MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients with anemia caused by the chemotherapy treatment of the malignant disease and should only be used in accordance with its approved product labeling.

Read the complete MedWatch 2007 Safety summary, including a link to the Dear Healthcare Professional letter, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Aranesp

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Subject: FDA MedWatch - November 2006 Safety Labeling Changes posted on website Date: Friday, January 26, 2007 3:50 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Safety-related drug labeling changes for November 2006 were posted on the MedWatch website.

The November 2006 posting includes 26 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

The Summary page --

http://www.fda.gov/medwatch/SAFETY/2006/nov06_quickview.htm

-- provides drug names and a listing of the sections changed.

The Detailed view --

http://www.fda.gov/medwatch/SAFETY/2006/nov06.htm

-- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Dolophine Hydrochloride (methadone hydrochloride tablets, USP) Herceptin (trastuzumab) Diovan (valsartan) Tablets Diovan HCT (valsartan and hydrochlorothiazide, USP) Combination Tablets Humira (adalimumab) Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) Lexiva (fosamprenavir calcium) Tablets Mirapex (pramipexole dihydrochloride) Tablets

The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]:

Dolophine Hydrochloride (methadone hydrochloride tablets, USP) Lexiva (fosamprenavir calcium) Tablets Mirapex (pramipexole dihydrochloride) Tablets Tamiflu (oseltamivir phosphate) Oral Suspension and Capsules Videx (didanosine)

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Subject: ***SPAM***FDA - MedWatch - Liviro3 Dietary Supplement Recall Date: Thursday, January 25, 2007 4:10 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company's dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction. Liviro3 is not approved by FDA to treat this condition. Tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers who have Liviro3 should stop using it immediately and contact their physician if they experience any problems that may be related to taking this product.

Read the complete MedWatch 2007 Safety summary, including links to the Manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Liviro3

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Subject: FDA MedWatch: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal Date: Friday, January 12, 2007 6:11 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.

Read the complete MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Healthcare Professional letter, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Composix

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Subject: Potential SPAM:FDA MedWatch: deaths in infants less than 12 months associated with cough/cold medications Date: Friday, January 12, 2007 4:15 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in US infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years.

Read the complete MedWatch 2007 Safety summary, including a link to the MMWR article, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#coughcold

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Subject: FDA MedWatch - October 2006 Safety Labeling Changes posted on website Date: Thursday, January 11, 2007 12:52 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

On 12/14/2006, safety-related drug labeling changes for October 2006 were posted on the MedWatch website.

The October 2006 posting includes 47 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

The Summary page --

http://www.fda.gov/medwatch/SAFETY/2006/oct06_quickview.htm

-- provides drug names and a listing of the sections changed.

The Detailed view --

http://www.fda.gov/medwatch/SAFETY/2006/oct06.htm

-- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Avastin (bevacizumab) for Intravenous Use ChloraPrep with Tint (2% chlorhexidine gluconate (w/v) topical solution) 26-mL Applicator Coumadin Tablets (warfarin sodium tablets, USP) Crystalline Coumadin for Injection (warfarin sodium for injection, USP) Remicade (infliximab) for IV Injection Seroquel (quetiapine fumarate) Tablets Allegra (fexofenadine hydrochloride) Tablets and Oral Suspension Opana (oxymorphone hydrochloride) Injection 0.9% Sodium Chloride Irrigation, USP Vicoprofen (hydrocodone bitartrate and ibuprofen tablets) Depacon (valproate sodium injection) Depakene (valproic acid capsules and oral solution, USP) Depakote (divalproex sodium) Delayed-Release Tablets Depakote ER (divalproex sodium) Extended-Release Tablets Depakote (divalproex sodium coated particles in capsules) Sprinkle Capsules Heparin Sodium Injection, USP Hep-Lock (heparin lock flush solution, USP) Hep-Lock U/P Preservative-Free (heparin lock flush solution, USP) Strattera (atomoxetine HCl) Capsules Taxotere (docetaxel) Injection Concentrate Vytorin (ezetimibe/simvastatin tablets)

