Subject: FDA MedWatch: Custom Ultrasonics Endoscope Washer/Disinfectors: Safety Alert of Feb 7 UPDATED with new recommendations Date: Wednesday, February 28, 2007 2:13 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Audience: Hospital risk managers, nursing supervisory staff FDA issued a Public Health Notification to further inform hospitals and other user facilities about FDA's action, and to provide recommendations for facilities currently using the affected products to wash and disinfect flexible endoscopes.
Read the complete MedWatch 2007 Safety Summary, including a link to the FDA Public Health Notification, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#System83
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Subject: FDA MedWatch: Baraclude (entecavir) - Risk of developing HIV resistance cannot be excluded when used in an HIV/HBV co-infected patient not receiving HAART Date: Saturday, February
24, 2007 4:16 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART).
Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.
Read the complete MedWatch 2007 Safety summary, including links to the Manufacturer's Dear Healthcare Provider Letter and revised labeling, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Baraclude
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Subject: FDA MedWatch: January 2007 Safety Labeling Changes posted on website Date: Friday, February 23, 2007 5:31 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Safety-related drug labeling changes for January 2007 were posted on the MedWatch website.
The January 2007 posting includes 29 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.
The Summary page --
http://www.fda.gov/medwatch/SAFETY/2007/jan07_quickview.htm
-- provides drug names and a listing of the sections changed.
The Detailed view --
http://www.fda.gov/medwatch/SAFETY/2007/jan07.htm
-- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Tasmar (tolcapone) Tablets Toradol (ketorolac tromethamine tablets) Sustiva (efavirenz) Capsules and Tablets Minocin (minocycline for injection) Intravenous Minocin (minocycline hydrochloride) Oral Suspension Mobic (meloxicam) Tablets and Oral Suspension Rapamune (sirolimus) Oral Solution and Tablets Zevalin (ibritumomab tiuxetan)
The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]:
Toradol (ketorolac tromethamine tablets) Sustiva (efavirenz) Capsules and Tablets Flomax (tamsulosin hydrochloride) Capsules NovoLog (insulin aspart [rDNA origin]) Injection Progesterone Injection, USP in Sesame Oil for Intramuscular Use Only Wellbutrin (bupropion hydrochloride) Tablets Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets Yaz (drospirenone and ethinyl estradiol) Tablets Minocin (minocycline hydrochloride) Pellet-Filled Capsules Ovcon 35 Fe (norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets)
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Subject: FDA MedWatch: Attention Deficit Hyperactivity Disorder (ADHD) drug products - Medication Guides required to alert patients to possible cardiovascular and psychiatric risks Date: Thursday, February 22, 2007 2:48 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals that the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)have been directed to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines and to advise them of precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers each time a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events.
An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).
Read the complete MedWatch 2007 Safety summary, including links to the draft version of the Medication Guides and the FDA press statement, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ADHD
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Subject: FDA MedWatch:Xolair (omalizumab) - new reports of serious and life-threatening allergic reactions (anaphylaxis) Date: Wednesday, February 21, 2007 11:15 AM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients.
Read the complete MedWatch 2007 Safety summary, including links to the Healthcare Professional information sheet and FDA press statement, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
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Subject: FDA MedWatch: Avandia (rosiglitazone maleate) - Increased incidence of fractures in females noted in clinical trial Date: Wednesday, February 21, 2007 9:36 AM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.
Read the complete MedWatch 2007 Safety summary, including a link to the GSK Dear Healthcare Professional letter, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone
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Subject: ***SPAM***FDA - MedWatch - Unsafe, Misrepresented Drugs Purchased Over the Internet: Ambien (zolpidem tartrate), Xanax (alprazolam), Lexapro ( escitalopram oxalate), Ativan (lorazepam) Date: Friday, February 16, 2007 7:27 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online. Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug. Several consumers experienced difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and had to seek emergency medical treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and sedation. Taking medication that contains an active ingredient other than what is prescribed by qualified healthcare professionals is generally unsafe. FDA urges consumers to review the FDA website for additional information prior to making purchases of medications over the internet (http://www.fda.gov/buyonline/).
