Why The FDA Did Nothing to Moderate Nexium Prilosec And PPI Prescriptions

Last Updated on January 23, 2022 by Shaun Snapp

Executive Summary

  • Nexium and Prilosec were widely used for decades and were generally considered safe.
  • After problems became obvious, the FDA did nothing.

Introduction

  • PPIs or proton pump inhibitors are directed at pumps in the stomach that produce stomach acid, and they inhibit their activity.
  • Everyone is familiar with antacids like TUMS, PPIs are very powerful antacids that control the body’s ability to produce acid rather than merely buffering the acid with a base like calcium carbonate.
  • PPIs are blockbuster drugs that have been overmarketed and overprescribed and taken for far too long a duration of treatment by many millions of people around the world.
  • PPIs are an example of how the FDA and pharmaceutical companies conspired to have patients continue to use, even though the problems with the long-term use of PPIs were well known.

Our References for This Article

If you want to see our references for this article and related Brightwork articles, visit this link.

The History of PPIs

Introduction

The article How Did The Nexium Prilosec And PPI Dangers Remain Hidden For So Long?, covers many health problems that come from taking PPIs. This article will focus on how the FDA failed to respond to what they knew were problems with PPIs.

How Did The FDA Ignore This?

The FDA puts the profits of pharmaceutical companies ahead of public health. The following statement by the FDA contains false information that I will address after you read it.

Update: 3/23/2011
FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely.

The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.

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 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. Healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label. – FDA

However, the FDA knew that patients were taking these drugs for far longer than this, and they knew this after this statement was made by them in 2011.

The FDA never did anything to limit the overuse of this drug.

Observe the following quotation from a lawsuit by the government against the pharmaceutical company Wyeth.

As alleged in the government’s complaint, Wyeth’s illegal promotional campaign for Protonix was multi-faceted. Before Wyeth even began promoting Protonix, the FDA warned Wyeth that its proposed promotional materials were misleading because Wyeth had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD. Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.” Despite the FDA’s admonishment, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.

In addition, Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn.” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.

“Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” said U.S. Attorney Carmen M. Ortiz. “Wyeth ignored the FDA’s warning not to promote Protonix off-label, and then went so far as to contaminate CME programs that physicians rely on for unbiased, independent scientific information. Today’s settlement reinforces this office’s historic commitment to holding drug companies responsible for their misconduct.” – DOJ

Note that the FDA warned Wyeth that their ads were deceptive, but took no action.

This is how the FDA functions now, it writes “warnings” when it sees deceptive tactics, but takes no action. This means that the FDA tolerates that pharmaceutical companies will deceive their customers and damage their health, and won’t do anything to stop it.

Public Citizen Requests A Black Box Label for PPIs In 2011

The following request for a black box label to be added to PPIs was made to the FDA by Public Citizen. The following quote is from their request.

For some of these risks, current FDA-approved PPI labels do not mention the adverse effect at all, including the potential for developing dependence on the drugs, which results in rebound hypersecretion of stomach acid and recurrence of symptoms after stopping PPI use. For other risks, even if mentioned, the label does not adequately explain or emphasize them. There are currently no black box warnings in the label of any PPI.

We petition the FDA to require the inclusion of black box warnings identifying the following risks for all prescription PPIs (and equivalent, prominent warnings for over-thecounter [OTC] PPIs):
– Rebound acid hypersecretion risk: This is a form of dependence on PPIs that can be seen after as little as four weeks of use. Patients and providers need to be made aware of the possibility of dependence on PPIs and alerted not to take or prescribe PPIs beyond indicated uses and time frames. (Currently, this serious adverse effect is entirely missing
from all PPI labels.)
– Fracture risk: Long-term and multiple daily-dose PPI therapy has been associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Due to its potential severity, this adverse effect also needs to be placed in a black box warning on all prescription PPIs and in an equivalent, prominent warning on OTC PPIs, in addition to its current place in the ―Highlights‖ section of the prescription label. – Public Citizen

This increased fracture risk is due to the body not being able to absorb nutrients from the digestive system as the PPIs reduce stomach acid to the degree that it does not break down the food sufficiently.

It means the patient has developed osteoporosis.

