Fw: Medwatch forms.Novartis Pharmaceuticals announced changes to the Prescribing

[Guest guest]

We URGE ALL of the new saline and/or silicone BI women to file a MedWatch Form, and ask your physicians to also file one on your behalf. It is extremely important that the FDA receive these forms on ALL defective products. How can we expect them to do what they should be doing to protect the general public, if WE do not let them know what products are defective?

Blessings,

MM / NSIF

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

-----Original Message-----From: ParfumGigi@... <ParfumGigi@...>SBI-Talk <SBI-Talk >Cc: SBIPrayerForum <SBIPrayerForum >; ilena@... <ilena@...>; Gimfl@... <Gimfl@...>; lillian45usa@... <lillian45usa@...>; weedsworld@... <weedsworld@...>; toxicnewsandviews@... <toxicnewsandviews@...>; nye822@... <nye822@...>; HORSRASER2@... <HORSRASER2@...>; myrlj@... <myrlj@...>; Lv7dove7@... <Lv7dove7@...>; lany25@... <lany25@...>; sharynn2@... <sharynn2@...>; NEspina@... <NEspina@...>; Cow22girl@... <Cow22girl@...>; LPar911@... <LPar911@...>; jussta@... <jussta@...>; wan6922@... <wan6922@...>; tennrose@... <tennrose@...>; REABEEE@... <REABEEE@...>; faussettdp@... <faussettdp@...>; Desertmouse@... <Desertmouse@...>; spudnik@... <spudnik@...>; janmarh@... <janmarh@...>; turnerdl@... <turnerdl@...>; MAM-NSIF@... <MAM-NSIF@...>; Dowlied@... <Dowlied@...>; lorenn@... <lorenn@...>; UBCDan@... <UBCDan@...>; RAve456201@... <RAve456201@...>Date: Thursday, February 01, 2001 12:41 AMSubject: Medwatch forms.Novartis Pharmaceuticals announced changes to the Prescribing Novartis Pharmaceuticals Corp. announced changes to the Prescribing Information (PI) for Exelon (rivastigmine tartrate), a drug indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Please tell any person, they can file a Medwatch form online. Would you show them how, they can go to this Internet site, and help them file one electronically? It's extremely necessary to report, all side effects from every medication, or medical device. I still have women, who have not filed a Medwatch form, and no one advised them to file a Medwatch form. Those of you who took fen-phen, need to file a Medwatch form, on that dangerous medication too. We take it for granted, that every person has filed a Medwatch form, the FDA is not fully informed on half of us. Please pass this on, I've advised the TMJ individuals, an others to please file a Medwatch form. Go here on the Internet, book mark this, where you can help those who still need to file one. We take it for granted, that everyone has a computer, an is up to date on all of this. I receive phone calls every day, many of those who phone us in Texas, are not up on any thing. I think we should post it on the boards, where to file a Medwatch form, or we will fax you one. NSIF will be happy to fax you a Medwatch form, where you can copy it off, and get it to the individuals you run into. I like what this says, so you get to read it too..it's cute * http://www.care2.com/ecards/funepages/45 gigi/ MedWatch web site at http://www.fda.gov/medwatch/feedback.htm http://www.fda.gov/medwatch/safety/2001/exelon.htm Here the article is in it's entirety, but first a commercial break, yep* CEO of this whole mess>Poor Tony & Mich! Nope we can't raise your salaries, cuz we haven't received a cent, an in Texas..they try for years to keep anyone for draw'n.. the disability $$$ they paid in. Ask me, I'm another victim, of that system too! Sure nuff.. stuff in Texas, smell kinda like those cows they raise. oOh Yuck! Yep it's me blab'n again, hoof, and mouth disease..along with every breast implant one. What a bore to be caged in your home, cuz your in so much pain, I think I'd rather be out on the range grase'n. MOO * the gigi from Texas, that state that hates to pay any of us, we got that Tort Reform instead..am I impressed my representatives passed this bias mess.. NO! Read on now.* Novartis would like to inform you of recent changes to the WARNINGS,PRECAUTIONS,and DOSAGE AND ADMINISTRATION sections of the prescribing information (PI) for Exelon® (rivastigmine tartrate). These changes provide guidelines for reinitiating therapy in patients who have interrupted treatment with Exelon to reduce the risk of severe vomiting. There is limited experience related to restarting Exelon after an interruption in therapy at doses higher than the recommended starting dose. However, to reduce the possibility of severe vomiting in patients who have interrupted Exelon therapy for longer than several days, treatment should be reinitiated with the lowest daily dose. After reinitiating therapy, patients should be titrated back to their maintenance dose as described in the DOSAGE AND ADMINISTRATION section of the PI. There has been one post-marketing case of severe vomiting with esophageal rupture reported to have occurred after reinitiation of treatment at an inappropriate single dose of 4.5 mg following an interruption of treatment for eight weeks.1 Novartis is committed to providing you with the most current product information available for the management of patients receiving Exelon. You can further our understanding of adverse events by reporting them.Healthcare professionals should report all serious adverse events suspected to be associated with use of Exelon to Novartis Pharmaceuticals Corporation, 59 Route 10, East Hanover, New Jersey 07936 by phone (888) NOW-NOVARTIS or (888-669-6682) or the internet at http://www.novartis.com. Alternatively, this information may be reported to the FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088, by fax 1-800-FDA-0178, by mail using the Form 3500 at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20857;

The Internet addy to file a medwatch form again..is: http://www.accessdata.FDA.gov/scripts/medwatch.Please note that the next revision of the Physicians’ Desk Reference (PDR) will not contain these PI changes; therefore, please see the enclosed revised PI for complete prescribing information. Future and current patients being treated with Exelon should be fully informed of the above information. Sincerely,Alan L. Bess, M.D. Vice President Clinical Safety & Epidemiology

R. Cunningham, M.D., FRCP, FFPM Vice President

Medical Affairs

Babic T, et al. Spontaneous rupture of oesophagus (Boerhaave's syndrome) related to rivastigmine [letter]. Age Aging, 2000, Jul 29(4):370-1 Novartis Pharmaceuticals Corporation East Hanover, New Jersey