Read the complete MedWatch 2007 Safety summary, including links to the FDA Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#internet
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Subject: FW: FDA - MedWatch - Erythropoiesis Stimulating Agents (ESAs) - Results of Aranesp Study May Apply to Other ESAs Date: Friday, February 16, 2007 6:53 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.
Read the complete MedWatch 2007 Safety summary, including links to the FDA Information For Healthcare Professionals Sheet and previous MedWatch alerts regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA
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Subject: FDA MedWatch: Rotavirus, Live, Oral, Pentavalent vaccine ( RotaTeq) associated with intussusception Date: Tuesday, February 13, 2007 6:29 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued a Public Health Notification to inform health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq). Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted.
Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Healthcare professionals and others are encouraged to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to the Vaccine Adverse Event Reporting System (VAERS). Parents should contact their child's doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception.
Read the complete MedWatch 2007 Safety summary, including links to the Notification, Label and Patient Product Information, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#RotaTeq
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Subject: FDA - MedWatch - Ketek (telithromycin) Changes to Prescribing information that Include the Removal of Two Previously Approved Indications, a BOXED WARNING, and a Patient Medication Guide Date: Monday, February 12, 2007 4:56 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Sanofi-Aventis notified healthcare professionals of revisions to the prescribing information, including a BOXED WARNING and a new Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The BOXED WARNING states that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely.
Read the complete MedWatch 2007 Safety summary, including links to the FDA Press Release and Drug Information Page and the Manufacturer's revised prescribing information and Medication Guide for Ketek regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ketek
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Subject: FDA - MedWatch - HoMedics Heating Pads- Nationwide Recall Date: Friday, February 09, 2007 4:30 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
HoMedics and FDA notified consumers and healthcare professionals of a nationwide recall of 292,108 heating pads produced by HoMedics and shipped within the United States in 2001 and 2002. Some of the heating pads contain an inadequate connector crimp, which can lead to a high resistance connection that may generate excessive heat. This can pose a risk of minor or first degree burn injuries, fire or damage to the heating pad itself or to materials (like bedding and furniture) that come in contact with the pad. Consumers who have any of the heating pads should discontinue use of the product and return it immediately to the retailer of purchase for a full refund. See recall notice for specific HoMedics Heating Pad Model Numbers.
Read the complete MedWatch 2007 Safety Summary, including links to the Manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#heatpad
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Subject: FDA MedWatch: Heparin Sodium Injection 10,000 units/mL and HEP-LOCK U/P 10 units/mL associated with fatal medication errors Date: Wednesday, February 07, 2007 9:38 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels.
Read the complete MedWatch 2007 Safety summary, including a link to the Baxter Dear Healthcare Provider letter, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Heparin
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Subject: FDA MedWatch: Custom Ultrasonics System 83 Plus Washer/Disinfector associated with risk of infection Date: Wednesday, February 07, 2007 3:16 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals that Custom Ultrasonics agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System 83 Plus Mini-flex Washer/Disinfector, used to wash and disinfect flexible endoscopes, until it brings its manufacturing methods and controls into compliance with FDA requirements. Endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. FDA advised health care providers to discontinue using these products, using an alternative device or following appropriate protocols to manually wash and disinfect the device.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA press statement, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#System83
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Subject: FDA MedWatch - December 2006 Safety Labeling Changes posted on website Date: Wednesday, February 07, 2007 11:28 AM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Safety-related drug labeling changes for December 2006 were posted on the MedWatch website.
The December 2006 posting includes 35 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.
The Summary page --
http://www.fda.gov/medwatch/SAFETY/2006/dec06_quickview.htm
-- provides drug names and a listing of the sections changed.
