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March 2007 |
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3/30 Zelnorm (tegaserod maleate)- Product Market Withdrawal 3/29 Woodridge Labs Recalls Certain DermaFreeze365 Products 3/28 Accutane (isotretinoin)- Webpage Warning Against Buying Product and Generic Versions On Line catheter-related bloodstream infections 3/16 February 2007 Monthly Safety Labeling Changes Posted 3/9 Erythropoiesis Stimulating Agents: studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs Subject: FDA - MedWatch - Zelnorm (tegaserod maleate)- Product Market Withdrawal - Study Results Showed Patients on Drug Had Higher Risk of Serious Cardiovascular Adverse Events Date: Friday, March 30, 2007 3:50 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate. Read the complete MedWatch 2007 Safety summary, including a link to the FDA Public Health Advisory regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm _________________________________________________________________ Subject: FDA - MedWatch - Permax (pergolide)- Product Market Withdrawal - New Studies Showed That Some Patients With Parkinson's Disease on Drug Had Serious Damage To Their Heart Valves Date: Thursday, March 29, 2007 4:03 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug. These two studies confirm earlier studies that also described this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professions should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide. Read the complete MedWatch 2007 Safety summary, including a link to the FDA Public Health Advisory regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Pergolide _________________________________________________________________ Subject: FDA - MedWatch - Woodridge Labs Recalls Certain DermaFreeze365 Products Because of Possible Health Risk Date: Wednesday, March 28, 2007 3:59 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Woodridge Labs and FDA informed consumers and healthcare professionals of a recall of all lots of its DermaFreeze365 Instant Line Relaxing Formula and DermaFreeze365 Neck and Chest products. The products were recalled because certain lots tested positive for Pseudomonas aeruginosa bacteria. The bacteria may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Because DermaFreeze365 Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that if the recalled product is inadvertently introduced in the eye, it could result in serious eye infections and, in rare circumstances, possible blindness. Read the complete MedWatch 2007 Safety summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#DermaFreeze365 _________________________________________________________________ Subject: FDA - MedWatch - Accutane (isotretinoin)- Webpage Warning Against Buying Product and Generic Versions On Line Date: Wednesday, March 28, 2007 3:13 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use. The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Read the complete MedWatch 2007 Safety summary, including a link to the FDA Accutane Product Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Accutane _________________________________________________________________ Subject: FDA MedWatch - Smith & Nephew Radio Frequency (RF) Denervation Probes: class 1 nationwide recall due to mislabeling as sterile Date: Tuesday, March 27, 2007 10:28 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death. Read the complete MedWatch 2007 Safety summary, including a link to the FDA recall notice and firm press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes _________________________________________________________________ Subject: FDA MedWatch-KETEK telithromycin) Dear Healthcare Professional letter issued re: safety related labeling changes Date: Monday, March 26, 2007 4:07 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Sanofi-aventis issued a Dear Healthcare Professional letter for KETEK telithromycin). The label has been revised to add a boxed warning and contraindication for myasthenia gravis patients. In addition, the indications for the treatment of acute exacerbation of chronic bronchitis and acute bacterial sinusitis have been removed from the labeling. In prescribing KETEK, it is important for healthcare professionals to inform and discuss with patients the four highlighted toxicities: exacerbation of myasthenia gravis, hepatotoxicity, visual disturbances, and loss of consciousness. A Medication Guide has been developed that replaces the Patient Information section of the US prescribing information for KETEK, to better inform and educate patients. The Medication Guide must be provided by pharmacists to patients when KETEK is dispensed. Healthcare professionals should advise patients to read the medication guide prior to taking KETEK. Read the complete MedWatch 2007 Safety summary, including a link to the Dear Healthcare Professional letter and the previous February 12 FDA MedWatch alert, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ketek _________________________________________________________________ Subject: ***SPAM***FDA MedWatch - V.MAX supplement product recalled due to undeclared drugs, aminotadalafil, which may result in low blood pressure Date: Monday, March 19, 2007 4:03 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have V.MAX in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. Read the complete MedWatch 2007 Safety summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#vmax _________________________________________________________________ Subject: ***SPAM***FDA MedWatch-Rhino Max supplement product: recall due to undeclared drug, aminotadalafil which may result in low blood pressure Date: Friday, March 16, 2007 10:42 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. Read the complete MedWatch 2007 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rhino _________________________________________________________________ Subject: FDA MedWatch: Zyvox (linezolid) - Clinical trial showed higher chance of death in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections Date: Friday, March 16, 2007 8:33 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection. Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with linezolid who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study. Linezolid is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately. Read the complete MedWatch 2007 Safety summary, including a link to the Drug Information Page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zyvox _________________________________________________________________ Subject: FDA MedWatch: February 2007 Monthly Safety Labeling Changes Posted on Website Date: Friday, March 16, 2007 5:40 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Safety-related drug labeling changes for February 2007 were posted on the MedWatch website. The February 2007 posting includes 46 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/feb07_quickview.htm -- provides drug names and a listing of the sections changed. The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2007/feb07.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 below the drug's name. The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Actiq (fentanyl citrate) Oral Transmucosal Lozenge Femring (estradiol acetate vaginal ring) Humira (adalimumab) Solution for Subcutaneous Injection Ketek (telithromycin) Tablets Lotensin (benazepril hydrochloride) Tablets Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP) Combination Tablets Lotrel (amlodipine besylate and benazepril hydrochloride) Rituxan (rituximab) Diprivan (propofol) Injectable Emulsion for IV Administration Nardil (phenelzine sulfate tablets, USP) Norditropin Cartridges (somatropin [rDNA origin] injection) Nutropin (somatropin [rDNA origin] for injection) Nutropin AQ (somatropin [rDNA origin] injection) Tev-Tropin (somatropin [rDNA origin] for injection) Actos (pioglitazone hydrochloride) Tablets Cymbalta (duloxetine hydrochloride) Delayed-release Capsules DepoDur (morphine sulfate extended-release liposome injection) Extraneal (icodextrin) Peritoneal Dialysis Solution Pravachol (pravastatin sodium) Tablets Prinivil (lisinopril) Tablets Prinzide (lisinopril-hydrochlorothiazide) Tablets Sutent (sunitinib malate) Capsules The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]: Femring (estradiol acetate vaginal ring) Humira (adalimumab) Solution for Subcutaneous Injection Ketek (telithromycin) Tablets Rituxan (rituximab) Extraneal (icodextrin) Peritoneal Dialysis Solution Sutent (sunitinib malate) Capsules Boniva (ibandronate sodium) Tablets Duetact (pioglitazone hydrochloride and glimepiride) Tablets Flomax (tamsulosin hydrochloride) Capsules Tracleer (bosentan) Film Coated Tablets Boniva (ibandronate sodium) Injectio Pulmicort Flexhaler (budesonide inhalation powder) for Oral Inhalation Only Omacor (omega-3-acid ethyl esters) Capsules Vyvanse (lisdexamfetamine dimesylate) _________________________________________________________________ Subject: FDA MedWatch - Sedative-hypnotic drug products: labeling strengthened to include warnings about risk of severe allergic reactions and sleep-driving Date: Wednesday, March 14, 2007 3:40 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Read the complete MedWatch 2007 Safety summary, including a link to the FDA press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative _________________________________________________________________ Subject: FDA MedWatch - Actimmune (Interferon Gamma 1-b): clinical trial showed that patients with IPF who received Actimmune did not benefit Date: Friday, March 09, 2007 7:30 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the early termination of the INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is not approved by the FDA to treat IPF. Read the complete MedWatch 2007 Safety summary, including a link to the Public Health Advisory and Drug Information Page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actimmune _________________________________________________________________ Subject: FDA MedWatch: Erythropoiesis Stimulating Agents: studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs Date: Friday, March 09, 2007 5:47 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs. Read the complete MedWatch 2007 Safety summary, including links to the Public Health Advisory, Q and A's, and updated healthcare professional information sheet, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA _________________________________________________________________ Subject: FDA - MedWatch - Actos (pioglitazone) Tablets - Evaluation of Safety Data Showed Increased Incidence of Fractures in Female Patients Date: Friday, March 09, 2007 12:13 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products. Read the complete MedWatch 2007 Safety summary, including links to the Manufacturer's Dear Healthcare Provider Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actos _________________________________________________________________ Subject: FDA MedWatch: Defibtech Lifeline and ReviveR Automated External Defibrillators recall due to failure to deliver shock Date: Wednesday, March 07, 2007 10:48 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient. The company provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies. Read the complete MedWatch 2007 Safety summary, including links to the Recall Notice and firm's press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Lifeline _________________________________________________________________ Subject: FDA - MedWatch - Salivart Oral Moisturizer - Nationwide Recall Because Some Units Do Not Meet Company's Internal Specification For Aerobic Microorganisms and Mold Date: Monday, March 05, 2007 5:35 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Gebauer Company notified healthcare professionals and consumers of a nationwide recall of certain lots of Salivart Oral Moisturizer. The recall was initiated because some lots do not meet the Company's internal specification for aerobic microorganisms and mold. Use of the affected units may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea. Customers who have the recalled product should stop using the product and dispose of it immediately. See the attached Manufacturer's recall notice for specific lot numbers and expiration dates of the recalled product. Read the complete MedWatch 2007 Safety Summary, including links to the Manufacturer's Recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Salivart ________________________________________________________________ Subject: FDA - MedWatch - Medical Device Safety - Change in Daylight Savings Time May Affect Medical Equipment in Unpredictable Ways Date: Friday, March 02, 2007 4:04 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of the possibility that some medical devices/equipment, hospital networks and associated information technology systems may generate adverse events because of the upcoming change in the start and end dates for Daylight Savings Time (DST), and suggested actions to prevent such occurrences. Medical equipment that uses, creates or records time information about a patient's diagnosis or treatment and has not been updated by the manufacturer, may not work properly when the new DST starts three weeks earlier and ends one week later this year. Medical equipment currently in use was likely made before the DST rules were changed and may cause patient's equipment to register the wrong dates for the start and end of daylight savings time this year. Additionally, if a medical device or medical device network are adversely affected by the new DST date changes, a patient's treatment or diagnostic result could be: -incorrectly prescribed -provided at the wrong time -missed -given more than once -given for longer or shorter durations than intended -incorrectly recorded Healthcare professionals and consumers are encouraged to see the attached Preliminary Public Health Notification and Advice for Patients for recommendations on what to do if their medical equipment uses or displays time. http://www.fda.gov/medwatch/safety/2007/safety07.htm#time _________________________________________________________________ Subject: FDA - MedWatch - Unapproved Ergotamine Products - Twenty Companies Ordered to Cease marketing Unapproved Drug Products Containing Ergotamine tartrate Date: Friday, March 02, 2007 4:40 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals and consumer that the Agency ordered twenty firms to stop marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. Unapproved drugs pose real risks to the American public because they have not been subject to FDA review, and the safety, effectiveness, and quality of such products are unknown. This action does not affect FDA-approved products containing ergotamine. Consumers who are using ergotamine products and have questions or concerns are urged to contact their health care provider. Read the complete MedWatch 2007 Safety summary, including links to the FDA Press Release and Warning Letters regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ergotamine _________________________________________________________________ Subject: FDA - MedWatch - March 2007 FDA Patient Safety News is now available Date: Friday, March 02, 2007 4:59 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 safety alerts, recalls, new product approvals, 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 March 2007 edition include: New Cooling Device to Treat Infants with HIE http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#1 Thrombosis Associated with Coronary Drug-Eluting Stents http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#2 Serious Infection in Lupus Patients Treated with Rituxan http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#3 Expanded Recall/Market Withdrawal of Hernia Repair Patch http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#4 Precautions in Using Vapotherm Humidifier http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#5 New Safety Information on Trasylol http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#6 Possible Dose-Counter Errors with the Asmanex Twisthaler http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#7 Danger in Products Containing Quinine http://www.accessdata.fda.gov/psn/transcript.cfm?show=61#8 _________________________________________________________________ |
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