FDA Warning – Tarceva – Erlotinib Tablets

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.

Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN.

Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range.

New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva

Toy Recall – Lead found in “Faded Glory” Bracelet

Lead is still being found in many popular children’s toys and items. It is thankful that this is being discovered since exposure to lead can be very harmful to a child’s health.

July 10th the U.S. Consumer Product Safety Commission in agreement with Wal-Mart Stores Inc. of Bentonville, Arkansas announced a voluntary recall on the “Faded Glory” Lip Gloss, Locket, and Bracelet Sets sold exclusively at Wal-Mart across the nation.

High levels of lead were found in the lobster claw clasp located on the charm bracelet included in this set. The lobster claw clasp is used to close the bracelet around the wrist. If the clasp is ingested, it can cause serious health injuries and/or illnesses. No injuries or incidents have been reported at this time.

This “Faded Glory” set was manufactured in China and sold in Wal-Mart from May 2008 through June 2008 selling for about $6 each. If you are in possession of this item, discontinue any use of this item immediately and return it to Wal-Mart for a full refund.

If you have experienced any adverse side effects after using this product, contact an attorney from our firm that has knowledge of product liability and personal injury.