Re: Warning~Low Mag assoc. with long term PPI use

[Guest guest]

Carolyn wrote:

> FDA Drug Safety Communication: Low magnesium levels can be associated with

long-term use of Proton Pump Inhibitor drugs (PPIs)

Major bummer! Thanks for the heads up though. There is nothing that

works as well for reducing acid production. The report does not mean

those of us taking PPIs need to stop using them but we should have our

magnesium levels checked regularly. If it is found that we need to stop

PPI use then hard choices may follow. Magnesium is a very important

mineral to the body. Not something to mess with. I guess it is time to

consider H2-blockers again.

notan

[Guest guest]

Thanks for finding this NEW report!

I was on Nexium 2-3 years and made my stomach alkaline and couldnt digest the

food.

I threw the Nexium out the door, NOw my stomach is normal.

http://www.fda.gov/Drugs/DrugSafety/ucm245011.htm?sms_ss=twitter & at_xt=4d6e74c4f\

7197dac,0

I would never use PPI'S again, at least at the present time. See my prevous

posts on this.

I take Magnesium 250 mg twice a day, my Achalasia is MUCH better than 3 years

ago I could not get coffee down and had to go to the Coke fountin at Macs

to get the CO2 to open the LES.

Ray CA OC MV

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> FDA Drug Safety Communication: Low magnesium levels can be associated

with long-term use of Proton Pump Inhibitor drugs (PPIs)

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> Safety Announcement

> Additional Information for Patients

> Additional Information for Healthcare Professionals

> Data Summary

> Safety Announcement [3-2-2011] The

> U.S. Food and Drug Administration (FDA) is informing the public that

> prescription proton pump inhibitor (PPI) drugs may cause low serum

> magnesium levels (hypomagnesemia) if taken for prolonged periods of time

> (in most cases, longer than one year). In approximately one-quarter of

> the cases reviewed, magnesium supplementation alone did not improve low

> serum magnesium levels and the PPI had to be discontinued.PPIs

> work by reducing the amount of acid in the stomach and are used to treat

> conditions such as gastroesophageal reflux disease (GERD), stomach and

> small intestine ulcers, and inflammation of the esophagus. In 2009,

> approximately 21 million patients filled PPI prescriptions at outpatient

> retail pharmacies in the United States.23 Patients who take prescription PPIs

usually stay on therapy for an average of about 180 days (6 months).Prescription

> PPIs include Nexium (esomeprazole magnesium), Dexilant

> (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium

> bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium),

> and AcipHex (rabeprazole sodium). Vimovo is a prescription combination

> drug product that contains a PPI (esomeprazole magnesium and naproxen).

> Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid

> OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR

> (lansoprazole).In contrast to prescription PPIs, OTC PPIs are

> marketed at low doses and are only intended for a 14 day course of

> treatment up to 3 times per year. FDA believes that there is very little

> risk of hypomagnesemia when OTC PPIs are used according to the

> directions on the OTC label.Low serum magnesium levels can result

> in serious adverse events including muscle spasm (tetany), irregular

> heartbeat (arrhythmias), and convulsions (seizures); however, patients

> do not always have these symptoms. Treatment of hypomagnesemia generally

> requires magnesium supplements. Treatment in patients taking a PPI and

> who have hypomagnesemia may also require stopping the PPI.Healthcare

> professionals should consider obtaining serum magnesium levels prior to

> initiation of prescription PPI treatment in patients expected to be on

> these drugs for long periods of time, as well as patients who take PPIs

> with medications such as digoxin, diuretics or drugs that may cause

> hypomagnesemia. For patients taking digoxin, a heart medicine, this is

> especially important because low magnesium can increase the likelihood

> of serious side effects. Healthcare professionals should consider

> obtaining magnesium levels periodically in these patients.Information

> about the potential risk of low serum magnesium levels from PPIs will

> be added to the WARNINGS AND PRECAUTIONS sections of the labels for all

> the prescription PPIs.Today's communication is in keeping with

> FDA's commitment to inform the public about its ongoing safety review of

> drugs. FDA is continuing to review reports of possible adverse events

> and drug interactions with PPI drugs submitted to our Adverse Event

> Reporting System. [see Data Summary]

