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May 2007 5/29 Similac Special Care 24 Cal/fl. oz. Infant Formula With Iron- Product Recalled -------------------------------------------------------------------------------- Similac Special Care 24 Cal/fl. oz. Ready to Feed Premature Infant Formula With Iron- Product Recalled Due To Less Iron Than Stated on The Label 5/29/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. The three lots of formula were recalled because they do not contain as much iron as indicated on the label. The formula was distributed in the United States between November 2006 and May 2007. Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional. No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's news release for a list of stock code and lot numbers for formula affected by this recall. Read the complete 2007 Safety Summary, including a link to the Manufacturer's news release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Similac _________________________________________________________________ Advanced Medical Optics Complete MoisturePlus Contact Lens Solution: Recall Due to Reports of A Rare, But Serious, Eye Infection Caused by A Parasite 5/29/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Advanced Medical Optics and FDA informed healthcare professionals and consumers who wear soft contact lenses of a recall of Complete MoisturePlus Multi-Purpose Solution manufactured by Advanced Medical Optics. The recall is based on reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. Symptoms of the infection can be very similar to those of other more common eye infections include eye pain or redness, blurred vision, light sensitivity, the sensation of something in the ye or excessive tearing, but Acanthamoeba is more difficult to treat. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePlus product immediately, discard all remaining solution including partially used or unopened bottles, and ask their healthcare professional about choosing an appropriate alternative cleaning/disinfecting product. Individuals should seek immediate treatment if they have symptoms of an eye infection as early diagnosis is important for effective treatment. Read the complete 2007 Safety summary, including a link to the FDA and Manufacturer's News Releases regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#AMO _________________________________________________________________ Integra LifeSciences EnDura No-React Dural Substitute Product Recall 5/25/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Integra LifeSciences (Integra) informed healthcare professionals and patients of a recall of all EnDura No-React Dural Substitute (EnDura) products. The products are manufactured by Shelhigh, Inc. and distributed by Integra. The recall is pursuant to an April 18, 2007, FDA Public Health Notification regarding products manufactured by Shelhigh, citing sterility and other manufacturing concerns and FDA's request that Shelhigh recall all of its medical devices remaining in the marketplace. Integra is recalling all EnDura products that may be in the field from the date of the first shipment by Integra in 2003 to present. On May 18, 2007, FDA classified the recall as Class I. A Class I recall is assigned when there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death. See the attached manufacturer's press release for a list of products affected by this recall. Read the complete 2007 Safety Summary, including a link to the Company's News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Integra _________________________________________________________________ Two Day Joint Public Workshop: Implementation of Risk Minimization Action Plans (RiskMAPs) To Support Quality Use of Pharmaceuticals: Opportunities and Challenges 5/23/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Agency for Healthcare Research and Quality (AHRQ) and FDA are announcing a 2-day joint public workshop entitled "Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges." The purpose of the public workshop is to get constructive input from a wide range of stakeholders, including clinicians, pharmacists, patients, third party payers of care, the pharmaceutical and biotechnology industries, researchers, and innovators in health information technology, to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns. The public workshop will be held on June 25 and 26, 2007, from 8:30 a.m. to 5 p.m. Copy and paste the entire link below into your web browser for information on how to register to attend or present at the meeting. June 4, 2007, is the registration deadline to attend or participate in the workshop. http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo .gov/2007/07-2574.htm _________________________________________________________________ Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging: FDA Requests That A Boxed Warning and New Warnings Be Added To Prescribing Information 5/23/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 square meters) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Read the complete 2007 Safety Summary, including a link to the FDA Healthcare Professional Sheet, FDA News Release, and Q & A Document regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium _________________________________________________________________ Exjade (deferasorix) Tablets For Oral Suspension: Changes Made to The WARNINGS and ADVERSE REACTIONS Sections of Prescribing Information 5/22/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders. Additionally, there were post marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some of the patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure. Further, cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) were reported. Healthcare professionals should monitor serum creatinine in patients who are at increased risk of complications, having preexisting renal conditions, are elderly, have co-morbid conditions, or are receiving medicinal products that depress renal function. Blood counts should also be monitored regularly and treatment should be interrupted in patients who develop unexplained cytopenia. Read the complete 2007 Safety Summary, including a link to the Manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Exjade _________________________________________________________________ Avandia (rosiglitazone) -Results Of An Ongoing Analysis of Safety Data Showed Differing Rates Of Ischemic Cardiovascular Events 5/21/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus. Read the complete 2007 Safety Summary, including a link to the FDA News Release and Prescribing Information regarding is issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia _________________________________________________________________ Caffeine Citrated, Powder, Purified - Product Recalled Because of Possible Sub Potency That May Lead To An Unacceptable Risk of Respiratory Depression 5/21/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus. Read the complete 2007 Safety Summary, including a link to the FDA News Release and Prescribing Information regarding is issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia _________________________________________________________________ MedWatch - The FDA Safety Information and Adverse Event Reporting Program Spectrum and FDA informed healthcare professionals of a nationwide recall of 3 lots (TS0225, UK0821, and V11203) of Caffeine Citrated, Powder, Purified. The product was recalled because of complaints about potential sub potency. Caffeine Citrated is a cerebral and respiratory stimulant used primarily to treat idiopathic apnea of premature infants. Blood levels of caffeine in patients were determined to be significantly lower than would be expected. The use of sub-potent compounded preparations may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression. Customers should examine their inventory, discontinue dispensing and using the product, quarantine the referenced lots of the product. and