We have added some new education sessions to our workshop schedule. Please CLICK HERE to see what is available and to register.
We have added some new education sessions to our workshop schedule. Please CLICK HERE to see what is available and to register.
FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.
Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.
CLICK HERE to read the MedWatch 2010 safety summary, including a link to the FDA Drug Safety Communication.
FDA and Thomas Medical Products Inc. notified healthcare professionals of a Class I Recall of certain lots of the product, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death.
CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice.
We have recently created and uploaded new versions of the Children, Pregnant Women, and Prisoner vulnerable population forms. We hope these new versions will better capture pertinent study related information. You can check them out HERE.
Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that:
Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.
Section 17.14, Need for comprehensive Treatment Program in Pediatric Patients: Zyprexa is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age.
CLICK HERE to read the complete MedWatch 2010 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information.
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA’s Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.
CLICK HERE to read the complete MedWatch 2010 Safety summary including a link to the Drug Safety Communication.
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice.
FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.
The device separates the red blood cells from plasma to determine the patient’s hematocrit. These recalled devices were distributed from January, 1999 through November, 2009. Hospitals, clinics and laboratories who have the listed centrifuge/rotor combination should immediately stop using the plastic rotors and contact Hettich to have these affected rotors replaced with metal rotors. The centrifuges can be identified by reading the model number on the front of the instrument or the name tag on the rear of the centrifuge; the rotors have the model numbers 2076 or 2050 stamped on them.
CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the FDA recall and firm press release.
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy. The changes also include new safety information on dose adjustment for patients with moderate to severe hepatic impairment in label Section 5.11, stating: “Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities.”
Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
CLICK HERE to read the complete MedWatch 2010 Safety Summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information.
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions.
Inspections conducted in October 2009 of Nipro facilities found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate and will update the public if there are new developments.
Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation.
There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the product codes or catalog numbers noted in the FDA news release.
CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the FDA News Release.