The following drugs had modification to patient information labeling [either Medication Guide or Patient Package Insert]:

Coumadin Tablets (warfarin sodium tablets, USP) Crystalline Coumadin for Injection (warfarin sodium for injection, USP) Remicade (infliximab) for IV Injection Seroquel (quetiapine fumarate) Tablets Vicoprofen (hydrocodone bitartrate and ibuprofen tablets) Strattera (atomoxetine HCl) Capsules Taxotere (docetaxel) Injection Concentrate Vytorin (ezetimibe/simvastatin tablets) Avandaryl (rosiglitazone maleate and glimepiride) Tablets Byetta (exenatide injection) Factive (gemifloxacin mesylate) Tablets Flovent HFA (fluticasone propionate) Inhalation Aerosol Neulasta (pegfilgrastim) Neupogen (filgrastim) Hepsera (adefovir dipivoxil) Tablets Yaz (drospirenone and ethinyl estradiol) Tablets Humatrope (somatropin [rDNA origin] for Injection) Intron A (interferon alfa-2b, recombinant) for Injection Topamax (topiramate) Tablets Topamax (topiramate capsules) Sprinkle Capsules

 

 

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Subject: FDA - MedWatch - January 2007 FDA Patient Safety News video program available Date: Friday, January 05, 2007 3:32 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant new product approvals, recalls and safety alerts, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the January 2007 edition include:

FDA Approves New Treatment for Type 2 Diabetes FDA has approved the first in a new class of drugs called DPP-4 inhibitors for treating type 2 diabetes... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#1

Cardiovascular Risk with Erythropoietic Agents FDA is warning health care professionals that patients treated with erythropoietic agents may have an increased risk of cardiovascular complications if the dosing recommendations in the labeling are exceeded... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#2 Caution on Neuropsychiatric Events with Tamiflu Roche Laboratories has alerted healthcare professionals about neuropsychiatric events that have occurred in influenza patients taking Tamiflu... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#3 Fatal Overdoses with Effexor Wyeth is alerting healthcare professionals about the risk of fatal overdoses occurring in patients taking Effexor and Effexor XR... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#4 Change in iPledge Program for Isotretinoin The iPledge program is a risk management program to reduce the possibility of fetal exposure to the acne drug isotretinoin, which can cause serious birth defects if taken during pregnancy... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#5 Warning on Avastin and Brain-Capillary Leaks Genentech is alerting healthcare professionals about two new safety issues for Avastin, a drug used to treat certain colorectal and lung cancers... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#6 Preventing Dosage Errors with Diastat AcuDial The Institute for Safe Medication Practices recently warned about potentially fatal dosing errors when using Diastat AcuDial... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#7

What Women Need to Know about Silicone Gel-Filled Breast Implants Patients may be asking about FDA's recent decision to approve the marketing of certain silicone gel-filled breast implants... http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#8

For more FDA Patient Safety News, visit http://www.fda.gov/psn. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm

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Subject: FDA - MedWatch - Tamiflu (oseltamivir phosphate) - Correction of dosing chart for the Tamiflu Oral Suspension for Prophylaxis of Influenza in Pediatric Patients Date: Thursday, January 04, 2007 4:16 PM

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Roche notified healthcare professionals of a correction to a Dear Healthcare professional letter issued on November 13, 2006. The original letter referenced changes to the PRECAUTIONS Section of prescribing information for Tamiflu about post marketing reports of self-injury and delirium with the use of Tamiflu in patients with influenza. The prescribing information that accompanied the letter contained an incorrect dosing chart for the Standard Dosage of Tamiflu Oral Suspension for prophylaxis of influenza in pediatric patients. The chart incorrectly specified twice daily instead of once daily dosing under "Recommended Dose" for 10 days. Healthcare professionals should discard the incorrect version of the package insert included in the November 13 mailing and refer to the new dosing chart included in the December 26 letter.

Read the complete MedWatch Safety summary, including a link to the manufacturer's Dear Healthcare Professional Letter at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Tamiflu

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