rhintransit
Super Nomad
Posts: 1588
Registered: 9-4-2006
Location: Loreto
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rheumaphen plus/reumafan plus FDA alert and Mexico recall
for any of you taking the above miracle drugs for arthritis pain, a huge RATS! FDA recommends stop taking immediately and consult physician.
unlisted ingredients with potential serious side effects.
a lot of us in Loreto had found the drug, touted as all natural, great for what ailed/ails us.
here's a link for the FDA report on it.
Press Announcements > FDA issues alert on Reumofan Plus
www.fda.gov/NewsEvents/Newsroom/.../ucm306348.htmrue
reality\'s never been of much use out here...
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bbbait
Nomad
Posts: 211
Registered: 9-9-2003
Location: Blythe, Ca
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Oh no! This stuff really works great!
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bbbait
Nomad
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Location: Blythe, Ca
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Personally, I really appreciate you posting this. I have several people on the string that I buy this for. I read the FDA report and passed it
around and notified others that are using it. A couple of them said they would continue to use it as the results they are getting out weigh the side
effects. I was in Algodones last Wednesday and tried to buy more and they "were out of it". And they were pushing the other sister blend, in the
blue box very hard. I thought about it then opted to wait for the other to come back in stock. Doesn't look like it will now! Looks like it has
been pulled already, not sure if the pharmacy personnel realized that or not. I will find out next trip...
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akshadow
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Registered: 2-1-2007
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recall
This became "unavailable" in San Felipe earlier this year. Was told that it was pulled and would not become available again, but who knows
Ron San Felipe Oct, Nov. Feb. Mar. April. remainder in Juneau Ak
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encanto
Junior Nomad
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FDA NEWS RELEASE
For Immediate Release: June 1, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA issues alert on Reumofan Plus
Health officials in Mexico order recall based on potentially harmful pharmaceutical ingredients
The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other
serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care
professional. Consumers should not buy or start using the product.
Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is
manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with
the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall
the product.
The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose
(sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).
An FDA laboratory analysis of Reumofan Plus found that it contains:
•diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart
attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of
the stomach and intestines.
•methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to
perform tasks such as driving a motor vehicle or operating machinery.
These ingredients also may interact with other medications and result in serious adverse events.
The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an
anti-inflammatory and immune system suppressant.
According to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. At least
one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt
discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever,
muscle, and joint pain, dizziness, and fainting.
Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients
present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.
Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac,
methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.
Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus to FDA’s MedWatch Safety Information and
Adverse Event Reporting Program:
•online at www.fda.gov/Medwatch/report.htm;
•by phone at 800-FDA-1088 (800-332-1088); or,
•by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at
800-FDA-0178.
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Breadguy
Newbie
Posts: 18
Registered: 5-7-2009
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Roughly translated and truncated:
Pharmaceutical mfr distances itself from reumofan plus
GRISI clarifies that the product reumofan plus, taken off the market by COFEPRIS, has no relationship with its product, reumofan. Announced on its
website www.reumofan.com, the company declares that reumofan meets all standards and is safe to take
Se deslinda farmacéutica de Reumofan Plus
Grisi aclara que el producto Reumofan Plus, retirado del mercado por la Comisión Federal de Protección contra Riesgos Sanitarios, no tiene ninguna
relación con el Reumophan que produce
Ciudad de México | Miércoles 22 de agosto de 2012
Notimex | El Universal
16:52
La empresa farmacéutica Grisi aclaró que el producto Reumofan Plus que fue retirado del mercado por la Comisión Federal de Protección contra Riesgos
Sanitarios (Cofepris) , no tiene ninguna relación con el Reumophan que ellos producen.
En un anuncio a través de la página de Internet www.reumophan.com, la compañía indicó que el medicamento que fabrican sí cumple con todas las aprobaciones que exigen las autoridades de salud en
México.
En tanto que Reumofan Plus es "una falsa copia de nuestra marca Reumophan Grisi, que se comercializaba engañando y confundiendo al consumidor sin
cumplir con los requisitos que exigen las autoridades sanitarias y protección de derechos de patentes y marcas" en el país.
En la página electrónica también se puede ver un aviso que advierte sobre la venta por internet del Reumofan Plus, atribuyendo beneficios falsos como
la prevención de cáncer en los huesos y otros padecimientos.
