ATTN: Patients with GI issues. Title is TO LONG to post.

FDA ^ | NA | FDA

[GailA]

Patient-Focused Drug Development for Functional Gastrointestinal Disorders; Public Meeting; Request for Comments

This conference is being held in the N.E so those of us in the South or West are excluded unless you take the time to EMAIL this person.

email Sayyedeh.Mariani@fda.hhs.gov

[GailA]

I don't know how much they will allow for posting so posted only the title and link. With the email for email Sayyedeh.Mariani@fda.hhs.gov

For those who cannot attend a meeting in the N. E. when they live to far away or have health issues that prevent them from attending.

Your voice should be heard, not just those folks in the N. E.

As I am the victim of several of these health issues I know there are more of you out there that are NOT being heard.

And NO one is telling you that, that PPI you are taking for GERD will cause you to develop Osteoporosis due to the fact they make your bones porous.

Nor will the doctors tell you those OP drugs have FDA warnings on them, they all have GI side effects. Foreto is black box labeled for bone cancer.

If you want the warnings I will post them.

[GailA]

PING

[GailA]

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. Patient-Focused Drug Development is part of FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of functional GI disorders on daily life and patient views on treatment approaches.

[Obadiah]

Many thanks for posting.

[Cold Heart]

There are 52 drugs with initials PPI

GERD means Gastro Intestinal Reflux Disease

I gave up looking for OP

[Nachum]

This actually a subject I have some knowledge of as there are people in my family with serious GI disorders. Yes, the drugs are harsh but sometimes there are few alternatives other than removing the colon entirely.

There is a clinic in Los Angeles that is famous for the treatment of this. Actually, the 3 main places I have heard that are tops for this issue are the IBD clinic at Cedars in Los Angeles, the Mayo Clinic (Minn. I think), and there is one specialist who is famous for it down in San Diego at Scripts Clinic.

Sympathy here for those who have to deal with this.

[GailA]

Osteoporosis brittle bones broken hips fractures of femur & other fractures.

[GailA]

I’m in TN so they are no help to me. I have a top GASTRO. But even he can’t fix Gastroparesis especially when patients are allergic to the drugs even if I weren’t there is still no cure they just treat symptoms.

Many have had colon surgery gallbladder which cuts the Vagas Nerve.

But when U are put on a PPI you should be weaned off them quickly due to the bone density issue not just kept on them for 30 yrs like I have been.

Few know female HRT have high Acid Reflux or that
osteoarthritis drugs do to.

Many IBS issues are from Cilic (?sp) disease or Crohn’s or parasites.

[Nachum]

You should really consult long distance with these doctors. PM me and I will give you contact info. If there is somebody, near you, they will tell you. They may recommend entirely different treatment.

[Cold Heart]

I was looking for drugs you referred to as OP in the context of treating gastrointestinal problems. Thanks.

I know someone who has been on arthritis meds, osteoporosis meds and gastro intestinal meds and has suffered side affects from all of them including the Vioxx heart attack. I suspect the person is presently on some sort of stomach medicine. Probably a PPI ? to which you referred to.

Don’t forget that artificial sweeteners are detrimental to good gut bacteria.

[GailA]

Dr Michael S. Dragutsky, of Gastro One pioneered the fiber optics for Colon screening.

The problem with Gastroenteritis is it is not curable. Most of the patients have had gallbladder surgery where the Vagas Nerve was cut, or had colon caners and had much of their intestines removed. There just is not real treatment for it.

Gastroparesis has also in a couple of very small studies been linked to PPI’s.

Reglan is Restricted by our FDA to 12 days due to the harsh side effects. The two antibiotics are Zoysin, which I was told had mild basically nausea only. Turned out it hit my vision very hard from the first IV drip. After 4 days of it, it took 2 weeks of living in a darken room before my vision slowly returned to normal. Erythromycin I have always been allergic to: nausea, dizzy, Drug induced bowel shut down.

The other drug DOMPERIDONE is only available over sea. And has been Restricted by the European equivalent of our FDA due to heart failure or deaths and disease.

DOMPERIDONE, (nearly 60 heart related deaths, and 350 heart related issues
http://www.netdoctor.co.uk/cancer/medicines/motilium.html

New restrictions on use of domperidone issued by the MHRA
http://www.pharmaceutical-journal.com/news-and-analysis/news/new-restrictio ns-on-use-of-domperidone-issued-by-the-mhra/11137797.article

UAE hospitals warned over Domperidone ‘sudden death’ risk
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals /Domperidone-containing_medicines/human_referral_prac_000021.jsp&mid=WC0b01 ac05805c516f

Drug can be fatal for elderly patients, says ministry
http://gulfnews.com/news/gulf/uae/health/uae-hospitals-warned-over-domperid one-sudden-death-risk-1.1348043

