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U.S. Department of Health and Human Services

Show #40, June 2005

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Show #40, June 2005

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 New Medical Products

June2005FDA Patient Safety News Homepage
New Device to Treat Descending Thoracic Aneurysms (Video, print, and e-mail functions)
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FDA recently approved the first device to prevent ruptures of descending thoracic aneurysms. It's an endovascular graft called the GORE TAG Endoprosthesis System, and it's made by W.L. Gore and Associates.

Descending thoracic aneurysms have traditionally been managed either with anti-hypertensive drugs or by open surgical repair. This GORE TAG graft can provide an alternative to these treatments. Using the device is less invasive than conventional surgery, but it still requires regular follow-up and testing to monitor the success of the treatment over time.

The GORE TAG System consists of an endovascular graft made of expanded polytetrafluoro-ethylene and an outer metal stent. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. At the site of the aneurysm, the graft is deployed and then self-expands to the diameter of the aorta, excluding the aneurysm and relining the artery wall. This can prevent further growth and possible rupture of the aneurysm.

FDA approved the device based on review of two clinical studies of approximately 200 people. Study results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the surgical control group.

FDA is requiring the company to conduct additional studies to evaluate its long-term clinical performance and to assure that when the device is used in the large general population, its safety and effectiveness will be comparable to the clinical trials.

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June2005FDA Patient Safety News Homepage
New Sealing System for Dura Mater Surgery (Video, print, and e-mail functions)
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FDA recently approved a new cranial sealing system for dura mater surgery to prevent cerebrospinal fluid (CSF) leakage from the incision site. The product, which is used as an adjunct to suturing, is called the Dura Seal Sealant System, and it's manufactured by Confluent Surgical, Inc. This is the first device specifically approved for this purpose. Until now surgeons have used a variety of approaches to prevent spinal fluid leakage, such as oversewing the area, or packing the area with other tissue.

The Dura Seal system consists of two solutions and an applicator. The solutions mix in the tip of the applicator as the product is being applied, forming a hydrogel that seals the dura mater. The gel biodegrades in four to eight weeks, which is enough time for healing to take place.

DuraSeal should not be used in confined bony structures where nerves are present, since the swelling of the hydrogel can result in neural compression.

The manufacturer will continue to study the DuraSeal system to further investigate infection rates, and to compare the device to existing methods of preventing CSF leakage.

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 Recalls and Safety Alerts

June2005FDA Patient Safety News Homepage
Recent FDA Actions on NSAIDS (Video, print, and e-mail functions)
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On April 7, 2005, FDA announced several important changes that pertain to the marketing of non-steroidal anti-inflammatory drugs (NSAIDs). FDA has asked that one product be withdrawn from the market, and is requiring stronger warnings in the labeling for the other products.

This is a continuation of the process that began several months ago with Vioxx (rofecoxib), when Merck withdrew that product from the market because of concerns about adverse cardiovascular events. These later actions are being taken because of concerns about other NSAIDs.

It's important to understand that the new actions don't just apply to the COX-2 selective inhibitors. They apply to both the COX-2 inhibitors and to other, non-selective NSAIDs, and they apply to both prescription and non-prescription products.

FDA asked the manufacturer of one of the COX-2 inhibitors, Bextra (valdecoxib), to withdraw it from the market based on concerns about cardiovascular events, and serious skin reactions.

In its decision about Bextra, FDA noted the lack of adequate data on the cardiovascular safety of this drug when it's used chronically, and also reports of serious skin reactions, including deaths. Another factor was the lack of demonstrated advantages of Bextra over other NSAIDs.

That leaves just one COX-2 inhibitor, Celebrex (celecoxib), still on the market. FDA decided that the benefits of Celebrex outweigh the risks, provided that patients are properly selected and informed. But FDA is requiring that certain actions be taken to minimize the risk with Celebrex.

For example, there will be a boxed warning in the labeling about CV and GI risks, and the labeling will encourage physicians to discuss benefits and risks with the patient. In addition, a Medication Guide will be given to the patient each time the drug is dispensed, informing them of the risks and the importance of using the lowest effective dose for the shortest time possible.

Non-selective NSAIDs, such as ibuprofen and naproxen, are also subject to new requirements. For prescription-only products, the requirements are similar to those for Celebrex, including the boxed warning in the labeling and the Medication Guide for patients. For OTC products, FDA is asking manufacturers of ibuprofen, naproxen and ketoprofen to change their labeling to give more information on CV and GI risks and provide other warnings.

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June2005FDA Patient Safety News Homepage
Warning about Liver Injury with Avonex (Video, print, and e-mail functions)
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Biogen Idec has notified healthcare professionals about safety changes in the labeling for Avonex (interferon beta-1a), which is used to treat relapsing forms of MS. The labeling now warns that severe hepatic injury, including hepatic failure, hepatitis, and elevated serum hepatic enzyme levels, have been reported in patients on Avonex.

Patients have also experienced asymptomatic elevation of hepatic transaminases, and this recurred in some patients when they were rechallenged with Avonex.

In some cases, these events occurred when the patient was taking other drugs that are associated with hepatic injury. The company says consider the potential for injury when Avonex is used in combination with other hepatotoxic products such as alcohol, or when new agents are added to the regimen of patients already on Avonex. The company also says that patients on Avonex should be monitored for signs of hepatic injury.