The Detailed view --
http://www.fda.gov/medwatch/SAFETY/2006/dec06.htm
-- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the "Prescribing Information" link in the detailed view.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Activella (estradiol/norethindrone acetate) Tablets Diskets Dispersible Tablets (methadone hydrochloride tablets, USP) Trasylol (aprotinin injection) Crixivan (indinavir sulfate) Capsules Vfend I.V. (voriconazole) for Injection, Vfend (voriconazole) Tablets, and Vfend (voriconazole) for Oral Suspension Colazal (balsalazide disodium) Capsules Emtriva (emtricitabine) Capsules and Oral Solution Ibuprofen Capsules, 200 mg Pexeva (paroxetine mesylate) Tablets Suprane (desflurane, USP) Volatile Liquid for Inhalation Twinject Auto-Injector (epinephrine injection, USP 1:1000)
The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]:
Activella (estradiol/norethindrone acetate) Tablets Crixivan (indinavir sulfate) Capsules Vfend I.V. (voriconazole) for Injection, Vfend (voriconazole) Tablets, and Vfend (voriconazole) for Oral Suspension Colazal (balsalazide disodium) Capsules Emtriva (emtricitabine) Capsules and Oral Solution Twinject Auto-Injector (epinephrine injection, USP 1:1000) Byetta (exenatide) Injection Fuzeon (enfuvirtide) for Injection Kaletra (lopinavir/ritonavir) Capsules and Oral Solution Kaletra (lopinavir/ritonavir) Tablets and Oral Solution Velcade (bortezomib) for Injection Viracept (nelfinavir mesylate) Tablets and Oral Powder Fosamax (alendronate sodium) Tablets and Oral Solution Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets Spiriva HandiHaler (tiotropium bromide inhalation powder) for Oral Inhalation Only Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules) Hyzaar (losartan potassium-hydrochlorothiazide tablets) PegIntron (peginterferon alfa-2b) Powder for Injection PegIntron (peginterferon alfa-2b) Redipen Single Dose Delivery System
Subject: FDA MedWatch: Use of Skin Products Containing Numbing Ingredients (Topical Anesthetic Drugs) for Cosmetic Procedures and Potential Life-Threatening Side Effects Date: Tuesday, February 06, 2007 7:31 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription. FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following:
- use a topical anesthetic approved by the FDA. - use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve pain. - ask for instructions from your doctor on how to safely use the topical anesthetic.
Read the complete MedWatch 2007 Safety summary, including the link to the FDA's Public Health Advisory regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Anesthetics
Subject: FDA MedWatch - New online tutorial on Drug Safety available for healthcare professionals and their patients Date: Tuesday, February 06, 2007 11:34 AM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Dear FDA MedWatch listserve subscriber;
These FDA MedWatch safety alert notices are sent at your request to help you rapidly learn about updated safety information on the human healthcare products - drugs, both Rx and OTC, medical devices and diagnostics, biologics, and dietary supplements that FDA monitors for safety following their approval and that you or your patients may use, prescribe or dispense in day to day care.
We intend that this information be concise, science-based, unbiased and clinically useful information that will help both provider and patient as they consider treatment choices. To assist both healthcare professionals and the healthcare consuming public to better understand the challenges of post-marketing drug and device surveillance and what FDA offers to address that challenge, I am pleased to announce the availability of a web-based self-learning tutorial, "FDA MedWatch and Patient Safety", http://www.connectlive.com/events/fdamedwatch/.
This 30 minute video program will allow you, as either provider or patient, to have a better understanding of why voluntary reporting of serious adverse events, product quality problems and product use errors is essential to FDA's safety monitoring process, how FDA evaluates and takes action on your reports, and how MedWatch takes that new safety information and makes it available for your use.
