IN THIS ISSUE:

• Most Pediatric Chemotherapy Mistakes Reach Patients, Study Finds
   
• Viagra May Give a Boost to the Jet-Lagged
   
• FDA Issues Safety Alert on Avandia
   
• Doctors Not Ready to Abandon Diabetes Drug
   
• Buyer Beware
   
• FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products
   
• Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution

• 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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Most Pediatric Chemotherapy Mistakes Reach Patients, Study Finds

The vast majority of chemotherapy errors identified in children reach patients, according to one of the first epidemiological studies of cancer drug errors in children. Published in the July 1, 2007 issue of Cancer, a peer-reviewed journal of the American Cancer Society, the study concluded that the antimetabolite class of chemotherapeutic agents are most likely associated with errors, and that errors in drug administration and errors in drug dosing and frequency were the most common mistakes made and consequently, the most potentially harmful.
Chemotherapeutic drugs have been credited with significant gains in survival from pediatric cancers. However, they are among the most toxic medications used today. Calculating dose, route, and frequency, which are often based on a child's weight, are critical to ensure that the drug concentration in the blood is within its narrow safety margins.
Medication errors are common during pediatric hospitalizations, occurring in almost 6 percent of all medication orders for pediatric inpatients. One of the only comprehensive studies of pediatric chemotherapy errors found that 13 percent of such errors reached children and 2 percent were serious and required intervention.
Dr. Marlene Miller of Johns Hopkins University and colleagues conducted a comprehensive review of a nationwide medication error database of inpatient facilities and outpatient clinics to characterize the patterns of errors and their causes for children receiving chemotherapy. Between 1999 and 2004, 829,492 errors were reported, of which 29,802 involved patients under 18 years old and 310 of these involved a chemotherapeutic drug.

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Viagra May Give a Boost to the Jet-Lagged

The little blue pill, approved in the early 1990s to treat erectile dysfunction, may someday be a boon to those who suffer from the dulling effects of jet lag, according to a new study.
The finding "opens a completely original way of dealing with this kind of disarrangement," says Diego Golombek, a chronobiologist at the National University of Quilmes in Buenos Aires, and senior investigator of research that indicates that Viagra prevents time-change fatigue in hamsters. "Moreover, since the drug has been extensively tested in humans—in terms of safety, efficacy and other pharmacological parameters—it could be argued that it should be quite straightforward to start a clinical test."
Jet lag affects the communication between light-responsive photoreceptor cells in the retina of the eye and the hypothalamus, a gland at the base of the brain that connects the nervous and endocrine systems, and, among other things, houses the body's circadian clock. Responding to cues of the light-dark cycle, the clock controls when animals sleep, eat and are active. Traveling through time zones requires adapting to a new light-dark cycle, which can take some people several days.

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FDA Issues Safety Alert on Avandia

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.
"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."
Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.
Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

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Doctors Not Ready to Abandon Diabetes Drug

The news that the popular diabetes drug Avandia may increase the risk of heart attack is being met with concern, but not alarm, by health-care professionals.
"We think people should speak to their physician. We don't feel this is an emergency situation," said Dr. Sue Kirkman, vice president of clinical affairs for the American Diabetes Association. "The study was concerning, but the numbers were very, very small -- about an additional one per 1,000."
"People should definitely not panic, and they should talk to their doctors," added Dr. Mary Ann Banerji, professor of medicine at SUNY Downstate Medical Center in New York City.
Rachel Villarreal, a health educator with the Diabetes Education Program in the Texas A&M Health Science Center Coastal Bend Health Education Center, said, "Patients should consult their health-care provider and determine if the risks outweigh the benefits, because there are a lot of benefits to Avandia."
"Don't just take yourself off the medication," Villarreal added. "If you don't feel comfortable taking it, there are other treatment options that are similar."

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Buyer Beware

We've all heard about herbal supplements that have worked for someone we know. People swear by them: echinacea for a cold, ginkgo biloba for memory or the peppermint in the salve your aunt believes can ease chest congestion. Over the past decade, use of herbal supplements has jumped 83%, going from $12.2 billion in U.S. sales in 1996 to a whopping $22.3 billion last year. While many of those users may be skeptical, they figure, Hey, these things are natural; what harm could they do?
As it turns out, in some cases they can do a lot of harm, and a surprising number of people are putting themselves at risk by using herbal supplements without being informed about their actual benefits and potential dangers. A new study conducted at the University of Iowa and published in the June issue of Mayo Clinic Proceedings reveals just how widespread the problem has become.
Researchers found that the most common mistake users of herbal remedies make is believing that the substances they take actually work. An earlier National Institutes of Health study showed that about 19% of Americans take herbal supplements and more than half the time they're using the substances to treat a specific health condition instead of just for general well-being. That's fine, provided the supplements treat those conditions, but in more than two-thirds of cases, the preparations have never been clinically proved to be effective for those uses. And as any scientist will tell you, clinical proof--a randomized, controlled trial--is the gold standard for establishing a drug's usefulness and safety. So a lot of dollars--not to mention medical faith--are being spent on potentially useless treatments.

For more information CLICK HERE

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FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products

The U.S. Food and Drug Administration (FDA) today announced its intention to take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs.
Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs.
"Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."
This action does not affect products containing guaifenesin in immediate release form, but rather only affects timed-release forms, often described as extended-release, long-acting or sustained-release. These dosage forms release their active ingredients over an extended period of time, reducing the number of doses needed per day. Many of the products that contain guaifenesin also contain other active ingredients that are intended to relieve nasal congestion, suppress cough, reduce fever or relieve pain.
Timed-release drugs require FDA approval because the FDA must ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work.

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Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution

The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.
The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.
"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."
Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

For more information CLICK HERE

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Believe It Or Not

Demand for "designer vagina" surgery rising

Rising numbers of women in Britain are seeking state-funded cosmetic surgery on their genitals, doctors said on Friday.
Writing in the British Medical Journal, they said the number of "labial reductions" carried out in National Health Service hospitals had doubled to 800 a year over five years.
"More and more women are said to be troubled by the shape, size or proportions of their vulvas", wrote Lih Mei Liao and Sarah Creighton from London's UCL Elizabeth Garrett Anderson Institute for Women's Health.
Articles in women's magazines about "designer vaginas", the rising popularity of cosmetic surgery and Internet promotion by private health clinics were all fuelling demand.
The authors said women seeking surgery were being influenced by idealised images of genitalia shown in pornography and on private genitoplasty Web sites.
Liao said research was needed into whether surgery was bringing long-term benefits to patients, before the NHS started routinely offering the cosmetic procedure

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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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