>  Additional Information for PatientsSeek

> immediate care if you (or your child) experience an abnormal heart rate

> or rhythm, or symptoms such as a racing heartbeat, palpitations, muscle

> spasm, tremor or convulsions while taking a PPI drug. In children,

> abnormal heart rates may cause fatigue, upset stomach, dizziness and

> lightheadedness.Tell your healthcare professional

> if you have ever been told you have low magnesium levels in your blood,

> or if you take the drug digoxin, diuretics, or other drugs that may

> cause hypomagnesemia.Your healthcare professional

> may occasionally check your serum magnesium level (a blood test) while

> you are taking your prescription PPI drug.Do not stop taking your prescription

PPI drug without talking to your healthcare professional.Discuss any questions

or concerns about your PPI drug with your healthcare professional.If you take an

over-the-counter (OTC) PPI drug, follow the directions on the package

carefully.Make sure your healthcare professional knows if you have been taking

an OTC PPI drug for a long period of time.Report

> any side effects you experience to the FDA MedWatch program using the

> information in the " Contact Us " box at the bottom of the page.

>  Additional Information for Healthcare ProfessionalsConsider

> obtaining serum magnesium levels prior to initiation of prescription

> PPI treatment and checking levels periodically thereafter for patients

> expected to be on prolonged treatment or who take PPIs with medications

> such as digoxin or drugs that may cause hypomagnesemia (e.g.,

> diuretics).Hypomagnesemia occurs with both loop

> diuretics (furosemide, bumetanide, torsemide, and ethacrynic acid) and

> thiazide diuretics (chlorothiazide, hydrochlorothiazide, indapamide, and

> metolazone). These agents can cause hypomagnesemia when used as a

> single agent or when combined with other anti-hypertensives (e.g.,

> beta-blockers, angiotensin receptor blockers and/or ACE inhibitors).Advise

> patients to seek immediate care from a healthcare professional if they

> experience arrhythmias, tetany, tremors, or seizures while taking PPIs.

> These may be signs of hypomagnesemia.Consider PPIs as a possible cause of

hypomagnesemia, particularly in patients who are clinically symptomatic.Patients

who develop hypomagnesemia may require PPI discontinuation in addition to

magnesium replacement.Be

> aware that consumers either on their own, or based on a healthcare

> professional's recommendation, may take OTC PPIs for periods of time

> that exceed the directions on the OTC label. This is considered an

> off-label (unapproved) use. Healthcare professionals should communicate

> the risk of hypomagnesemia to patients if they are recommending

> prolonged use of an OTC PPIs.Report adverse events

> involving PPIs to the FDA MedWatch program, using the information in the

> " Contact Us " box at the bottom of the page.

>  Data SummaryFDA

> has reviewed reports from the Adverse Event Reporting System (AERS),

> medical literature, and periodic safety update reports for cases of

> hypomagnesemia in patients undergoing prolonged treatment with PPI

> medications. FDA's review focused on 38 cases in AERS and 23 cases

> reported in the literature (which include at least 8 cases of the

> identified AERS cases).4,5,6,7,8,9,10,11 The AERS case series

> excluded patients who were on diuretics. The cases from the literature

> included patients on diuretics when either (a) change in diuretic was

> not associated with an improvement in serum magnesium level, or ( when

> increase in serum magnesium level occurred with documented PPI

> discontinuation. The FDA review suggests an association between

> hypomagnesemia-related serious adverse events and prolonged PPI use.

