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U.S. Department of Health and Human Services

Show #63, May 2007

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Show #63, May 2007

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 New Medical Products

May2007FDA Patient Safety News Homepage
FDA Clears Rapid Test for Meningitis (Video, print, and e-mail functions)
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FDA recently cleared for marketing a rapid test to help detect the presence of viral meningitis. The test is called Xpert EV, and was developed by the company Cepheid. When used in combination with other laboratory tests, Xpert EV can help distinguish between viral meningitis and bacterial meningitis, which is less common, but more severe.

Typically, diagnostic tests for meningitis can take up to a week to get results, but results from the Xpert EV test are available in two and one-half hours. Since bacterial meningitis can be deadly within as little as two days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial disease. This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics.

The accuracy of the Xpert EV test was confirmed in a study at six clinical sites. About 250 patient samples were tested. Ninety-six percent of patients who tested positive did have viral meningitis and 97 percent of patients who tested negative did not have viral meningitis.

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 Recalls and Safety Alerts

May2007FDA Patient Safety News Homepage
Important Safety Advisory on Procrit, Aranesp and Epogen (Video, print, and e-mail functions)
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FDA has issued a Public Health Advisory which summarizes several recent safety concerns with the use of erythropoiesis stimulating agents (ESAs). These products, marketed as Procrit (epoetin alfa), Aranesp (darbepoetin alfa), and Epogen (epoetin alfa), stimulate the production of red blood cells. They are used to reduce the number of red blood cell transfusions given to patients with certain serious conditions who are, or may become, anemic.

FDA is re-evaluating the safe use of these products because a number of recent studies have shown an increased risk of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs. In one study of patients with chronic kidney failure there was an increased number of deaths and non-fatal heart attacks, strokes, heart failure, and blood clots when product dosages were adjusted to maintain hemoglobin levels higher than 12 g/dL.

In another study, patients with head and neck cancer receiving radiation therapy had a higher chance of death and faster tumor growth when ESA doses achieved hemoglobin levels higher than 12 g/dL.

Another study showed that cancer patients who were not on chemotherapy died sooner and did not require fewer blood transfusions when they were given these agents. And in yet another study, patients scheduled for orthopedic surgery who received ESAs to reduce perioperative blood transfusions had more blood clots than those not given an ESA.

The FDA Advisory contains a number of recommendations for prescribing these agents:

• Consider both the risks of transfusions and those of ESAs when deciding to prescribe these products.

• Adjust the dose of ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions.

• Monitor patients' hemoglobin levels to ensure they don't exceed 12 g/dL.

In addition, prescribers should understand that there are no data to support claims that ESAs can improve quality of life for cancer patients whose anemia is caused by chemotherapy, or for HIV-positive patients whose anemia is caused by AZT. Also, these agents have not been shown to improve the outcomes of chemotherapy treatment.

The manufacturers of Procrit, Aranesp and Epogen have agreed to change the labeling for these products to reflect the new safety information and to provide additional instructions for their use.

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May2007FDA Patient Safety News Homepage
Increased Risk of Bone Fractures in Women Treated with Diabetes Drugs (Video, print, and e-mail functions)
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Two manufacturers of thiazolidinedione drugs, which are used to treat type 2 diabetes, have notified healthcare professionals that women taking these drugs have an increased risk of bone fractures. The first company, GlaxoSmithKline, makes Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride), which all contain rosiglitazone.

In a recent clinical trial, women who took drugs containing rosiglitazone experienced a higher incidence of fractures than those treated with metformin or glyburide therapy. The majority of these fractures were in the upper arm, hand and foot.

The second company, Takeda, makes Actos (pioglitazone), ACTOplus met (pioglitazone and metformin hydrochloride), and Duetact (pioglitazone and glimepiride) which all contain pioglitazone. An analysis of the company's clinical trial database showed that drugs that contain pioglitazone may also increase fracture risk in women.

The clinical significance of these findings is uncertain at present. Still, both companies recommend that the possibility of fracture be taken into account when rosiglitazone or pioglitazone are considered for treating female patients with type 2 diabetes.

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May2007FDA Patient Safety News Homepage
Software Problems with Defibtech Lifeline and ReviveR External Defibrillators (Video, print, and e-mail functions)
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The device company Defibtech is recalling two models of semi-automatic external defibrillators because the self-test software in these devices may clear a defibrillator that has a low battery condition. If that happens, the device may be unable to deliver a shock and resuscitate a patient.

The action affects over 40,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. These devices have been distributed to schools, fire and emergency medical services, businesses and health clubs.

Defibtech is notifying its distributors and customers about the software problem and the company is working on a new version of the software to fix it. When it is ready, this new software will be sent to customers free of charge.

In the meantime, the company says that these devices can still be used if customers follow specific maintenance instructions for verifying that the defibrillator will function. To identify which version of software a device is using, contact Defibtech at 1-877-453-4507.

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May2007FDA Patient Safety News Homepage
Cardiovascular and Psychiatric Risks with ADHD Drugs (Video, print, and e-mail functions)
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Patients with Attention Deficit Hyperactivity Disorder(ADHD) who are taking stimulant drugs such as Adderall (amphetamine-dextroamphetamine), Ritalin (methylphenidate) and Strattera (atomoxetine hydrochloride) will soon be given a Patient Medication Guide each time the prescription is filled.

The medication guide will warn that there have been reports of sudden death in children and adolescents with pre-existing structural cardiac abnormalities or other serious heart problems who were taking stimulant drugs to treat their ADHD. Sudden death, stroke and MI have also been reported in adults with underlying risk factors for these events who took ADHD drugs.

