Nearly 20 percent of people in the United States suffer from peptic-acid disorders such as chronic heartburn. When the first proton pump inhibitor(PPI) medication received approval in 1989, many patients with persistent heartburn—as well as other conditions such as peptic ulcer disease (PUD), nonsteroidal anti-inflammatory drug-induced gastropathy, and gastroesophageal reflux disease (GERD)—thought they'd finally found relief. In fact, the drug proved so popular that several other PPI drugs were approved in subsequent years.
However, many patients now have questions about this popular class of drugs, due to the results of a recent Johns Hopkins University study that found a link between long-term PPI use and a 50 percent increased risk of developing chronic kidney disease. We've compiled answers to the most common questions our clients ask about PPIs and potentially dangerous side effects. Please review the list below, and learn more about what you can do if you sustained injuries while taking the drug. If you have additional questions or are considering filing a PPI kidney lawsuit, contact McGartland Law today to schedule a free initial case consultation.
Q: What are PPIs?
A: Proton pump inhibitors, also known as PPIs, are a class of drugs approved by the Food and Drug Administration (FDA) to treat various acid-peptic disorders, including:
- Severe persistent heartburn
- Nonsteroidal anti-inflammatory drug-induced gastropathy, which is a stomach problem caused by the frequent use of NSAIDs, like ibuprofen
- Gastroesophageal reflux disease (GERD)
- Peptic ulcer disease (PUD).
First approved by the FDA in 1989, PPIs have become one of the most popularly prescribed classes of medication.
Q: What are some examples of available PPIs?
A: There are a wide variety of PPIs on the market today, available in both brand name and generic versions. The FDA approved:
- Prilosec® (omeprazole) in 1989
- Prevacid® (lansoprazole) in 1995
- AcipHex (rabeprazole)® in 1999
- Protonix® (pantoprazole) in 2000
- Nexium® (esomeprazole) in 2001
- Zegerid® (omeprazole and sodium bicarbonate) in 2004
- Dexilant® (dexlansoprazole) in 2009
Over-the-counter versions of Prilosec, Prevacid, and Zegerid are also available.
Q: How do PPIs work?
A: PPIs, or proton pump inhibitors, decrease stomach acid by blocking the gastric proton pump—the enzyme in the stomach lining that's responsible for the production of acid. These medications can reduce acid for up to two days, but may take several days to start working.
Q: When were PPIs first approved by the FDA?
A: Prilosec was the first PPI medication approved for sale in the United States. It gained FDA approval in 1989. Today, there are a wide variety of generic and brand-name PPI drugs available both over the counter and by prescription. PPIs come in capsule, tablet, and liquid forms, and range in dosage from 10 mg to 60 mg.
Q: Why are people filing PPI lawsuits?
A: Most recently, lawsuits against PPI manufacturers focus on a newly revealed link between PPI use and the development of chronic kidney disease. In 2016, a former Nexium patient sued the drug's manufacturer, AstraZeneca, claiming that using the drug caused his kidneys to fail and required a life-saving kidney transplant. The lawsuit further alleges that AstraZeneca was aware of the risk of kidney damage and disease, but failed to warn consumers of those risks.
In the past, plaintiffs sued PPI manufacturers such as AstraZeneca, Takeda Pharmaceuticals (the makers of Prevacid), and Pfizer Inc. (maker of Protonix) claiming PPIs weakened their skeletal system, causing their bones to fracture while performing simple daily activities.
Q: Have PPIs been recalled?
A: No, there hasn't been a widespread FDA recall of PPI medications in response to recent studies linking use of the drugs to serious kidney, heart, and bone problems. Additionally, the companies that manufacture PPIs haven't voluntarily recalled these medications. However, patients began filing lawsuits against some PPI manufacturers in 2016, alleging that the companies knew of the risks associated with the use of these medications, but continued to market them, and failed to communicate the risks to patients and their physicians.
Q: Has the FDA issued any warnings about PPIs?
A: Yes. The FDA has a variety of warnings related to PPI medications, including a warning that long-term PPI use may increase the risk of hip, spine, and wrist fractures in some patients, as well as a recommendation against taking PPIs for more than three 14-day periods in a year.However, as of early 2017, the FDA hasn't issued a comment or warning in response to recent studies linking PPI use to an increased risk of developing chronic kidney disease or kidney failure.
Q: Are the risks for kidney disease higher with PPIs than H2 blockers?
A; Yes. A study published in the Journal of the American Society of Nephrology found that patients who were taking PPIs had a 28 percent increased risk of developing chronic kidney disease compared to patients who used histamine H2 receptor blockers—such as Zantac® and Pepcid®—to treat acid-related gastrointestinal problems. Recent research shows that H2 blockers may be a better choice for gastrointestinal patients without ulcers who require heartburn or acid reflux relief on a long-term basis.
Q: What are the manufacturer warnings for PPIs?
A: The manufacturers of PPI medications such as Prilosec, Prevacid, and Nexium shouldn't be used by people who are allergic to the medication's active ingredients, or by people who are taking:
- Other types of blood-thinners
- Certain anxiety medications
- Prescription anti-fungal medications
- Immune system medications
- Heart medications
- Digoxin, which is used to treat atrial fibrillation, or irregular heart beat
Patients also shouldn't take PPIs if they have any of the following problems:
- Trouble swallowing food
- Frequent chest pain
- Heartburn with dizziness, lightheadedness, and sweating;
- Vomiting with blood
- Black or bloody stools
Q: What are the most common side effects associated with PPIs?
