 This is FDA Patient Safety News. In this edition, a new type of drug to treat HIV infections, a product used to prevent adhesions is withdrawn from the market, new warnings on using lindane to treat scabies and lice, and new cautions for MS patients using beta interferons. These stories and more in this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rainer. Let's start with some medical products FDA recently approved. You can find information on all FDA-cleared medical products on FDA's website. 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 Corporation. 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 the age of 30. The FDA announcement said that it's not intended to substitute for regular pap screening. It's an adjunct to the pap test. Well, why is this test only approved for women over 30? Well, the answer really is risk. There's a higher risk of cervical cancer among women over 30. Although the rate of HPV infection in women under 30 is relatively high, most of those 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. Well, Mark, what's the real message here for women about HPV and cervical cancer risk? Well, there are several things patients should understand. First, having the virus increases the risk of cervical cancer. But they should also understand that HPV infections are common, and 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 a negative HPV test can't assure that things aren't going to change. Infections or cellular abnormalities could develop in the future, which is why continued screening is important. The American Cancer Society has an excellent website that explains HPV and its possible health effects in late terms. It's called What Women Should Know About HPV and Cervical Health. It's a good place to send patients for more information, and you'll find the address on our website. FDA recently approved a new type of drug to treat advanced HIV-1 infection in adults and children age six and older. The drug is called Fuzion, 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's ability to infect cells. Fuzion's generic name is infuvertide, and it will be distributed by Roche pharmaceuticals. What's this mean for patients? Well, actually, the key words here are drug resistance, 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, Fuzion 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, Fuzion can be used as part of a drug regimen for patients who have limited options. Fuzion 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 Fuzion on an analysis of six months of data from two ongoing clinical studies of about 1,000 patients. Patients who received Fuzion 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 Fuzion are not known at this time, but they're being evaluated by the ongoing clinical studies. Anything to look out for with this drug? Well, actually, several things. Although bacterial pneumonia was uncommon in clinical study patients, those treated with Fuzion developed more bacterial pneumonia than the control patients. So patients taking Fuzion 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. Fuzion 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 Fuzion is administered as a subcutaneous injection, local skin reactions, which may be painful, occur in almost all patients. FDA recently approved a new anti-imetic drug to prevent nausea and vomiting in chemotherapy patients. The drug is called E-Mend. Its generic name is a prepitant. And it's made by Merkin Company. E-Mend 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. E-Mend 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 anti-imetic 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 E-Mend and cause serious life-threatening reactions. For example, E-Mend may interact with certain anti-coagulants. So patients being treated with drugs such as Coumadin should have their clotting sedas checked after each chemotherapy cycle where E-Mend is used. E-Mend may also reduce the effectiveness of oral contraceptives. So women who use birth control pills should use an alternative or backup method of contraception. 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 postoperative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients, a residual material is observed during the repeat surgery. Gynecare worldwide, a division of Ethicon Incorporated, 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 this assessment will include adverse events associated with off-label use. For example, in laparoscopy and non-conservative surgical procedures such as hysterectomy. Roche Diagnostics Corporation has issued an urgent product correction on some of its AccuCheck 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 AccuCheck Comfort Curve and AccuCheck 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's 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. For more information, go to our website. 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. Mark, as I understand it, lindane shouldn't be used as a first choice in treating scabies and lice. It's definitely not a first choice in treating scabies and lice. The FDA advisory stresses that lindane is a second line treatment that 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. Well, before you mentioned misuse of the product, what type of misuse are we talking about? Mainly we're talking about overusing the product. Many of the serious adverse events reported to the 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 scabies or lice and they 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 and neonates. So what's FDA doing to make sure that prescribers and patients get the message? Basically there are three things to remember and those three things are warnings, package size and education. FDA is requiring a new boxed warning on the packaging of lindane products describing these precautions and the package sizes of lindane products are gonna 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. You can get copies of the medication guide from our website. 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, Beta Seron manufactured by Chiron Corporation and Rebeth manufactured by Serono Incorporated. 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 develop 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. The companies have developed medication guides for patients which are available on our website. FDA has received over a dozen reports of poor neonatal outcomes associated with the use of the Nelcor oxy first 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, Nelcor 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 oxy first 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 oxy first system, but reminded clinicians that these guidelines are recommendations that may not apply to every clinical situation. You can find the Dear Doctor letter on our website. Well, that's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can alert others. We'll be back next month with another edition, so watch for us. Until then, for the Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rayner. See you next time.