Archive for January, 2007

FDA Public Health Notification: Precautions in Using the Reintroduced Vapotherm® 2000i [Respiratory Gas Humidifier] System

Vapotherm, Inc. has reintroduced the 2000i [Respiratory Gas Humidifier] System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures.
Original post by Google Inc.

Recalls and Safety Alerts: Avoiding Accidental Overdoses when Methadone is Prescribed for Pain

FDA has issued a Public Health Advisory cautioning practitioners about avoiding overdoses when they are prescribing methadone or managing patients taking this drug. Since the 1970s, methadone has been primarily used in treating drug abuse, but now i…
Original post by Google Inc.

Recalls and Safety Alerts: Delayed Onset of Heparin-induced Thrombocytopenia

FDA is alerting healthcare professionals that the onset of heparin-induced thrombocytopenia (HIT) can be delayed in patients who had previously been treated with heparin sodium injection.
HIT results from an irreversible aggregation of platelets…
Original post by Google Inc.

Recalls and Safety Alerts: Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

FDA’s Medwatch program allows health care professionals and consumers to report to the FDA serious problems with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify importan…
Original post by Google Inc.

Recalls and Safety Alerts: Cardiac Events with Gleevec

Novartis is notifying healthcare professionals about new precautions for Gleevec (imatinib mesylate). Gleevec is used to treat certain patients with chronic myeloid leukemia and gastrointestinal stromal tumors.
A recent article published in Natu…
Original post by Google Inc.

Preventing Medical Errors: Avoiding Burns from Electrodes and Cables during MRI Exams

A recent FDA article in Nursing2006 describes second and third degree burns in patients undergoing MRI exams while they were wearing ECG electrodes and cables. Many of these burns were discovered only after the exam was over and some were severe eno…
Original post by Google Inc.

Preventing Medical Errors: Possible Dosing Errors with the OptiClik Insulin Injection Device

A recent report from the Institute for Safe Medication Practices points out a potential problem in using the OptiClik injection pen, which administers Lantus or Apidra insulin. ISMP says that practitioners or patients could administer the wrong dose…
Original post by Google Inc.

Preventing Medical Errors: Dangerous Use of Saline Flush Syringes

The Institute for Safe Medication Practices recently alerted health professionals about the danger of using pre-filled saline flush syringes to reconstitute medications. In this process the practitioner first discards any unneeded saline from the sy…
Original post by Google Inc.

FDA Warns Obesity Doctor Over Implants (RedNova) WASHINGTON - A

FDA Warns Obesity Doctor Over Implants (RedNova) WASHINGTON - A Los Angeles-area doctor who lent his name to a type of stomach-shrinking surgery failed to obtain the full informed consent of 175 patients implanted with an experimental medical device, according to a federal warning letter released Tuesday. Dr. Mathias A.L.
Original post by News Editor

FDA Approvals - FDA Revamps Process for Safety of Drugs After Approval (Washington

FDA Revamps Process for Safety of Drugs After Approval (Washington Post) The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.
Ranbaxy Gains FDA Approval to Market Amoxicillin and Clavulanate Potassium for Oral […]