IN THIS ISSUE:

• Antidandruff Compound May Help Fight Epilepsy
   
• Aspirin May Be Less Effective Heart Treatment For Women Than Men
   
• Diabetes Drugs May Lower Risk Of Lung Cancer
   
• New Therapy For Patients With Crohn's Disease Identified
   
• FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications
   
• Second Vaccine Shows 100 Percent Protection Against Viruses
   
• NIH Funds Center in Iowa to Study Botanicals Used in Dietary Supplements

• 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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Antidandruff Compound May Help Fight Epilepsy

Researchers at Johns Hopkins have discovered that the same ingredient used in dandruff shampoos to fight the burning, itching and flaking on your head also can calm overexcited nerve cells inside your head, making it a potential treatment for seizures. Results of the study can be found online in Nature Chemical Biology.
Epilepsy and other seizure disorders result when nerves excessively or inappropriately “fire” in the brain. The brain’s “off” switches fail in part due to protein defects that prevent potassium from exiting nerve cells and calming them. “Channels that carry potassium,” says Min Li, Ph.D., professor of neuroscience at Johns Hopkins, “must open on cue to make sure nerve cells only fire for defined periods of time.”
In their studies of these channels, Li and his colleagues developed a new way of testing thousands of druglike molecules to find any that could turn the potassium switch on or off. Their approach involved chemically shaving off all the potassium channels on the cell surface and forcing the cells to make new channels. By measuring the activity of the new channels, the researchers could identify molecules that accelerated the recovery.

For more information CLICK HERE

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Aspirin May Be Less Effective Heart Treatment For Women Than Men

A new study shows that aspirin therapy for coronary artery disease is four times more likely to be ineffective in women compared to men with the same medical history.
Historically, studies have shown that aspirin therapy is less effective in women than in men, but it has remained unclear how much less effective and whether this affects patient outcomes, said Michael Dorsch, clinical pharmacist and adjunct clinical instructor at the University of Michigan College of Pharmacy.
Dorsch is the lead author of the paper, "Aspirin Resistance in Patients with Stable Coronary Artery Disease," which is published in the Annals of Pharmacotherapy.
Originally, Dorsch and his team set out to determine if patients with a history of heart attacks were more apt to be aspirin resistant than those with coronary artery disease but no history of heart attack. They found that gender and not medical history was a predictor for aspirin resistance, Dorsch said. The results surprised him.

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Diabetes Drugs May Lower Risk Of Lung Cancer

The use of diabetes drugs called thiazolidinediones, such as rosiglitazone (Avandia) and pioglitazone (Actos), may reduce the risk of lung cancer, according to a report in the Journal of Clinical Oncology.
These are preliminary findings, Dr. Rangaswamy Govindarajan from the University of Arkansas for Medical Sciences, Little Rock, told Reuters Health. "Physicians should be cautioned not to start using these agents for cancer prevention."
Govindarajan and colleagues investigated the effect of thiazolidinediones on the risk of lung, prostate, and colon cancer in men aged 40 years and older with diabetes, using a database covering 10 Veterans Affairs medical centers.
Among 87,678 individuals identified, there were 1137 cases of colon cancer, 3246 cases of prostate cancer and 1371 cases of lung cancer.

For more information CLICK HERE

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New Therapy For Patients With Crohn's Disease Identified

A study led by Mayo Clinic found that adalimumab (HUMIRA®)) is an effective treatment for adults with Crohn's disease who do not respond to infliximab (REMICADE®) therapy.
Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. One common therapy is a series of intravenous infusions of infliximab, which blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease.
"Approximately 50 percent of Crohn's disease patients who receive repeated administration of infliximab will eventually develop an allergic reaction, need higher doses, or completely stop responding to the therapy," says William J. Sandborn, M.D., the lead author and a gastroenterologist at Mayo Clinic. "Our goal with this study was to determine if adalimumab was a safe and effective alternative for these patients."
Like infliximab, adalimumab is a human monoclonal antibody that blocks tumor necrosis factor. However, it is administered via a series of subcutaneous injections, rather than intravenously.

