FDA Patient Safety News: Show #51, May 2006

FDA Approves Emsam - First Drug Patch for Depression

FDA recently approved the first transdermal drug patch for treating major depressive disorder. The patch, called Emsam and marketed by Bristol-Myers Squibb, is applied once a day to deliver the drug selegeline, an MAO inhibitor.

MAO inhibitors taken orally usually require specific dietary restrictions because when these drugs are combined with certain foods (such as aged cheeses), they can cause a hypertensive crisis. However, patients can use the lowest strength (6 mg per day) Emsam patch without observing these dietary restrictions. At the higher dosage strengths (9 mg and 12 mg per day) patients will still have to avoid these certain foods.

The manufacturer and distributor of this new product have planned an educational campaign for patients and prescribers to ensure that advice on dietary modifications for the higher patch strengths is adhered to. They are planning to conduct surveys to measure the effectiveness of the campaign, and they'll closely track adverse events for hypertensive events.

Although the effects of heat on the patch are not known, the drug labeling advises patients to keep the patch away from sources of heat because direct heat could increase the absorption of the drug. Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight. And like other antidepressants, the Emsam patch carries a warning about the possibility of an increased risk of suicidality in children and adolescents.

Additional Information:

FDA Press Release - FDA Approves Emsam (Selegiline) as First Drug Patch for Depression. February 28, 2006.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108607.htm


FDA Approves First Inhaled Insulin

FDA recently approved Exubera, the first inhaled insulin product. It's a powdered form of recombinant human insulin that is self-administered using a specially designed inhaler. Exubera, manufactured by Pfizer, is intended to treat types 1 and 2 diabetes in patients over the age of 18.

For patients with type 1 diabetes, Exubera can replace the short-acting insulin that is generally taken with meals, because with the inhaled form of insulin, patients can achieve peak levels of insulin quicker than with the injectable form.
But Exubera doesn't replace their longer-acting insulin – Type 1 diabetics will still have to take injections for that. With type 2 diabetics, Exubera can be used alone, or in combination with oral antidiabetic drugs or longer-acting injectable insulin.

Because Exubera is a fine powder that could have an affect on the lungs, the drug isn't recommended in patients with underlying lung diseases such as poorly controlled asthma, COPD or emphysema. And it should not be used by smokers.

It’s also recommended that patients receive a baseline pulmonary function test prior to starting Exubera, with repeat tests after six months on the drug and then every year thereafter, even if there are no pulmonary symptoms. Pfizer will do long-term studies of the drug to continue to look at safety issues, such as the effect of Exubera on patients with underlying lung disease.

Every time patients fill a prescription for Exubera, they’ll be given a Medication Guide. The Guide explains how the drug is to be used, contraindications, and possible side effects. It also lets patients know about possible effects on the lungs, and about the need for periodic lung function tests.

Additional Information:

FDA Press Release - FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes. January 27, 2006.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108585.htm


Recall of Cefazolin for Injection

In February, Hanford Pharmaceuticals announced that it was recalling four lots of Cefazolin for Injection, an antibiotic primarily used in hospitals. Vials in these lots may be contaminated with bacteria that could pose a life-threatening risk for some patients.

Two of the four recalled lots were distributed by Sandoz, Inc., as numbers C4650 and C4537. The other two lots were distributed by Watson Pharmaceuticals, as numbers C4689 and C4665.
Hospitals, clinics and patients should stop using the affected products immediately. Patients who believe they may have experienced an adverse reaction to the product should seek medical help. Health care facilities or patients can contact Hanford Pharmaceuticals at 315-476-7418.

Additional Information:

FDA MedWatch Safety Alert - Cefazolin for Injection. March 1, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150506.htm


Recall of Certain Hernia Repair Patches

Now for a recall of certain lots and sizes of a surgical product used to repair hernias. The product is the Composix Kugel Mesh Patch and it's used to repair ventral hernias which usually appear at the site of a prior surgical incision. The patch is marketed by Davol, Inc. a subsidiary of Bard.

