IN THIS ISSUE:

• Hospitals Wage Battle Against Drug Diversion
   
• FDA to Review Cold Remedies for Kids
   
• New Study Finds Antibiotic Vancomycin May Trigger Dangerously Low Platelet Count
   
• A Mix of Medicines That Can Be Lethal
   
• FDA Set To Approve Controversial Cow Drug
   
• FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches
   
• Stanford Study Drives Stake Through Claims That Garlic Lowers Cholesterol Levels

• 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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Hospitals Wage Battle Against Drug Diversion

Recently, a former nurse who worked at the Veterans Administration Medical Center in Bedford, the Somerville Hospital, and the Metro West Medical Center-Framingham—all in Massachusetts—was sentenced because she stole numerous controlled substances, including codeine, oxycodone, and fentanyl, from these facilities. She had falsely stated on medication administration records that she was administering the medications to patients, all the while keeping the medications for herself.
Drug Topics contacted the hospitals involved to find out what measures they have put in place to prevent such thefts in the future, but all three declined to comment.
Diversion of controlled substances and other pharmaceutical products is recognized as a critical problem in the United States. Many hospitals are fighting back, however, by utilizing medication monitoring devices, such as Pyxis machines from Cardinal Health, and tighter medication distribution security to assist them in preventing drug diversion.

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FDA to Review Cold Remedies for Kids

U.S. health officials said Friday that they are reviewing the safety of children's over-the-counter cold and cough remedies.
Dr. Charles Ganley, the FDA's director of the Office of Nonprescription Products, said the agency has been "looking into the issue of safety of children's cough medicine since the middle of last year." He noted that when these medicines were originally approved, in some cases several decades ago, there was no mandate that the effectiveness, safety or dose be determined for children; rather, the guidelines were extrapolated from studies done with adults.
"We have not established a dose that is safe for children 2 and under," Ganley said during a teleconference. "We hope to have our review done in several months and then make recommendations."
When these drugs are taken in higher-than-normal doses, they can affect the heart's electrical system, leading to arrhythmias, which are irregular heartbeats. Some medicines affect the blood vessels and, in high doses, have been associated with high blood pressure and stroke. In rare cases, children have been injured even when given recommended doses, The New York Times reported.

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New Study Finds Antibiotic Vancomycin May Trigger Dangerously Low Platelet Count

The antibiotic vancomycin often used in intensive care units is considered the drug of choice for the treatment of staphylococci (staph) infections that are resistant to most other antibiotics. Researchers at the Medical College of Wisconsin in Milwaukee and the BloodCenter of Wisconsin's Blood Research Institute have linked vancomycin to an abnormal decrease in blood platelet count, a condition called thrombocytopenia. If accompanied by uncontrollable bleeding, thrombocytopenia can be fatal.
The study led by Annette Von Drygalski, M.D., third year internal medicine resident, and Richard H. Aster M.D., professor of medicine at the Medical College, and senior investigator at the Blood Research Institute, will appear in the March 1, 2007, edition of New England Journal of Medicine.
Patients suspected of having thrombocytopenia, or low blood platelet count often associated with bleeding, can be tested for a special type of antibody to see if it is related to medications. For this study, the researchers obtained clinical information on 29 patients who tested positive for vancomycin-dependent platelet antibodies. The patients were seen at major U.S. hospitals.
"We found a close correlation between exposure to vancomycin, development of a vancomycin-dependent antibody, and the onset of severe thrombocytopenia accompanied by serious bleeding in most cases," Says Dr. Aster. "Three of the 29 cases described ended fatally. Serious bleeding appears to have contributed to these outcomes."

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A Mix of Medicines That Can Be Lethal

The death of Libby Zion, an 18-year-old college student, in a New York hospital on March 5, 1984, led to a highly publicized court battle and created a cause célèbre over the lack of supervision of inexperienced and overworked young doctors. But only much later did experts zero in on the preventable disorder that apparently led to Ms. Zion’s death: a form of drug poisoning called serotonin syndrome.
Ms. Zion, who went to the hospital with a fever of 103.5, had been taking a prescribed antidepressant, phenelzine (Nardil). The combination of phenelzine and the narcotic painkiller meperidine (Demerol) given to her at the hospital could raise the level of circulating serotonin to dangerous levels. When she became agitated, a symptom of serotonin toxicity, and tried to pull out her intravenous tubes, she was restrained, and the resulting muscular tension is believed to have sent her fever soaring to lethal heights.
Now, with the enormous rise in the use of serotonin-enhancing antidepressants, often taken in combination with other drugs that also raise serotonin levels, emergency medicine specialists are trying to educate doctors and patients about this not-so-rare and potentially life-threatening disorder. In March 2005, two such specialists, Dr. Edward W. Boyer and Dr. Michael Shannon of Children’s Hospital Boston, noted that more than 85 percent of doctors were “unaware of the serotonin syndrome as a clinical diagnosis.”
In their review in The New England Journal of Medicine, Dr. Boyer and Dr. Shannon cited a report based on calls to poison control centers around the country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In 2005, the last year for which statistics are available, 118 deaths were reported.)