The causative role of the stimulants is not clear because pre-existing heart problems themselves carry an increased risk of sudden death. Nevertheless, patients with known serious cardiac problems should generally not use stimulant drugs.

The medication guide will also warn about a slight increased risk for drug-related psychiatric adverse events, such as hearing voices, paranoia or mania, even in patients who did not have previous psychiatric problems.

FDA recommends that patients who may be treated with these drugs work with their health care provider to develop a treatment plan that includes a careful health and family history, and an evaluation of current health status, especially for cardiovascular and psychiatric conditions. Patients should contact a doctor promptly if symptoms develop that are suggestive of heart disease, or of new or worsening psychiatric problems.

ADHD Drugs:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product)
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride)
• Metadate CD(methylphenidate hydrochloride)
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules

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May2007FDA Patient Safety News Homepage
Warnings for Sleeping Pills (Video, print, and e-mail functions)
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There are now stronger warnings on the possible risks of taking drugs to treat sleep disorders - drugs such as Ambien (zolpidem tartrate), Lunesta (eszopiclone) and Restoril (temazepam). FDA is asking all manufacturers of sedative-hypnotic drugs to strengthen the language in the product labeling about two issues: severe allergic reactions, and unusual behavior in patients who take these products.

The warnings will point out that anaphylaxis and angioedema have been reported in patients as early as the first time the drugs are taken. In addition, the label will warn that patients on these drugs have engaged in certain behaviors after having gone to sleep, such as driving or eating, often with no recollection of the event.

Although all sedative-hypnotic drugs have these risks, there may be differences among these products in how often they occur. Because of this, FDA is recommending that the drug makers conduct clinical studies to investigate how often sleep-driving and other unusual behaviors occur with their products.

The manufacturers will also be developing Medication Guides to be given to patients whenever the drug is dispensed. The guide will explain the drug's proper use, its risks, and precautions patients should take while using it. This includes avoiding alcohol and other central nervous system depressants because they can increase the risk of sleep-driving and other unusual behaviors.

Sleep Disorder (Sedative-Hypnotic) Drugs:

• Ambien, Ambien CR (zolpidem tartrate)
• Butisol sodium
• Carbrital (pentobarbital and carbromal)
• Dalmane (flurazepam hydrochloride)
• Doral (quazepam)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital sodium)
• Sonata (zaleplon)

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May2007FDA Patient Safety News Homepage
Advisory on Treating IPF with Actimmune (Video, print, and e-mail functions)
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FDA is alerting healthcare professionals that early results of a clinical study have indicated that patients with idiopathic pulmonary fibrosis (IPF) did not show a survival benefit from being treated with Actimmune, a synthetic version of interferon gamma-1b. Actimmune is not approved to treat IPF.

InterMune, the maker of Actimmune, has stopped the study because an interim analysis showed that mortality in IPF patients treated with the drug was 14.5% compared to 12.7% in patients receiving placebo. Reported side effects of treatment included constitutional symptoms, neutropenia, and possibly pneumonia.

Although Actimmune has not been approved to treat IPF, some IPF patients may be receiving this product off-label. Healthcare providers should discuss the results of this trial with IPF patients on Actimmune and should carefully consider whether to continue treatment with the drug.

FDA is evaluating the study results and will notify healthcare providers if the review reveals additional important information.

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May2007FDA Patient Safety News Homepage
Anaphylaxis Warnings for Xolair (Video, print, and e-mail functions)
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FDA has asked Genentech, the manufacturer of Xolair (omalizumab) to add a new boxed warning to the drug's labeling. This warning will emphasize that the product can cause anaphylaxis, sometimes with delayed onset.

Xolair, administered subcutaneously, is used to treat allergen-induced asthma in certain patients whose symptoms are not adequately controlled with inhaled steroids.

The strengthened warning includes the possibility that patients can develop anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose, and that anaphylaxis may be delayed up to 24 hours after the dose is given. Healthcare personnel should observe patients for at least two hours after an injection and be ready to manage anaphylaxis if it occurs.

Patients being treated with Xolair should be told about the signs and symptoms of anaphylaxis, how delayed anaphylaxis can occur, and how to treat it if it does occur. A Medication Guide with this information will be given to patients each time the drug is dispensed.

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May2007FDA Patient Safety News Homepage
Clinical Trial Terminated for CellCept (Video, print, and e-mail functions)
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Roche Laboratories has alerted healthcare professionals that a clinical trial of CellCept (mycophenolate mofetil) has been terminated. CellCept is an immuno-suppressant used to prevent organ rejection in patients receiving renal, cardiac or hepatic transplants.

The trial was stopped because heart transplant patients who were switched from CellCept in combination with a calcineurin inhibitor to CellCept and sirolimus had an increased incidence of grade IIIA acute organ rejection. Roche Laboratories says it will continue to monitor the safety of CellCept.

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May2007FDA Patient Safety News Homepage
Gebauer Salivart Oral Moisturizer Recalled (Video, print, and e-mail functions)
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The device company Gebauer is recalling several lots of Salivart Oral Moisturizer. Salivart is an aerosol that is used to lubricate and moisten the oral tissue of patients who are suffering from dry mouth caused by a variety of drug treatments, head and neck radiation, and autoimmune diseases such as Sjogren's syndrome.

Gebauer is recalling the product because some cans of Salivart do not meet the company's specifications for aerobic microorganisms and mold. Anyone in possession of the recalled product should stop using it and dispose of it immediately. To find the affected lot numbers, contact Gebauer Company Customer Service at 800-321-9348.

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