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June2005FDA Patient Safety News Homepage
Alert on Atypical Antipsychotics (Video, print, and e-mail functions)
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FDA has issued an alert about increased mortality when using “atypical” antipsychotic drugs to treat behavioral disorders in elderly patients with dementia. The alert applies to drugs such as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax (olanzapine and fluoxetine HCl), an antidepressant, is also covered by the advisory.

These drugs are not approved for treating behavioral disorders in patients with dementia. In fact, they're approved only for treating schizophrenia and mania. So this constitutes an unapproved, “off-label” use.

The situation came to light when these drugs were being tested in clinical trials on elderly patients with dementia. Those treated with the drugs had a higher mortality rate than those receiving placebo. The causes of death were varied, but most of them appeared to be either cardiovascular or due to infection, such as pneumonia.

FDA has asked the manufacturers of these drugs to add a boxed warning to the labeling describing the increased mortality risk. The labeling will also state that these drugs are not approved for treating behavioral symptoms in elderly patients with dementia.

FDA is also considering adding a warning to the labeling of older antipsychotic medications, because limited data suggest that there may be a similar increase in mortality for these drugs.

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June2005FDA Patient Safety News Homepage
New Zometa Dosing for Patients with Renal Impairments (Video, print, and e-mail functions)
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Novartis has notified healthcare professionals about new warnings and dosing recommendations for the company's bisphosphonate drug, Zometa (zoledronic acid). Zometa is used to treat multiple myeloma and metastatic bone lesions from solid tumors, and hypercalcemia of malignancy. The changes are intended to improve the renal safety of Zometa.

The revised labeling includes an additional warning regarding patients with preexisting renal impairment who are undergoing multiple treatments with
Zometa and other bisphosphonates, because they may be at increased risk of renal deterioration.

The new dosing recommendations are intended for patients with advanced cancer who also have reduced renal function, that is, those patients whose baseline creatinine clearance is 60 ml/min or lower. The revised labeling stratifies the recommended Zometa doses for patients with mild and moderate renal impairment according the baseline creatinine clearance rates.

The company recommends that during Zometa treatment, serum creatinine be measured before each dose, and that treatment should be withheld when there's evidence of renal deterioration.

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June2005FDA Patient Safety News Homepage
Drug-Induced Hepatitis when Rifampin is Given with Ritonavir/Saquinavir Combination (Video, print, and e-mail functions)
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Roche Pharmaceuticals has notified health care professionals about new information that reinforces a contraindication when prescribing combination antiretroviral therapy for treating HIV infection..

Rifampin has been contraindicated with saquinavir, because the rifampin will reduce plasma levels of saquinavir. A study was recently performed to see whether boosting saquinavir with ritonavir would overcome this problem. But when healthy volunteers in the study were given rifampin along with the combination of saquinavir and ritonavir, 39 percent developed significant hepatocellular toxicity.

As a result, Roche Pharmaceuticals is cautioning that rifampin should not be given to patients who are also receiving a combination of saquinavir and ritonavir.

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June2005FDA Patient Safety News Homepage
New Trecator Formulation Requires Dosing Adjustment (Video, print, and e-mail functions)
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In a recent letter, Wyeth Pharmaceuticals alerted health professionals about changes in the tuberculosis drug Trecator (ethionamide tablets, USP) which may make it necessary to retitrate patient dosages. The older, sugar-coated version of the drug, called Trecator-SC, has been replaced by a film-coated version called Trecator.

The new formulation is more rapidly absorbed, leading to higher peak concentrations and could result in patient intolerance if given at the same dose as Trecator-SC. So it's important that patients switching from Trecator-SC to Trecator be monitored and have their dosages adjusted.

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June2005FDA Patient Safety News Homepage
Recall of Certain Magnesium Sulfate Solutions (Video, print, and e-mail functions)
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In April 2005, PharMEDium Services of Houston, Texas announced a recall of some of its Magnesium Sulfate solution because of a possible sterility problem.

All strengths of 50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution are affected by this recall. Two lots of this product have been associated with outbreaks of Serratia marcescens infection. This can cause serious or life-threatening conditions, particularly among immuno-compromised patients.
The company has stopped producing and distributing this product until it can determine and correct the source of this problem.

Hospitals with questions should contact the company at
1-847-457-2300.

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June2005FDA Patient Safety News Homepage
Medication Guide for Cordarone (amiodarone HCl) (Video, print, and e-mail functions)
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FDA is notifying physicians and pharmacists that a Medication Guide for patients must be distributed with each prescription for Cordarone tablets, or generic
amiodorone. This is an anti-arrhythmic drug used to treat severe ventricular arrhythmias. FDA requires these guides for drugs that pose a serious public health concern. The guide explains to patients that Cordarone can cause lung damage and liver damage, and in some cases can worsen the heart rhythm problems that the drug is intended to treat. It describes the warning symptoms that should lead patients to seek medical attention, and explains that the drug should only be used when other agents did not work.

In a letter to health care professionals, Cordarone's manufacturer, Wyeth Laboratories, cautions that the Medication Guide should not be used as a substitute for talking to patients about the risks and benefits of the drug.

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