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U.S. Department of Health and Human Services

Show #64, June 2007

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Show #64, June 2007

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 New Medical Products

June2007FDA Patient Safety News Homepage
FDA Approves Avian Flu Vaccine (Video, print, and e-mail functions)
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FDA has approved the first human vaccine in the U.S. to be used against the H5N1 influenza virus, commonly referred to as avian flu or bird flu. The vaccine is made by sanofi pasteur Inc. If an avian flu pandemic emerges, the vaccine could provide early, limited protection in the months before a vaccine tailored to the virus is developed. Testing has shown that about 45% of people who received this vaccine produced levels of antibodies expected to reduce the risk of getting the H5N1 flu.

The vaccine is indicated for those who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. However, it will not be available commercially, but will be placed in the National Stockpile for future use if needed.

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 Recalls and Safety Alerts

June2007FDA Patient Safety News Homepage
Managing Parkinson’s Patients Who have Taken Permax (Video, print, and e-mail functions)
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The companies that manufacture and distribute pergolide (marketed as Permax and in its generic form) have agreed to withdraw this drug from the market because of the potential for heart damage. Pergolide is a dopamine agonist used in treating Parkinson's disease.

Two new studies have shown that Parkinson's patients treated with pergolide experienced an increased risk of heart valve damage compared with patients who did not receive this drug.

Physicians caring for patients taking pergolide should assess whether they still need dopamine agonist therapy. If so, substitute another dopamine agonist. Several of them are approved for treating Parkinson's disease that are not associated with heart valve damage.

Physicians who decide that a patient no longer needs dopamine agonist treatment should gradually decrease the dose of pergolide, since stopping the drug abruptly can be dangerous. Note that pharmacies will continue to stock pergolide for a limited period of time, so that physicians and patients can discuss treatment options and change drugs.

FDA is working with the manufacturers of pergolide to see whether the drug might still be made available on a limited basis for those few patients whose efforts to switch drugs are unsuccessful.

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June2007FDA Patient Safety News Homepage
Market Withdrawal of Zelnorm (Video, print, and e-mail functions)
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Novartis Pharmaceuticals has agreed to stop selling Zelnorm because of safety concerns. Zelnorm (tegaserod maleate) had been approved to treat certain patients with irritable bowel syndrome and chronic constipation.

Zelnorm was taken off the market because a new analysis of 29 studies showed that taking this drug increased the risk of serious cardiovascular adverse events. Because of this, FDA believes that the benefits of the drug no longer outweigh the risks.

Patients being treated with Zelnorm should contact their doctors to discuss alternative treatments.

Prescribers should work with their patients to find other appropriate therapies. There may be some patients, however, with no other treatment options where the benefits of Zelnorm outweigh the risks. These patients may continue to receive Zelnorm if necessary through a special program that FDA has established with Novartis. Physicians can apply to the FDA for permission to prescribe Zelnorm for a patient through what's called an "Emergency IND."

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June2007FDA Patient Safety News Homepage
Griseofulvin Anti-fungal Oral Suspension Recalled (Video, print, and e-mail functions)
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Ortho-McNeil is recalling the company's griseofulvin 125 mg/ml oral suspension, which is used to treat ringworm and other fungal infections. The drug is being recalled because glass fragments were found in two of the bottles.

The affected products are Grifulvin V, marketed by Ortho Dermatological, and the generic griseofulvin oral suspension, which has a Patriot Pharmaceuticals label. The recall is limited to the liquid formulation of the medication and does not include any other dosage form.

The recalled lots were shipped to distributors in the United States between August 2005 and March 2007. The company is sending recall letters to wholesalers and pharmacies nationwide. Consumers who believe they have the recalled product should contact the pharmacy where they purchased the medicine.

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June2007FDA Patient Safety News Homepage
New Safety Concerns about Zyvox (Video, print, and e-mail functions)
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FDA has issued an alert to health professionals on emerging safety concerns about the antibiotic Zyvox (linezolid). A recent clinical study compared Zyvox with vancomycin, oxacillin or dicloxacillin in patients with catheter-related bloodstream infections or catheter site infections. The study showed that patients on Zyvox had a higher chance of death than with any of the other drugs, and that the increased risk occurred in patients infected with Gram negative bacteria.

Healthcare professionals should note that Zyvox is not approved to treat Gram negative infections, nor is it approved for catheter-related bloodstream infections or catheter-site infections.

FDA will continue to evaluate this study, along with other information about Zyvox, and will update the alert as more information becomes available.

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June2007FDA Patient Safety News Homepage
Genetic Testing to Help Reduce Chemotherapy Toxicity (Video, print, and e-mail functions)
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Everyone responds differently to medicines. The dose of a drug that cures one person can be ineffective-or even toxic-in someone else. Although many non-genetic factors play a role in how an individual patient responds to a particular drug treatment, many differences in drug response come from genetic variation. Individualizing a drug's dose based on pharmacogenomic information can help a patient get the most benefit from a drug while minimizing side effects.

