This information was sent out by Ken Eutenier from www.fibrohugs.com and called to my attention by Pattie Caprio, founder of the Million Letter Campaign www.fms-help.com/letter.htm Please read below--many with FMS/CFIDS are taking these drugs! - Dominie
1. Major Drug Recall
2.
Duragesic and the generic product WARNING
3. Pregabalin, Report Describes
Potential Problem
4. Antidepressant Medications and the risk of
suicidality
5. Suicidality in Pediatric and Adult Patients on/off
Paxil
1. Major Drug Recall. N.J. drug
maker, Able Laboratories, suspends
manufacturing
operations and recalls all
drugs.
New Jersey company Able Laboratories
suspended manufacturing operations and voluntary recalled all of their drug
products because of the FDA's serious concerns that they were not produced
according to quality assurance standards. It is important to note that
this recall only
applies to the drugs produced by
Able Laboratories - and not to the same drugs produced by other
manufacturers. For more information, please see FDA press release. Recalled
drugs include: Acetaminophen & codeine,
Hydrocodone bitartrate apap, Indomethacin, Naproxen Sodium, Propoxyphene
naps/apap (generic name and under the Ivax label), and Tramadol HCL (under the
Ivax label).
Download a sample patient notice at http://www.spine.org/Forms/Able_laboratories_sample.pdf
2. Duragesic and the generic
product WARNING
FDA issued a public health advisory
to alert health care professionals, patients and their caregivers of
reports of death and other serious side effects from overdoses of fentanyl in
patients using fentanyl transdermal (skin) patches for pain control. Deaths and
overdoses
have occurred in patients using both the brand name product
Duragesic and the generic product. Some patients and health care providers may
not be fully aware of the dangers of this very strong narcotic painkiller. The
directions for using the fentanyl skin patch must be followed exactly to prevent
death or other serious side effects from overdosing with fentanyl.
Read
the MedWatch safety summary, including links to the Public Health Advisory,
Healthcare Professional and Patient Information Sheets, and the Drug Information
Page at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Fentanyl
3. Pregabalin, Report Describes
Potential Problem
A report in the July Annals of
Neurology describes a serious adverse event experienced by a participant in a
clinical trial that may raise a new caution about the use of antiepileptic drugs
for conditions other than epilepsy. An elderly women enrolled in a clinical
trial of pregabalin, a new drug for the treatment of pain and seizures, abruptly
discontinued the medication and then developed neurological symptoms including
headache, confusion and hallucinations. The study's authors from Massachusetts
General Hospital (MGH) suggest that all patients stopping antiepileptic drugs
(AEDs) should do so gradually to avoid complications of withdrawal.
Full Story: http://www.sciencedaily.com/releases/2005/07/050711015101.htm#
4. Antidepressant Medications and
the risk of suicidality
FDA notified healthcare
professionals about the availability of updated Healthcare Professional and
Patient Information Sheets for antidepressant medications that were the subject
of a June 30, 2005 Public Health Advisory issued about the risk of suicidality
(suicidal thinking or
behaviour) in adults being treated with antidepressant
medications. Read the complete MedWatch 2005 Safety summary, including
links to the original June 30 PHA and the updated information sheets, at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#antidepressant
5. Suicidality in Pediatric and Adult Patients on/off Paxil
FDA has concluded that
suicidal thinking or behaviour may increase in pediatric patients treated with
any type of antidepressant, especially early in treatment. Increases in suicidal
thinking or behaviour due to drug can be expected in about 1 out of 50 treated
pediatric patients. Note that, although paroxetine is prescribed for
pediatric patients, it is not approved by FDA for use in pediatric patients.
Full Story: http://www.fda.gov/cder/drug/InfoSheets/HCP/paroxetineHCP.htm
If someone you know is abusing prescription drugs, there are several drug rehab facilities available to help.
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DISCLAIMER: I am not a medical doctor. I am a fibromyalgia / chronic fatigue syndrome survivor. The purpose of this website is not to diagnose or cure any disease or malady, but is presented as food for thought. This information cannot take the place of professional medical advice. Any attempt to diagnose and treat an illness should come under the direction of a physician. No guarantees are made regarding any of the information in this website.