This is the second in the AboutLawsuits.com annual series highlighting the top stories and issues that emerged in 2016
Over the past year, a number of series side effects and safety problems emerged in connection with drugs and medical devices that were already on the market. Below is a list of the Top 10 Drug Side Effects and Health Risks that Emerged in 2016, including several blockbuster medications. In many cases, new label warnings were added to the drugs years after they were introduced and marketed to unsuspecting consumers, who were not provided information about severe and potentially life-threatening side effects.
1. Nexium, Prilosec and Other Heartburn Drug Kidney Risks
In January 2016, a study published in the medical journal JAMA Internal Medicine found that the side effects of Nexium, Prilosec and other proton pump inhibitors (PPI) may increase the risk of kidney disease by as much as 50%.
The findings added to prior kidney risks highlighted in an April 2015 study published in the medical journal CMAJ Open, which found that users of the popular heartburn drugs may face a three fold increased risk of developing acute interstitial nephritis, which involves inflammation of the kidneys, and a 2.5 fold increased risk of acute kidney injury. Both of these conditions can lead to the development of chronic kidney disease and end-state renal failure.
The findings have led to a growing number of Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits, Dexilant lawsuits and other claims brought on behalf of long-term users of the popular acid reflux drugs, alleging that they may have avoided serious kidney problems if the manufacturers had adequately warned about the risks.
Amid aggressive marketing by the makers of PPI medications, without warning about the potential kidney side effects, many doctors have continued patients on the drugs for years, with little or no effort to reduce treatment. However, a growing number of health experts are now questioning that practice, suggesting that many users may be able to avoid the recently discovered kidney risks through other treatment alternatives.
2. Invokana Health Problems
Over each of the first three years that Invokana has been on the market, a number of serious side effects and health problems have emerged in connection with the new-generation diabetes drug. Invokana was the first member of a new class of diabetes drugs introduced in mid-2013, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which also include similar medications like Farxiga, Invokamet, Jardiance, and Xigduo
At the end of last year, the FDA announced that Johnson & Johnson and the makers of other SGLT2 inhibitors were being required to add new diabetic ketoacidosis warnings to their medications, indicating that users may experience a dangerous buildup of acid levels in the blood. These new warnings that were in place for the first time by early 2016, urging users to to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In June 2016, the FDA announced another new Invokana warning update, indicating that the medication may increase the risk of acute kidney injury and other kidney problems.
As a result of prior studies that highlighted these risks, a growing number of Invokana lawsuits and Farxiga lawsuits were filed over 2016, alleging that the manufacturers of these new generation diabetes drugs should have done a better job researching the potential side effects, and provided warnings for consumers and the medical community before encouraging doctors to switch diabetics to the new medications.
3. Abilify Gambling and Other Compulsive Behaviors
Following years of concerns that side effects of Abilify may increased the risk of gambling, sex addiction, binge shopping and other compulsive behaviors, the FDA finally announced that new warnings would be added to the popular antipsychotic drug in May 2016.
Although gambling warnings have been provided with Abilify in several other countries, doctors and consumers in the United States were not provided with any information until this year about the risk that the medication may cause uncontrollable urges to engage in destructive behavior.
The new Abilify warnings highlight the importance of doctors and family members monitoring Abilify users for gambling problems, compulsive shopping and other impulsive activities, suggesting that symptoms may appear shortly after starting use of the drug or increasing dosage, often going away shortly after the medication is discontinued.
The label update came after a study published in early December 2015 indicated that users of Abilify face a 532% increased risk of pathological gambling when compared to those who did not take the drug.
Bristol-Myers Squibb and Otsuka Pharmaceuticals now face a growing number of Abilify gambling lawsuits brought on behalf of individuals throughout the U.S., alleging that they may have avoided substantial losses and damage to their financial security if the drug makers had not withheld the warnings from American consumers and doctors.
4. Essure Label Warning Update
After years of women indicating that they suffered painful and debilitating complications from Essure birth control implants, which have been found to migrate out of position, puncturing organs, and cause severe allergic reactions, the FDA finally ordered the manufacturer to add in-depth Essure label warnings in November 2016.
Essure is a medical device that provides women with permanent sterilization, involving coils that are placed in the fallopian tubes during an out-patient procedure. The Essure coils cause scar tissue to form and prevent pregnancy.
The black box warning added in 2016 is the strongest that the FDA can require a medical device carry, and comes after independent experts recommended that additional information be provided about the Essure procedure problems experienced by many women who received the coils, including perforation of the uterus and fallopian tubes, pain and allergic reactions. The new warnings also inform women that if Essure needs to be removed, it must be done through a surgical procedure.
Women who are considering the birth control procedure will also now be presented with a patient checklist, which is designed ensure that they are aware of the potential health risks.
Recently, the FDA reported that it had received nearly 10,000 Essure adverse event reports between the date the device was first put on the market in November 2002, and the end of December 2015. Of those, 6,989 involved pain or abdominal pain, 3,210 involved unusually heavy or other menstrual irregularities, 2,990 were reports of headaches, 2,159 reports of fatigue, 2088 reports of weight fluctuation, 2016 reports of patient-device incompatibility, such as nickel allergies, 854 reports of device migration, 490 reports that the Essure operated differently than expected, 429 reports that the Essure coils broke, 280 reports that it was difficult to remove, 199 reports of the Essure coils positioned incorrectly, and 187 reports that doctors had difficulty implanting it. In many cases, reports included multiple complication complaints.
Bayer faces a growing number of Essure lawsuits, filed by women nationwide who said the manufacturer failed to warn them about the risks linked to the birth control coils.
5. Hernia Mesh Complications
Concerns emerged last year about the safety of several high-profile hernia mesh implants, amid reports that a large number of users were experiencing hernia repair complications, including adhesion to organs, recurrent hernia and the need for risky surgery to remove the mesh years later.
