FDA NEWS

Recalls and Safety Alerts: Recall of Pediatric Tracheostomy Tubes
Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl...
Source: www.accessdata.fda.gov

Preventing Medical Errors: Don?t Share Insulin Pens Between Patients
FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as h...
Source: www.accessdata.fda.gov

Preventing Medical Errors: Removing Insulin from Cartons
The Institute for Safe Medication Practices (ISMP) warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong ca...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Alert on Metabolic Acidosis from Zonisamide
FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion Pumps
Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Warning on Metoclopramide
FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled
The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Burns from Medicated Patches during MRI Exams
FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar...
Source: www.accessdata.fda.gov

New Medical Products: FDA Approves First Human Drug from Genetically Engineered Animals
FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The...
Source: www.accessdata.fda.gov