call the manufacturer to arrange to return the product for credit or replacement. Read the complete 2007 Safety Summary, including a link to the Manufacturer's Recall Quick Facts Sheet and Costumer Survey regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Caffeine _________________________________________________________________ NBTY Shark Cartilage Capsules Recalled Because Of Possible Health Risk 5/17/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program NBTY and FDA informed consumers and healthcare professionals of a nationwide recall of 3 lots of Shark Cartilage Capsules the company manufactured in 2004 and distributed to consumers through mail and internet orders, and retail stores throughout the United States. The product was recalled because of possible contamination with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis. Customers can return the product back to the place of purchase for a full refund. Read the press release for specific names and lot numbers of the recalled product. Read the complete 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#NBTY _________________________________________________________________ OxyContin - Illegal Promotion By Manufacturer May Cause Health Risks For Consumers 5/10/2007 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces. The manufacturer's sales force was trained to make false claims about the product to healthcare professionals, thereby, misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. These practices falsely promote the product and may cause health risks for consumers. Read the complete 2007 Safety summary, including a link to the FDA Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin _________________________________________________________________ MedWatch - The FDA Safety Information and Adverse Event Reporting Program True Man and Energy Max Products Health Risk Alert 5/10/2007 FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared ingredients. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Both products contain either a thione analog of sildenafil, the active ingredient of Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. Both Viagra and Levitra are FDA approved products for the treatment of ED. FDA has not approved True Man and Energy Max, therefore, the safety and effectiveness of these products are unknown. Consumers should discontinue use of these products and consult their healthcare professional about approved treatments for ED. Read the complete 2007 Safety summary, including a link to the FDA News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#TrueMan ___________________________________________________ FDA Warns Of The Importance Of Assuring That The Glycerin Used In Compounded Products Is Not Contaminated With Diethylene Glycol 5/7/2007 FDA warned pharmaceutical manufacturers, suppliers, drug repackers, and healthcare professionals who compound medications using glycerin of the importance of assuring that the glycerin used is not contaminated with diethylene glycol (DEG), a known poison used in antifreeze and as a solvent. Glycerin is a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products. Although, at the present time, FDA has no reason to believe that the U. S. supply of glycerin is contaminated with DEG, it is aware of reports from other countries over the past several years in which DEG contaminated glycerin has caused human deaths. FDA emphases the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem. FDA issued guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before using glycerin in the manufacture or preparation of pharmaceutical products. Read the complete 2007 safety summary, including a link to the FDA's News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Glycerin _________________________________________________________________ Antidepressant Medications - FDA Proposes That Manufacturers Update Product Labeling To Include New Warnings About Suicidal Thinking and Behavior In Young Adults Wednesday, May 02, 2007 3:27 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. Read the complete MedWatch 2007 Safety summary, including a link to the FDA Press Release and Antidepressant Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant _________________________________________________________________ Subject: FDA - MedWatch - Recall Of Compounded Injectable Colchicine- All Strengths, Sizes and Lots Date: Wednesday, May 02, 2007 12:36 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine .5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product to return to the company. Read the complete 2007 MedWatch 2007 Safety summary, including a link to the Manufacturer's Recall Notice and Return Fax Cover Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Colchicine _________________________________________________________________ Subject: FDA - MedWatch - May 2007 FDA Patient Safety News video program available Date: Tuesday, May 01, 2007 4:27 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA Patient Safety News 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. Watch or download the video program and read the complete stories at http://www.fda.gov/psn. You may have previously received notification of some of these safety issues through the MedWatch listserve. However, many of these stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions. Stories in the May 2007 edition include: FDA Clears Rapid Test for Meningitis http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#1 Important Safety Advisory on Procrit, Aranesp and Epogen http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#2 Increased Risk of Bone Fractures in Women Treated with Diabetes Drugs http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#3 Software Problems with Defibtech Lifeline and ReviveR External Defibrillators http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#4 Cardiovascular and Psychiatric Risks with ADHD Drugs http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#5 Warnings for Sleeping Pills http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#6 Advisory on Treating IPF with Actimmune http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#7 Anaphylaxis Warnings for Xolair http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#8 Clinical Trial Terminated for CellCept http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#9 Gebauer Salivart Oral Moisturizer Recalled http://www.accessdata.fda.gov/psn/transcript.cfm?show=63#10 _________________________________________________________________ Subject: FDA - MedWatch - Warning About Counterfeit Drugs From Multiple Internet Sellers Date: Tuesday, May 01, 2007 4:49 PM MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet. FDA received information showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs. The website appear to be operated from outside the United States. On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120 mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose and maintain weight loss, from two different websites. Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche Inc, consumers received sibutramine, the active ingredient in Meridia. Although Meridia is also used to lose and maintain weight loss, the drug should not be used in certain patient populations and is not a substitute for other weight loss products. Consumers should be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from their doctor is required. Additionally, consumers are urged to review the FDA web page at www.fda.gov/buyonline for additional information prior to making purchases of prescription drugs over the internet. See FDA press release for the list of the 24 web site that may be involved in the distribution of counterfeit prescription drugs. Read the complete 2007 MedWatch 2007 Safety summary, including a link to the FDA Press Release regarding this issue at:http://www.fda.gov/medwatch/safety/2007/safety07.htm#Counterfeit |
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