admitted during testimony that the family had never "broached the topic" of euthanasia even though they were distraught over her failing health.
The jury decided that Tramois should not get a criminal record because of the conviction.

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Testing Adult Stem Cells For Heart Damage Repair

The University of Wisconsin School of Medicine and Public Health is among the first medical centers in the country taking part in a novel clinical trial investigating if a subject's own stem cells can treat a form of severe coronary artery disease.
The trial, just underway at UW Hospital and Clinics, is enrolling subjects in the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial. The first patient underwent the procedure March 7. Because the study is randomized and "double-blinded," however, neither the patient nor the research physician knows if he received his own stem cells or a placebo substance.
This trial is the first human Phase II adult stem cell therapy study in the U.S. Its goal is to investigate the efficacy, tolerability, and safety of blood-derived selected stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
Myocardial ischemia, which affects hundreds of thousands of people, is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.

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Soy Study Opens More Questions Than Answers

Eating foods rich in isoflavone the active chemicals in soy foods, decreased the risk of localized prostate cancer but increased the risk of advanced prostate cancer, say researchers leading the largest study to date examining the link between soy and cancer.
Led by Dr. Norie Kurahashi, of the Epidemiology and Prevention Division of Japan's National Cancer Center the study analyzed the diet and prostate cancer history of 43,509 Japanese men. The results, published in the March issue of Cancer Epidemiology, Biomarkers & Prevention, suggests that the effects of isoflavones on prostate cancer development may differ according to disease stage.
"The present findings provide no clear understanding of when or how localized cancer will develop into aggressive cancer, and of the related effect of isoflavones," Kurahashi said in a prepared statement. "Given that Japanese consume isoflavones regularly throughout life, we do not know the period during which the effects of isoflavones on prostate cancer are preventive, and further research is required to find that out, including well-designed clinical trials," she said.
In this study the researchers polled thousands of men age 40-69 about their consumption of 147 foods, the most popular of which were miso soup (primarily made from fermented soybeans), natto (also a product of fermented soybeans) and tofu, made from soy milk. Japanese consume miso soup more frequently, usually daily, than other soy foods, and miso, natto, and tofu account for about 90 percent of the population's consumption of daidzein and genistein, according to Kurahashi.
The researchers then followed participants from 1995 through 2004 and found that 307 men were diagnosed with prostate cancer. In this group, 74 cases were advanced, 218 were confined to the prostate organ, and 15 were of undetermined stage.

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FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."
In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:
* Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
* Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

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Want to Live Longer? Reach Past That O.J. for Some Grape Juice

Americans drink half the world's orange juice — 21 quarts per person each year. Most of them do so because of reasons connected to taste and to the perceived health benefits of a glass of O.J. every day.
But that may change soon. According to a new study by scientists at the University of Glasgow in Scotland, purple grape juice is now your best bet for preventing heart disease, Alzheimer's disease and a host of other chronic ailments.
Elixir for a Long Life
What's the secret ingredient that makes juice such a potent weapon against disease?
Well, all juices contain chemical compounds known as polyphenols — a variety of antioxidant that, when consumed, helps to remove harmful free radicals from the body. Although exact information about how antioxidants combat illness is not forthcoming, a number of studies place them at the forefront of protecting the body from free radicals, molecules that destroy cells and allow diseases to develop.
The findings from the University of Glasgow come on the heels of the recent U.S.-based Kame project, which suggested that volunteers who drank three or more glasses of juice a week could reduce the risk of Alzheimer's by 76 percent, compared with those who drank juice less than once a week.

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Believe It Or Not

N.M. man arrested on 28th DWI charge

Bernalillo County sheriff's deputies have arrested a man on suspicion of driving while intoxicated, marking his 28th such offense. Joseph Brill, 53, was driving on a revoked license when deputies saw him park in a driveway in a northeast Albuquerque neighborhood and fall out of his pickup truck Wednesday evening. He smelled of alcohol and had bloodshot eyes and slurred speech, according to a criminal complaint.
Deputies said they tried to give Brill a field sobriety test but he could not complete the test. He then refused to give a breath test.
Deputies also found an open container of beer in his truck.
"People like Joseph Brill will never get it. They don't care," Sheriff Darren White said. "He needs to go to prison, and that's the way we're going to insure he does not drive a car drunk."
According to the complaint, Brill had 27 prior DWI offenses with at least 14 convictions before his arrest Wednesday. Records also show that he has had his license revoked five times and has spent nearly four years in New Mexico jails and prisons on DWI charges.
At the time of his arrest, he was on parole for two of the convictions, according to records.
Linda Atkinson, executive director of the Albuquerque-based DWI Resource Center, said she had never seen someone with 28 DWI arrests.
"It's pretty disgusting to see someone who can continue to defy the odds with a history like that," she said.
Brill was being held at the Metropolitan Detention Center on a $100,000 bond. His case will be heard in state district court because it is a felony.
Under New Mexico law, the maximum sentence for a seventh or subsequent DWI is three years in prison, a $5,000 fine, alcohol treatment and lifetime driver's license revocation.

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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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