Re: Drug Safety Labeling Changes for 47 drugs now available on web

[Guest guest]

About a year ago, my mom was put on the Duragesic patches. She put one on early in the day, went to sleep that night, and never woke up the next morning. It was 1 PM, when my aunt called to say that she couldn't wake her. I called an ambulance, and she was taken to the ER. Her O2 sats were in the low 80's. She was in the hospital a week, having hallucinations. She had to be restrained, when she became combative. She was looking into a lawsuit against the maker, right before she got sick in March. Shirley wrote: The February 2008 posting includes 47 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/2008/feb08_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/2008/feb08.htm In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir

disoproxil fumarate 300 mg) Tablets Cleocin Sterile Solution (clindamycin injection) Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution Duragesic (fentanyl) Transdermal System Emsam (selegiline transdermal system) Patches Fentora (fentanyl buccal tablet) Lincocin (lincomycin) Injection Asmanex Twisthaler (mometasone furoate inhalation powder) Abilify (aripiprazole) Tablets and Oral Solution Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets Abilify (aripiprazole) Injection for Intramuscular Use Only Avastin (bevacizumab) for Intravenous Use Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP) Cortenema (hydrocortisone retention enema) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Eryc (erythromycin delayed-release capsules, USP) Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution Geocillin (carbenicillin indanyl sodium) Tablets Halcion (triazolam tablets) Janumet (sitagliptin/metformin HCl) Tablets Letairis (ambrisentan) Tablets Premarin Intravenous (conjugated estrogens, USP) for injection Remodulin (treprostinil sodium) Injection Restoril (temazepam) Capsules Reyataz (atazanavir sulfate) Capsules Sensipar (cinacalcet) Tablets Ultram ER (tramadol HCl) Extended-Release Tablets Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Vibra-Tabs (doxycycline hyclate tablets, USP) Film Co This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). Blessings, Trista

Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

[Guest guest]

Shirley, I do hope that your mother has recovered.

Thank you for posting this. I subscribe to MedWatch

and had read about these warnings before I left for the

day. I am so glad that they were able to revive your

mother. Love to you and to her, and. . .

to all in our group,

n

Re: Drug Safety Labeling Changes for 47 drugs now available on web

About a year ago, my mom was put on the Duragesic patches. She put one on early in the day, went to sleep that night, and never woke up the next morning. It was 1 PM, when my aunt called to say that she couldn't wake her. I called an ambulance, and she was taken to the ER. Her O2 sats were in the low 80's. She was in the hospital a week, having hallucinations. She had to be restrained, when she became combative. She was looking into a lawsuit against the maker, right before she got sick in March. Shirley <shirleyann64@ att.net> wrote:

The February 2008 posting includes 47 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/2008/ feb08_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/2008/ feb08.htm

In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets

Cleocin Sterile Solution (clindamycin injection)

Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

Duragesic (fentanyl) Transdermal System

Emsam (selegiline transdermal system) Patches

Fentora (fentanyl buccal tablet)

Lincocin (lincomycin) Injection

Asmanex Twisthaler (mometasone furoate inhalation powder)

Abilify (aripiprazole) Tablets and Oral Solution

Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

Avastin (bevacizumab) for Intravenous Use

Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)

Cortenema (hydrocortisone retention enema)

Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets

Eryc (erythromycin delayed-release capsules, USP)

Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution

Geocillin (carbenicillin indanyl sodium) Tablets

Halcion (triazolam tablets)

Janumet (sitagliptin/ metformin HCl) Tablets

Letairis (ambrisentan) Tablets

Premarin Intravenous (conjugated estrogens, USP) for injection

Remodulin (treprostinil sodium) Injection

Restoril (temazepam) Capsules

Reyataz (atazanavir sulfate) Capsules

Sensipar (cinacalcet) Tablets

Ultram ER (tramadol HCl) Extended-Release Tablets

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup

Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Co

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

Blessings, Trista

Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

[Guest guest]