Infection risk: An increased likelihood of serious infections, such as C. difficile-caused diarrhea and community-acquired pneumonia has been seen with both short- and longterm PPI use. Pneumonia risk is currently entirely missing from all PPI labels, while information on C. difficile infections — although attributed to all PPIs in the label — is only present on three (Nexium, Prilosec, and Vimovo). Given the potentially fatal nature of these two conditions, particularly in elderly and other vulnerable populations, information about both conditions needs to be placed in a black box warning.

– Magnesium deficiency risk: Information on the risk of severe magnesium deficiency with long-term PPI use needs to be placed as a black box warning due to its potentially fatal course. This adverse effect is particularly concerning, given the possibility of concomitant use with many medications that prolong the QTc interval on an electrocardiogram, which in the presence of low magnesium would increase the likelihood of life-threatening heart rhythm disruptions, or arrhythmias. (The FDA has recently placed this information in the ―Highlights‖ section of all prescription — but not OTC — PPI labels but has decided not to insert a black box warning.)

Vitamin B12 deficiency: The available evidence on the potential for vitamin B12 deficiency with long-term PPI use needs to be placed in the appropriate section of the label. Although the label states that this can occur with ―any acid-suppressing medication,‖ the warning has only been placed on the label for one PPI (Dexilant). – Public Citizen

There are more problems with PPIs, and you can read the full request at this link.

These are all very serious problems. You can find out more about the serious side effects of PPIs by reviewing the lawsuits that have been filed against PPI manufacturers available at Drugwatch.

Public Citizen Sues the FDA for Ignoring Their Request

After ignoring the request by Public Citizen for 2.5 years, Public Citizen finally decided to file a lawsuit against the FDA.

In a lawsuit filed in federal court in D.C. on April 30, Public Citizen seeks declaratory and injunctive relief to require the FDA to respond to a petition calling for stronger warnings on the stomach acid reducing drugs. According to the complaint (PDF), the FDA has illegally ignored a Public Citizen petition for more than two and half years.

Public Citizen indicates that patients who use the drugs for more than a month and then stop taking them suffer from levels of stomach acid that exceed the levels they had before they started PPI treatment. The increased acid often results in patients going back on Nexium, Prilosec or a similar drug to combat the even stronger acid levels, resulting in drug dependence.

“The agency has had more than two and a half years to respond to our petition. Meanwhile millions of people are taking these drugs without adequate warnings. The urgency of our petition is that only with these additional, serious warnings, will unnecessary PPI use decrease rather than continually increase.” – About Lawsuits

The FDA Feels Little Allegiance to the Public

This is one of the many problems with the FDA. The FDA does not feel that it has a responsibility to the public or to entities like Public Citizen that is set up to look out for the public interests. However, if Pfizer or Merck contact them and make a request or some type, the FDA jumps to attention. This means that FDA is funded (roughly 1/2) by the public purse, but works for the pharmaceutical companies. The FDA retains the credibility and prestige of being independent of pharmaceutical companies, but in reality, is responsive to the pharmaceutical companies over the government or the public. Observe that the FDA did issue a statement about PPIs six months after they were sent the request to add a black label to PPIs by Public Citizen, but they never responded to Public Citizen.

This is a pattern by the FDA of covering their backsides, but issuing an official statement. I observed the FDA did this exact thing on opioids. You can see this same tactic employed in the article How Purdue Pharma Created the Opioid Epidemic.

How PPIs Were Deceptively Marketed

After reading about the reality of PPIs, it is instructive to read about how they were marketed. This is covered in the article Analysis of The Deceptive Marketing of PPIs Like Nexium And Prilosec.

Conclusion

The FDA did not appear to care about the damage and dependency created by PPIs.

  • This problem with PPIs was obvious when they first went through clinical trials. It was why the duration of the drugs was so restricted, yet the FDA knew PPIs has become a wildly overprescribed drug, and the FDA PPIs had become normalized so that they were being added to hospital admission protocols and many people were using them for years.
  • The FDA knew that many millions of people were taking these drugs, and damaging their health.
  • Furthermore, the FDA has known about this for decades and covered for the pharmaceutical companies, who the FDA considers to be their “real customers.”

PPIs are an example of pharmaceutical companies and the FDA damaging public health, and doing so in a premeditated fashion for profit maximization.

This is just one of many areas that we track which medicine got wrong. The list just continues to grow the more things we evaluate.

You can see other areas medicine got wrong in the article Things Western Medicine Got and Continues to Get Wrong.

This is an excellent video that explains how PPIs have been broadly used for years.