The patch contains a "memory recoil ring" that allows it to be folded for insertion and then, once it's in place, to spring open and lay flat. The problem is that this ring can break, and if that happens, it can cause bowel perforations or chronic intestinal fistulae.

Davol has notified customers to stop using patches from the affected lots and return any unused units to the company. For more information on which lots and sizes are affected, you can contact Bard Customer Service at 1-800-FOR-BARD

Additional Information:

FDA MedWatch Safety Alert - Davol/Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE. March 31, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151442.htm


Dangerous Contamination of Certain Balanced Salt Solutions

FDA is alerting health care professionals that dangerous levels of endotoxins have been found in certain brands of balanced salt solution. These solutions are used to irrigate the eyes, nose and throat during a variety of surgical procedures, including cataract surgeries.

FDA has received over 300 injury complaints in patients treated with these solutions, including reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome. This condition occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction.

The contaminated solutions were manufactured by Cytosol Laboratories, Inc. and distributed under three labels:

• "AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
• "Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC;
• "Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

An estimated one million units of these solutions were distributed between December 2003 and December 2005.

FDA has asked the company to immediately retrieve all inventories of the product, including any existing stock at physician offices and hospitals. Hospitals, physicians, and consumers who have any of these products should immediately stop using them, quarantine any remaining product, and destroy it unless they receive return instructions from Cytosol. For more information, call the FDA at 1-888-463-6332.

Additional Information:

FDA MedWatch Safety Alert - Cytosol Laboratories, Inc. Balanced Salt Solution (BSS). February 14, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150520.htm


Certain ACCU-CHEK Aviva Glucose Meters Recalled

Roche Diagnostics has recalled certain ACCU-CHEK Aviva glucose meters because an electronic malfunction may cause the meter to show an erroneous result or to become inoperable. To date, three malfunctions have been confirmed in this country and five outside the U.S.

This recall affects meters within a range of serial numbers (Serial numbers 52500000000 through 52510999999). An estimated 150,000 ACCU-CHEK Aviva meters are affected.

Patients, health care professionals, pharmacists, and distributors who have a meter with a recalled serial number should call 1-888-591-5084 to get a replacement product.

Additional Information:

FDA MedWatch Safety Alert - Roche ACCU-CHEK Aviva Blood Glucose Meters. January 19, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151531.htm


Renal and Cardiovascular Toxicities with Trasylol

FDA recently issued a public health advisory about the possibility of serious side effects from Trasylol (aprotinin), a drug used to prevent perioperative blood loss in patients undergoing CABG surgery.

The advisory was based on two recently published observational studies. One reported that Trasylol may be associated with an increased risk of MI, stroke and renal dysfunction, and the other reported that Trasylol may increase the risk of renal toxicity. Neither study used the randomization or control procedures that would be needed to thoroughly evaluate the drug's safety.

The FDA is evaluating the information from these studies, along with other safety information, to determine if additional action is necessary. In the meantime, here are FDA's recommendations:

• Consider limiting Trasylol to those situations where reduced blood loss is essential to patient management and outweighs the potential risks.

• Carefully monitor Trasylol patients for toxicity, particularly to the kidneys, heart or central nervous system.

• Report adverse events to Bayer, the drug's manufacturer, or through the FDA MedWatch program.

Additional Information:

FDA MedWatch Safety Alert - Trasylol (aprotinin). February 8, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150765.htm


Erythropoietic Agents and Antibody-Mediated Anemias

The manufacturers of the erythropoietic agents Procrit, Aranesp and Epogen have provided updated information about certain antibody-mediated reactions in patients treated with these drugs.

Patients taking these drugs can produce antibodies to erythropoietin, resulting in loss of drug activity and pure red cell aplasia or severe anemia. This is most common in patients with chronic renal failure who receive these drugs subcutaneously.

