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U.S. Department of Health and Human Services

Show #87, June 2009

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Show #87, June 2009

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 Recalls and Safety Alerts

June2009FDA Patient Safety News Homepage
Raptiva Withdrawn from the Market (Video, print, and e-mail functions)
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Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by the JC virus, is a rapidly progressive and irreversible infection of the central nervous system that leads to death or severe disability. Although the overall risk of PML for patients on Raptiva is low, it appears to be increased in long-term users of the drug and in those with compromised immune systems.

Prescriptions for Raptiva will no longer be refilled after June 8, 2009, and so prescribers should not start Raptiva treatment in any new patients. Patients already on Raptiva should be counseled about the risks of the drug, and prescribers should immediately begin discussing alternative therapies with them. Genentech's letter to prescribers suggests that they carefully manage their patients' transition from Raptiva to other therapies, and consider that abrupt discontinuation of the drug might seriously worsen the patient's psoriasis.

After Raptiva treatment is stopped, prescribers should continue to carefully monitor patients for any signs or symptoms suggestive of PML, as well as for infections and other adverse effects.

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June2009FDA Patient Safety News Homepage
Zoll AED Plus Defibrillator Recalled (Video, print, and e-mail functions)
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The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adequately detect defective batteries. And so these devices could fail to deliver a shock to a patient during sudden cardiac arrest.

The affected devices have serial numbers whose last six digits are below 200000. If you have a device with such a serial number, you should upgrade the software to version 5.32. The company says the new software will allow the defibrillators to monitor the performance of the batteries through periodic self testing. If the software detects defective batteries, the device will prompt users to install fresh batteries. The new software can be ordered or downloaded from the company.

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June2009FDA Patient Safety News Homepage
Recalls of Digoxin and Propafenone Tablets (Video, print, and e-mail functions)
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FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets:

• Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin tablets. Included in the recall are 0.125 and 0.25 mg tablets that were distributed prior to March 31, 2009 and which show an expiration date of September, 2011.

Because of the variation in tablet size, these products could contain either more or less than the labeled amount of digoxin. Digoxin has a narrow therapeutic index, which means that small variations in tablet potency could have serious effects. Too much of the drug can cause digoxin toxicity, which can include hypotension and cardiac instability and may lead to death. Too little can lessen the drug's effectiveness, which can also lead to cardiac instability.

• Watson Pharmaceuticals recalled one lot of 225 mg propafenone HCL tablets, packaged in bottles of 100, because they may contain slightly more than the labeled amount of the drug. The recalled tablets show an expiration date of July 31, 2010. Like digoxin, propafenone has a narrow therapeutic index, and too much of the drug can cause hypotension and arrhythmias.

Patients and providers should report problems they encounter with any of these recalled products to FDA's MedWatch program.

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June2009FDA Patient Safety News Homepage
Recall of Medtronic Ventricular Snap Shunt Catheters (Video, print, and e-mail functions)
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Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and that may require emergency revision surgery.

Medtronic has notified its customers that they should stop implanting the device and return all unused catheters to the company. Patients who already have the shunt system implanted but are not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols. If a disconnection does occur, patients may experience a return of the symptoms of hydrocephalus, which could include nausea, vomiting, headache, lethargy, change in mental status, seizures and more serious conditions. Patients with these symptoms should be assessed for shunt malfunction.

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June2009FDA Patient Safety News Homepage
Recall of Zencore Plus (Video, print, and e-mail functions)
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Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as sildenafil, tadalafil, and vardenafil, which have been approved by FDA for the treatment of erectile dysfunction.

A person taking organic nitrates who also took Zencore Plus could experience a sudden and profound drop in blood pressure, which would pose a significant health risk.

Zencore Plus capsules, which were supplied by Hi-Tech Pharmaceuticals, have been sold in health food stores, by mail order and on the internet. People who have this product should stop using it immediately. For more information, contact Bodee LLC at 1-800-935-0296.

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 New from FDA

June2009FDA Patient Safety News Homepage
Campaign on Using Methadone Safely (Video, print, and e-mail functions)
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FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addiction, but it is now also being used to treat moderate to severe pain in patients who don't respond to non-narcotic pain medications. Healthcare professionals and patients need to understand the power and potential dangers of methadone in order to reduce the risk and get the maximum benefit from the drug.

Healthcare providers should make sure patients understand that methadone remains in the body even after the pain relief wears off, so taking an additional dose to relieve pain while the earlier dose is still in the body could lead to an unintentional overdose. Also, methadone interacts with many other drugs and supplements. These interactions could decrease a patient's pain relief, or cause a toxic buildup of methadone in the body. That could lead to dangerous changes in breathing or heart beat that could be fatal.

Here are some of the things patients should do if they take methadone:

• Share your complete medical history with your healthcare provider, especially if you are using methadone for the first time.

