FDA Patient Safety News: Show #88, July 2009

Warning on Testosterone Gel Products

FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription, are used to treat men who don't produce sufficient testosterone. The products are Testim 1%, which is applied to the shoulders and upper arms, and AndroGel 1%, which can also be applied to the abdomen.

The current labeling does have precautions about exposing children, but FDA continues to receive reports where children have come in contact with the gel on another person's body, with serious effects. Some children have experienced inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, and behavioral changes. In a few cases, some signs did not regress when the exposure to testosterone stopped.

To minimize the possibility of exposing children to the gel, FDA recommends that users wash their hands with soap and water after every application. They should cover the site with clothing after the gel dries. And they should wash the application site with soap and water before any skin-to-skin contact with another person. As a further precaution, children and women should avoid contact with application sites on the skin of men who use these products.

FDA is requiring the gel manufacturers to develop a Medication Guide that will describe these risks. It will be given to patients each time their prescriptions are dispensed.

Additional Information:

FDA MedWatch Safety Alert. Testosterone gel products (AndroGel 1% and Testim 1%). May 7, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm149346.htm


Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps

Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps.

The defect can cause the "up" and "down" buttons on these pumps to stop working, either completely or intermittently. These buttons are used to change the pump programming or to administer additional insulin through a bolus delivery. So if they do not work, pump users may not be able to change any of the pump's programmed settings.

When the buttons are pushed, the pump normally responds with a confirmation signal: a sound, a vibration, or both. If the buttons stop working, the signal will not occur, and the pump display will not change. If pump users cannot confirm that a change was made, they should disconnect the pump and switch to a back-up pump or other insulin delivery method. Then they should immediately contact the company's hotline to get a replacement pump.

If the buttons on the pump continue to work, the company says the pumps can still be used, but users should make sure the "up" and "down" buttons are working, by verifying that they get a confirmation signal after each pump operation.

For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095.

Additional Information:

Disetronic Website. ACCU-CHEK Spirit Insulin Pump System – Important Recall Information. April 30, 2009.
http://www.disetronic-usa.com/dstrnc_us/rewrite/generalContent/en_US/article/DCM_general_article_125.htm


Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps

Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps.

The defect can cause the "up" and "down" buttons on these pumps to stop working, either completely or intermittently. These buttons are used to change the pump programming or to administer additional insulin through a bolus delivery. So if they do not work, pump users may not be able to change any of the pump's programmed settings.

When the buttons are pushed, the pump normally responds with a confirmation signal: a sound, a vibration, or both. If the buttons stop working, the signal will not occur, and the pump display will not change. If pump users cannot confirm that a change was made, they should disconnect the pump and switch to a back-up pump or other insulin delivery method. Then they should immediately contact the company's hotline to get a replacement pump.

If the buttons on the pump continue to work, the company says the pumps can still be used, but users should make sure the "up" and "down" buttons are working, by verifying that they get a confirmation signal after each pump operation.

For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095.

Additional Information:

FDA MedWatch Safety Alert. Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump. May 1, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm144233.htm


New Safety Information on Tarceva

New information has been added to the labeling of the chemotherapy drug Tarceva (erlotinib). The revised labeling now warns about three kinds of serious adverse events:

• Gastrointestinal perforation, which may be fatal. This risk is increased in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, and it is also greater in those with a history of peptic ulceration or diverticular disease. Tarceva should be permanently discontinued if the patient develops gastrointestinal perforation.

• Bullous, blistering and exfoliative skin conditions, possibly including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal. Tarceva treatment should be interrupted or discontinued if the patient develops one of these conditions.

• Ocular disorders, including corneal perforation or ulceration. Tarceva should be interrupted or discontinued if the patient experiences symptoms of an acute or worsening eye disorder, such as eye pain.

Additional Information:

FDA MedWatch Safety Alert. Tarceva (erlotinib). May 8, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150596.htm


Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products

FDA is updating earlier recommendations about the interaction between the antibiotic ceftriaxone and intravenous products that contain calcium. In certain circumstances, this interaction can cause dangerous precipitates to form. Ceftriaxone is sold as Rocephin and also as a generic. Products that contain calcium include Ringer's solution, Hartmann's solution and parenteral nutrition formulations that contain calcium.