Popular heartburn and anti-nausea drug taken by millions to be curtailed after nearly SIXTY die from heart problems after taking the medication
http://www.dailymail.co.uk/news/article-2613729/Popular-heartburn-anti-naus ea-drug-taken-millions-curtailed-nearly-SIXTY-die-heart-problems-taking-med ication.html

Reglan is the most side effect prone of all the GP drugs with neurological side effects. http://www.rxlist.com/reglan-side-effects-drug-center.htm

Reglan
http://www.drugs.com/sfx/reglan-side-effects.html

For those with parasites this is the most recommended.
Earthbiotics UK
http://www.earthbiotic.com/home/4574574457

US
http://lovingsuperfoods.com/rawfood/vitamineralearth.html

Let us not forget the need for keeping the flora of our gut which is one of the most important immune protection we have is Probiotics. And antibiotics kill off all of them. So you have to replace the good Flora.

Health benefits of taking probiotics
http://www.washingtonpost.com/lifestyle/wellness/probiotics-benefits-go-beyond-digestion/2013/10/15/30aab59e-3052-11e3-8906-3daa2bcde110_story.html

http://www.healthline.com/health-slideshow/surprising-benefits-probiotics

[GailA]

So are Sodas they are very destructive to your gut.

[GailA]

Nachum, I have half the GP under control. Now my first concern is not to fall and get the OP that is -4 under control. I’ve ruled the drugs out, so I’m looking or facing double hip replacement. I can’t live with pain coming from multiple sites and not be able to take any kind of pain meds. None of the OTC stuff works. And I’m not allowed narcotics because of the Gastroparesis.

And after my history with OA drugs I don’t want a repeat with the OP drugs.

Here is another promising GP treatment but the study is very small. John Hokins Stent
http://www.hopkinsmedicine.org/news/media/releases/_johns_hopkins_gi_doctors_use_endoscopy_to_place_transpyloric_stent

[GailA]

Three books to read you can get them on Amazon.

Your Bones: How You Can Prevent Osteoporosis and Have Strong Bones for Life - Naturally Dr Lara Pizzorno 2013

The Whole Body Approach to OP
R. Keith McCormick

Vitamin K2 and the Ca Paradox’ by Kate Rheaume Bleue.

Here are your FDA WARNINGS ON OP DRUGS.
ALL of which have GI side effects.

Reclast UPS kidney failure, A FIB risk. NOT TO BE GIVEN TO ASTHMA PATIENTS
http://www.webmd.com/osteoporosis/news/20110901/fda-osteoporsis-drug_ups-kidney-failure-risk

Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
http://www.fda.gov/drugs/drugsafety/drugsafetypodcasts/ucm229800.htm

FDA ALERT RECLAST higher risk of Kidney Failure and A Fib.
http://www.natap.org/2011/newsUpdates/090911_03.htm

Reclast UPS kidney failure, A FIB risk. WebMD works closely with FDA.
http://www.webmd.com/osteoporosis/news/20110901/fda-osteoporsis-drug_ups-kidney-failure-risk

Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
http://www.fda.gov/drugs/drugsafety/drugsafetypodcasts/ucm229800.htm

Both Reclast and Boniva if you get down into the fine print NEVER leave your system! Foreto is Black Box labeled for Bone Cancer.

Forteo Side Effects ( ALL GAINS REVERSES THEMSELVES after treatment course!) epi pen, needs refrigerated
http://www.drugs.com/sfx/forteo-side-effects.html

MY reactions after all the reading was KEEP YOUR POISONS! Hips can be replaced before they fracture!

[GailA]

These 2 OP drugs are still in trial phase. But I would not want them based on what I read.

romosozumab
http://saveourbones.com/big-pharma-admits-failure-shocking-new-osteoporosis-drug-conflict-of-interest-osteoporosis-drug-pulled-from-market-and-more/

During clinical trials, the most common side effects were nausea, diarrhea, headaches and skin irritation. Other quite dangerous but fortunately less commonly reported side-effects were blood clots, fainting, memory troubles and, in rare cases, seizures.” MONTHLY

odanacatib WEEKLY
http://www.medscape.com/viewarticle/832009

However, small increases in numbers of serious adverse effects, including stroke, atrial fibrillation, and atypical fractures, remain a concern.

[Nachum]

Interesting treatment. Johns Hopkins is a quality facility.

[Cold Heart]

My grand kids rarely drink soda anymore. Every time I saw them with one I told them they were drinking poison. Their dad and his dad drank gallon a day for years. They are both falling apart.

[nascarnation]

10 cans of pop a day would definitely do that.
WOW.
Just the trips to the bathroom would be a time waster.

[ladyjane]

Maybe they just stopped drinking soda when you were around?

[MayflowerMadam]

This is gross and disgusting (and may or may not be true): I read about labs or doctors who pay people with perfectly healthy digestive systems to donate their... well... feces. That, in turn, is somehow transferred to people with GERD (and possibly other intestinal issues), and the problem is cured. Sounds nasty, and I may have been punked, but there it is FWIW.