> However, because hypomagnesemia is likely under-recognized and

> under-reported, the available data are insufficient to quantify an

> incidence rate for hypomagnesemia with PPI therapy.Hypomagnesemia

> has been reported in adult patients taking PPIs for at least three

> months, but most cases occurred after a year of treatment. Approximately

> one-quarter of these cases required discontinuation of PPI treatment in

> addition to magnesium supplementation. Some cases cited both positive

> dechallenge as well as positive rechallenge (i.e., resolution of

> hypomagnesemia with PPI cessation and recurrent hypomagnesemia with PPI

> resumption). After discontinuing the PPI, the median time required for

> the magnesium to normalize was one week. After restarting the PPI, the

> median time to develop hypomagnesemia again was two weeks. In most cases

> reviewed the patients did not continue on PPIs after the hypomagnesemia

> was treated.Examples of positive dechallenge in two patients

> include a 63-year-old woman and a 67-year-old man who were both treated

> with PPIs for 6 and 11 years, respectively. Both patients presented with

> seizures and hypomagnesemia. Although both patients' hypomagnesemia

> partially resolved with intravenous replacement, in both cases

> discontinuation of PPI treatment was necessary to stop ongoing symptoms

> and to stop magnesium loss.Clinically serious adverse events were

> consistent with commonly reported signs and symptoms of hypomagnesemia,

> which are similar to the signs and symptoms reported with hypocalcemia.

> The serious events included tetany, seizures, tremors, carpo-pedal

> spasm, atrial fibrillation, supraventricular tachycardia, and abnormal

> QT interval. Hypomagnesemia also produces impaired parathyroid hormone

> secretion which may lead to hypocalcemia. In cases where comprehensive

> clinical laboratory data were available, most patients had concomitant

> hypocalcemia and normal parathyroid hormone levels. Therefore, these

> findings confirm hypomagnesemia as the primary deficit.The

> mechanism responsible for hypomagnesemia associated with long term PPI

> use is unknown; however, long term use of PPIs may be associated with

> changes in intestinal absorption of magnesium.5OTC

> PPIs are marketed for the treatment of frequent heartburn under the

> brand names Prilosec OTC, Zegerid OTC, and Prevacid 24 HR. OTC PPIs are

> labeled for 14 days of use, and this treatment course may be repeated

> every 4 months, up to 3 times per year. FDA acknowledges that consumers,

> either on their own, or based on a healthcare professional's

> recommendation, may take these products for periods of time that exceed

> the directions on the OTC label. This is considered an off-label

> (unapproved) use, based on the directions of use for OTC PPIs.

> Healthcare professionals should be aware of the risk of hypomagnesemia

> if they are recommending use of OTC PPIs for longer periods of time than

> in the OTC PPI label. FDA believes that OTC PPIs carry very little risk

> of hypomagnesemia when used according to the package directions, and

> therefore the Drug Facts box for the OTC PPIs will not be changed to

> include the risk of hypomagnesemia. SDI, Vector One®: National (VONA). 2002-

2010. Data extracted 3-12-10.SDI, Vector One®: Total Patient Tracker (TPT).

2002-2009. Data extracted 3-24-10.IMS Health, IMS Health Plan Claims

DatabaseTMBroeren

> MA, Geerdink EA, Vader HL, van den Wall Bake AW. Hypomagnesium induced

> by several proton-pump inhibitors. Ann Intern Med (Nov 17, 2009).

> 151(10); 755-756.Cundy T, Dissanayake A. Severe

> hypomagnesemia in long-term users of proton-pump inhibitors. Clinical

> Endocrinology (2008). 69; 338-341.Epstein M,

> McGrath S, Law F. Proton-pump inhibitors and hypomagnesemic

> hypoparathyroidism. NEJM. October 26, 2006. 355;17:1,834-1,836.Hoorn

> EJ, MD, van der Hoek J, de Man RA, Kuipers EJ, et al. A case series of

> proton pump inhibitor†" induced hypomagnesemia. Am J Kidney Dis. February

> 25 2010. (epub).Kuipers MT, Thang HD, Arntzenius

> AB. Hypomagnesaemia due to use of proton pump inhibitors†" a review. Neth J

> Med (May 2009). 67(5);169-172.Metz DC, Sostek MB,

> Ruszniewski P, Forsmark CE, et al. Effects of esomeprazole on acid

> output in patients with Zollinger-Ellison syndrome or idiopathic gastric

> acid hypersecretion. Am J Gastroenterol. (December 2007). 102(12);

> 2648-2654.Shabajee N, Lamb E, Sturgess I, Sumathipala R. Omeprazole and

refractory hypomagnesemia. BMJ (2008): 337; 173-175.Mackay JD and Bladon PT.

