Wednesday, February 9, 2011

"Watson Announces Important Alert Regarding FDA-Recalled Triad Alcohol Pads Packed With Their Prostate Cancer Drug Trelstar" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets The Cross"

TRELSTAR is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The empirical formula is C64H82N18O13 · C23H16O6 and the molecular weight is 1699.9. The structural formula is:

The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials. http://pi.watson.com/data_stream.asp?product_group=1684&p=pi&language=E 
Dear Ones:
     Problems arising from TRIAD alcohol pads and swabs potentially contaminated with Bacillus cereus continue on.  Please note that the manufacturers of all the injectables involved in these recalls maintain that the drugs, themselves, are SAFE!
     It is imperative that patients NOT USE the Triad alcohol prep pads included with injectables, in this case for Trelstar aka triptorelin pamoate for injectable suspension. 
     Trelstar is a form of 'hormone therapy' for prostate cancer.  In the common vernacular, it is an agent of 'chemical castration'. 
     Specifically, Trelstar is a Gonadotropin releasing hormone (GnRH) agonist, which means it 'mimics' natural GnRH  and is capable of 'blocking' GnRH receptors in the brain. 
     (Yes...the 'brain' really IS our major sex organ as I have said many times before, a concept which is finally enjoying the attention it deserves from my 'traditionally-oriented' colleagues.
     See: "Mercury Poisoning Makes Birds Act Homosexual LINK: http://news.nationalgeographic.com/news/2010/12/101203-homosexual-birds-mercury-science/
     Then read my trail-blazing alternative biomedicine 'piece' on how the drugs we take, environmental factors and the food we eat affect likewise affect our 'sexuality'.  LINK: http://dearoneshealingministry.blogspot.com/2010/09/drugs-we-take-in-our-food-which-affect.html )
     Trelstar (or a similar GnRH agonist) 'fools' brain receptors into thinking all of it's GnRH receptors are being 'blocked' by the 'real thing'.
     The pituitary thus becomes 'stimulated' and it's secretion of FSH and LH eventually decreases.  This, in turn, ultimately causes the testes to produce less testosterone, as well as reducing PSA levels.* (please see my note below)
         Many cases of prostate cancer respond positively to efforts to decrease testosterone and this is why Trelstar is as useful as it is as a pharmaceutical option in prostate cancer treatment.
     According to the data Watson shows, Trelstar, in fact, is extremely effective:
"6-month Trelstar 22.5 mg maintains testosterone levels similar to those achieved with surgical castration.     Here are the specifics from the FDA Recalls site:

Mean testosterone level of 12.8 ng/dL in months 2 through 122
97.5% of patients achieved castrate serum testosterone level by day 291
98.3% of patients were below castrate level at month 6 and month 122"
http://www.trelstar.com/hcp-trelstar-22.5-mg.asp

"FOR IMMEDIATE RELEASE - February 4, 2011 -Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

The Company emphasized that there is no potential contamination of the Trelstar product, the MIXJECT® system or components in the Trelstar packaging, other than the Triad alcohol prep pad. The Trelstar drug and the MIXJECT® system have not been affected in any way.

Watson has ceased shipments of Trelstar packaging components that incorporate the Triad alcohol pad while it pursues options to remove or replace the prep pad. Convenience kits will not be available in Trelstar commercial packages until new convenience kits incorporating a replacement alcohol prep pad are available for distribution in March 2011. The Company also noted that it was cooperating fully with the FDA, and notifying its customers.

Watson instructs customers to immediately discontinue the use of the Triad alcohol prep pad included in the Trelstar convenience kit and to appropriately dispose of the entire convenience kit. The Company also recommends customers use an alternative alcohol prep pad product that is not involved with this recall, or to use a sterile gauze pad in conjunction with isopropyl alcohol as an alternative. Both prep pads and gauze should be available at your local pharmacy.

Further information on this Triad alcohol prep pad recall can be found on the FDA website at
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm9
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm10   
• Regular Mail: use postage-paid, pre-addressed Form FDA
3500 available at:www.fda.gov/MedWatch/getforms.htm11
Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178"
LINK: http://www.fda.gov/Safety/Recalls/ucm242359.htm
     The last thing a prostate cancer patient needs is any kind of infection at an injection site, especially with all the hot-flashes you have to contend with. 
     So please take care with the alcohol prep pads you may be using at this time!
     If anything 'good' can be gleaned from this Triad situation, it is this: for once, health care professionals are finally advising that isopropyl alcohol and a sterile gauze pad are all it takes to cleanse an injection site.
      Who knows?  Maybe common sense will prevail and health care cost-savings may be realized in some small way with this Triad alcohol prep pad and swab stick recall.
     Alcohol prep pads are not all that expensive in and of themselves.  But when they are fanci-packed in so-called 'Convenience Kits',  packaging costs can sky-rocket, for patients, hospitals and in this case, for the drug-manufacturers themselves.
     I pray this information is of use to you or someone you love.
God Bless You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/
*Note: this is a very condensed and abbreviated version of the complicated endocrinology under discussion here. Nothing is straightforward in this particular discipline and there are 'lag-periods', 'surge periods' and various 'weaning periods' for hormonal agents--both synthetic and natural--used in the treatment of hormonally-dependent cancers.  If you have something you would like to have translated from 'medical-ese' into 'English', Rev. Barb may be able to help you if you email her with your general questions at BarbaraKSexton@aol.com
If you would like to subscribe to Reverend Barbara Sexton's newsletter for the Dear Ones Healing Ministry, just send your name and e-mail address to: BarbaraKSexton@aol.com  

Stay current with medical issues from a biochemist's point-of-view. Get tips, alerts and sound advice on the many different healthcare topics that affect you and your loved ones on a daily basis as news breaks. It's FREE, so sign up TODAY, if you are not already receiving this informative and potentially life-saving newsletter.
Please understand that Reverend Barbara Sexton is a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided by her is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice.
DISCLAIMER FOR HEALTH CARE PROFESSIONALS AND THEIR PATIENTS:
Please understand that I am a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided at http://www.dearoneshealingministry.blogspot.com/ and in any emails sent out by BarbaraKSexton@aol.com is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice. You are encouraged to share the contents at http://www.dearoneshealingministry.blogspot.com/ and of any e-mails specifically sent to you by Reverend Barbara Sexton, M.Sc. with your medical doctor and/or other healthcare providers with the understanding that all Intellectual Property Rights belong to Reverend Barbara Sexton, M.Sc. As such, this intellectual property may not be copied, transferred, transmitted, utilized or distributed by or for anyone else without my express permission and in accordance with all applicable laws. Any case-specific e-mails sent out by Reverend Barbara Sexton, M.Sc. are for the individuals for whom they are intended only and are subject to the Intellectual Property Rights restrictions above. Healthcare professionals may contact BarbaraKSexton@aol.com for terms, restrictions and fees (if any) if they wish to utilize this intellectual property for themselves or in their practices. Exceptions: FREE NEWSLETTER RECIPIENTS may share their copies with friends and family. Healthcare Professionals may sign up for the SAME FREE Dear Ones Healing Ministry NEWSLETTER by sending their name, address and email address to Reverend Barbara Sexton, M/Sc. at BarbaraKSexton@aol.com Public Domain: This disclaimer published 3/8/10 on http://www.dearonesministry.blogspot.com/  Updated 2/9/11 All contents copyrighted 2011.

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