Check Your Medicine Cabinet: FDA Announces Voluntary Recall for Over-the-Counter CVS Nasal Mist Due to Microbiological Contamination

For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves. Product Quest Manufacturing, a Florida company that manufactures the product, recommends consumers stop using it immediately and either discard or return the spray to the place of purchase.

On August 8, 2018, the U.S. Food and Drug Administration (“FDA”) announced a voluntary recall of the CVS Health 12 Hour Sinus Relief Nasal Mist. Product Quest Manufacturing found a specific lot of their spray was contaminated with bacteria Pseudomonas aeruginosa. According to Product Quest, “repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised.”

The recalled products can be identified by locating the side panel. The side panels are coded with “Lot 173089J” and “EXP 09/19.” 16,896 units are involved in the recall. The units were sold nationwide.

What is Pseudomonas aeruginosa?

Pseudomonas aeruginosa is the most common strain of the Pseudomonas infection to cause problems in humans. Infections with this type of bacteria are generally treated with antibiotics, although the Centers for Disease Control and Prevention notes that some strains – mostly in healthcare facilities – can be multidrug-resistant. Pseudomonas aeruginosa infections associated with healthcare facilities often cause bloodstream infections, pneumonia, urinary tract infections, and surgical wound infections. Exposure to Pseudomonas aeruginosa is seen in hot tubs and swimming pools. These mild exposures in normally healthy people result in ear infections or skin rashes. Symptoms can also mimic the common cold or flu and include sinus pain and pressure, fever and chills, body aches, light-headedness, rapid pulse and breathing, nausea and vomiting, diarrhea, or decreased urination.

Regulation of Over-the-Counter Medications

As an over-the-counter, or nonprescription, medication the CVS Health 12 Hour Sinus Relief Nasal Mist is sold directly to consumers without a prescription. In 1951, the Durham-Humphrey Amendment to the Federal Food, Drug and Cosmetic Act of 1938 established a legal framework for prescription and non-prescription drugs. The Amendment also authorized the FDA to make this prescription/over-the-counter distinction. The FDA states that medications designated as over-the-counter are generally safe and effective when used as directed. However, just because the FDA presumes over-the-counter drugs are safe does not mean they are free of defects. Being vigilant requires reading warning labels, taking medications as directed and watching for recalls such as this one for the CVS 12 Hour Sinus Relief Nasal Mist.

The FDA announcement directs consumers who have been injured by the nasal mist to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail or by fax.

If you become ill or are injured by an over-the-counter medication, seek the assistance of a physician or health care provider.

Popular Fluticasone Nasal Spray Recalled by Manufacturer

Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.

The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.

Glass Particles Found in Spray Bottle

“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”

With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.

“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”

Fluticasone Widely Used for Allergies

Fluticasone By Ramon FVelasquez [CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0)], from Wikimedia Commons

Fluticasone inhalers

Fluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:

“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”

WebMD notes that the drug does not relieve symptoms immediately.

“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.

Precautions Necessary for Fluticasone Use

WebMD describes some of the precautions, as well.

“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”

Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.

“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”

Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at uscustomerservice@apotex.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.

Addicts Not Only Ones Paying Price of Opioid Epidemic

One trillion dollars. That’s how much the country spent on the opioid epidemic between 2001 and 2017, according to a report released by the nonprofit institute Altarum, a consulting group focused on improving public health.

The cost of the crisis trickles both up and down and impacts corporations, governments and insurance companies, as well as families, local businesses and neighborhoods.

“The greatest cost comes from lost earnings and productivity from overdose deaths – estimated at $800,000 per person based on an average age of 41 among overdose victims,” the report states. “This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs.”

Opioid Epidemic Results in High Costs to Society

More than 42,000 deaths were caused by opioid overdoses in 2016, according to the U.S. surgeon general’s office. In 2010, the death toll was 21,000. The startling spike spurred the office to take action, with Dr. Jerome Adams issuing an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone is an easily administered nasal spray that quickly reverses the deadly symptoms of an overdose.

“Health care costs related to the opioid crisis reached $215.7 billion from 2001 to 2017,” the report states. “This stemmed largely from emergency room visits to treat and stabilize patients after an overdose, any associated ambulance and Naloxone use required, and related indirect health care costs associated with the increased risk of other diseases or complications.”
And the costs have nowhere to go but up.

