FDA Patient Safety News: Show #100, July 2010

New Cellular Immunotherapy for Advanced Prostate Cancer

The FDA has approved a new therapy for certain men with advanced prostate cancer called Provenge (sipuleucel-T). Provenge, an autologous cellular immunotherapy, is manufactured by Dendreon Corporation. It is intended for men with asymptomatic or minimally symptomatic prostate cancer that has metastasized and is resistant to standard hormone treatment.

Provenge is designed to stimulate the patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by first obtaining immune cells from the patient's blood using leukapheresis. Then the cells are exposed to a protein linked to an immune-stimulating substance that's found in normal prostate tissue and in most prostate cancers. Finally, the cells are infused back into the patient to treat the cancer.

The effectiveness of Provenge was studied in 512 patients enrolled in a multi-center trial. Patients receiving Provenge survived about four months longer than those not receiving the treatment. Almost all the patients receiving Provenge had some type of adverse reaction, most of which were mild or moderate. About 25 percent of the adverse events were serious, including some acute infusion reactions and stroke.

Additional Information:

FDA Press Release. FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer. April 29, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm


New Cellular Immunotherapy for Advanced Prostate Cancer

The FDA has approved a new therapy for certain men with advanced prostate cancer called Provenge (sipuleucel-T). Provenge, an autologous cellular immunotherapy, is manufactured by Dendreon Corporation. It is intended for men with asymptomatic or minimally symptomatic prostate cancer that has metastasized and is resistant to standard hormone treatment.

Provenge is designed to stimulate the patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by first obtaining immune cells from the patient's blood using leukapheresis. Then the cells are exposed to a protein linked to an immune-stimulating substance that's found in normal prostate tissue and in most prostate cancers. Finally, the cells are infused back into the patient to treat the cancer.

The effectiveness of Provenge was studied in 512 patients enrolled in a multi-center trial. Patients receiving Provenge survived about four months longer than those not receiving the treatment. Almost all the patients receiving Provenge had some type of adverse reaction, most of which were mild or moderate. About 25 percent of the adverse events were serious, including some acute infusion reactions and stroke.

Additional Information:

FDA Center for Biologics Evaluation and Research Approval. PROVENGE (sipuleucel-T). April 29. 2010.
http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm


Warning on Liver Injury with Propylthiouracil

In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil. This drug, which is used to treat hyperthyroidism, is considered second-line therapy when compared with methimazole, another anti-thyroid drug that poses less risk of liver damage.

The new warning highlights that propylthiouracil should be reserved for patients who cannot tolerate methimazole, radioactive iodine or surgery. But propylthiouracil may be the drug of choice during the first trimester of pregnancy, since methimazole has been associated with birth defects. Propylthiouracil is not recommended for children, except in rare instances where other treatments aren't appropriate.

Patients receiving propylthiouracil should be told about the possibility of liver damage, and should be instructed to promptly report symptoms such as fever, loss of appetite, nausea, tiredness, dark urine, or yellowing of the skin or eyes. A Medication Guide containing this information must be given to every patient filling a prescription for this drug.

Additional Information:

FDA MedWatch Safety Alert. Propylthiouracil. April 21, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm


Medication Guide Required for Vivitrol

The pharmaceutical company Alkermes has developed a Medication Guide for patients being treated with Vivitrol. Vivitrol (naltrexone for extended-release injectable suspension) is administered intramuscularly to treat alcohol dependence.

The Medication Guide highlights what patients need to know about Vivitrol treatment, including side effects, what to avoid during treatment, and what to tell their health care provider. The guide should be given to patients before starting Vivitrol and before each injection. Healthcare professionals should also counsel patients about the risks and benefits of receiving the drug, and ensure that patients understand the risks.

FDA is also reminding practitioners that Vivitrol should only be administered into the gluteal muscle using the customized needle that comes with the drug. Take care not to inject the medication intravenously. If a patient has significant gluteal fat, the needle may not be long enough to reach muscle tissue. Healthcare providers should consider alternative treatment for these patients.

Vivitrol should not be injected subcutaneously or into fatty tissue, because this could increase the risk of serious injection site reactions. Instruct patients to report injection site symptoms that become worse over time or do not resolve after two weeks, including intense pain, an open wound, bruising, swelling, blisters or hardness.

