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U.S. Department of Health and Human Services

Show #57, November 2006

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Show #57, November 2006

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 Recalls and Safety Alerts

November2006FDA Patient Safety News Homepage
New Studies on Antidepressants in Pregnancy (Video, print, and e-mail functions)
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In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.

The first study followed pregnant women with a history of depression who had been taking antidepressants before they got pregnant. Those who stopped their medications were five times more likely to experience a relapse of depression during their pregnancy than those who continued to take the drugs. FDA's Advisory recommends that women who are pregnant or considering pregnancy not discontinue their antidepressants without consulting their physician. If the medication is stopped, patients should be monitored closely for signs of a relapse.

The second study found that infants born to women who had taken SSRIs after the 20th week of pregnancy experienced a sixfold increase in the risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a life-threatening condition that becomes evident soon after birth and occurs in one to two per thousand births in the U.S. Infants with PPHN become hypoxemic because of abnormal blood flow through the heart and lungs.

This link between SSRIs and PPHN has not been investigated in other studies, and FDA is seeking more information about the possible risk of PPHN in infants born to mothers who took antidepressants during pregnancy. In the meantime, FDA has asked the manufacturers of all SSRIs to add the potential risk of PPHN to their prescribing information.

The possible risk of PPHN adds to concerns raised in other reports that infants of mothers who take antidepressants late in pregnancy may experience problems such as irritability, difficulty in feeding, and in rare cases, difficulty in breathing. And the labeling for Paxil (paroxetine hydrochloride) now cautions that exposure during the first trimester could be associated with an increased risk of cardiac anomalies in the newborn.

These two studies underscore the need to weigh the risk of relapse in a pregnant woman who discontinues her antidepressant medication against the risk of rare but serious adverse effects in her infant if she continues to take the drug.

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November2006FDA Patient Safety News Homepage
Safety Information on Alaris SE Infusion Pumps (Video, print, and e-mail functions)
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Cardinal Health, the owner of Alaris Products, has recalled all models of the Alaris Signature Edition (or SE) infusion pumps. These pumps have a design defect called "key bounce" that may cause over-infusion of medications. The affected models are 7130, 7131, 7230, and 7231.

Key bounce occurs when a number pressed on the pump registers twice even though the operator only pressed the key once. For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If a key bounce occurs and isn't detected, it may result in an infusion rate at least 10 times the intended infusion rate, which could cause serious patient harm or death.

Alaris is working on a permanent correction for the key bounce problem. When this becomes available, they'll fix the pumps that are currently in use. In the meantime, healthcare facilities can continue to use these pumps if they follow certain precautions and check all programming parameters before starting infusion therapy. Here are the precautions Alaris recommends:

• When programming the pump, stand squarely in front of the keypad to help assure that you're pressing the keys to the proper depth. For the best visibility, the pump should be at eye level.

• Listen to the number of beeps while programming the pump. Each beep will correspond to a single digit entry. An unexpected double beep could indicate an unintended entry.

• When programming the pump or changing settings, before you start or re-start the infusion, always compare the displayed pump settings against the patient's prescribed therapy or the medication administration record, the original order, or the bar code device.

• When infusing high-alert drugs, ask for an independent double check of pump settings by another practitioner before starting or changing infusions.

• Before leaving the patient's room, look at the IV tubing drip chamber to see if the rate of infusion looks faster or slower than expected, and adjust accordingly.

Also note that Alaris has sent warning labels that should be attached to these pumps until the permanent correction is made.

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November2006FDA Patient Safety News Homepage
Increased Risk of Infectious Disease Transmission from Human Tissues recovered by Donor Referral Services (Video, print, and e-mail functions)
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FDA is notifying healthcare professionals that certain human tissues used in patients may have an increased risk for transmitting infectious diseases. These tissues, including human bone and soft tissue such as tendons, came from a tissue recovery company called Donor Referral Services (DRS). The problem is that DRS' tissues may not have met FDA requirements for donor eligibility, which involve donor screening and donor testing.

These tissues did undergo processing after recovery to reduce the risk of disease transmission, and at this time no adverse reactions have been reported.
Even so, FDA and CDC are strongly recommending that healthcare providers tell patients who received these tissues that they may have been from donors who didn't meet requirements for eligibility. Practitioners should also offer patients appropriate infectious disease testing, including HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis.

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 Preventing Medical Errors

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Drug Name Confusion: Mucomyst and Mucinex (Video, print, and e-mail functions)
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A recent FDA article describes another case of mix-ups between two drugs whose names look and sound alike. Mucinex is an OTC extended-release guaifenesin tablet used as an expectorant. Mucomyst (acetylcysteine) is approved in its inhaled form as a mucolytic agent and orally to treat acetaminophen overdoses. However, Mucomyst has also been prescribed off-label to prevent acute renal failure associated with radiographic contrast media.

These mix-ups can occur because of illegible handwriting, mistakes in order transcribing the order, selecting the wrong product during computer order entry, or even selecting the wrong product in the pharmacy.

