MedWatch - December 2007 Monthly Safety Labeling Changes Posted on MedWatch Website

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Adverse warnings include Ambien, Effexor and Levoquin . . . You may want to check this list.Thanks Carolyn.Rogene---------------------------------------------------------- Forwarded Message ----From: "carwol@..." <carwol@...>

Hope you all will be able to check list for any medications you/family?friends might be taking. Have had letters from 2 sisters who found domr of their medicines on the last list forwarded..They had had no warning from their doctors --who, admittedly, are very busy...Carolyn=============Date: Mon, 24 Mar 2008 14:31:24 -0500 (CDT)From: "U.S. Food & Drug Administration (FDA)" <fda@...>Subject: MedWatch - December 2007 Monthly Safety Labeling Changes Posted on MedWatch Websitecarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The December 2007 posting includes 43 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/dec07_quickview.htm The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2007/dec07.htm In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Carbatrol (carbamazepine) Extended-Release Capsules Equetro (carbamazepine) Extended-Release Capsules Omniscan (gadodiamide) Injection for Intravenous Use Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension Tegretol-XR (carbamazepine extended-release tablets) Ambien CR (zolpidem tartrate extended-release) Tablets AndroGel (testosterone gel) 1% Dostinex (cabergoline) Tablets Aredia (pamidronate disodium for injection) Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets) Biaxin Granules (clarithromycin for oral suspension, USP) DepoDur (morphine sulfate extended-release liposome injection) Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Exjade (deferasirox) Tablets for Oral Suspension Heparin Sodium Injection, USP Heparin Sodium Injection, USP (porcine) 5,000 U/mL Hepsera (adefovir dipivoxil) Tablets Invega (paliperidone) Extended-Release Tablets Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use Monodox (doxycycline monohydrate) Capsules Sonata (zaleplon) Capsules ________________________________________________________________________Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service.govdelivery.com/service/user.html?code=USFDA ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@.... This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ http://www.fda.gov/ ]. FDA [ http://www.fda.gov/ ] HHS [ http://www.hhs.gov/ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420=============

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Rogene, honey, thank you to all of my Angels for the good wishes. I am so very sick, but I wanted to let you all know that I will pray for everyone.

Honey, I am on Levaquin, and you have it on your list of drugs that could make me sicker. What thinks thee?

I must go back to bed...love you all so much...Lea

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MedWatch - December 2007 Monthly Safety Labeling Changes Posted onMedWatch Websitecarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The December 2007 posting includes 43 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/dec07_quickview.htm The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2007/dec07.htm In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Carbatrol (carbamazepine) Extended-Release Capsules Equetro (carbamazepine) Extended-Release Capsules Omniscan (gadodiamide) Injection for Intravenous Use Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension Tegretol-XR (carbamazepine extended-release tablets) Ambien CR (zolpidem tartrate extended-release) Tablets AndroGel (testosterone gel) 1% Dostinex (cabergoline) Tablets Aredia (pamidronate disodium for injection) Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets) Biaxin Granules (clarithromycin for oral suspension, USP) DepoDur (morphine sulfate extended-release liposome injection) Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Exjade (deferasirox) Tablets for Oral Suspension Heparin Sodium Injection, USP Heparin Sodium Injection, USP (porcine) 5,000 U/mL Hepsera (adefovir dipivoxil) Tablets Invega (paliperidone) Extended-Release Tablets Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use Monodox (doxycycline monohydrate) Capsules Sonata (zaleplon) Capsules ________________________________________________________________________Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service.govdelivery.com/service/user.html?code=USFDA ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact supportgovdelivery. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ http://www.fda.gov/ ]. FDA [ http://www.fda.gov/ ] HHS [ http://www.hhs.gov/ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420=============

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Hi Ladies:

Thank you for your good wishes. Our family doctor called this morning because he is concerned about Lea. He has now put her on what he considers to be a better drug for pneumonia, keeping in mind that she has a severely compromised immune system. I have forgotten the name of the drug, but I will let you know what it is as soon as I have picked it up later today.