The labeling now says that any patient who suddenly stops responding to Procrit, Aranesp or Epogen and who develops severe anemia and a low reticulocyte count should be evaluated. If you suspect an antibody-mediated anemia, stop using the product and contact the manufacturer to perform antibody assays on the patient's blood.

If it's found that the patient has developed antibody-mediated anemia, erythropoietic treatment should be permanently discontinued. These patients should not be switched to other erythropoietic proteins because their antibodies could cross-react with these products as well.

Additional Information:

FDA MedWatch Safety Alert 2005 - Aranesp (darbepoetin alfa). December 1, 2005.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110251.htm


Erythropoietic Agents and Antibody-Mediated Anemias

The manufacturers of the erythropoietic agents Procrit, Aranesp and Epogen have provided updated information about certain antibody-mediated reactions in patients treated with these drugs.

Patients taking these drugs can produce antibodies to erythropoietin, resulting in loss of drug activity and pure red cell aplasia or severe anemia. This is most common in patients with chronic renal failure who receive these drugs subcutaneously.

The labeling now says that any patient who suddenly stops responding to Procrit, Aranesp or Epogen and who develops severe anemia and a low reticulocyte count should be evaluated. If you suspect an antibody-mediated anemia, stop using the product and contact the manufacturer to perform antibody assays on the patient's blood.

If it's found that the patient has developed antibody-mediated anemia, erythropoietic treatment should be permanently discontinued. These patients should not be switched to other erythropoietic proteins because their antibodies could cross-react with these products as well.

Additional Information:

FDA MedWatch Safety Alert 2005 - Epogen (epoetin alfa)/Procrit (epoetin alfa). December 1, 2005.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110251.htm


New Information on Cochlear Implants and Meningitis

FDA has notified healthcare professionals and patients about the continued risk of bacterial meningitis in children with cochlear implants. A new CDC/FDA study followed children with cochlear implants for two years after the device was implanted. The study showed that children whose implants have a positioner get bacterial meningitis more often than children with implants that don’t have positioners or children without implants.

These findings underscore how important it is to continue monitoring children with cochlear implants for bacterial infections even beyond two years post implantation, and to treat infections promptly. This is particularly important for those children whose implants have a positioner.

Here are FDA's recommendations for children with cochlear implants.

• Follow CDC's recommendations for vaccinations in cochlear implant patients.
• Recognize the signs of meningitis early and intervene without delay.
• Diagnose and treat middle ear infections promptly.
• Consider prophylactic antibiotics peri-operatively in children receiving the implants.

Additional Information:

FDA MedWatch Safety Alert 2006 – Cochlear Implants with a Positioner. February 6, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151441.htm


Pet Turtles and Salmonella

FDA is warning parents that turtles can be a source of Salmonellosis, and so they're not suitable pets in households with small children. In fact, FDA has banned the sale of small turtles since 1975 because of the Salmonella risk.

Salmonella are carried routinely in the GI tract of the turtle. The turtle shows no signs of infection and then sporadically will shed the bacteria. Turtles with Salmonella usually do not appear sick in any way.
Of course anybody can catch salmonella, but when the infection occurs in infants or small children, it can be more serious. Also, young children are likely to handle their pets and then, without washing their hands, they handle food or touch their mouths, and of course, that increases the possibility of ingesting the bacteria. Salmonella infection can also be especially serious in the elderly, pregnant women and people with compromised immune systems, including chemotherapy and transplant patients.

Turtles in settings such as daycare facilities and petting zoos can also carry salmonella, so parents should thoroughly wash their children's hands with soap and water after they’ve done the handling.

The bottom line is that turtles are not suitable pets in households with young children, the elderly or immuno-compromised people. Remember that the salmonella carried by these animals can be a serious threat to health.

