Food and Drug Adminstration (FDA): MedWatch

Over The Counter Cough and Cold Medications

10/09/2008 03:40 PM
Product labels being modified to state "do not use" in children under 4 years of age.

Tiotropium (marketed as Spiriva HandiHaler)

10/07/2008 10:32 AM
UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics.

Nebion HLX-8 Magnetic Resonance Device

10/03/2008 03:10 PM
Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit

10/02/2008 09:50 AM
Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump.

October 2008 Patient Safety News

10/01/2008 04:55 PM
Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Statin drugs and amyotrophic lateral sclerosis (ALS)

09/30/2008 10:00 AM
New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS.

Epoetin alfa

09/26/2008 10:10 AM
Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo.

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%

09/23/2008 01:35 PM
Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process.

Tarceva (erlotinib)

09/23/2008 01:35 PM
Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.

Infant Formula Manufactured in China Contaminated With Melamine

09/22/2008 10:25 AM
UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves.

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