Hypomagnesaemia due to proton-pump inhibitor therapy: a clinical case series. QJ

Med 2010; 103:387-395.    

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[Guest guest]

Ray wrote:

> I was on Nexium 2-3 years and made my stomach alkaline and couldnt digest the

food.

Amazing! What was the chemical source of the alkalinity? Bile reflux? I

understand the PPI would reduce the acid in the stomach but there would

in most people still be some acid production, just a reduced amount of

it. What eliminated the rest of the acid and turn the stomach alkaline?

Digestion should still have happened as it does for most, if not all,

people on PPIs or many of us would be dead by now. Digestion may be

changed but not being able to digest food seems extreme.

notan

[Guest guest]

> Digestion may be changed but not being able to digest food seems extreme.

Yes it was extreme to me !! I was on digestive enzymes while my stomach was

ALKALINE, maybe the wrong word in notans view, " " in my opinion " " , but then they

the pills were too large to swallow.

Study the Harvard info below. Maybe that is what is causing the pneumonia in

some Achalasia patients.

http://www.health.harvard.edu/fhg/updates/do-ppis-have-long-term-side-effects.sh\

tml

PPI-associated pneumonia

A connection to C. difficile

Bad for bone — and your B12 levels?

AND now low magnesium levels.

I am sure PPI's are necessary for some people especially if they have the E

removed, but in general get off them if possible! Sleep on an elevated bed or

chair. I very rarely have reflux at night and if I do I use a cold can of COKE

to wash it down, sitting in a Lasy Boy chair.

And dont forget you may break a hip, if you fall, if you have been on them for

5-7 years and over 50.

Notan is this one of your critical days? haha

Ray CA OC MV 80 old as dirt! I am so so much better than 3 years ago!

> > I was on Nexium 2-3 years and made my stomach alkaline and couldnt digest

the food.

>

> Amazing! What was the chemical source of the alkalinity? Bile reflux? I

> understand the PPI would reduce the acid in the stomach but there would

> in most people still be some acid production, just a reduced amount of

> it. What eliminated the rest of the acid and turn the stomach alkaline?

> Digestion should still have happened as it does for most, if not all,

> people on PPIs or many of us would be dead by now. Digestion may be

> changed but not being able to digest food seems extreme.

>

> notan

>

[Guest guest]

Ray wrote:

> ...I was on digestive enzymes while my stomach was ALKALINE, maybe the

> wrong word in notans view, ...

The context is PPIs and gastric acid, so we are discussing an acid and

chemistry. In that context I expect alkaline to refer to something with

a pH above 7. I understand that in some alt-med circles alkaline is

sometimes used as a buzz word with little real meaning. I suppose one

could say that a pH of 6 is more alkaline than a pH of 5 but it would be

better to say it was less acidic. You didn't say " more alkaline. " You

said simply " was alkaline. " Of course the stomach could become alkaline

if bile was refluxed into it. It could also become alkaline if one

ingested enough antacids or other alkaline substances. However, PPIs are

not antacids. People may erroneously call them that but they are not.

Even if they were alkaline (antacid), at only something like 20mg there

is not enough there to counteract enough acid in the stomach to make a

difference. PPIs are Proton Pump Inhibitors. As such, they inhibit the

release of protons. A proton being a hydrogen ion. Hydrogen ions combine

with chloride ions to make HCl, gastric acid. So, you should be able to

see that PPIs reduce the production of acid but don't increase any bases

or cause the gastric pH to become alkaline. In normal use they don't

even stop acid production, just reduce it.