It was my mom. She recovered from this, but passed April 29th, this yr, and the young age of 58. Tristamarion j rojas wrote: Shirley, I do hope that your mother has recovered. Thank you for posting this. I subscribe to MedWatch and had read about these warnings before I left for the day. I am so glad that they were able to revive your mother. Love to you and to her, and. . . to all in our group, n Re: Drug Safety Labeling Changes for 47 drugs now available on web About a year ago, my mom was put on the Duragesic patches. She put one on early in the day, went to sleep that night, and never woke up the next morning. It was 1 PM, when my aunt called to say that she couldn't wake her. I called an ambulance, and she was taken to the ER. Her O2 sats were in the low 80's. She was in the hospital a week, having hallucinations. She had to be restrained, when she became combative. She was looking into a lawsuit against the maker, right before she got sick in March. Shirley <shirleyann64@ att.net> wrote: The February 2008 posting includes 47 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/2008/ feb08_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/2008/ feb08.htm In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets Cleocin Sterile Solution (clindamycin injection) Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

Duragesic (fentanyl) Transdermal System Emsam (selegiline transdermal system) Patches Fentora (fentanyl buccal tablet) Lincocin (lincomycin) Injection Asmanex Twisthaler (mometasone furoate inhalation powder) Abilify (aripiprazole) Tablets and Oral Solution Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets Abilify (aripiprazole) Injection for Intramuscular Use Only Avastin (bevacizumab) for Intravenous Use Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP) Cortenema (hydrocortisone retention enema) Doryx (doxycycline

hyclate) Capsule, Delayed Release Pellets Eryc (erythromycin delayed-release capsules, USP) Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution Geocillin (carbenicillin indanyl sodium) Tablets Halcion (triazolam tablets) Janumet (sitagliptin/ metformin HCl) Tablets Letairis (ambrisentan) Tablets Premarin Intravenous (conjugated estrogens, USP) for injection Remodulin (treprostinil sodium) Injection Restoril (temazepam) Capsules Reyataz (atazanavir sulfate) Capsules Sensipar (cinacalcet) Tablets Ultram ER (tramadol HCl) Extended-Release

Tablets Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Vibra-Tabs (doxycycline hyclate tablets, USP) Film Co This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). Blessings, Trista Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance. Blessings, Trista Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

[Guest guest]

Thanks. I read that the patches release too much med, when used on hot blooded people, or if using an electric blanket. I am scared to try each new med I'm prescribed. Anne Whitworth wrote: I'm sorry about your Mom - it is a good example of why we have to be careful - I am a firm believer in herbs and vitamens - I was considerably worse when I was on a lot of prescribed medications - having a rough go with things this spring - but I will live - if I have to take it (meds) I will

and get off as soon as I can Re: Drug Safety Labeling Changes for 47 drugs now available on web About a year ago, my mom was put on the Duragesic patches. She put one on early in the day, went to sleep that night, and never woke up the next morning. It was 1 PM, when my aunt called to say

that she couldn't wake her. I called an ambulance, and she was taken to the ER. Her O2 sats were in the low 80's. She was in the hospital a week, having hallucinations. She had to be restrained, when she became combative. She was looking into a lawsuit against the maker, right before she got sick in March. Shirley <shirleyann64att (DOT) net> wrote: The February 2008 posting includes 47 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/2008/feb08_quickview.htm The Detailed View Page identifies safety labeling sections and s! ubsections 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/2008/feb08.htm In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: Atripla (efavirenz 600 mg/emtricitabi! ne 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets Cleocin Sterile Solution (clindamycin injection) Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution Duragesic (fentanyl) Transdermal System Emsam (selegiline transdermal system) Patches Fentora (fentanyl buccal tablet)

Lincocin (lincomycin) Injection Asmanex Twisthaler (mometasone furoate inhalation powder) Abilify (aripiprazole) Tablets and Oral Solution Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets Abilify (aripiprazole) Injection for Intramuscular Use Only Avastin (bevacizumab) for Intravenous Use Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP) Cortenema (hydrocortisone retention enema) Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets Eryc (erythromycin delayed-release capsules, USP) Erythrocin Lactobinate (erythromycin lactobionate) Injection,