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FDA Set To Approve Controversial Cow Drug

The Food and Drug Administration may be poised to approve a controversial antibiotic for cattle despite fears it could hurt human health, The Washington Post reported in Sunday's edition.
The drug, called cefquinome, is a fourth-generation cephalosporin, a class of antibiotics used for a range of human diseases including serious gastrointestinal diseases in children and meningitis.
The fear is that using such drugs in animals can lead to the emergence of new drug-resistant "superbugs" which will be immune to similar drugs when used in people.
The overuse of antibiotics in both humans and animals has already helped such bacteria evolve, and infectious disease experts have been warning doctors to use them more judiciously.

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FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches

The Food and Drug Administration (FDA) today told 20 companies to cease marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. As part of the FDA’s continued efforts to combat the marketing of unapproved drugs, the agency sent warning letters to eight manufacturers and 12 distributors warning them that they are subject to further enforcement action if they do not stop manufacturing and distributing these products.
The agency urges consumers who are using ergotamine products and have questions or concerns to contact their health care provider. This action does not affect FDA-approved products containing ergotamine, which will remain on the market.
“Unapproved drugs pose real risks to the American public,” said Steven Galson, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Because they have not been subject to FDA review, the safety, effectiveness, and quality of such products are unknown. We remain dedicated to tackling this problem through education and outreach, as well as enforcement actions like these. It is central to our mission to ensure a safe and effective drug supply for the American public.”

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Stanford Study Drives Stake Through Claims That Garlic Lowers Cholesterol Levels

When it comes to lowering cholesterol levels, garlic stinks, according to a new study from the Stanford University School of Medicine.
Despite decades of conflicting studies about the pungent herb’s ability to improve heart health, the researchers say their study provides the most rigorous evidence to date that consuming garlic on a daily basis—in the form of either raw garlic or two of the most popular garlic supplements—does not lower LDL cholesterol levels among adults with moderately high cholesterol levels.
“It just doesn’t work,” said senior author Christopher Gardner, PhD, assistant professor of medicine at the Stanford Prevention Research Center. “There’s no shortcut. You achieve good health through eating healthy food. There isn’t a pill or an herb you can take to counteract an unhealthy diet.”
Gardner said the study, published in the Feb. 26 issue of the Archives of Internal Medicine, is the first independent, long-term, head-to-head assessment of raw garlic and garlic supplements. The study also drew on the expertise of two of the nation’s foremost garlic experts—Larry Lawson, PhD, of the Plant Bioactives Research Institute in Utah, and Eric Block, PhD, professor of chemistry at the University at Albany, State University of New York—who have devoted much of their careers to understanding the biochemical properties of the herb and who ensured the quality and stability of the garlic consumed in the study.

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Believe It Or Not

Body parts delivered to Michigan home

Two packages containing human body parts — including a liver and part of a head — meant for a medical research lab instead were delivered to a home.
The body parts, sent from China, were mistakenly dropped off Thursday at Franck and Ludivine Larmande's home by a DHL express driver who believed the bubble-wrapped items were pieces to a table.
"My husband started to unwrap one and said, 'This is strange, it looks like a liver,'" Ludivine Larmande said. "He started the second one, but stopped as soon as we saw the ear.
"Something wasn't right. It was scary, and I'm glad I didn't open them."
The couple called Kent County sheriff's deputies, who determined the preserved body parts were for medical research, Lt. Roger Parent said.
Authorities believe 28 more bubble-wrapped human organs and body parts could be dispersed across the country, The Grand Rapids Press reported. Two of five packages headed to the northern Michigan lab broke open, scattering their contents.
"There will definitely be a shock to people if they see these things, but there is no hazard to health," Parent said.
DHL is investigating whether it should have shipped the body parts and how the packages were dispersed, spokesman Robert Mints said.

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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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