"Este producto carece de registro de salud" . "No caiga en el engaño, el único producto farmacéutico, autorizado y avalado por la Secretaria de Salud
es: Reumophan® de Grisi Laboratorios Grisi, División Farma" , se lee en el aviso con la leyenda de engaño al consumidor.
Ayer la Cofepris, de la Secretaría de Salud (Ssa) , informó que autoridades sanitarias de Tamaulipas, Nayarit, Baja California, Oaxaca y Sonora
reportaron el retiro del mercado del citado producto por considerarlo un riesgo contra la salud pública y no tener registro sanitario.
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Pescador
Ultra Nomad
Posts: 3587
Registered: 10-17-2002
Location: Baja California Sur
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Here is an update from 9 hours ago:
August 22, 2012Updated Aug 22, 2012 at 12:13 PM CDT
(FDA news release) The U.S. Food and Drug Administration on Wednesday issued a new warning to consumers about the potential health risks of two
products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.
According to the FDA news release:
News Fast. News First. Subscribe for text alerts, e-news & more.
The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on
the product labels.
The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the
agency issued its first warning about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose
(sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression.
Consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium should immediately consult a
health care professional. Consumers should not buy or start using these products.
Ongoing FDA laboratory analyses of Reumofan Plus found that it contains the prescription drug ingredients:
dexamethasone – a corticosteroid, commonly used to treat inflammatory conditions, that can impair the body’s ability to fight infections and cause
high blood sugar levels, bone and muscle injuries, and psychiatric problems. Dexamethasone can also cause adrenal suppression when taken for a
prolonged period of time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a
withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.
diclofenac sodium – a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack and
stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines.
methocarbamol – a muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks,
such as driving a motor vehicle or operating machinery.
A separate FDA lab analysis of Reumofan Plus Premium found that it contains two of the ingredients listed above, diclofenac sodium and methocarbamol.
Reumofan Plus and Reumofan Plus Premium are labeled in Spanish. However, versions of these products may also exist with English labeling.
The products are manufactured in Mexico by Riger Naturals and sold in the U.S. in some retail outlets, at flea markets, and on various popular
Internet sites.
The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium may interact with other medications and result in serious adverse events.
Health care professionals are urged to ask their patients about use of Reumofan Plus, Reumofan Plus Premium, and other similar products marketed as
dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt
discontinuation of corticosteroids.
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Pescador
Ultra Nomad
Posts: 3587
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This just came up on the internet:
http://www.reumofanplusingredients.com/
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Pescador
Ultra Nomad
Posts: 3587
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Location: Baja California Sur
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And the most informative blog I have found is this one:
http://homeschoolanswers.net/
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EnsenadaDr
Banned
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Location: Baja California
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Mood: Move on. It is just a chapter in the past, but don't close the book- just turn the page
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I don't think the three components separately are bad, its just that taking steroids can cause serious side effects and cause adrenal shutdown and/or
death if discontinued suddenly. The other components have side effects but I have not seen adverse effects if they are taken with food to avoid
stomach ulcers and patients are warned about drug interactions.
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Pescador
Ultra Nomad
Posts: 3587
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Location: Baja California Sur
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| Quote: | Originally posted by EnsenadaDr
I don't think the three components separately are bad, its just that taking steroids can cause serious side effects and cause adrenal shutdown and/or
death if discontinued suddenly. The other components have side effects but I have not seen adverse effects if they are taken with food to avoid
stomach ulcers and patients are warned about drug interactions. |
Well then read all the reports and blogs. I thought this stuff was a miracle producer after I fell off the roof and hurt my back, but I spent several
hours reading all the reports from the Feds, the Mexican reports, and there are some serious side effects that have been shown. Of course not
everyone has those effects and may be alright, but each person will have to make their own decisions. I have run this by a couple of real doctors who
think that there is some danger with the combinations.
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Russ
Elite Nomad
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I also tried it for constant back ache and it helped some. Then I heard of others having really bad side effects and quit. Took 2 days in a
hangover/depression fog to get it out of my system enough so I didn't notice it. Bad stuff!
[Edited on 8-23-2012 by Russ]
Bahia Concepcion where life starts...given a chance!
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bbbait
Nomad
Posts: 211
Registered: 9-9-2003
Location: Blythe, Ca
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Headed down tomorrow to get some more of this stuff. Still lots of people using it!
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