Additional Information:

FDA MedWatch Safety Alert. Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients. May 4, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210755.htm


Certain AQUA+FLEX Humidifiers Recalled

Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers. These devices are passive humidifiers used during mechanical ventilation to warm and humidify inspired gas.

The company has received complaints that the flex tube connector may not fit securely inside the endotracheal tube connector, and that could cause these components to come apart. That should trigger an alarm from the ventilator, the oxygen sensor or other devices connected to the AQUA+FLEX tubing. But if the alarm isn't responded to promptly, a disconnected tube could lead to serious injury or death in ventilator-dependent patients.

The recall affects AQUA+FLEX humidifiers manufactured between March 2, 2009 and December 14, 2009. Anyone who has the recalled devices should not use them and contact Teleflex Medical at 866-246-6990.

Additional Information:

FDA MedWatch Safety Alert. Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) – Recall. May 6, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211153.htm


Recall of Shiley Cuffed Tracheostomy Tubes

Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air. If a cuff does not stay inflated, a patient's ventilation could be compromised, which could lead to serious injury or death.

The recall affects certain lots of Shiley tracheostomy tubes and Shiley custom/ specialty tracheostomy tubes.

Healthcare facilities with unused tubes from the recalled lots should segregate them and return them to the company. If a tube from the recalled lots is being used in a patient, Covidien says to replace the affected tube with one not being recalled as soon as it is clinically appropriate.

If the patient's physician wants to wait for a more acceptable opportunity to replace the tube, the company recommends increased monitoring of the patient's cuff inflation system.

Patients and caregivers using cuffed Shiley tracheostomy tubes at home should also check the lot numbers of their products. If they have unused tubes from the recalled lots, or if they can't tell if their tubes are included in the recall, they should contact their home care or medical equipment provider. If the tracheostomy tube currently being used by the patient is or may be one of the recalled tubes, the patient or caregiver should call their clinician for advice.

Additional Information:

FDA MedWatch Safety Alert. Covidien Initiates Voluntary Recall of Certain Shiley Tracheostomy Tubes. April 24, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209712.htm


Recall of Shiley Cuffed Tracheostomy Tubes

Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air. If a cuff does not stay inflated, a patient's ventilation could be compromised, which could lead to serious injury or death.

The recall affects certain lots of Shiley tracheostomy tubes and Shiley custom/ specialty tracheostomy tubes.

Healthcare facilities with unused tubes from the recalled lots should segregate them and return them to the company. If a tube from the recalled lots is being used in a patient, Covidien says to replace the affected tube with one not being recalled as soon as it is clinically appropriate.

If the patient's physician wants to wait for a more acceptable opportunity to replace the tube, the company recommends increased monitoring of the patient's cuff inflation system.

Patients and caregivers using cuffed Shiley tracheostomy tubes at home should also check the lot numbers of their products. If they have unused tubes from the recalled lots, or if they can't tell if their tubes are included in the recall, they should contact their home care or medical equipment provider. If the tracheostomy tube currently being used by the patient is or may be one of the recalled tubes, the patient or caregiver should call their clinician for advice.

Additional Information:

Covidien Customer Notification Letter. Voluntary Recall - Certain Shiley™ Tracheostomy Tubes. April 13, 2010.
http://respiratorysolutions.covidien.com/LinkClick.aspx?fileticket=GTn1%2f3%2f6cko%3d&tabid=234


Parent Errors in Measuring Children’s Doses

The Institute for Safe Medication Practices (ISMP) recently reported on a study of the errors parents make when measuring children's doses of oral medications. In the study, 300 parents were observed as they attempted to measure liquid doses using dosing cups, droppers, dosing spoons and oral syringes.

Parents using dosing cups made many more errors than those using the other methods. The cups were also associated with large dosing errors, where the measured dose differed from the prescribed dose by more than 40 percent. Parents with low health literacy scores were more likely to make errors.

The authors of the study speculate that the higher failure rate with the dosing cups might be due to legibility difficulties, or to parents assuming that a full cup is the unit of measure, or to confusion between teaspoon “tsp” and tablespoon “tbsp” markings, especially with the abbreviations for teaspoon and tablespoon.

When using the dosing cups, parents should always verify the dose at eye level. But whichever dosing device you provide for your patients, ISMP recommends using the "teachback method." That is where the parent or caregiver demonstrates they understand how to use the device before it's dispensed.