Part of the problem is that the first part of the names "Mucinex" and "Mucomyst" both look and sound similar, and the ending of each name may not be distinguishable if not written clearly on an order. Errors have also occurred when selecting a drug from a computerized listing. In several reports, the first three letters of the drug name were typed into the computer, but the wrong drug name was inadvertently selected from the list.

Adding to the probability of an error is the problem of overlapping doses. The dose of the extended-release Mucinex, which is given twice a day, is 600 or 1200 mg. The dose of Mucomyst, when it's used off-label, has also been 600 or 1200 mg. In this case, it is taken orally twice on the day before and on the day when the radiographic contrast media is administered.

The FDA article suggests that facilities educate the staff about the potential for confusion between these two drugs. Shortcuts or mnemonics for these products should be removed from the computer, or an alert should be added to ensure that the correct drug is being ordered. The article also says that Mucomyst and Mucinex should not be stored close together on pharmacy shelves, or at a minimum, alerts should be placed on shelves to help ensure that the right product is selected.

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November2006FDA Patient Safety News Homepage
Danger in Administering Azathioprine and Mercaptopurine Together (Video, print, and e-mail functions)
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A recent Institute for Safety Medication Practices report alerted readers to the possibility of patient death if azathioprine, an immunosuppressant, and mercaptopurine, an antimetabolite, are given together. The report points out that mercaptopurine is a metabolite of azathioprine, and so if the two drugs are taken together, the patient is receiving duplicate therapy. ISMP cites a case in which a patient with a history of Crohn's disease took the medications together, as prescribed, and later developed profound myelosuppression and severe sepsis, and died.

ISMP notes that many drug information software programs do not warn of this particular therapeutic duplicaton. They suggest that hospitals ask that their drug information computer programs be modified to show this information if it doesn't already appear, and that drug reference materials also include a warning about this potentially fatal drug combination.

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November2006FDA Patient Safety News Homepage
Vaccine Mix-ups: Adacel (Tdap) and Daptacel (DTaP) (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices recently reported on several mix-ups between two vaccines. The first is DAPTACEL, which is diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP). The second is ADACEL, which is tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap). Daptacel is used in infants and children 6 weeks to 6 years old for active immunization. Adacel is used for active booster immunization in persons 11 to 64 years old and it is also the first vaccine approved as a pertussis booster for adults.

The component antigens in Adacel and Daptacel are the same, so ISMP says this contributes to making them easy to confuse. In one clinic, 13 adults were mistakenly vaccinated with Daptacel. At another clinic, seven adults received Daptacel instead of Adacel. Fortunately, none of the patients appeared to have experienced any unusual vaccine reactions, despite the fact that the pediatric formulation contains greater amounts of both the detoxified pertussis toxin and the diphtheria toxoid.

ISMP says that the similarities of the brand names, generic designations, and vaccine abbreviations also probably contribute to the confusion. In addition, these two vaccines have similar packaging - both are Aventis Pasteur products and they come in stylized, colorful cartons of the same size.

ISMP makes several recommendations to help prevent mix-ups between these two products.

• Verify the patient's age before dispensing or administering any vaccines.

• Separate stock of the pediatric and adult formulations and place alerts (e.g., "Adult" or "Pediatric") on the products.

• Where feasible, place alerts in computer software to warn practitioners about the differences between the adult and pediatric formulations.

• If possible, configure the order entry system to disallow selection of the wrong product based on the patient's age.

• Check your computer system to see how the vaccine names are displayed. ISMP says that some commonly used drug references, drug information vendor databases, and drug wholesalers refer to the component antigens of Adacel as "diphtheria, tetanus, and acellular pertussis" rather than the way it is listed on the package label, with tetanus toxoid first. If that's the case, it could increase the chance for confusion. Pharmacists may also have difficulty finding the correct product when entering orders and selecting medications. And pharmacy generated labels may list the components differently from the way they're listed by the manufacturer.

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 Advice for Patients

November2006FDA Patient Safety News Homepage
Ibuprofen Can Interfere with Aspirin’s Antiplatelet Effect (Video, print, and e-mail functions)
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FDA is alerting healthcare professionals that taking 400 mg of ibuprofen can interfere with the antiplatelet effect of low dose aspirin i.e., the 81 mg of aspirin per day taken by many patients for its cardioprotective effect. Because of this interference, FDA suggests that you advise patients who use both immediate-release, low-dose aspirin and ibuprofen at the 400 mg strength to take the ibuprofen at least 30 minutes after the aspirin, or at least 8 hours before the aspirin.

This is most important for those patients who use the ibuprofen on a regular basis. Occasional use of ibuprofen is not likely to alter the cardioprotective effect of aspirin significantly. You should also assume that other nonselective OTC NSAIDs can interfere with the cardioprotective effect of low-dose aspirin unless proven otherwise. It is not certain at this point whether ibuprofen doses greater or less than 400 mg can interfere with the cardioprotective effect of low-dose aspirin.

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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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