Take the example of treating colorectal cancer with a chemotherapy regimen that includes Camptosar (irinotecan). A gene, called UGT1A1, produces an enzyme that metabolizes Camptosar. Variations in this gene can influence a patient's ability to break down the drug.

About 10 percent of the North American population has a variation of the UGT1A1 gene that reduces their ability to metabolize Camptosar, leading to high blood levels of the drug and a higher risk of toxic side effects. If these patients are given standard doses of Camptosar, about half will develop severe neutropenia, which can be fatal.

A test, called the Invader UGT1A1 Molecular Assay, can identify whether a patient has the genetic variant affecting the metabolism of Camptosar and thus would be at higher risk for developing severe neutropenia. The drug label says to consider lowering the starting dose of the Camptosar for those patients found to be high risk.

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 Preventing Medical Errors

June2007FDA Patient Safety News Homepage
Preventing Problems with Hemodialysis Catheters (Video, print, and e-mail functions)
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Hemodialysis catheters, both implanted and non-implanted, are often used as “bridge” devices until a patient's AV graft or native fistula is ready to be used. But if the catheter inadvertently separates from the venous blood line or is otherwise compromised, serious patient injury can occur.

FDA has received a number of reports describing hemodialysis catheters that have separated, leaked, cracked, torn, or broken. These catheter problems have led to patient infections, air embolisms, blood loss, and even death.

A recent FDA article in the journal Nursing2007 describes one case where a patient's venous blood line separated from the catheter about ten minutes after starting dialysis. Shortly after the venous blood line was clamped, the patient complained of shortness of breath. Despite swift and appropriate intervention, the patient died of an air embolism.

Here are some precautions:

• Use the vascular access site only for hemodialysis.

• Use luer connections or tape with hemodialysis catheters and tubing as your facility's protocol indicates.

• During dialysis, monitor catheters and arterial and venous blood line tubing for cracks, tears, or breaks of the catheter hub or luer connection. Remember, alarms may not sound if a catheter separates from the venous blood line, because the alarm triggers only when the pressure in the venous blood line falls below the limit set by the user.

• Make sure the catheter site remains visible during treatment. Remove sheets and blankets if necessary.

• If a catheter separates from the blood line tubing, or the integrity of the catheter is compromised in any other way, follow the facility's policy for preventing air embolism and infection, including clamping the line immediately.

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June2007FDA Patient Safety News Homepage
Preventing Drug Mix-Ups: Bumetanide and Norepinephrine (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices is warning health care professionals about several recent mix-ups between two injectable drugs made by Bedford Laboratories: bumetanide, a diuretic, and norepinephrine, used to treat MI and hypotension. These mix-ups occurred because the vial labels and caps make the two bottles look very similar.

In one report, a pharmacy bin marked “bumetanide” was mistakenly filled with vials of norepinephrine. A pharmacy technician, pharmacist and nurse all failed to notice the mistake. As a result, a patient who should have been received 1 mg of bumetanide instead was given 4 mg of norepinephrine. The patient developed chest pain and ventricular tachycardia and had to be transferred to the ICU.

ISMP says that Bedford Laboratories changed the color of the bumetanide cap from silver to green in April 2006. However, these recent errors suggest that the older vials may still be in circulation. And once the cap is removed, these two vials still look very similar. So it remains important to take extra care when handling and administering bumetanide and norepinephrine made by this firm.

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 Advice for Patients

June2007FDA Patient Safety News Homepage
Hazards of Buying Prescription Drugs Online (Video, print, and e-mail functions)
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Many people are choosing to buy prescription drugs online, but unless they are very careful, this can be a risky undertaking. Drugs bought over the internet can be fake, substandard in potency, unapproved by the FDA, counterfeit, or just plain dangerous.

For example some people who ordered tranquilizers, such as Ambien (zolpidem tartrate), Xanax (alprazolam), Lexapro (escitalopram oxalate) and Ativan (lorazepam), actually received a product that may have contained haloperidol, a powerful antipsychotic used to treat schizophrenia.

Some of these people needed emergency medical treatment for difficulty breathing and muscle spasms. Haloperidol can also cause agitation and sedation.

If patients are concerned that the tranquilizers they ordered may contain haloperidol, they can see photographs of the affected tablets above, and packages at the "Additional Information" link below. If the product resembles these photos, consumers should not take the drug.

There has also been some concern lately about people buying Accutane over the Internet. Accutane can cause severe birth defects if taken by a pregnant woman.

There is a special risk management program where women of childbearing age taking Accutane must register and undergo periodic pregnancy testing. But buying the drug over the Internet can circumvent all these precautions, and babies may be at risk.

So, now when a person searches the Internet for Accutane or its generic equivalents, a link to an FDA web page that warns about this problem will appear.

If buying medicines over the Internet, make sure the site is reputable. The site should be licensed by a State Board of Pharmacy, and have a registered pharmacist on hand to answer questions. Some sites display a so-called “VIPPS® seal” (Verified Internet Pharmacy Practice Sites™ Seal), which shows that they meet State and federal rules. And if the site does not require a prescription, it may not be legitimate.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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