Additional Information:

ISMP Medication Safety Alert! Community and Ambulatory Care Edition. Parents’ Dosing Accuracy. February 2010.
http://www.ismp.org/newsletters/ambulatory/archives/201002-2.asp


Warning on Swallowing Benadryl Topical Gel

FDA is warning people not to swallow Benadryl Extra Strength Itch Stopping Gel, an OTC product that should only be used on the skin.

FDA has received a number of reports where people experienced serious side effects after mistakenly swallowing this product, potentially exposing them to large amounts of the active ingredient, diphenhydramine. The reported effects included hallucinations, confusion, tachycardia and unconsciousness.

Several factors may have contributed to the problem. For example, a number of oral diphenhydramine products are sold under the Benadryl name, so people may associate "Benadryl" only with oral medications. And the gel was only identified as a "Topical Analgesic" in small letters on the front of the bottle.

To help fix this situation, the manufacturer has now added a prominent statement to the front of the bottle and the bottle cap that says, "For skin use only."

Pharmacists and other healthcare professionals should remind patients that Benadryl Extra Strength Itch Stopping Gel and similar topical products should only be applied to the skin.

Additional Information:

FDA MedWatch Safety Alert. Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors. May 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211792.htm


Warning on Swallowing Benadryl Topical Gel

FDA is warning people not to swallow Benadryl Extra Strength Itch Stopping Gel, an OTC product that should only be used on the skin.

FDA has received a number of reports where people experienced serious side effects after mistakenly swallowing this product, potentially exposing them to large amounts of the active ingredient, diphenhydramine. The reported effects included hallucinations, confusion, tachycardia and unconsciousness.

Several factors may have contributed to the problem. For example, a number of oral diphenhydramine products are sold under the Benadryl name, so people may associate "Benadryl" only with oral medications. And the gel was only identified as a "Topical Analgesic" in small letters on the front of the bottle.

To help fix this situation, the manufacturer has now added a prominent statement to the front of the bottle and the bottle cap that says, "For skin use only."

Pharmacists and other healthcare professionals should remind patients that Benadryl Extra Strength Itch Stopping Gel and similar topical products should only be applied to the skin.

Additional Information:

FDA Press Release. Serious Side Effects from Swallowing Topical Benadryl Product. May 12, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm211773.htm


Warning about Lipodissolve Products

FDA is cautioning the public about products used in lipodissolve procedures. Lipodissolve is a cosmetic procedure where people are given a series of injections with the intent of dissolving pockets of fat in the body. The process, also known as lipozap, lipotherapy, mesotherapy and injection lipolysis, is usually done in a medical spa. The injections typically contain phosphatidylcholine (PC) and deoxycholate (DC) in various combinations with one another. Vitamins, minerals, herbal extracts and other drugs are sometimes added to the mixture.

FDA has not approved any injectable drug to eliminate fat, and is not aware of any credible scientific evidence that supports the effectiveness of these substances in eliminating fat. The safety of these products, used alone or in combination, is unknown.

FDA has received reports of people suffering serious side effects after having lipodissolve procedures, such as permanent scarring, skin deformation, and deep painful knots under the skin at the injection site.

FDA recently warned a number of medical spas against making false or misleading statements about the drugs used in lipodissolve procedures, including claims that these products are safe and effective, that they have an outstanding safety record, or that they are better than other fat-loss procedures, such as liposuction.

Report problems with the use of lipodissolve products to FDA's MedWatch program by calling 800-FDA-1088 or by going to the link below.

Additional Information:

MedWatch – The FDA Safety Information and Adverse Event Reporting System.
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm


Warning about Lipodissolve Products

FDA is cautioning the public about products used in lipodissolve procedures. Lipodissolve is a cosmetic procedure where people are given a series of injections with the intent of dissolving pockets of fat in the body. The process, also known as lipozap, lipotherapy, mesotherapy and injection lipolysis, is usually done in a medical spa. The injections typically contain phosphatidylcholine (PC) and deoxycholate (DC) in various combinations with one another. Vitamins, minerals, herbal extracts and other drugs are sometimes added to the mixture.

