July 10, 2009Recalls and Safety Alerts: Safety Problems with Denture Cleansers Recalls and Safety Alerts: Safety Problems with Denture Cleansers
FDA wants healthcare professionals to know about two serious safety problems that have occurred in patients who use denture cleansers. The first is the risk of allergic reactions to these products. These reactions can arise soon after the initial u... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps. The defect can cause the "up" and "down" buttons on these pumps to stop working, ... Source: www.accessdata.fda.gov Preventing Medical Errors: Avoiding Errors with Lamictal Starter Kits A recent FDA article describes medication errors that occurred with patients using Lamictal starter kits. Lamictal (lamotrigine) is used to treat epilepsy and bipolar disorder. The starter kits give patients the recommended initial dose and dose... Source: www.accessdata.fda.gov Recalls and Safety Alerts: New Safety Information on Tarceva New information has been added to the labeling of the chemotherapy drug Tarceva (erlotinib). The revised labeling now warns about three kinds of serious adverse events: ? Gastrointestinal perforation, which may be fatal. This risk is increased i... Source: www.accessdata.fda.gov Preventing Medical Errors: Warning on Accidental Ingestion of Benadryl Topical Gel FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products FDA is updating earlier recommendations about the interaction between the antibiotic ceftriaxone and intravenous products that contain calcium. In certain circumstances, this interaction can cause dangerous precipitates to form. Ceftriaxone is sold... Source: www.accessdata.fda.gov July 8, 2009U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud
A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein Source: www.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov FDA Improves Egg Safety A new regulation means eggs will be safer for people to eat. Source: www.fda.gov Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review FDA provides its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Source: www.fda.gov Skin Products Made by Clarcon FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse. Source: www.fda.gov U.S. Attorney News Release: Former Managing Pharmacist Pleads Guilty To Conspiracy to Defraud Health Insurers The former managing pharmacist at a Middlesex County pharmacy pleaded guilty today to conspiring to defraud health insurers, including the federal Medicaid program, by submitting phony claims for reimbursement for prescription drugs, Acting U.S. Attorney Ralph J. Marra, Jr., announced. Source: www.fda.gov July 5, 2009U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials
U.S. Attorney news release Source: www.fda.gov Preventing Medical Errors: Warning on Accidental Ingestion of Benadryl Topical Gel FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring... Source: www.accessdata.fda.gov FDA Warns Consumers Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning consumers not to eat any varieties of Nestle Toll House Refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Source: www.fda.gov U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. Source: www.fda.gov |
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