She must stay in bed for the time being. Our doctor said that he might come by later today to check Lea's vital signs and general condition.

Incidentally, we had an interesting experience when we were in ER all that time Saturday night. Lea told the RN who was seeing to her about her breast implants. The RN responded that she had seen a young woman who had been in just a few days previously who had been terribly sick from an infection in her recently implanted breast implants. The young woman told the RN that she had not had them long, but was going to get them out right away if this was what they were going to do her. On it goes....

Cheers

MedWatch - December 2007 Monthly Safety Labeling Changes Posted onMedWatch Websitecarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The December 2007 posting includes 43 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/dec07_quickview.htm The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2007/dec07.htm In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Carbatrol (carbamazepine) Extended-Release Capsules Equetro (carbamazepine) Extended-Release Capsules Omniscan (gadodiamide) Injection for Intravenous Use Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension Tegretol-XR (carbamazepine extended-release tablets) Ambien CR (zolpidem tartrate extended-release) Tablets AndroGel (testosterone gel) 1% Dostinex (cabergoline) Tablets Aredia (pamidronate disodium for injection) Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets) Biaxin Granules (clarithromycin for oral suspension, USP) DepoDur (morphine sulfate extended-release liposome injection) Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Exjade (deferasirox) Tablets for Oral Suspension Heparin Sodium Injection, USP Heparin Sodium Injection, USP (porcine) 5,000 U/mL Hepsera (adefovir dipivoxil) Tablets Invega (paliperidone) Extended-Release Tablets Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use Monodox (doxycycline monohydrate) Capsules Sonata (zaleplon) Capsules ________________________________________________________________________Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service.govdelivery.com/service/user.html?code=USFDA ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact supportgovdelivery. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ http://www.fda.gov/ ]. FDA [ http://www.fda.gov/ ] HHS [ http://www.hhs.gov/ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420=============

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Lea,Levoquin is a very powerful drug to be used only when absolutely necessary.Right now, it's absolutely necessary you take it. . . Just be sure to take probiotic supplements and eat probiotic foods while you're taking it. . . And, take Magnesium at a different time that you take Levoquin. From what I read, it appears it binds with Magnesium and pulls it out of your body.Please take care of yourself so you can get well really soon.Hugs and prayers,Rogene MedWatch - December 2007 Monthly Safety Labeling Changes Posted onMedWatch Websitecarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The December 2007 posting includes 43 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/ dec07_quickview. htm The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda. gov/medwatch/ safety/2007/ dec07.htm In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Carbatrol (carbamazepine) Extended-Release Capsules Equetro (carbamazepine) Extended-Release Capsules Omniscan (gadodiamide) Injection for Intravenous Use Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension Tegretol-XR (carbamazepine extended-release tablets) Ambien CR (zolpidem tartrate extended-release) Tablets AndroGel (testosterone gel) 1% Dostinex (cabergoline) Tablets Aredia (pamidronate disodium for injection) Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets) Biaxin Granules (clarithromycin for oral suspension, USP) DepoDur (morphine sulfate extended-release liposome injection) Derma-Smoothe/ FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Exjade (deferasirox) Tablets for Oral Suspension Heparin Sodium Injection, USP Heparin Sodium Injection, USP (porcine) 5,000 U/mL Hepsera (adefovir dipivoxil) Tablets Invega (paliperidone) Extended-Release Tablets Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use Monodox (doxycycline monohydrate) Capsules Sonata (zaleplon) Capsules ____________ _________ _________ _________ _________ _________ _________ ______Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service. govdelivery. com/service/ user.html? code=USFDA ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery .com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ http://www.fda. gov/ ]. FDA [ http://www.fda. gov/ ] HHS [ http://www.hhs. gov/ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420= ========= ===