Archive | January 9, 2012

Urgent Notice from the FDA – Pain Medication Mis-Labeling!!

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk

Including the following products:

Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
Opana (oxymorphone hydrochloride) CII
Oxymorphone hydrochloride Tablets CII
PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
MORPHINE SULFATE Extended-Release Tablets CII
ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

[Posted 01/09/2012]

AUDIENCE: Pharmacy, Consumers

ISSUE: FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.

BACKGROUND: Opiates are potent medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists. Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.

RECOMMENDATION: FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: http://www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm286280.htm?source=govdelivery

[01/09/20121 – Public Health Advisory – FDA]

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A Little Help From My Friends

I am tired today.Fighting off a head cold and succeeding. Still yet I am not as thriving as I would like to be. This what it can be like living with a chronic illness of any kind.

I am not feeling as perky as I’d like either today. I woke up hurting more than usual, exhausted from broken sleep and was even feeling a bit down in the mouth. Before I get out of bed every morning I read. I read with a purpose. I read only things of a spiritual nature during this quiet time. This can encompass many different books, magazines and even pamphlets sent my way. I am a woman of deep faith but it one that is custom-made just for myself. I have many beliefs from many faiths, that all say the same thing to me but in different ways.

This morning I went to my Bible. There is a Psalm that I often turn to because it comforts this wild beast called chronic illness born sadness.

This beautiful poem is Psalm 139.  I’ve been thinking about its truths for me, for my own vessel of a body I live in.

Psalm 139

 {My favorite verses}

1 O Lord, you have examined my heart
and know everything about me.

2 You know when I sit down or stand up.
You know my thoughts even when I’m far away.

3 You see me when I travel
and when I rest at home.
You know everything I do.
4 You know what I am going to say
even before I say it, Lord.
5 You go before me and follow me.
You place your hand of blessing on my head.
6 Such knowledge is too wonderful for me,
too great for me to understand!

7 I can never escape from your Spirit!
I can never get away from your presence!
8 If I go up to heaven, you are there;
if I go down to the grave,[a] you are there.
9 If I ride the wings of the morning,
if I dwell by the farthest oceans,
10 even there your hand will guide me,
and your strength will support me.
11 I could ask the darkness to hide me
and the light around me to become night—
12 but even in darkness I cannot hide from you.
To you the night shines as bright as day.
Darkness and light are the same to you.

13 You made all the delicate, inner parts of my body
and knit me together in my mother’s womb.
14 Thank you for making me so wonderfully complex!
Your workmanship is marvelous—how well I know it.
15 You watched me as I was being formed in utter seclusion,
as I was woven together in the dark of the womb.
16 You saw me before I was born.
Every day of my life was recorded in your book.
Every moment was laid out
before a single day had passed.

17 How precious are your thoughts about me,[b] O God.
They cannot be numbered!
18 I can’t even count them;
they outnumber the grains of sand!
And when I wake up,
you are still with me!

©tjhelser 2012