FDA NEWS

FDA Warns About Risk of Wearing Medicated Patches During MRIs
Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.
Source: www.fda.gov

December 2008 Safety Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
Source: www.fda.gov

Patients Are Asking: Potentially Fatal Salmonella Infections from Pet Turtles
Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant d...
Source: www.accessdata.fda.gov

Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep
Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ...
Source: www.accessdata.fda.gov

Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review
FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris.
Source: www.fda.gov

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Source: www.fda.gov

Preventing Medical Errors: Preventing Dosing Errors with Alteplase
In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified. ISMP described a case of a patient in an i...
Source: www.accessdata.fda.gov

March 2009 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
Source: www.fda.gov

Zonisamide (marketed as Zonegran, and generics)
Treatment with zonisamide can cause metabolic acidosis in some patients.
Source: www.fda.gov