“An additional $500 billion is estimated through 2020 if current conditions persist,” the report states.

opioid epidemic

Governing magazine, a nonpartisan news outfit, reports that Middletown, Ohio, spent $1 million-plus on ambulance dispatches for overdoses between October 2016 and October 2017. It also reports that Pennsylvania will spend $5 million this year on naloxone alone. In Nebraska, the epidemic costs $465 per resident. In West Virginia, it costs $4,793 per resident.  The state has one of the highest rates of opioid overdoses in the country.

“The costs build up slowly over time, so you almost don’t even notice it,” Nashville lawyer Mark Chalos told the magazine in an article titled “How Much Is the Opioid Crisis Costing Governments?” “But when our people really started to dig into the budgets, they realized the costs are more significant.”

Geographic Factors in Opioid Epidemic

The American Enterprise Institute, a public-policy think tank, conducted a study on “The Geographic Variation in the Cost of the Opioid Crisis” and found the costs of the opioid epidemic are disproportionate at state and local levels, as exemplified by the Nebraska / West Virginia comparison.

“The types of costs attributable to opioid abuse – health care costs, criminal justice costs, and lost productivity, for example – are fairly well understood, as is the economic impact of the crisis at the national level,” the study states. “However, the economic burden of the opioid epidemic is unevenly distributed across the country, with many communities especially hard hit. As federal, state, and local policymakers and stakeholders seek to curb the epidemic, it is vitally important that they know how these costs are distributed.”

VSL – Value of a Statistical Life – A New Way to Measure Cost of Opioid Epidemic

Enter the White House’s Council of Economic Advisers, or CEA. The federal agency compiled a paper in November 2017 that used a metric called the Value of a Statistical Life, or VSL, to gain insight into the costs of the opioid epidemic. The VSL essentially puts a price tag on one’s willingness to lower his or her death risk. It is helpful for shaping policies and programs that reduce fatalities.

“CEA finds that previous estimates of the economic cost of the opioid crisis greatly understate it by undervaluing the most important component of the loss – fatalities resulting from overdoses,” states the executive summary of the paper, titled “The Underestimated Cost of the Opioid Crisis.” “CEA estimates that in 2015, the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP that year. This is over six times larger than the most recently estimated economic cost of the epidemic.”

The paper states that though this is the first of its kind to be published, it will not be the last.

“A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it,” it concludes. “CEA will conduct further economic analysis of actual and proposed demand- and supply-side interventions; consider the impact of public programs such as Medicare and Medicaid; and explore the important role of medical innovation in combatting the crisis.”

Sorin Stöckert 3T Heater-Cooler Bacteria Lawsuits Coordinated in Pennsylvania

On February 1, 2018, lawsuits filed in federal district courts around the country against Sorin Group USA, Inc., Sorin Deutschland GmbH, and LivaNova PLC began the process of being transferred to Harrisbug, Pennsylvania for coordinated proceedings in an MDL, or multidistrict litigation. Multidistrict litigation is often utilized to streamline complex cases where many plaintiffs have been injured by a drug, medical device, consumer product, or incident (such as the BP oil spill, hotel fires, airline crashes, etc.).  The Sorin heater-cooler bacteria lawsuits stem from infections allegedly caused by the Sorin Stöckert 3T Heater-Cooler device, a machine that helps regulate a patient’s body temperature during cardiothoracic surgery.

The First Attempt at Coordination Denied in Early 2017

In March 2017, the Judicial Panel on Multidistrict Litigation held a hearing on the first effort to coordinate then-pending Sorin cases into an MDL. The Judicial Panel on Multidistrict Litigation is the group of federal court judges that determine whether multidistrict coordination is necessary.

In the first petition, a group of plaintiffs asked that the cases be re-assigned to a federal judge in South Carolina.  The initial request for coordination included fifteen individual lawsuits filed in South Carolina as well as North Carolina, Iowa, South Dakota, and Pennsylvania.  The Defendants vigorously opposed the establishment of an MDL initially.  They argued that there were too few cases pending, that the parties were already informally coordinating with success, and that the cases were too dissimilar to benefit from coordinated discovery – especially since the Defendants contended that discovery would be focused on the actions of the hospitals and surgeons with regard to their use of the heater-cooler devices in individual surgeries rather than more generic issues focused on the presence of a general defect in the heater-cooler products that were sold around the world.

The Judicial Panel denied the request for coordination in an April 5, 2017 order. The Panel found that the individual federal lawsuits pending around the country were already moving at an acceptable pace and the judges assigned to the fewer than 20 individual lawsuits could coordinate informally and still achieve the desired efficiencies regarding discovery and prosecution of the cases.

