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U.S. Department of Health and Human Services

Show #16, June 2003

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Show #16, June 2003

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 New Medical Products

June2003FDA Patient Safety News Homepage
Expanded Use for HPV Test (Video, print, and e-mail functions)
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FDA recently approved the expanded use of a laboratory test to detect human papillomavirus, or HPV, in the uterine cervix. HPV infection, which is transmitted sexually, is a risk factor for cervical cancer. The test, called the HC2 High-Risk HPV DNA test, is manufactured by Digene Corp. FDA had previously approved this product as a follow-up test for women who had abnormal Pap tests. The product is now approved to be used along with the Pap test on any woman over age 30. Although it’s an adjunct to Pap screening, it’s not intended to substitute for Pap screening.

The approval specifies women over 30 because of the higher risk of cervical cancer in this age group. Although the rate of HPV infection in women under 30 is relatively high, most infections in this age group are short-lived, and women under 30 rarely develop cervical cancer. On the other hand, women over 30 have fewer HPV infections, but cervical cancers are more likely to occur in older women.

There are several things patients should understand about the HPV test. First, they should know that having the virus increases the risk of cervical cancer. But they should also understand that HPV infections are common, that most of them resolve on their own, and that only a very small proportion of these infections lead to cancer. In other words, a positive HPV test can provide useful information for the woman and her physician, but it doesn't necessarily mean that cancer is going to develop. On the other hand, patients should understand that a negative pap smear and HPV test can't assure that things won't change. Infections or cellular abnormalities could develop in the future, which is why continued screening is important.

The American Cancer Society has an excellent web site that explains HPV and its possible health effects in Iay terms. It's called “What Women Should Know about HPV and Cervical Health.” It's a good place to send patients for more information.

Additional Information:

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June2003FDA Patient Safety News Homepage
FDA Approves First Drug in New Class of HIV Treatments (Video, print, and e-mail functions)
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FDA recently approved a new type of drug to treat advanced HIV-1 infection in adults and children six and older. The drug is called Fuzeon and it's the first of the so-called “fusion inhibitor” drugs to be approved anywhere in the world. Fusion inhibitors work by inhibiting the fusion of viral and cellular membranes, thus blocking the HIV virus' ability to infect cells. Fuzeon's generic name is enfuvirtide and it will be distributed by Roche Pharmaceuticals.

A significant percentage of patients with chronic HIV develop infection that's resistant to many existing medications. By affecting the spread of the virus differently than current drugs, Fuzeon can help reduce viral loads and slow HIV progression in patients who have developed resistance to current drugs. Since HIV must be treated with a combination of drugs, Fuzeon can be used as part of a drug regimen for patients who have limited options. Fuzeon should only be used in patients who have previously used other anti-HIV medications and still have ongoing evidence of viral replication.

FDA based its accelerated approval of Fuzeon on an analysis of six months of data from two ongoing clinical studies of about 1,000 patients. Patients who received Fuzeon plus a regimen of other anti-HIV drugs had a reduced viral load compared to patients who received only the other anti-HIV drugs. The long-term effects of Fuzeon are not known at this time, but they're being evaluated by the ongoing clinical studies.

There are several things to be alert for with this drug. Although bacterial pneumonia was uncommon in clinical study patients, those treated with Fuzeon developed more bacterial pneumonia than the control patients. So patients taking Fuzeon should be monitored carefully for symptoms of pneumonia, and they should be advised to seek medical evaluation immediately if they develop signs and symptoms suggestive of pneumonia such as cough with fever, rapid breathing and shortness of breath.

Fuzeon can also cause serious hypersensitivity reactions, so patients should be warned to discontinue therapy and immediately seek medical evaluation if they develop symptoms of hypersensitivity, such as breathing problems, fever or skin rashes. And because Fuzeon is administered as a subcutaneous injection, local skin reactions, which may be painful, occur in almost all patients.

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June2003FDA Patient Safety News Homepage
New Drug to Combat Nausea and Vomiting in Chemotherapy Patients (Video, print, and e-mail functions)
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FDA recently approved a new antiemetic drug to prevent nausea and vomiting in chemotherapy patients. The drug is called Emend. Its generic name is aprepitant and it's made by Merck and Co.

Emend is approved for preventing both acute and delayed nausea and vomiting -- in fact, this is the first FDA approved treatment that prevents the nausea and vomiting that occur more than 24 hours after patients receive chemotherapy.

Emend reduces nausea and vomiting in a new way---- by blocking NK1 receptors in the brain. But it should always be used in combination with two other antiemetic agents -- it's one part of a three-drug regimen.

Patients should be advised to report the use of any other prescription or non-prescription drugs and herbal products because these may interact with Emend and can cause serious, life-threatening reactions. For example, Emend may interact with certain anti-coagulants, so patients being treated with drugs such as Coumadin should have their clotting status checked after each chemotherapy cycle where Emend is used. Emend may also reduce the effectiveness of oral contraceptives, so women who use birth control pills should use an alternative or back-up method of contraception.

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 Recalls and Safety Alerts

June2003FDA Patient Safety News Homepage
Urgent Market Withdrawal of GYNECARE INTERGEL Solution (Video, print, and e-mail functions)
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Now for an alert about a product that's been voluntarily withdrawn from the market. The product is the GYNECARE INTERGEL Adhesion Prevention Solution, and it's used to reduce post-surgical adhesions in patients undergoing open, conservative gynecologic surgery.