FDA had previously recommended that ceftriaxone and calcium-containing IV products not be administered within 48 hours of one another for patients of all ages. This has now changed. It is no longer necessary to wait 48 hours in patients over 28 days old, provided that certain precautions are followed. And FDA is still stressing that ceftriaxone must not be used in neonates if they are receiving or will receive calcium-containing IV products.

Ceftriaxone and products that contain calcium may now be administered sequentially to patients older than 28 days of age, as long as the infusion lines are thoroughly flushed between infusions with a compatible fluid. However, ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions through a Y-site. FDA also continues to advise practitioners not to reconstitute or mix ceftriaxone with products that contain calcium.

There are no data on whether ceftriaxone might interact with calcium-containing products that are given orally. It's also not clear whether intramuscular ceftriaxone might interact with calcium-containing products, either IV or oral.

Additional Information:

FDA MedWatch Safety Alert. Ceftriaxone (marketed at Rocephin and generics). April 14, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm136533.htm


Safety Problems with Denture Cleansers

FDA wants healthcare professionals to know about two serious safety problems that have occurred in patients who use denture cleansers. The first is the risk of allergic reactions to these products. These reactions can arise soon after the initial use, or after years of exposure. Symptoms include gum tenderness, rash, urticaria, respiratory distress and hypotension.

Research suggests that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers as cleaning and bleaching agents.

The second safety problem is mis-use. Some of these products have mentioned mouthwash as an ingredient, and some have been described as "minty fresh." If patients are confused by this, they may mistakenly rinse their mouths with the product, gargle with it, or swallow it. That can cause bleaching of tissue, gum damage, vomiting, seizures and hypotension.

Healthcare professionals should be aware that patients with dentures may present with symptoms of an allergic reaction, and that a denture cleanser may be the cause.

FDA has asked manufacturers of denture cleansers to warn in the labeling about allergic reactions, and to consider using alternative ingredients in place of persulfates.

Additional Information:

FDA MedWatch Safety Alert. Denture Cleanser Allergic Reactions and Misuse. February 26, 2008.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm078705.htm


Avoiding Infant Burns from Heel Warmers

A recent FDA article in the journal Nursing 2009 warns about the possibility of burns from infant heel warmers. These devices are disposable heat packs used during neonatal care to increase circulation in the infant's heel. Activating the pack produces a chemical reaction that heats it to around 104 degrees F. When the pack is applied to the heel, the heat increases capillary circulation, and this helps to draw blood during a heel stick.

Although infant heel warmers are safe and effective when they are used according to the manufacturer's instructions, the article points out that FDA has received several reports about infants suffering first and second degree burns from these devices. In one case the device was re-heated and re-used, which the label warns against. In several other cases, the pack ruptured during activation and the contents splashed on the infant or the attending nurse.

The article lists a number of precautions to avoid these kinds of accidents. Here are some of them:

• Check the infant's skin integrity before applying the warmer. If the skin is compromised in any way, don't use the warmer.

• Be especially cautious if using the warmer on a premature infant.

• Do not activate the warmer near the infant or anyone's eyes.

• Use the device for three to five minutes, or as directed by the manufacturer.

• Monitor the application site at least every 30 seconds while the warmer is in use.

• Do not wrap the warmer with any additional heat source, such as a warm washcloth.

• After removing the warmer, check the skin for blisters or erythema.

• Do not re-use the warmer, which is intended for one-time use. Re-heating it could cause a burn.

• If the contents of the heel warmer leak onto the skin, wash immediately with mild soap and water, and change affected clothing and bedding. If it contacts the eyes, flush thoroughly with water.

Additional Information:

Dwyer, Diane; RN, BSN. Use Infant Heel Warmers with Care. FDA/CDRH Medical Device Safety Page. April 9, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm129270.htm


Warning on Accidental Ingestion of Benadryl Topical Gel

FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring hospitalization or emergency treatment.

Benadryl Gel contains the antihistamine diphenhydramine as well as camphor, which is toxic and potentially fatal if ingested. Camphor can cause a variety of symptoms, such as burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma, and respiratory difficulties. It is not clear whether the adverse reactions experienced by the people who ingested Benadryl Gel were due to the camphor or to an overdose of Benadryl, since the symptoms can be similar.