FDA has not approved any injectable drug to eliminate fat, and is not aware of any credible scientific evidence that supports the effectiveness of these substances in eliminating fat. The safety of these products, used alone or in combination, is unknown.

FDA has received reports of people suffering serious side effects after having lipodissolve procedures, such as permanent scarring, skin deformation, and deep painful knots under the skin at the injection site.

FDA recently warned a number of medical spas against making false or misleading statements about the drugs used in lipodissolve procedures, including claims that these products are safe and effective, that they have an outstanding safety record, or that they are better than other fat-loss procedures, such as liposuction.

Report problems with the use of lipodissolve products to FDA's MedWatch program by calling 800-FDA-1088 or by going to the link below.

Additional Information:

FDA Press Release. FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedures. April 7, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207453.htm


Using External Infusion Pumps Safely

External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. They can improve patient care by delivering drugs and other substances with a high level of control, accuracy, and precision. But they have also been a source of persistent safety problems.

In the last five years, FDA has received numerous reports of adverse events associated with external infusion pumps, including serious injuries and deaths. During roughly the same period of time, there were over 80 recalls because of safety issues. Problems have been reported with a variety of pumps, including large volume, syringe and elastomeric pumps, as well as specialty infusion pumps such as enteral, insulin and PCA pumps.

Many adverse events are attributed to use error, but some are related to problems with device design or engineering, including software defects, user interface issues, and mechanical or electrical failures. These problems can compromise patient care by leading to over- or under-infusions, missed treatments or delayed therapy.

FDA has launched a new initiative to address these problems in a number of ways --- for example, by establishing additional requirements for infusion pump manufacturers, and facilitating the development of safer and more effective pumps.

In the meantime, there are steps clinicians can take to reduce pump-related risks. Here are some of the things FDA recommends:

• Have a back up plan if the pump fails, including how to get a working pump and tubing quickly, and how to get a back-up battery or power supply.

• Use instruction manuals or trouble-shooting guides, as well as the pump's drug library, if applicable. And remember the "5 rights" for medication administration - the right patient, drug, dose, route and time.

• If appropriate, label infusion pump channels and tubing with the name of the medication or fluid to help avoid errors.

• Do not use a pump if it is broken or damaged, even if there are only small chips or cracks. And do not use a pump if an unexplained alarm occurs or if the pump does not function as you expect it to. Tag the pump with details about the problem and report it.

• Be sure that the preventive maintenance recommended by the manufacturer is performed.

Additional Information:

FDA Information on Infusion Pumps. April 26, 2010.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm


Using External Infusion Pumps Safely

External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. They can improve patient care by delivering drugs and other substances with a high level of control, accuracy, and precision. But they have also been a source of persistent safety problems.

In the last five years, FDA has received numerous reports of adverse events associated with external infusion pumps, including serious injuries and deaths. During roughly the same period of time, there were over 80 recalls because of safety issues. Problems have been reported with a variety of pumps, including large volume, syringe and elastomeric pumps, as well as specialty infusion pumps such as enteral, insulin and PCA pumps.

Many adverse events are attributed to use error, but some are related to problems with device design or engineering, including software defects, user interface issues, and mechanical or electrical failures. These problems can compromise patient care by leading to over- or under-infusions, missed treatments or delayed therapy.

FDA has launched a new initiative to address these problems in a number of ways --- for example, by establishing additional requirements for infusion pump manufacturers, and facilitating the development of safer and more effective pumps.

In the meantime, there are steps clinicians can take to reduce pump-related risks. Here are some of the things FDA recommends:

• Have a back up plan if the pump fails, including how to get a working pump and tubing quickly, and how to get a back-up battery or power supply.

• Use instruction manuals or trouble-shooting guides, as well as the pump's drug library, if applicable. And remember the "5 rights" for medication administration - the right patient, drug, dose, route and time.

• If appropriate, label infusion pump channels and tubing with the name of the medication or fluid to help avoid errors.

• Do not use a pump if it is broken or damaged, even if there are only small chips or cracks. And do not use a pump if an unexplained alarm occurs or if the pump does not function as you expect it to. Tag the pump with details about the problem and report it.

• Be sure that the preventive maintenance recommended by the manufacturer is performed.

Additional Information:

FDA Press Release. FDA Launches Initiative to Reduce Infusion Pump Risks. April 23, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209042.htm



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