It is speculated that the Judicial Panel denied this initial request for coordination due to the relatively small number of cases pending at the time as well as the fact that some of the cases had been pending for quite some time and were quite advanced in pretrial proceedings.  In most instances where the Judicial Panel has granted an MDL and ordered national coordination, there are at least 50 lawsuits pending, and most MDLs involve thousands of individual lawsuits.

Following denial of the MDL petition in April, plaintiffs’ lawyers around the country continued to work together to engage in informal cooperation and the sharing of resources in the hopes of achieving some of the same efficiencies that can be achieved through MDL proceedings without experiencing the delays that are also, unfortunately, part of the MDL process.  In the months that followed, additional individual lawsuits were filed in state and federal courts and trial preparation continued in the filed cases.

New Cases Lead to a Second Petition – and a JPML Change of Heart

stockert 3t heater cooler bacteria

In a surprising turn of events in November 2017, the Defendants filed a motion to establish an MDL and coordinate the litigation.  It is unusual for the Judicial Panel to grant such a motion when they have already denied coordination, but second requests are often made.  In its petition, Sorin and LivaNova noted that it was facing 40 individual lawsuits at that time, including the 26 that were pending at the time of the initial request for coordination plus additional personal injury and wrongful death cases filed involving heater-cooler-induced mycobacterium infections in Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Minnesota, New York, and Tennessee.  Some plaintiffs filed briefs opposing the manufacturers’ coordination request due to concerns that the establishment of an MDL might delay cases that had been pending for several years and were approaching trial dates, while others supported the renewed request. The Judicial Panel heard arguments for and against the motion in late January of 2018.

On February 1, 2018, the Judicial Panel issued an order granting the Defendants’ request.  This order established MDL No. 2816, known as In Re: Sorin 3T Heater-Cooler System Products Liability Litigation (No. II), and transferred all pending federal court cases to Judge John E. Jones, III, a federal court judge in Scranton, Pennsylvania.  Judge Jones was already presiding over other Stöckert 3T cases, including the Whipkey case which should be the first heater-cooler case to be tried before a jury in 2019.  Judge Jones recently held an introductory phone conference with the attorneys involved in the 40 filed cases and is expected to hold some preliminary hearings in the coming weeks.

In addition to the federal court cases, there are also several cases concurrently pending in state court venues, primarily in Pennsylvania, Iowa, and California.  Many of these cases involve local defendants, including the hospitals.  Most of the federal court cases are solely focused on product liability claims against the heater-cooler manufacturers and do not include claims against the hospitals, as it is believed that the hospital and surgical personnel acted appropriately with regard to use and attempts to clean the heater-cooler device given the information that they were provided by the manufacturers as well as the challenges in being able to properly decontaminate the heater-cooler system due to its inherent design defects.

Nontuberculous Mycobacterium (NTM) Infections

Currently, most of the pending cases involve patients who developed M. chimera mycobacterium infections after undergoing a surgical procedure (usually a heart or transplant surgery) where a Stöckert 3T heater-cooler device was utilized.  It is estimated that several hundred thousand patients may have undergone procedures and potentially been exposed to contaminated water that circulates through this medical device.

Over the past 12 months, many hospitals have written to patients to alert them to this potential exposure, although not all hospitals have yet to do so.  It is believed that Sorin has the majority of the market share for heater-cooler device sales in the United States, which is why so many patients were potentially exposed.  The good news is that the actual number of patients that have been diagnosed with confirmed mycobacterium infections suspected to have been caused by contaminated aerosolized water coming from the Stöckert 3T heater-cooler devices is relatively small.

While the reported governmental investigations have focused on the M. chimera mycobacterium, other forms of non-tuberculous mycobacterium infections have been reported in the FDA’s MAUDE database as coming from the Stöckert 3T heater-cooler devices.   These other non-tuberculous mycobacterium infections include but are not limited to, the following:  M. abscessus, M. chelonae, M. fortuitum, M. gordonae, M. intracellulare, and M. kansasii.

In the coming months as the state court and MDL proceedings move into the expert witness discovery phase, more efforts will be focused on identifying the precise species that are non-tuberculous mycobacterium that can be scientifically and legally linked to use of the Sorin 3T heater-cooler devices.

Xarelto Lawsuit Update

The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley, led by veteran pharmaceutical and medical device lawyers Brenda Fulmer and C. Calvin Warriner, III, recently filed several more lawsuits against the manufacturers of Xarelto. The law firm has filed dozens of personal injury and wrongful death lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto is defective and has caused numerous serious and some fatal bleeding injuries to patients.