• Take methadone exactly as prescribed and be sure to follow all your doctor's directions.

• Never take more methadone than the amount prescribed, at the times prescribed. If you miss a dose or feel it is not working, do not take more. Instead, call your doctor.

• Do not consume alcohol and be careful driving or operating machinery.

• Never give methadone to anyone else, and take steps to keep children from accidently taking it.

• Stop taking methadone and call your doctor or 911 if you have trouble breathing; feel dizzy, lightheaded or faint; have chest pain or a fast or pounding heartbeat; are confused or have hallucinations; or develop hives or a rash, or have swelling in the face, lips, tongue or throat.

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 Advice for Patients

June2009FDA Patient Safety News Homepage
Help Patients Use Acetaminophen Safely (Video, print, and e-mail functions)
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Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in this country each year. Many of these events are happening because patients are unknowingly taking too much of the drug.

Several factors contribute to these unintentional acetaminophen overdoses. First, people may not be aware that they are in danger of liver damage if they exceed the maximum recommended dose, or that alcohol exacerbates the risk. Also, they may not realize how much acetaminophen they are consuming if they take more than one product containing this drug. Taking too much can be easy to do, because acetaminophen is widely found in both OTC and prescription drug products, in as many as 600 of them, including analgesics, antipyretics, cough/cold remedies and sleep aids. In this situation, people may not even recognize that some of the drugs they are taking contain acetaminophen.

One study, published in the Journal of the American Pharmacists Association in 2007, surveyed 104 adult patients presenting to an internal medicine clinic. 79% reported using a product that contained acetaminophen within the previous six months, but only 43% could identify problems that could arise from high doses of acetaminophen. And while 71% of patients recognized that Tylenol contains acetaminophen, fewer than 15% knew that Vicodin (hydrocodone/ acetaminophen), Darvocet (propoxyphene napsylate/) and Percocet (oxycodone/acetaminophen) contain acetaminophen.

Children are also at risk of acetaminophen overdose if they are given the adult formulation or the wrong pediatric formulation, if the dose is not calculated correctly for the child's weight, or if the wrong dosing device is used.

FDA is encouraging health care providers to educate patients and caregivers about how to use pain medicines safely. Instruct them about the correct dosing frequency for products that contain acetaminophen, and be sure they understand that having three or more alcoholic drinks per day can raise the risk of acetaminophen toxicity. Warn them about taking multiple products containing the same active ingredient. And instruct parents on the correct weight-based dose for their child and remind them to use the proper measuring device for liquid formulations.

Acetaminophen is a safe and effective analgesic and antipyretic when it is used properly. But careless or uninformed use can lead to serious liver damage and death. Healthcare providers can play an important role in protecting their patients from acetaminophen toxicity.

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 FDA Consumer Corner

June2009FDA Patient Safety News Homepage
Don’t Overdo It with Acetaminophen (Video, print, and e-mail functions)
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If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and pains. But they're only safe if you follow the directions.

That's particularly important with acetaminophen, an active ingredient in many over-the-counter and prescription medicines that are used to relieve pain or reduce a fever. Acetaminophen is generally safe at recommended doses, but if you take more than that, even just a little more, it can cause serious, even fatal liver damage. In fact, acetaminophen poisoning is a leading cause of liver failure in this country.

You don't have to look very far to find acetaminophen. It's sold under a number of brand names, such as Tylenol, and it's often included with other ingredients in over-the-counter cough and cold medicines, as well as sleep aids. Acetaminophen is also found in prescription medicines, such as Vicodin and Percocet, but that may not be clear from the label.

If you take several medicines that all contain acetaminophen, you might take more than the recommended dose without realizing it.

To avoid taking too much acetaminophen, it's important to know if your medicine contains it. If you're taking an over-the-counter medicine, look for the name acetaminophen on the Drug Facts label under the section called "Active Ingredients." If you're taking a prescription medicine and you don't know the active ingredients, ask your doctor, nurse or pharmacist.

Then follow all the directions on the Drug Facts label or prescription label. For safety's sake, don't take more than one medicine at a time that contains acetaminophen. And don't take more than the maximum amount, even if your pain or fever isn't getting better. Be sure you know how many hours you need to wait before taking another dose.

If you have 3 or more alcoholic drinks per day or have liver disease, this could increase your risk of liver damage, so talk to your doctor before taking medicines that contain acetaminophen.

Finally, when giving acetaminophen to children, make sure to use the right formulation for your child's age and weight. Use that formulation in the right amount and at the right time. To avoid error, use the measuring tool that comes with the medicine and keep a record of the times and doses you give your child. Share that record with your child's caregivers, so they'll know how much medicine your child has had.

If you take acetaminophen, please be careful. Read the label and follow the directions.

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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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