FDA and ISMP suggest that the way the product is packaged may contribute to these errors. Instead of being packaged in a tube, like many topical products, the Benadryl Gel is available in a 4 ounce bottle. That means it can be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products. And although the Benadryl brand now includes many combination products, most are intended for oral or parenteral use. ISMP also points out that although the words "external use" appear on the back of the bottle, the front of the bottle says "Topical Analgesic" in small letters that consumers could miss or not understand.

Here are some ways that pharmacists can help consumers avoid confusion:

• Keep topical products separated from the ones intended for ingestion.

• Advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home.

• Remind consumers to read the drug facts label before using OTC products.

Additional Information:

ISMP Medication Safety Alert! Benadryl topical product poses danger if swallowed. January 29, 2009.
http://www.ismp.org/newsletters/acutecare/articles/20090129-1.asp


Warning on Accidental Ingestion of Benadryl Topical Gel

FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring hospitalization or emergency treatment.

Benadryl Gel contains the antihistamine diphenhydramine as well as camphor, which is toxic and potentially fatal if ingested. Camphor can cause a variety of symptoms, such as burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma, and respiratory difficulties. It is not clear whether the adverse reactions experienced by the people who ingested Benadryl Gel were due to the camphor or to an overdose of Benadryl, since the symptoms can be similar.

FDA and ISMP suggest that the way the product is packaged may contribute to these errors. Instead of being packaged in a tube, like many topical products, the Benadryl Gel is available in a 4 ounce bottle. That means it can be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products. And although the Benadryl brand now includes many combination products, most are intended for oral or parenteral use. ISMP also points out that although the words "external use" appear on the back of the bottle, the front of the bottle says "Topical Analgesic" in small letters that consumers could miss or not understand.

Here are some ways that pharmacists can help consumers avoid confusion:

• Keep topical products separated from the ones intended for ingestion.

• Advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home.

• Remind consumers to read the drug facts label before using OTC products.

Additional Information:

Drug Topics – The News Magazine for Pharmacists. Taylor, Kellie; PharmD, MPh. Benadryl Itch Stopping Gel Goes on the Body, Not into the Mouth. Don't swallow it. November 10, 2008.
http://drugtopics.modernmedicine.com/drugtopics/Safety/Benadryl-Itch-Stopping-Gel-goes-on-the-body-not-in/ArticleStandard/Article/detail/562973?contextCategoryId=47453


Avoiding Errors with Lamictal Starter Kits

A recent FDA article describes medication errors that occurred with patients using Lamictal starter kits. Lamictal (lamotrigine) is used to treat epilepsy and bipolar disorder.

The starter kits give patients the recommended initial dose and dose escalation regimen for the first five weeks of treatment. There are three different Lamictal starter kits - orange, blue and green. The titration schedules of these kits vary depending on other medications a patient is taking. Patients must use the right starter kit to avoid over or underdosing. Overdosing a patient could result in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay. Patients who are underdosed may get only limited relief from their epilepsy or bipolar disorder.

Some of the reports say that the wrong kit was dispensed to the patient. Others say the patient administered the product incorrectly. The patients experienced adverse events ranging from sensations of fuzziness and buzzing in the head to Stevens-Johnson Syndrome.

The article outlines several ways pharmacists can help avoid these errors. Here are some of them:

• Ask patients what medications they're taking to be sure the right starter kit has been prescribed.

• If you get a prescription that specifies the Lamictal starter kit by color only, verify that the correct one has been ordered.

• Make sure patients know how to take the tablets in the starter pack correctly. Advise them that the dose will increase from week to week.

• Warn patients to contact their prescriber immediately if a rash appears, since this may be a sign of a serious reaction.

Additional Information:

Holquist, Carol; RPh, USPHS, Bridges, Todd; RPh, Oleszczuk, Zachary; RPh, PharmD. Lamictal starter kits: What you need to know to avoid medication errors. Drug Topics: FDA Safety Page. March 2009.
http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Lamictal-starter-kits-Avoiding-medication-errors/ArticleStandard/Article/detail/585683



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