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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 05:43:41 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: January 31, 2008 |
The following new items were added to the CDRH web pages on January 30, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Class I Medical Device Recall: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 13:08:12 -0600 (CST)
Subject: Consumer Warning: Contaminated Cheese (Jan. 30)
Consumer Warning: Contaminated Cheese (Jan. 30)
Thu, 31 Jan 2008 11:51:00 -0600
Routine surveillance by the Indiana State Board of Animal Health's Dairy Division revealed high levels of staphylococcus aureus (or "staph") in several raw milk cheeses manufactured by Grassy Meadows dairy of Howe, Ind. Products of concern include, but are not limited to, Colby (lot no. 210317 and 19177), Jalapeno natural cheese (lot no. 2617, 21017 and 11017), "Homemade" cheese (lot no. 19267 and 19227), Monterey Jack (lot no. 18207 and 2937), and garlic pepper cheese (lot no. 19147). All are sold in wedges or blocks of various weights.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 15:41:21 -0600 (CST)
Subject: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) Recall - Medical Device Safety
AM2 PAT Inc. has recalled all lots and all sizes of its pre-filled heparin lock flush syringes and normal saline IV flush syringes after they were found to be contaminated with the bacteria Serratia marcescens, which resulted in patient bloodstream infections. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun.
You are subscribed to Medical Device Safety for U.S. Food & Drug Administration (FDA).
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 18:06:53 -0600 (CST)
Subject: FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications
FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications
Thu, 31 Jan 2008 16:54:00 -0600
The U.S. Food and Drug Administration today issued new information to health care professionals to alert them about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 13:04:52 -0600 (CST)
Subject: FDA MedWatch- NuCel Labs Eye Drops and Eye/Ear Wash- Nationwide Recall Because Of The Presence Of Bacteria And Particulate Matter
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NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/War Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries have been reported to date. There are no lot numbers or expiration dates on the products. Consumers who have the product should discontinue use of the product and return it to NuCel Lab. See the manufacturer's press release for return shipping information.
Read the complete 2008 MedWatch Safety Summary, including a link to the Manufacturer's Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#NuCel
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 13:13:00 -0600 (CST)
Subject: FDA MedWatch - October 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
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The October 2007 posting includes 49 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2007/oct07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2007/oct07.htm
In October 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Definity Vial for (perflutren lipid microsphere) Injectable Suspension For Intravenous Use
Elaprase (idursulfase) Solution For Intravenous Infusion
Erbitux (cetuximab) Solution for Intravenous Use
Soriatane (acitretin) Capsules
Aptivus (tipranavir) Capsules
Azithromycin for Injection For I.V. Infusion Only
DDAVP Injection (desmopressin acetate) 4 mcg/mL
DDAVP Nasal Spray (desmopressin acetate)
DDAVP Rhinal Tube (desmopressin acetate)
DDAVP Tablets (desmopressin acetate)
Inderal LA (propranolol hydrochloride) Long-Acting Capsules
Januvia (sitagliptin) Tablets
Lodine (etodolac capsules and tablets)
Prevpac (lansoprazole 30-mg capsules, amoxicillin 500-mg capsules, USP, and clarithromycin 500-mg tablets, USP)
ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] [Frozen Formulation]
ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live][Refrigerator-Stable Formulation]
Zithromax (azithromycin tablets and azithromycin for oral suspension)
Zmax (azithromycin extended release) for Oral Suspension
Cubicin (daptomycin for injection)
Dalmane (flurazepam hydrochloride) Capsules
Doral (quazepam tablets, USP)
Lexxel (enalapril maleate-felodipine ER) Tablets
Lymphazurin 1% (isosulfan blue) Aqueous Solution
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) For Vaginal Use Only
Rapamune (sirolimus) Oral Solution and Tablets
Renagel (sevelamer hydrochloride) Tablets For Oral Use
Vaseretic (enalapril maleate - hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Visken (pindolol) Tablets, USP
Zestoretic (lisinopril and hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jan 2008 13:41:37 -0600 (CST)
Subject: FDA MedWatch- Antiepileptic Drugs- FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation
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FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
Read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic
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