A: Although PPIs such as Nexium and Prilosec are used to relieve heartburn, acid reflux, and other gastrointestinal maladies, they can also cause a number of other health problems that, while not life-threatening, are decidedly undesirable. Common side effects of PPI medications may include gas, constipation, severe diarrhea, nausea, vomiting, stomach pain, itching, skin rashes, headaches, dizziness, joint pain, and anxiety.
Q: What serious side effects or complications are related to PPIs?
A: While many PPI side effects are relatively mild, some are serious, debilitating, and even life-threatening. Patients taking PPIs may have low magnesium levels or difficulty absorbing nutrients. More serious PPI-related side effects and complications can include bone fractures, osteoporosis, artery damage, heart attack, pneumonia, C. difficile infections, dementia, kidney injury, chronic kidney disease, and kidney failure.
Q: How do PPIs cause kidney disease?
A: Medical researchers aren't certain exactly how PPI medications cause kidney disease or failure. However, these drugs are known to inflame body tissue, and many medical specialists speculate that this inflammation plays a role in the development of PPI-related kidney issues. Additionally, the risk of these kidney problems increases the longer a patient takes PPIs.
As a result, the FDA recommends limiting PPI use to three 14-day treatment cycles or less in a year. When used for the treatment of ulcers, Prilosec, Nexium, and other PPIs may be prescribed for a longer period of time.
Q: What are the symptoms of PPI-related kidney disease?
A: Unfortunately, the symptoms of kidney disease are both gradual and subtle. As a result, the disease isn't diagnosed until it's in the later stages. Symptoms associated with kidney disease or failure can include:
- Skin rashes
- Shortness of breath
- Feeling cold
- Leg, side, or back pain
- Swelling of the face, feet, legs, or hands
Kidney disease or failure may also cause changes in urination. Patients may urinate less or more frequently; less or more than usual; have bloody or foamy urine; or have trouble urinating. Patients may also have the scent of ammonia on their breath or a metallic taste in their mouths.
Q: Are PPIs safe for women who are pregnant or breastfeeding?
A: Heartburn, indigestion, and other gastrointestinal complaints are common during pregnancy. Currently, no PPIs are approved for use by women who are pregnant or breastfeeding. In fact, both Prilosec and Nexium were shown to adversely affect the fetus in animal trials. If you're pregnant or nursing, and are suffering from severe heartburn or acid reflux, talk to your doctor about alternative treatment options. However, in cases where the benefits to the patient greatly outweigh the potential risks, doctors may instruct patients to continue their PPI medication.
Q: What should I do if I developed heart, bone, or kidney problems while taking PPIs?
A: Talk to your physician about another form of treatment for your gastrointestinal conditions, and to carefully document any diagnosis of heart, bone, or kidney problems. Keep records of medical visits, treatments, or procedures related to that diagnosis. As soon as you're able, contact a reputable and experienced personal injury or dangerous drugs attorney to discuss the details of your case. You may be eligible to seek compensation for your injuries.
Q: Have PPI lawsuits already been filed?
A: Yes. In 2016, a plaintiff filed a lawsuit against AstraZeneca, maker of the popular PPI Nexium, alleging that using the drug caused his kidneys to fail, necessitating a kidney transplant. The lawsuit also alleges that AstraZeneca was aware of the risk of kidney disease and failure associated with Nexium, but continued to market it without warning patients and their doctors.
This isn't the first time AstraZeneca's PPI medications have come under legal fire. The drugmaker was sued by multiple patients in 2011 over complaints that PPI use weakened bone structure, resulting in fractures. Takeda Pharmaceuticals, which manufacturers the PPI Prevacid, and Pfizer Inc., which manufacturers the PPI Protonix, have both faced similar lawsuits over fractures.
Q: How long do I have to file a PPI lawsuit?
A: How long you have to file a personal injury lawsuit is governed by the statutes of limitation. While these laws vary from state to state, in most instances, people who were harmed by dangerous drugs such as PPIs have just two years to file a lawsuit. This two-year window usually begins on the date that the patient was diagnosed with the related side effect or complication. Contact McGartland Law today for information on how your state's statute of limitation laws might affect your potential PPI lawsuit.
Q: How much does it cost to file a PPI lawsuit?
A: Most law firms that handle personal injury or dangerous drug cases work on a contingency basis. This means clients aren't billed until the case is resolved in their favor. Under this type of arrangement, the client pays the attorney for their legal services out of the settlement they receive in the case, rather than paying for the legal representation upfront. Because these firms only get paid when and if you receive a settlement, you don't have to let limited financial means stop you from fighting for the compensation you need and deserve.
Q: How long will a PPI lawsuit take?
A: The length of litigation might vary significantly from case to case, making it difficult to determine just how long a case will take to resolve. Some cases may conclude in days, weeks, or months, while others stretch on for years. Discussing the details of your particular case with an experienced personal injury attorney can give you a better idea of how long your PPI lawsuit might take. McGartland Law offers no-cost, no-obligation initial case consultations. Contact us today to schedule an appointment.
Q: What damages can I recover in a PPI lawsuit?
A: If you developed serious kidney, heart, or bone problems while taking a PPI, or lost a loved one due to a PPI-related disease or complication, you may be able to seek compensation for damages. These damages are usually divided into two categories. One is economic damages, which includes medical costs (including doctors' visits, treatments, surgeries, medical-related travel expenses, and more); and lost wages and loss of earning capacity. The other is non-economic damages, such as reduced quality of life, and pain and suffering. Contact McGartland Law today to learn what types of damages might be applicable in your case.