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U.S. Department of Health and Human Services

Show #96, March 2010

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Show #96, March 2010

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 Recalls and Safety Alerts

March2010FDA Patient Safety News Homepage
Safety Precautions for Huber Needles (Video, print, and e-mail functions)
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FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products. Huber needles are used to access ports implanted in chronically ill patients to withdraw blood and infuse medication and other solutions.

Huber needles should be designed to penetrate a port without cutting or dislodging any silicone slivers or cores from the port. Coring could damage a port and cause leakage. In addition, if a silicone core enters a patient's vasculature, it could lead to serious adverse events. FDA inspections of one Huber needle manufacturer, Nipro Medical Corporation, found that this company's needles produced cores in 60 - 72 percent of tests.

Because of this, Huber needle products manufactured by Nipro Medical Corporation for Exel International Corporation have been recalled.

These products include:

• Exel and EXELint Huber needles

• Exel and EXELint Huber Infusion Sets

• Exel "Securetouch+" Huber Safety Sets

• EXELint Huber Safety Sets

Affected lot numbers and catalogue numbers can be found in the links below. Hospitals, clinics and patients who have any of the recalled products should stop using them immediately and return them to the company.

As part of a broader investigation, FDA has tested Huber needles from a number of manufacturers. To date, only needles manufactured by Nipro have shown a high frequency of coring.

FDA is continuing to investigate this issue. In the meantime, the agency recommends taking the following precautions when using any Huber needle to access an implanted port:

• When initially confirming a needle's patency, avoid flushing the syringe. If a needle has cored a port, flushing may introduce the core into the patient's body, and this could lead to serious adverse events.

• When possible, consider aspirating a small amount of blood from the port after puncturing the port septum, and then discard the syringe with its contents. Doing this may recapture any silicone sliver. If the needle clogs when attempting to aspirate, remove the needle, discard it and select a new one.

• Watch for signs and symptoms that may indicate damage to the port's septum, such as medication leakage. This can lead to inadequate delivery of therapy, localized erythema, and tissue, nerve or muscle damage.

Additional Information:

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March2010FDA Patient Safety News Homepage
Don't Use Thermoflect Products with MRI (Video, print, and e-mail functions)
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The manufacturer Encompass Group is alerting healthcare professionals that Thermoflect products should not be used in an MRI environment. These products, such as blankets and apparel, are intended to prevent hypothermia by keeping patients warm using reflected radiant heat from the patient's body.

The company had previously said that Thermoflect products could be used with MRI. However, after receiving a report that suggested a Thermoflect blanket may have contributed to an injury in a patient undergoing an MRI exam, the company now says that these products should not be used with MRI. The company is making warning labels available to attach to Thermoflect products currently in inventory. New shipments will already have the warning label.

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March2010FDA Patient Safety News Homepage
Valproate Sodium and Birth Defects (Video, print, and e-mail functions)
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FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and migraine headaches, include valproate sodium, valproic acid and divalproex sodium. They are marketed as Depacon (valproate sodium injection), Depakene (valproic acid), Stavzor (valproic acid), and Depakote (divalproex sodium).

Valproate has been associated with neural tube defects and craniofacial defects, as well as cardiovascular and other malformations. These kinds of malformations occur almost four times more frequently in babies born to women with epilepsy who took valproate during pregnancy than in babies born to women with epilepsy who used other anti-epileptic drugs.

Physicians should consider alternative therapies for women of childbearing age, especially if valproate is used for migraines and other conditions not usually considered life threatening. They should inform women who are taking or considering valproate about the risk of birth defects, and they should recommend contraception for those who are not planning a pregnancy.

Physicians should also advise patients that taking folic acid before and during the first trimester can decrease the risk of neural tube defects. FDA will require that a Medication Guide explaining the benefits and risks of valproate be provided with each outpatient prescription.

Women who become pregnant while taking valproate should be offered prenatal testing to detect malformations, and they should be encouraged to enroll in a special registry that gathers information about the effects of antiepileptic drugs during pregnancy.

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March2010FDA Patient Safety News Homepage
Kidney Impairment with Byetta (Video, print, and e-mail functions)
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To help clinicians weigh the benefits and risks of the diabetes drug Byetta (exenatide), FDA is requiring that information about the risk of renal impairment be added to the drug's labeling.

From April 2005 to October 2008, FDA received 78 reports of altered kidney function in patients treated with Byetta. Some of the patients had pre-existing kidney disease and other risk factors for developing kidney problems. Acute renal failure occurred in 62 patients and renal insufficiency in 16 patients.

More than 6.6 million Byetta prescriptions were dispensed during this same time period, so these cases represent a small percentage of the total number of patients treated with the drug.

Here's what the drug's labeling says. Byetta should not be used in patients with severe renal impairment or end-stage renal disease. For patients with moderate renal impairment, use caution when starting Byetta or increasing the dose from 5 mcg to 10 mcg.