At the forefront were concerns over the Atrium C-Qur, and the Ethicon Physiomesh.
The Atrium C-Qur (pronounced “secure”) mesh is a polypropylene mesh with an outer coating of gel made from triglycerides and omega-3 fatty acids, known as the O3FA layer. Many say this is made from fish oils, which can cause allergic reactions in some patients.
Reports indicate that the mesh can lose its coating, stick to organs and bowels, causing them to tear, and that it can get folded and twisted in the body, resulting in severe pain and infections. Its adhesive nature often makes it hard to surgically remove, according to some doctors.
Problems with the Ethicon Physiomesh became so widespread that a Physiomesh recall was issued in June 2016 after the manufacturer sent out an urgent field notice to doctors worldwide. Although the action was classified as a “market withdrawal” by the FDA, the manufacturer indicates that it has permanently removed the hernia mesh product from the market, and asked medical providers to return any implants that were not already used during a hernia repair.
The recall came after an analysis of unpublished data found that problems with Ethicon Physiomesh were higher than average recurrence and reoperation rates. Ethicon reports that it tried, but failed, to find a definitive cause and solution for the problem; ultimately deciding to pull them from the market.
The reports of complications and the recall have led to a growing number of hernia mesh lawsuits being filed in courts nationwide, and the number is expected to reach several thousand cases by the end of 2017.
6. Stryker LFit and Accolade Hip Stem Implants
In August 2016, a Stryker LFit V40 recall was announced for certain large-diameter femoral heads, which the manufacturer indicated were failing at rates higher than expected.
According to reports and a growing number of Stryker Accolade and LFit lawsuits, the implants are prone to what are known as taper lock failures, which indicates failures where the femoral head connects to the femoral neck.
These failures are often associated with metal blood poisoning, known as metallosis, which occurs when high levels of chromium and cobalt shed as debris from the components enters the surrounding tissue and bloodstream. This increases the risk of failure, and many recipients of these implants have had to undergo risky revision surgery to have them removed or replaced after having them implanted for just a short period of time.
8. Onglyza Heart Failure Warnings
In recent years, there has been concern within the medical community about a heart failure risk with Onglyza, an AstraZeneca type 2 diabetes drug, leading the FDA to require new safety warnings in April 2016.
The FDA initially launched a safety review into the Onglyza heart risks in February 2014, following publication of a study in the New England Journal of Medicine, known as “SAVOR”, which found an increased rate of hospitalization due to heart failure among Onglyza users compared to those given a placebo.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.
The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
On April 5, the FDA issued a drug safety communication, announcing that new heart failure warnings will required for the diabetes drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, which are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
9. Flavored Electronic Cigarettes
As the use of electronic cigarettes, often referred to as vaping, continued to grow in popularity throughout 2016, researchers worldwide have been taking a closer look at the potential side effects associated with the devices, raising concerns about what they find.
Of particular concern were reports that flavored liquid nicotine products not only drew the attention of teens and children, but also may carry higher risks of health and respiratory problems than other liquid nicotine products.
The concerns culminated in a rare warning by U.S. Surgeon General Dr. Vivek H. Murthy in December 2016, warning that e-cigarettes prime a new, younger generation for the risks of nicotine. Use of e-cigarettes are associated with the use of other tobacco products, like traditional cigarettes.
More so, e-cigarettes are often easily accessible to the nation’s youth via the internet. Teens can easily skirt age regulations when buying the devices online.
The warning also concluded the effects of the aerosol are not harmless flavored water vapor, as many believe. E-cigarette liquids contain nicotine and other chemicals and compounds which may have lasting harmful effects.
A study published in November 2016 found that flavoring additives commonly used in e-cigarette liquid often convert to high amounts of toxic chemicals, including formaldehyde. Those findings appear to confirm a previous study published in 2015, which found that e-cigarettes released higher levels of formaldehyde when the devices were set to a higher voltage, exceeding levels released by traditional cigarettes. A person vaping at high voltage will consume 14.4 milligrams of formaldehyde per day, that study found.
The study is not the first to specifically look at the effects of flavorings. A study published in October found that flavored liquid nicotine vapors are toxic to a user’s lungs. The chemicals, especially those with strawberry flavoring, could cause widespread inflammation and lung cell damage.
10. Distracted and Drowsy Driving
This year, traffic safety officials were surprised to discover that there was a sharp rise in auto accident fatalities in 2015, and that trend appears to be continuing in 2016, as they scrambled for a reason for the higher death rates amid wider use of seat belts and overall much safer vehicles on the road.
In May 2016, University of Houston and the Texas A&M Transportation Institute researchers released a new study suggesting drivers who text while driving are more prone to veering off course, suggesting that the activity has a greater disruption to the eye-hand coordination, increasing the risk of an auto accident.
Sleepy drivers also contributed to the problems, with researchers from AAA Foundation for Traffic Safety reporting in December that attempting to drive drowsy was as dangerous as driving drunk.
A previous AAA study, released in November 2015, found that more than two in five drivers, or 43.2%, admitted to falling asleep or nodding off while driving at least once in their lifetime. Nearly 20% of all drivers have fallen asleep at the wheel three times or more in their lifetime.
Tags: 3T Heater-Cooler System, Abilify, Atrium C-Qur, Auto Accident, Diabetes Drugs, Electronic Cigarette, Essure, Ethicon, Heart Attack, Hernia Mesh, Hospital Infection, Invokana, Ketoacidosis, Kidney Failure, Liver Failure, Nexium, Onglyza, Physiomesh, Prilosec, Proton Pump Inhibitors, Stryker Accolade, Stryker LFit, Top 2016