Additional Information:

Alert to Parents – Pet Turtles May be Harmful to Your Children’s Health. July 2005.
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm090573.htm


Pet Turtles and Salmonella

FDA is warning parents that turtles can be a source of Salmonellosis, and so they're not suitable pets in households with small children. In fact, FDA has banned the sale of small turtles since 1975 because of the Salmonella risk.

Salmonella are carried routinely in the GI tract of the turtle. The turtle shows no signs of infection and then sporadically will shed the bacteria. Turtles with Salmonella usually do not appear sick in any way.
Of course anybody can catch salmonella, but when the infection occurs in infants or small children, it can be more serious. Also, young children are likely to handle their pets and then, without washing their hands, they handle food or touch their mouths, and of course, that increases the possibility of ingesting the bacteria. Salmonella infection can also be especially serious in the elderly, pregnant women and people with compromised immune systems, including chemotherapy and transplant patients.

Turtles in settings such as daycare facilities and petting zoos can also carry salmonella, so parents should thoroughly wash their children's hands with soap and water after they’ve done the handling.

The bottom line is that turtles are not suitable pets in households with young children, the elderly or immuno-compromised people. Remember that the salmonella carried by these animals can be a serious threat to health.

Additional Information:

Human Health Hazards Associated with Turtles, Information for Regulators and Public Health Educators.
http://www.fda.gov/cvm/turtlereg.htm


Pet Turtles and Salmonella

FDA is warning parents that turtles can be a source of Salmonellosis, and so they're not suitable pets in households with small children. In fact, FDA has banned the sale of small turtles since 1975 because of the Salmonella risk.

Salmonella are carried routinely in the GI tract of the turtle. The turtle shows no signs of infection and then sporadically will shed the bacteria. Turtles with Salmonella usually do not appear sick in any way.
Of course anybody can catch salmonella, but when the infection occurs in infants or small children, it can be more serious. Also, young children are likely to handle their pets and then, without washing their hands, they handle food or touch their mouths, and of course, that increases the possibility of ingesting the bacteria. Salmonella infection can also be especially serious in the elderly, pregnant women and people with compromised immune systems, including chemotherapy and transplant patients.

Turtles in settings such as daycare facilities and petting zoos can also carry salmonella, so parents should thoroughly wash their children's hands with soap and water after they’ve done the handling.

The bottom line is that turtles are not suitable pets in households with young children, the elderly or immuno-compromised people. Remember that the salmonella carried by these animals can be a serious threat to health.

Additional Information:

CDC. Salmonellosis Associated with Pet Turtles- - -Wisconsin and Wyoming, 2004. MMWR 2005; 54(9): 223-226.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a3.htm


Pet Turtles and Salmonella

FDA is warning parents that turtles can be a source of Salmonellosis, and so they're not suitable pets in households with small children. In fact, FDA has banned the sale of small turtles since 1975 because of the Salmonella risk.

Salmonella are carried routinely in the GI tract of the turtle. The turtle shows no signs of infection and then sporadically will shed the bacteria. Turtles with Salmonella usually do not appear sick in any way.
Of course anybody can catch salmonella, but when the infection occurs in infants or small children, it can be more serious. Also, young children are likely to handle their pets and then, without washing their hands, they handle food or touch their mouths, and of course, that increases the possibility of ingesting the bacteria. Salmonella infection can also be especially serious in the elderly, pregnant women and people with compromised immune systems, including chemotherapy and transplant patients.

Turtles in settings such as daycare facilities and petting zoos can also carry salmonella, so parents should thoroughly wash their children's hands with soap and water after they’ve done the handling.

The bottom line is that turtles are not suitable pets in households with young children, the elderly or immuno-compromised people. Remember that the salmonella carried by these animals can be a serious threat to health.

Additional Information:

CDC. Salmonella Infection (salmonellosis) and Animals.
http://www.cdc.gov/healthypets/diseases/salmonellosis.htm



FDA Patient Safety News is available at www.fda.gov/psn