If you have comments about our FDA MedWatch safety alert process, this Patient Safety tutorial or suggestions for how to share this FDA safety message more widely, please address your reply to CDERMedWatchTutorial@fda.hhs.gov
Norman S Marks, MD, MHA Medical Director, MedWatch FDA/CDER/Office of the Center Director Safety Policy and Communication Staff www.fda.gov/medwatch * * * * * In September 2006, the Institute of Medicine (IOM) issued a report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, that included substantive recommendations on how the FDA can improve its drug safety efforts. The FDA response, issued on January 30, 2007, details a comprehensive approach to the IOM's suggestions. It includes 18 actions that were initiated recently as a result of FDA's own assessment of the drug safety system, eight items that are part of the proposed recommendations for the reauthorization of the Prescription Drug Users Fee Act [PDUFA] and 15 new items. To learn more about the FDA response, please see:
FDA's "The Future of Drug Safety" report: http://www.fda.gov/oc/reports/iom013007.html "FDA's Commitment to Drug Safety" Fact Sheet: http://www.fda.gov/oc/factsheets/drugsafety-iom.html
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Subject: FDA - MedWatch - February 2007 FDA Patient Safety News video program available Date: Friday, February 02, 2007 4:17 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant new product approvals, recalls and safety alerts, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the February 2007 edition include:
You can find more information about the show, read the complete stories and watch or download the program on our web site (http://www.fda.gov/psn ).
Avoiding Accidental Overdoses when Methadone is Prescribed for Pain FDA has issued a Public Health Advisory cautioning practitioners about avoiding overdoses when prescribing methadone or managing patients taking this drug... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#1
Delayed Onset of Heparin-induced Thrombocytopenia FDA is alerting health care professionals that heparin-induced thrombocytopenia (HIT) can occur in patients who had been treated several weeks earlier with heparin sodium injection... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#2
Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements FDA encourages health care professionals and consumers to report to the FDA serious problems with the medical products they prescribe, dispense, or use through FDA's MedWatch program... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#3
Cardiac Events with Gleevec Novartis is notifying healthcare professionals about new precautions about severe congestive heart failure and left ventricular dysfunction for Gleevec (imatinib mesylate)... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#4
Avoiding Burns from Electrodes and Cables during MRI Exams A recent FDA article in Nursing 2006 describes second and third degree burns in patients undergoing MRI exams while they were wearing ECG electrodes and cables... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#5
Possible Dosing Errors with the OptiClik Insulin Injection Device A recent ISMP report points out a potential problem when left-handed patients use the OptiClik injection pen, which administers Lantus or Apidra insulin... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#6
Dangerous Use of Saline Flush Syringes A recent ISMP report alerted health professionals about the danger of using pre-filled saline flush syringes to reconstitute medications... http://www.accessdata.fda.gov/psn/transcript.cfm?show=60#7
For more FDA Patient Safety News, visit http://www.fda.gov/psn. Please send any comments, questions or suggestions about the program to PSNews@fda.gov <mailto:PSNews@fda.gov>
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Subject: FDA - MedWatch - Vapotherm 2000i [Respiratory Gas Humidifier] System Date: Friday, February 02, 2007 8:48 AM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of the reintroduction of the 2000i Respiratory Gas Humidifier System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures. FDA noted that premature neonates, immunocompromised patients and those with underlying respiratory illness (such as cystic fibrosis) or malignancy may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm device. FDA issued recommendations for the steps to take before using the reintroduced device.
Read the complete MedWatch Safety summary, including links to the FDA Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Vapotherm
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Subject: FDA - MedWatch - Lucentis (ranibizumab injection) - Preliminary Safety Information From a Planned Interim Analysis In an On-Going Study (SAILOR Study) Date: Thursday, February 01, 2007 5:53 PM
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Genentech informed healthcare professionals of preliminary safety information from a planned interim analysis in an ongoing study (SAILOR) which confirmed the higher incidence of stroke in the o.5 mg dose group compared to the 0.3 mg dose group (1.2% versus 0.3%, respectively; P=0.02) of patients with neovascular (wet) age-related macular degeneration who received intravitreal Lucentis. The rates of stroke for both dose groups are lower than the rates seen in the controlled clinical trials and included in the approved labeling. The planned frequency of dosing was not the same as that described in the approved labeling. This comparison was one of many made during this interim analysis.
Read the complete MedWatch 2007 Safety summary, including links to the Sponsor's Dear Healthcare Provider Letter regarding this issue and prescribing information for Lucentis at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Lucentis
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