Posted on 08/10/2007 12:59:21 AM PDT by neverdem
Associated Press
The popular heartburn drugs Prilosec and Nexium don't appear to spur heart problems, say preliminary U.S. and Canadian probes announced Thursday.
The Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people, back in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.
Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, and tracked patients for five to 14 years. The company's initial analysis counted more patients treated with drugs who had had heart attacks, heart failure or heart-related sudden death.
The FDA followed up on those studies, and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link was a coincidence.
While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said Thursday.
The FDA then looked at 14 additional studies of the drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.
The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."
Health Canada reached the same initial conclusion. It also urged doctors and patients to make no changes until its own probe is finished by year's end, noting that untreated GERD can lead to serious complications.
The drugs are among a family of acid-reducers known as proton pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while the agency's focus is on Nexium and Prilosec, it is "interested in the data from all similar products" as it looks for all available evidence to settle the heart question.
Nexium is the world's No. 2 selling drug, with 2006 sales of $6.7 billion, according to health care research firm IMS Health.
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That would be a heck of a hurdle to overcome for marketing if the drug actually worked by killing you.
Then again, prospects would be much brighter in the Chinese market.
Another study, just out, shows that acid reflux may increase esophageal cancer. So “you pay your money and take your choice”.
Ugh. I take “Prevacid” almost every day or I get extreme burning in the gut & throat - I wonder if that’s next. OTC stuff don’t work. Am in shape and eat well, it’s just there.
I went “cold turkey” on antacids, and immediately stopped getting kidneystone attacks. Transfats (Olestra) were alleged to cause reflux.
ever try taking digestive enzymes?
Sounds interesting — more detail please.
Yes - I eat Yogurt essentially everyday.
I have been drinking one of those "Dan Active" bottles every day. It is the one that says 70% of your immune system is in your stomach.
It has about 1 Billion Bacteria in every small bottle...
ER docs and Cardiologists have been using these drugs for over a decade to help diagnose/separate a heart attack from severe gastric reflux/GERD.
After doing an EKG and if the results are normal, a quick trial and rx for these drugs will eliminate the heart as the culprit for each patient. If the patient gets better and the symptons go away, they had a severe GERD episode which can be controlled by these drugs and diet.
as we age, we lose production of digestive enzymes. lose production of betain hydrochloride.
10% every 10 years.
by 50 we lose 1/2 production. Look into a multi enzyme product, and drink more water.
hyper acidity is actually a very rare disorder. hypo acidity is the problem, and a multi enzyme will actually help you digest your food instead of dumping the stomach by alkalizing it.
my father was a chiropractor, and swore by this. He died, at the ripe old age of 93. Most doctors do not last that long.
Thank you - I’m going to further check into this.
I have been on meds for this for way too long.
A gastro-type doctor told me a couple of months ago to start taking over the counter Prilosec. Apparently I had this GERD condition and didn’t feel it, but over the course of several years the acid scarred and narrowed my esophagus until a standard size vitamin pill was hard for me to choke down. One night back in June a tiny piece of pork chop got stuck and I had to go to the ER to get it taken out.
The nurse said that here in the Phoenix area, this one doctor alone sees two or three patients a week with food stuck in their esophagus. On a followup visit he will go in and stretch it back out to its normal inside diameter again. Some of his patients come in every 5-10 years to get stretched when the narrowing gets to be too much. They will be there for 2 hours and the entire procedure takes all of 15 minutes.
I thought I had a birth defect or something, and was surprised and relieved to find that it’s not all that uncommon and it can be treated fairly easily. Anyone who has any trouble at all swallowing due to a narrowed esophagus should consult a gastrointestinal doctor and get stretched out again. Just FYI, for anyone who might need the information.
Have you tried Prilosec? I couldn’t live without it. Once a day, every day.
When I took Prilosec for a while, I got heart palpitations. Then I would go off it, and within a day the heart palpitations went away. Then I’d go back on the Prilosec, and within a week or so the palpitations would come back. Rinse and repeat. So I know it was the Prilosec causing the palps. Since I stopped taking it, those palpitations have never returned.
Now I take a whey protein powder, and it has the reflux under control. I have also found that certain foods (like cheese or maybe ice cream) make the reflux worse, perhaps related to a “food sensitivity” which I am trying to figure out.
About 8-10 weeks ago I started getting heart burn during my daily bike ride. After a couple of weeks, it got bad, and antacids didn't seem very effective.
Went to the Doc. EKG, stress test, cardiac cath, angioplasty and two stents later...my heart burn is gone!
The moral to the story is, if antacids don't make your heartburn go away and stay away, it isn't heart burn, and you should call 911.
Oh, I'm only 43 and exercize every day. Don't think it can't happen.
Milk and milk products have lactic acid. It’s the acidity aggravating your GERD.
That is quite likely. I figured out a year or so ago that I was sensitive to milk, because I craved it in the middle of the night. Sounds weird, but that is one sign of a food sensitivity. I have continued eating cheese and ice cream and other dairy products. Last weekend we had some fresh mozzarela cheese, and my stomach was not happy! Still trying to figure things out. Any suggestions?
control portions, drink lots of water.
just work with your system. It will work with you.
When Prilosec was prescription only, it was pretty expensive, but it worked for me. Now that it’s over the counter, it works just as well and is a heck of a lot cheaper. I recommend it.
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