Drug Safety

... a video in that format. Segment RealPlayer Windows Media Show #100, July 2010 View complete video of this show New Cellular Immunotherapy for Advanced Prostate Cancer Warning on Liver Injury with Propylthiouracil Medication Guide Required for Vivitrol Certain AQUA+FLEX Humidifiers Recalled Recall of Shiley Cuffed Tracheostomy Tubes Using External Infusion Pumps Safely Parent Errors in Measuring Childrenâ €™ s Doses Warning on Swallowing Benadryl Topical Gel Warning about Lipodissolve Products Read full transcript of this show Show #99, June 2010 View complete video of this show New Formulation for OxyContin First Absorbable Sealant ... Bed Safety Antiepileptic Drugs and Suicidality Increased Mortality in Liver Transplant Patients Treated with Rapamune Certain Skin Sanitizers / Protectants Contaminated Intranasal Zinc May Cause Loss of Smell Read full transcript of this show Show #88, July 2009 View complete video of this show Warning on Testosterone Gel Products Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps New Safety Information on Tarceva Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products Safety Problems with Denture Cleansers Avoiding Infant Burns from Heel Warmers Avoiding Errors with Lamictal Starter Kits Warning on Accidental Ingestion of Benadryl Topical Gel Read full transcript ...

... :// www.accessdata.fda.gov / cdrh_docs / psn / video / podcast / FDA-SHOW100.M4V In this broadcast: New Cellular Immunotherapy for Advanced Prostate Cancer-Warning on Liver Injury with Propylthiouracil-Medication Guide Required for Vivitrol-Certain AQUA+FLEX Humidifiers Recalled-Recall of Shiley Cuffed Tracheostomy Tubes-Using External Infusion Pumps Safely-Parent Errors in Measuring Children? s Doses-Warning on Swallowing Benadryl Topical Gel-Warning about Lipodissolve Products Broadcast #99, Jun 2010 Tue, 01 Jun 2010 04: 00: 00 GMT http :// www.accessdata.fda.gov / cdrh_docs / ... Contaminated-Intranasal Zinc May Cause Loss of Smell Broadcast #88, Jul 2009 Wed, 01 Jul 2009 04: 00: 00 GMT http :// www.accessdata.fda.gov / cdrh_docs / psn / video / podcast / FDA-SHOW88.M4V In this broadcast: Warning on Testosterone Gel Products-Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps-New Safety Information on Tarceva-Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products-Safety Problems with Denture Cleansers-Avoiding Infant Burns from Heel Warmers-Avoiding Errors with Lamictal Starter Kits-Warning on Accidental Ingestion of Benadryl Topical ...

... and Therapeutic Biological Products Product Name Date Issued / Updated Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand) 09 / 10 / 2009 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels-Incorrect Packaging 12 / 09 / 2009 Atlas Operations, Inc: Recall of Sexual Enhancement Products 04 / 14 / 2010 Dietary Supplements Sold on Internet by Bodybuilding.com 11 / 03 / 2009 Body Building Products (Marketed as Containing Steroids or Steroid-like Substances) 07 / 28 / 2009 Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc ( ... with Attention-Deficit / Hyperactivity Disorder-Communication about an Ongoing Safety Review 06 / 15 / 2009 Steam Dietary Supplement 08 / 24 / 2009 Tamiflu (oseltamivir) for Oral Suspension 10 / 16 / 2009 Tarceva (erlotinib) May 2009 05 / 08 / 2009 Testosterone gel products (AndroGel 1 %and Testim 1 %) 05 / 07 / 2009 Topical Anesthetics 01 / 16 / 2009 Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 08 / 31 / 2009 ...

... down" buttons are working, by verifying that they get a confirmation signal after each pump operation. For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095. Additional Information: Disetronic Website. ACCU-CHEK Spirit Insulin Pump System â €“ Important Recall Information. April 30, 2009. http :// www.disetronic-usa.com / dstrnc_us / rewrite / generalContent / en_US / article / DCM_general_article_125.htm Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps ... FDA Patient Safety News: Show #88, July 2009 Warning on Testosterone Gel Products FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription, are used to treat men who don't produce sufficient testosterone. The products are Testim 1 %, which is applied to the shoulders and upper arms, and AndroGel 1 %, which can ...

... down" buttons are working, by verifying that they get a confirmation signal after each pump operation. For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095. Additional Information: Disetronic Website. ACCU-CHEK Spirit Insulin Pump System â €“ Important Recall Information. April 30, 2009. FDA MedWatch Safety Alert. Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump. May 1, 2009. Return to Top Return to FDA Patient Safety News Home New Safety Information on Tarceva New information has been added to the labeling of the ... Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-FDA Home Show #88, July 2009 Show #88, July 2009 View a video of this entire show. Recalls and Safety Alerts Warning on Testosterone Gel Products FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription ...

... down" buttons are working, by verifying that they get a confirmation signal after each pump operation. For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095. Additional Information: Disetronic Website. ACCU-CHEK Spirit Insulin Pump System â €“ Important Recall Information. April 30, 2009. http :// www.disetronic-usa.com / dstrnc_us / rewrite / generalContent / en_US / article / DCM_general_article_125.htm Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps ... FDA Patient Safety News: Show #88, July 2009 Warning on Testosterone Gel Products FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription, are used to treat men who don't produce sufficient testosterone. The products are Testim 1 %, which is applied to the shoulders and upper arms, and AndroGel 1 %, which can ...

... down" buttons are working, by verifying that they get a confirmation signal after each pump operation. For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095. Additional Information: Disetronic Website. ACCU-CHEK Spirit Insulin Pump System â €“ Important Recall Information. April 30, 2009. FDA MedWatch Safety Alert. Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump. May 1, 2009. Return to Top Return to FDA Patient Safety News Home New Safety Information on Tarceva New information has been added to the labeling of the ... Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-FDA Home Show #88, July 2009 Show #88, July 2009 View a video of this entire show. Recalls and Safety Alerts Warning on Testosterone Gel Products FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription ...

... , you should read the letter from Aventis, which describes in detail the periodic lab tests that should be performed on these patients. Additional Information: MedWatch Safety Alert-ARAVA (leflunomide). Return to Top Return to FDA Patient Safety News Home Recall of Certain ComfortGelÂ ® Nasal Masks Respironics, Inc. is recalling some of the company's ComfortGelÂ ® nasal masks. The masks are used with CPAP devices to treat patients with obstructive sleep apnea or respiratory failure. The recalled masks were distributed from September 5 through September 15, 2003 ... of this entire show. New Medical Products New Drug for Advanced Prostate Cancer FDA recently approved a new drug to treat advanced prostate cancer for patients who have no alternative therapy. The drug, called Plenaxis, is a gonadotropin-releasing hormone antagonist that lowers testosterone levels. Plenaxis, or abarelix for injectable suspension, is made by Praecis Pharmaceuticals, Incorporated. Plenaxis is approved to treat the symptoms of advanced prostate cancer in men who can't take other hormone therapies and refuse surgical castration. A clinical trial of 81 such patients showed that these men ...