For more information CLICK HERE

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FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality. .

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Second Vaccine Shows 100 Percent Protection Against Viruses

One hundred percent of young women vaccinated against the viruses most commonly linked to cervical cancer have remained free of the virus five years later, data from an ongoing trial shows.
The trial results demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date. The vaccine, CERVARIX®, developed by GlaxoSmithKline is seeking FDA approval for the prevention of cervical cancer. Merck's Gardasil®, received FDA approval last fall.
In this analysis of 776 women, none had developed precancerous lesions due to cancer-causing human papillomavirus types 16 and 18 for up to 5.5 years after receiving a series of 3 vaccinations against the viruses. The data was presented today in Los Angeles at the 2007 Annual Meeting of the American Association for Cancer Research by lead investigator Dr. Stanley Gall Professor of Obstetrics, Gynecology and Women's Health of the University of Louisville, Kentucky.
"These new data from this extended follow-up trial are exciting for those of us who are working to prevent cervical cancer, and for women around the world," Gall said in a prepared statement. "Demonstrating 100 percent effectiveness and sustained immune response for more than five years is a significant contribution to the scientific understanding of preventing cervical cancer and precancerous lesions through vaccination."

For more information CLICK HERE

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NIH Funds Center in Iowa to Study Botanicals Used in Dietary Supplements

The Office of Dietary Supplements (ODS), a component of the National Institutes of Health (NIH), today announced a grant to Iowa State University to study botanicals used as ingredients in dietary supplements. A multidisciplinary research team will study Hypericum (St. John’s wort), Prunella (Self-heal), and several types of Echinacea (for example, Purple Coneflower) for their anti-viral and anti-inflammatory properties. The center will be headed by Dr. Diane Birt, Distinguished Professor at Iowa State University, and will bring together researchers from ISU, the University of Iowa and Yale University.
“The work of all of the NIH-sponsored botanical research centers has proven to be important in advancing science in this area. We expect that this center at Iowa State University and the University of Iowa will continue to provide new insights into factors that can influence levels of bioactive components in plants and thereby modify the biological effects of botanicals used in dietary supplements,” said Paul Coates, Ph.D., Director of ODS.
NIH currently funds six dietary supplement research centers focused on botanicals. Scientists within these centers emphasize basic and preclinical research of potential benefit to human health. The studies at ISU will focus on identifying compounds and chemical profiles for anti-viral and anti-inflammatory activities and complement research at other centers that are studying the botanicals and inflammation. In recent years, inflammation has been identified as a common denominator of a number of chronic diseases, such as heart disease.
The National Center for Complementary and Alternative Medicine (NCCAM) at NIH will co-fund the Iowa center. “Given that millions of Americans are using natural products, this research center will join several other NIH-funded botanical centers in conducting key research to determine whether and by what mechanisms botanicals may serve as effective treatments or preventive approaches,” said Ruth L. Kirschstein, M.D., Acting Director of NCCAM.

For more information CLICK HERE

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Believe It Or Not

Man accused of dental work in garage

A man was held Wednesday on charges that he performed dental work on customers without a license in his "filthy" garage, authorities said. Roger Bean, 60, was arrested Tuesday and held on $6,000 bond.
Bean performed denture fittings and made false teeth in his garage, charging just $200 for a full set of dentures, a procedure that typically costs more than $2,000, authorities said. But he was not licensed to practice in Florida.
Palm Beach County Sheriff's detective Don Zumpano said there were "health risks with operating this type of facility outside of your house," adding that Bean's workspace was "filthy."
Neighbors and clients, however, praised Bean for saving them thousands of dollars.
Ron St. Mary, 73, head of the neighborhood crime watch, said Bean is no criminal.
"He's helping the old people who don't have a few dollars," he said. "I think the world of him."
It was not immediately clear if Bean had an attorney.

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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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