Monitor patients for signs and symptoms of altered kidney function, including increased serum creatinine, changes in urination, unexplained swelling, increases in blood pressure, lethargy, or dull ache in the mid to lower back. Consider discontinuing the drug if a patient's kidney function worsens while using it.

Patients receiving Byetta should be told to watch for the signs and symptoms of altered kidney function and report these to their healthcare professional. Patients should also report nausea and vomiting, because these could lead to dehydration and increase the risk of impaired kidney function.

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March2010FDA Patient Safety News Homepage
Cleviprex Recalled due to Particulates (Video, print, and e-mail functions)
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Here's information about a recall of certain lots of Cleviprex injectable emulsion, an antihypertensive drug made by The Medicines Company.

Vials in the recalled lots may contain particulate matter which has been found to be inert stainless steel particles. Although the company has not received any reports of adverse events, if these particles were to aggregate, or if larger particles were present, it is possible that patients could experience a reduction in capillary blood flow, mechanical damage to some tissues, or inflammatory reactions.

Anyone who has vials from the affected lots should contact their wholesaler or distributor to arrange for return of the product. To get more information and to see the recalled lot numbers, click on the "Additional Information" link below or contact The Medicines Company at 1-888-977-6326.

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 Preventing Medical Errors

March2010FDA Patient Safety News Homepage
Warning on Counterfeit Alli (Video, print, and e-mail functions)
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FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for over-the-counter use, contains a substance that prevents the absorption of fats from the diet.

The counterfeit Alli contains the stimulant drug sibutramine, which can cause potentially fatal side effects, particularly in people with a history of heart disease.

Sibutramine is an ingredient in an approved weight loss drug, but it is available only by prescription and must be used under the supervision of a physician. FDA tests have shown that people taking the counterfeit Alli in the dose specified on the package may be receiving several times the usual daily dose of sibutramine.

People taking Alli should check to be sure that they do not have the counterfeit version. Here are some things to look for:

• The counterfeit has a missing lot number on the outer cardboard packaging.

• The counterfeit has an expiration date that includes a month, day and year-the real Alli has only a month and year.

• The foil safety seal on the mouth of the counterfeit bottle has no writing-the seal on the real Alli says "Sealed for your protection."

• The counterfeit capsules contain a white powder-the real capsules contain small white pellets.

• The counterfeit version is packaged in a plastic bottle that has a slightly taller and wider cap than the real Alli, with coarser ribbing.

People who think they may have the counterfeit product should stop using it immediately and contact FDA's Office of Criminal Investigations at 1-800-551-3989. Anyone having side effects such as nausea, insomnia and an unusually fast or irregular heart beat, should contact their healthcare professional. This is especially important for people with a history of heart disease.

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March2010FDA Patient Safety News Homepage
Medical Errors from Misreading Letters and Numbers (Video, print, and e-mail functions)
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An article by the Institute for Safe Medication Practices (ISMP) reminds healthcare practitioners how dangerous it can be to misread the letters and numbers on prescriptions, drug orders and medical records. Unfortunately, these mistakes are easy to make because some of the alphanumeric symbols we use look so similar.

Research has shown that more than 50 percent of letter-number errors come from just four basic mixups:

• the letter "L" and the number "1"

• the letter "O" and the number "0"

• the letter "Z" and the number "2"

• the numbers "1" and "7"

These mixups are most likely to occur when the information contains both letters and numbers, as in most medication orders.

The complete ISMP article, includes a list of more than 20 commonly confused letters and numbers.

Additional Information:

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 FDA Consumer Corner

March2010FDA Patient Safety News Homepage
Caution about Sexual Enhancement Products (Video, print, and e-mail functions)
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You can easily find them on the internet - products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make you think they're harmless. But they may not be.

FDA has found that many of these supposedly "all natural" products actually contain ingredients that aren't on the label, and these ingredients could lead to serious and even fatal effects.

An FDA investigation of a number of these sexual enhancement supplements found that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl.

Taking products that contain these kinds of ingredients can be particularly dangerous for people who are also taking prescription drugs that contain nitrates, such as nitroglycerin. That's because they can interact to cause dangerously low blood pressure.

People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. And since erectile dysfunction is common in men with these conditions, they may seek out these sorts of products.

To make matters worse, these so-called supplements are not likely to be made under the same quality controls as prescription drugs, so the identity or the amount of the Viagra-like ingredients could vary greatly.

Sometimes they have been found in enormous quantities --- much higher than approved dosages.

FDA has issued many alerts about these types of supplements over the past several years, but their number seems to be growing.

So the bottom line is this: Don't be misled by claims of "all natural" ingredients. Sexual enhancement products that claim to work as well as prescription products are likely to contain ingredients that could pose a serious health risk.

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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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