Powder, Lyophilized, For Solution Geocillin (carbenicillin indanyl sodium) Tablets Halcion (triazolam tablets) Janumet (sitagliptin/metformin HCl) Tablets Letairis (ambrisentan) Tablets Premarin Intravenous (conjugated estrogens, USP) for injection Remodulin (treprostinil sodium) Injection Restoril (temazepam) Capsules Reyataz (atazanavir sulfate) Capsules Sensipar (cinacalcet) Tablets Ultram ER (tramadol HCl) Extended-Release Tablets Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup Vibramycin Hyclate (doxycycline hyclate capsules,

USP) Capsules Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Vibra-Tabs (doxycycline hyclate tablets, USP) Film Co This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). Blessings, Trista Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance. No virus found in this incoming message.Checked by AVG. Version: 8.0.100 / Virus Database: 270.4.1/1514 - Release Date: 6/23/2008 7:17 AM No virus found in this outgoing message.Checked by AVG. Version: 8.0.100 / Virus Database: 270.4.1/1514 - Release Date: 6/23/2008 7:17

AMBlessings, Trista Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

[Guest guest]

that's why I have a herbalist and both of my sister check out meds before I take them - you can't be too careful

Re: Drug Safety Labeling Changes for 47 drugs now available on web

About a year ago, my mom was put on the Duragesic patches. She put one on early in the day, went to sleep that night, and never woke up the next morning. It was 1 PM, when my aunt call! ed to say that she couldn't wake her. I called an ambulance, and she was taken to the ER. Her O2 sats were in the low 80's. She was in the hospital a week, having hallucinations. She had to be restrained, when she became combative. She was looking into a lawsuit against the maker, right before she got sick in March. Shirley <shirleyann64att (DOT) net> wrote:

The February 2008 posting includes 47 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.fd a.gov/medwatch/SAFETY/2008/feb08_quickview.htm

The Detailed View Page identifies safety labeling sections and s! ubsections 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/2008/feb08.htm

In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Atripla (efavirenz 600 mg/emtricitabi! ne 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets

Cleocin Sterile Solution (clindamycin injection)

Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

Duragesic (fentanyl) Transdermal System

Emsam (selegiline transdermal system) Patches

Fentora (fentanyl buccal tablet)

Lincocin (lincomycin) Injection

Asmanex Twisthaler (mometasone furoate inhalation powder)

Abilify (aripiprazole) Tablets and Oral Solution

Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

Avastin (bevacizumab) for Intravenous Use

Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)

Cortenema (hydrocortisone retention enema)

Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets

Eryc (erythromycin delayed-release capsules, USP)

Erythrocin Lactobinate (erythromycin lact! obionate) Injection, Powder, Lyophilized, For Solution

Geocillin (carbenicillin indanyl sodium) Tablets

Halcion (triazolam tablets)

Janumet (sitagliptin/metformin HCl) Tablets

Letairis (ambrisentan) Tablets

Premarin Intravenous (conjugated estrogens, USP) for injection

Remodulin (treprostinil sodium) Injection

Restoril (temazepam) Capsules

Reyataz (atazanavir sulfate) Capsules

Sensipar (cinacalcet) Tablets

Ultram ER (tramadol HCl) Extended-Release Tablets

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup

Vibramycin Hyclate (doxycyclin! e hyclate capsules, USP) Capsules

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Co

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

Blessings, Trista

Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

No virus found in this incoming message.Checked by AVG. Version: 8.0.100 / Virus Database: 270.4.1/1514 - Release Date: 6/23/2008 7:17 AM

No virus found in this outgoing message.Checked by AVG. Version: 8.0.100 / Virus Database: 270.4.1/1514 - Release Date: 6/23/2008 7:17 AM

Blessings, Trista

Christians who stand strong are like flowers; the more you crush them, the stronger the fragrance.

No virus found in this incoming message.Checked by AVG. Version: 8.0.101 / Virus Database: 270.4.1/1516 - Release Date: 6/24/2008 7:53 AM

No virus found in this outgoing message.

Checked by AVG.

Version: 8.0.101 / Virus Database: 270.4.1/1516 - Release Date: 6/24/2008 7:53

AM