Dozens of patients filed lawsuits over Prilosec after the blockbuster heartburn drug was linked to an increased risk for broken bones. Now, a series of new studies have discovered that long-term Prilosec patients may be at risk for an even more troubling complication: progressive kidney disorders.
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Pharmaceutical giant AstraZeneca is responsible for two of the world’s best-selling heartburn drugs: Prilosec and Nexium. While Nexium has now surpassed Prilosec in sales, the two drugs are actually very similar.
Both Prilosec and Nexium are “proton pump inhibitors,” which knock out the stomach’s ability to produce and secrete gastric acid – thus reducing the side effects of conditions like acid reflux disease and duodenal ulcers. Both drugs have this desirable effect through a similar mechanism – and both have been linked to serious side effects, from an increased risk of bone fractures to progressive kidney disorders.
Researchers Note Safety Risks Of Prilosec
Despite their widespread popularity, proton pump inhibitors were actually approved to treat specific conditions, disorders caused or worsened by the production of gastric acid:
- active duodenal ulcers
- gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
You’ll notice that none of these conditions are named “heartburn.” That’s because heartburn is a symptom, not a condition in itself. Indigestion, too, another common off-label use for Prilosec, is a symptom. In particular patients, these ailments may have nothing to do with GERD, ulcers or a pathological hypersecretory condition like Zollinger-Ellison syndrome – the conditions for which Prilosec is actually approved.
But in many ways, proton pump inhibitors have become a fall-back solution for some doctors who are struggling to tackle a wide range of gastrointestinal disorders. Of course, proton pump inhibitors work for many of these unapproved indications, at least those in which gastric acid is implicated. The problem, however, is that once PPIs start working, it can be nearly impossible for patients to stop taking them. That’s where the long-term side effects of proton pump inhibitors become seriously troubling.
Over the last decade, researchers have identified a number of significant side effects linked to the use of Prilosec and other proton pump inhibitors:
- bone fractures (wrist, hip, spine)
- hypomagnesemia, a dangerously low level of the mineral magnesium
- infections, like C. diff (Clostridium difficile)
- acute kidney injuries, including acute interstitial nephritis
- chronic kidney disease
- kidney failure
In some sense, this research was only made possible after patients began taking the drugs for longer periods of time – something the FDA strongly discourages against.
A Long & Checkered Legal History
Prilosec’s active ingredient omeprazole is one of the oldest proton pump inhibitors, discovered in 1979 and developed initially by AstraZeneca for the US market throughout the 1980s.
As the first representative of the class, approved for sale in 1988, omeprazole wasn’t perfect. In particular, the chemical’s effects are highly dependent on a patient’s native chemistry. To receive the same reduction in symptoms, some patients will require relatively low dosages, while others will need high, or even multiple, doses. Even before Prilosec was approved by the FDA, AstraZeneca set out to find a solution, investigating a number of avenues in search of the “perfect” proton pump inhibitor. That task would take more than a decade.
Confusion, & Death, Follow Prilosec’s Approval
Prilosec wasn’t approved as Prilosec. In 1989, the drug was named Losec, but that name proved confusing for prescribing physicians. Once the FDA caught wind that doctors, intending to prescribe Losec, were accidentally prescribing their patients a diuretic called Lasix, the agency told AstraZeneca to change the name.
The FDA’s caution was not unwarranted: reports of patient deaths had emerged, receiving widespread attention in the medical literature. In his book Nothing Is Without Poison: Understanding Drugs, Michael B. Roberts noted how “bad writing by a hospital doctor” led to a patient’s death in Belgium. Soon after, AstraZeneca announced the change to Prilosec, which is how we know the drug today.
Patent Dispute Leads To Settlement
In 2000, AstraZeneca unleashed the fruit of its search for a better PPI, releasing Nexium onto the US market. Some companies, however, were not impressed by the claims of Nexium’s superiority – accusing the drug’s manufacturer of “patent evergreening.”
To understand this allegation, leveled most notably by the Walgreens chain of pharmacies, it’s crucial to note that AstraZeneca’s patent on omeprazole was set to expire in April 2001. After that, a flood of generics would sweep the market, reducing the price of AstraZeneca’s branded version to a new low. Obviously, that wouldn’t be a good thing for the company’s profits, Plaintiffs pointed out.
Replacing Prilosec: Fending Off The Threat Of Generics
But this problem wasn’t new to AstraZeneca. By 1995, the company had organized “a group of marketers, lawyers and scientists” to devise “possible solutions to the patent-expiration disaster facing the company,” the Wall Street Journal reported in 2002.
After sketching out “nearly 50” ideas, the Shark Fin project identified the best solution, “finding a new heartburn drug that worked significantly better” than Prilosec, along with the worst, “launching a successor drug that was virtually no better but had several more years of patent exclusivity.” Ultimately, AstraZeneca would implement the latter plan.
First, however, the company would try to fend off the impending wave of generics by suing potential competitors. AztraZeneca sued Indian generics manufacturer Ranbaxy over patent infringement in 2005. Canadian drugmaker Apotex also came under fire. The plan worked, and fifteen months after April 2001, AstraZeneca was still holding the exclusive patent rights to sell and market omeprazole in the United States.
Nexium Captures The Market
At the same time, the company had finally introduced Nexium, backing the drug’s release with an annual marketing budget of nearly half a billion dollars.
As the Wall Street Journal put it, AstraZeneca’s plan was simple: “convert Prilosec users to the new branded product,
Nexium proved to be a blockbuster, overshadowing its predecessor Prilosec. But one group of critics wasn’t sold on AstraZeneca’s strategies: the Shark Fin group. Speaking to the Wall Street Journal, former members of the company’s tactical team said: “Nexium was among the poorest of the many drug solutions they pondered back in 1995 – a new medicine that isn’t any better for ordinary heartburn than [Prilosec].”
Walgreens, Consumers File Suit
Walgreens and Rite Aid, among other companies dependent on pharmaceutical sales, were not impressed. Joining forces, the pharmacies filed suit against AstraZeneca, arguing that the company had attempted to create a monopoly over omeprazole in violation of the Sherman Anti-Trust Act. They lost. In 2008, district court judge Richard W. Roberts dismissed the case, in part because AstraZeneca had never removed Prilosec from the market altogether.
Consumers, however, didn’t lose. In the early and mid-2000s, several groups of American consumers filed class actions against AstraZeneca, accusing the company of “patent evergreening” and monopolistic intentions. While some of these class actions were dismissed, at least one reached a somewhat successful resolution. In 2012, a Nexium class action filed in Massachusetts was settled for an undisclosed amount, although AstraZeneca continues to deny allegations that it intentionally manipulated the market for omeprazole.
Product Liability Lawsuits Surge
After the FDA announced that proton pump inhibitors were linked to bone fractures, injured Prilosec patients turned to the legal system, filing lawsuits against the drug’s manufacturer AstraZeneca. While many patients may still be able to file lawsuits for bone injuries, legal experts believe AstraZeneca’s legal troubles may be heading in a different direction. The drug’s recent link to progressive kidney disorders is expected to kick off a renewed wave of litigation, in part because the injuries involved could be fatal.
To learn more about filing a Prilosec lawsuit, click here.