Adverse event reports associated with this solution have included late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients, a residual material was observed during the repeat surgery.

GYNECARE Worldwide, a division of Ethicon, Inc. is urging customers to immediately stop using the INTERGEL Adhesion Barrier Solution, and return all remaining product and samples to the company.

GYNECARE is taking this action while it completes an assessment of the experience with the device. Part of the assessment will include adverse events associated with off-label use, for example in laparoscopy and non-conservative surgical procedures such as hysterectomy.

Additional Information:

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June2003FDA Patient Safety News Homepage
Cracked Vials of Some Glucose Test Strips (Video, print, and e-mail functions)
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Roche Diagnostics Corporation has issued an urgent product correction on some of its Accu-Chek glucose test strips because of a defect in the vials that hold these strips. The problem is that some of these vials may be cracked and allow moisture to get in, causing inaccurate results. The affected brands are Accu-Chek Comfort Curve and Accu-Chek Advantage test strips. The manufacturer believes that only a small percentage of vials are affected.

Cracks may develop in these vials at any time, including after the vial has been opened. Roche is asking users to inspect the bottom of every vial for cracks before each use, and not use test strips from a cracked vial. If there is no crack in the vial, but blood glucose results are unusually high, low, or inconsistent, the test should be repeated along with a quality control check.

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Warning on Lindane for Scabies and Lice (Video, print, and e-mail functions)
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In a recent Public Health Advisory, FDA warned health professionals and consumers about the potential toxicity of Lindane when it's used to treat scabies and lice. FDA has reports of neurologic effects from topical Lindane products, ranging from dizziness to seizures, as well as several deaths. Most of the serious effects were due to misuse of the products, but there have been rare case reports of serious reactions from apparently normal use.

The FDA advisory stresses that Lindane is a second-line treatment. It should be prescribed only when the patient doesn't respond to safer treatments, such as permethrin or malathion products, or if the patient can't tolerate these safer products.

Many of the serious adverse events reported to FDA occurred when the medication was applied several times. And so the FDA advisory says that patients should be instructed that Lindane products should be applied just once. Patients should understand that itching after treatment may be due to the Lindane itself rather than the scabies or lice, and shouldn't be tempted to reapply the medication.

The FDA advisory also advises special caution in prescribing Lindane products for specially susceptible population groups. These include patients weighing less than 110 pounds, the elderly, those with HIV infections, and those on medications that may predispose them to seizures. And Lindane products are contraindicated in neonates.

FDA is requiring a new boxed warning on the packaging of Lindane products describing these precautions. And the package sizes of Lindane products will be limited to one and two ounces, to help prevent patients from reapplying the medication. Pharmacists should dispense only enough of the product for a single treatment, not to exceed two ounces. And pharmacists must provide a Medication Guide to the patient with each new prescription. The Guide describes the risks of Lindane, and gives instructions for appropriate use.

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June2003FDA Patient Safety News Homepage
New Cautions on Beta Interferons for MS (Video, print, and e-mail functions)
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The prescribing information for three brands of beta interferon now contains new and strengthened warnings, cautions and information on adverse reactions. Beta interferon is used to treat multiple sclerosis, where it's intended to slow the progress of the disease and reduce the frequency of exacerbation. The products are Avonex, manufactured by Biogen Incorporated, Betaseron, manufactured by Chiron Corporation, and Rebif, manufactured by Serono, Inc.

Some of the new information is based on reports of psychiatric effects among patients treated with beta interferon, including depression and suicidal ideation. Some patients developed psychiatric disorders for the first time, including psychosis. Others experienced a worsening of existing psychiatric conditions. The labeling now contains a cautionary note about using beta interferon in patients with depression, mood disorders, or other severe psychiatric symptoms.

There have also been reports of anaphylaxis, decreased blood counts, autoimmune disorders and liver damage in patients treated with beta interferon. And so the labeling now advises monitoring patients for signs of blood abnormalities, hepatic injury and possibly autoimmune disorders.

Additional Information:

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June2003FDA Patient Safety News Homepage
Proper Use of Fetal Pulse Oximeter (Video, print, and e-mail functions)
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FDA has received over a dozen reports of poor neonatal outcomes associated with the use of the Nellcor OxiFirst Fetal Pulse Oximetry System. This system is used to measure fetal oxygenation during labor. The adverse event reports we've seen include three stillbirths, low Apgar scores, acidosis, and transient neonatal depression.

As a result of these reports, Nellcor issued a Dear Doctor letter in February to clarify the instructions for use, and to change some of the clinical management recommendations.

The letter made four points.

First, the OxiFirst system should only be used as an adjunct to fetal heart rate monitoring. It's not a substitute for clinical interpretation of fetal heart rate.

Second, when a fetal oxygen saturation signal isn't present, and readjusting the monitor doesn't restore the signal, clinical management of the fetus should be based on fetal heart rate and clinical signs alone. No inferences about fetal status should be made based on earlier values from the device.

Third, the letter expanded the definition of what should be considered an “ominous” fetal heart rate. If the heart rate pattern is ominous, even when the fetal oxygen saturation values are normal, the company says that the clinician should deliver the baby.

And finally, the letter included updated clinical guidelines for using the OxiFirst system, but reminded clinicians that these guidelines are recommendations that may not apply to every clinical situation.

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