Searcy Denney Files Xarelto Lawsuits

One of the newly-filed lawsuits involves a Dade County, Florida resident who began taking Xarelto after being diagnosed with atrial fibrillation after failing aspirin therapy. The patient was placed on Xarelto in 2014. One of the allegations in the national Xarelto litigation effort is that prescribing doctors should have been warned by Xarelto’s manufacturers that this particular blood thinner should not be considered as first-line therapy in light of the reported increased incidence of bleeding injuries, the lack of an antidote to reverse the anti-clotting effects of Xarelto (which is available for Coumadin and Pradaxa), and the inability to determine which patients might be particularly susceptible to a bleeding episode while on Xarelto. This patient developed an acute upper GI bleed, the most common injury associated with Xarelto, after taking the drug for about a year. The patient developed significant hematuria (blood in urine), severe abdominal pain, and coffee-ground stool (a classic sign of bleeding in the gastrointestinal tract). The patient developed severe anemia which led to respiratory failure and significant abdominal bleeding which caused the bladder to rupture.

Searcy Denney’s pharmaceutical lawyers also filed a recent lawsuit on behalf of a Delray Beach, Florida patient who developed a GI bleed and bleeding in his brain after taking Xarelto for three years. This patient was prescribed Xarelto in 2012, shortly after this drug was approved by the FDA. At the time, there was a lot of hype over Xarelto and its ease of use over Coumadin, which requires regular blood monitoring of INR levels and dietary and medication restrictions. Patients were assured that Xarelto had the same safety profile as Coumadin, yet it would be easier to use and be less of a hassle, which was very compelling to young patients with busy lives. Unfortunately, since then, Xarelto has become one of the drugs with the highest number of adverse events reported to the FDA. In the pending Xarelto MDL litigation, the plaintiffs contend that Xarelto patients face a far greater risk of developing bleeding injuries than patients who ingest Coumadin and that representations in Xarelto’s warning label and marketing materials to the contrary were false.

The third recent lawsuit filing by our Mass Tort Unit involves a wrongful death claim on behalf of the surviving family members of a Pompano, Florida man who died in Broward County earlier this year due to an intracranial hemorrhage after ingesting Xarelto for a few months. Prior to starting Xarelto in 2016, the patient had taken Plavix and aspirin for several years for his atrial fibrillation. The primary use of Xarelto is in patients with this common heart arrhythmia who are at risk of developing blood clots and ischemic strokes from pooling of blood in the heart. Anticoagulant drugs (like Coumadin, warfarin, Xarelto, Pradaxa, and Eliquis) thin the blood and make patients less likely to develop blood clot-related injuries, including ischemic strokes where a clot blocks blood flow in the brain. Xarelto, however, has a propensity to cause hemorrhagic strokes, where there is bleeding in the brain (rather than a blockage).

Xarelto Lawsuits Consolidated into MDL

clot formation

These individual lawsuits will become a part of MDL No. 2592, which are coordinated legal proceedings for Xarelto pending in New Orleans. Currently, there are more 18,000 individual lawsuits pending in these multi-district litigation proceedings. These cases include both personal injury and wrongful death claims, and most involve allegations that use of Xarelto led to the development of bleeding injuries in the GI tract or brain. Bleeding injuries have been reported after just a single dose of Xarelto. Judge Eldon Fallon is presiding over the national litigation and has extensive experience with supervising complex pharmaceutical cases. There are also nearly 1,500 cases pending in state court in Pennsylvania.

The third bellwether trial against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer Corporation began on August 7, 2017, at a federal courthouse in the Southern District of Mississippi in Jackson. This case involves Dora Mingo, a 69-year-old retired schoolteacher from Summit, Mississippi who developed deep vein thrombosis (a “DVT”) in January of 2015, after undergoing hip implant surgery earlier that month. She developed by the DVT while she was on the blood thinner Lovenox following her hip surgery, so a hospital doctor prescribed Xarelto 15 mg to be taken twice a day for 21 days and then a 20-mg dose to be taken daily after that. After taking Xarelto for only a few weeks, Ms. Mingo’s blood work showed significant abnormalities in her hemoglobin and hematocrit levels, and she was instructed to go to the ER immediately. At the hospital, she was diagnosed with severe anemia and testing showed that she had an acute upper GI bleed for which she received blood transfusions and underwent a procedure to clip a bleeding ulcer. She was hospitalized for two days for the Xarelto-induced bleed and associated anemia.