You can check out the definition of " alkaline " here:

http://lmgtfy.com/?q=define%3Aalkaline

Careful, I may take over your computer. ;-)

> Study the Harvard info below. Maybe that is what is causing the pneumonia in

some Achalasia patients.

>

>

http://www.health.harvard.edu/fhg/updates/do-ppis-have-long-term-side-effects.sh\

tml

>

> PPI-associated pneumonia

Yes, there is a risk. Unfortunately they don't tell you that there are a

number of studies that looked into this and the results conflict. In the

ones that do find risk, some of them were of people in intensive care or

otherwise confined to bed. If you take those studies out the risk is

going to be very small and that based on studies that don't all agree

that there even is a risk. Also it has been reported that there is a

risk when the PPIs are used for treating dyspepsia or peptic ulcer but

not for reflux. However, if I am ever confined to bed with gastric

ulcers I will consider the risk.

> A connection to C. difficile

Again, this is mostly a hospital problem. It has an incidence of about

12 cases per 100,000 population. If you are on antibiotics the rate may

be as high as 1 in 10,000. PPI use has been reported to increase the

risk 1.5 fold. If we apply that to the antibiotic risk then there would

1.5 cases in 10,000 people treated. I can live with that.

> Bad for bone — and your B12 levels?

I already went over this in another post. It is not proven to be bad for

bones and not proven to cause fractures. There is reason to be cautious

though. It is very likely that studies that found a correlation did so

because of confounding variables. A person can have bone density checked

if concerned. Likewise just have the B12 checked and deal with it. The

B12 problem was only found at very high doses and not with all PPIs.

> AND now low magnesium levels.

It isn't a problem until the magnesium goes low, so have it checked and

deal with it if it does. Going off PPIs and taking magnesium gets rid of

the problem. I can live with that until it is a problem, then I can go

off and take some magnesium. Not a big deal if you stay on top of it.

> I am sure PPI's are necessary for some people especially if they have the E

removed,

Very, unless a person doesn't mind the risk of strictures, ulcers,

heartburn, Barrett's and cancer from acid reflux. Weigh these against

the other risks you listed.

> but in general get off them if possible!

That goes for almost any medication. If you think PPI are special in

having risks take a look at the inserts that come with your other

medications. Like for PPIs, risks are often small.

> Sleep on an elevated bed or chair.

I agree.

> I very rarely have reflux at night

Lucky you. We are not all the same.

> and if I do I use a cold can of COKE to wash it down, sitting in a Lasy Boy

chair.

Does not work for me. It may wash it down but it is right back. My PPI

prevents it all day and night.

> And dont forget you may break a hip, if you fall, if you have been on them for

5-7 years and over 50.

Yes you may but it has not been proven that PPIs cause that. It may just

be that there are people who are likely to get fractures that are also

likely to need PPIs, not that the PPIs caused the condition.

> Notan is this one of your critical days? haha

I try to be critical everyday. I don't want to be fooled. I don't

subscribe to the, don't judge, don't be critical, and don't talk behind

backs, mentality. Ba ba. Those are for sheep. However I do try to avoid

being, vituperative, condemning and maliciously gossipy.

notan - Just some nut on the internet.

[Guest guest]

notan wrote:

> Again, this is mostly a hospital problem. It has an incidence of about

> 12 cases per 100,000 population. If you are on antibiotics the rate may

> be as high as 1 in 10,000.

Got an extra 0 in that 1 in 10,000. It should be 1 in 1,000. These are

community acquired, not hospital acquired, cases. The number are kind

of rough. They vary from study to study which can be influenced by where

in the progress of an out break the population is when the study was

done. In any case the main risk is from antibiotics not PPIs but if one

were on a PPI it could be good to keep in mind when using an antibiotic.

Something to ask your doctor at that time. Not something I am going to

worry about otherwise.

notan