No Need to Stop Taking Nexium or Prilosec by Robert Fusco, MD

One aspect of technology that has just recently exploded is the field of communications. Our children will never know a world without Google and instant text messaging. With Internet news sites, bloggers, rss, podcasts, and TV cable news, information can now be widely disseminated throughout the world in seconds. For the most part, this is a good thing. But, sometimes quickly getting out the word can have bad consequences, especially if the information is faulty to begin with.

Nexium, Prilosec, and Heart Damage?
An example would be recent news headlines stating that Nexium and Prilosec may cause heart damage. This report arose from a preliminary FDA communication stating that they were reviewing data from two studies - a long-term study of Prilosec and more recent data concerning Nexium. Initial review of these two small studies raised concerns that daily use of Prilosec or Nexium may cause a slight increase in the risk of heart attacks and heart failure or heart-related sudden death.

Of course, if this were true, it would be important information as so many individuals depend upon these medications every day. Called Proton Pump Inhibitors, or PPIs for short, this class of drugs has been quite dramatic in helping those who suffer from acid reflux and severe heartburn. Nexium and other PPIs are used by tens of millions of people across the world. Last year, Nexium was the second-biggest-selling drug in the world, behind the cholesterol medicine Lipitor, with global sales totaling $4.6 billion.

As one might expect, as soon as this headline hit the news our office was bombarded by phone calls from anxious patients. They were worried that they may have a heart attack if they continued taking their Nexium or Prilosec. Many abruptly stopped their medications and now were suffering from severe heartburn. They were miserable and didn't know what to do.

A False Alarm
Unfortunately, this scare was much to do about nothing. Since the initial report, AstraZeneca provided the FDA with a large amount of additional data. The FDA performed a more detailed review of those studies and found that the data was skewed on an age basis. After this re-review, the FDA concluded that the heart link was a coincidence. Health Canada, who performed the same analysis, reached the same conclusion. The FDA also looked at 14 additional previous studies of these drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy placebo pill, those who took the heartburn drugs actually had a lower incidence of heart problems.

FDA Recants
At this point, the FDA's review does NOT suggest an increased risk of heart problems for patients treated with Prilosec or Nexium. On August 9th, the FDA issued a public notice 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." So, it was all a false alarm brought about by prematurely release information into the world of communication. Of course, you can't fault the FDA since if they had not informed the public of their concern and the risk of heart disease was true, they would have been accused of withholding life-saving information. I'm glad I don't work for the FDA. That would be a hard position to be in.

What Are The True Side effects?
Okay, so all this fuss over possible heart damage from PPIs a false alarm. Well, what are the true side effects. In fact, there are very few. Over the past twenty years, PPIs have proven themselves to be dramatically effective and extremely safe. While a small percentage of individuals may experience minor side effects such as headache, abdominal pain, or diarrhea, these problems are infrequent and temporary. They usually can be controlled just by reducing the dose and are eliminated if the drug is discontinued. I have been prescribing these medications for over 20 years and have yet to see a serious side effect.

There was one study reported from England last year that suggested that acid suppression from PPI treatment may reduce calcium absorption from the diet and increase the risk of hip fracture, especially in the elderly. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid. So far, this conclusion seems true, but most doctors feel that this risk can be averted by proper monitoring the bone density of elderly people taking the drugs and recommending calcium-rich diets to all patients.

What Should You Do?

1. If you take Nexium, Prilosec, or any of the other PPI drugs, you do NOT need to stop taking them. The news that these drugs may cause heart attacks was premature and false. The FDA says there is no need to stop them and doing so will cause a return of acid damage and symptoms.

2. If you are post-menopausal woman or anyone with a family history of osteoporosis, you should consider supplementing your diet to include 1500 mg of total calcium per day and 400 - 800 mg of vitamin D. Of course, this it true whether you take PPIs or not. Those at high risk should talk to their doctors about periodically monitoring bone density with a simple x-ray.

3. Don't always believe what you hear about prescription drugs in the popular new media. If you have any questions, discuss them with your doctor.