The Xarelto defendants sought to dismiss her lawsuit and prevent the jury trial from proceeding in July and contended that Ms. Mingo was unable to prove that Xarelto was defective under Mississippi’s product liability law which requires that the plaintiff prove that the product was unreasonably dangerous to consumer and that she was injured by the drug. Further, Bayer and Janssen contended that Ms. Mingo’s case should be dismissed as they do not believe that she can fulfill her burden to prove that the Xarelto that she ingested failed to function as expected and that there was a feasible alternative medication available that she could have taken and avoided the risk of developing the upper GI bleed and anemia. In the Xarelto MDL litigation, the plaintiffs contend that there are safer alternative blood thinners available, including Coumadin or warfarin (which have been prescribed for decades) as well as other modern blood thinners, including Eliquis (which has a different dosing regimen) and Pradaxa (which reportedly now has an antidote available). The plaintiffs have also argued that manufacturers should warn that patients be given a blood test (known as an anti-Factor Xa assay, which is being used in Europe to identify high-risk patients) prior to use of the newer blood thinners to confirm that the patient will tolerate the drug.

The biggest challenge in meeting the plaintiff’s burden of proof is that the FDA has not determined that Xarelto is unreasonably dangerous (and, in fact, has promoted the safety of the drug). The plaintiff also has a burden in proving that the risk of a GI bleed is higher with Xarelto than with the other blood thinners, as the studies on this issue are conflicting and all blood thinners can cause GI bleeding events. The FDA originally approved Xarelto (also known as rivaroxaban) in 2011 for blood clot and stroke prevention in patients with atrial fibrillation and those who have undergone orthopedic surgeries.

Request for Summary Judgment from Defendants Denied

On July 21, 2017, Judge Fallon denied the defendants’ request for a summary judgment dismissing the lawsuit under Mississippi’s product liability statute, finding that there were disputed fact issues that prevented the claims from being dismissed prior to trial. It is likely that these same issues will be raised during the course of the trial after evidence and testimony on the existence of a product defect is presented to the Mississippi federal court jury. Additional motions to dismiss the case on the basis of federal court preemption and claims that federal law prevented Xarelto’s manufacturers from enhancing the safety warnings for the blood thinner have also been denied by the MDL judge. Judge Fallon also considered and rejected motions from both parties to exclude their opponents’ expert opinions on the risks associated with other anti-coagulants, unapproved dosing and monitoring regimens, and whether Ms. Mingo’s injuries were caused by her short-term use of Xarelto.

Judge Fallon is expected to preside over a fourth Xarelto bellwether trial, the Henry case, in Texas federal court later this year. The first two MDL bellwether trials were tried before juries in New Orleans and both resulted in verdicts in favor of the drug’s manufacturers. Appeals are pending regarding these trial losses by the plaintiffs.

The law firm of Searcy Denney, with offices in West Palm Beach and Tallahassee, represents more than 50 clients in their mass tort product liability lawsuits against the manufacturers of Xarelto. The firm has a dedicated Mass Tort Unit that focuses solely on drug and medical device claims. The timeframe for filing of lawsuit over a defective drug can be short, so please do not delay in contacting a lawyer if you or a loved one have suffered a gastrointestinal bleed, bleeding in the brain, or other injury associated with the use of Xarelto.

Invokana Under New Scrutiny as FDA Publishes Further Research

Janssen Pharmaceuticals’ type 2 diabetes medication is under new scrutiny. This new scrutiny follows confirmation from the Food and Drug Administration (FDA) that use of the drug canagliflozin, sold as Invokana and Invokamet, potentially increases the risk of amputation of the feet or legs. Most of these amputations have involved the toe and middle of the foot. Amputations of the leg, both above and below the knee, have also been necessary in some cases.

New Clinical Trials Show Dangers of Invokana

invokanaThe FDA initially highlighted this alarming side effect last year following results from two clinical trials. These clinical trials indicated that Invokana and Invokamet XR potentially caused patients to be twice as likely to require an amputation than those who received a placebo. The initial trial, CANVAS, demonstrated that 5.9 of 1,000 patients taking Invokana had an amputation within a year. Meanwhile, the number of individuals who had amputations from those taking a placebo was 2.8 out of 1,000. A second trial, CANVAS-R, was conducted with similar results. Out of 1,000 people, 7.5 taking the drug had an amputation while the amount of those who received an amputation while on a placebo was 4.2.

On Tuesday, the FDA stated that these medications will now receive mandatory black box warnings. This is the strictest type of warning issued by the FDA, indicating significant health risks and detrimental side effects for patients. Janssen also announced that a majority of patients who had undergone amputations would likely require additional surgery. In response to the recent FDA studies, Janssen issued a statement saying, “Patient safety is our highest priority. We are working with the FDA to include this information in the prescribing information for canagliflozin and look forward to the presentation of the full CANVAS Program results at the American Diabetes Association Scientific Sessions in June.”

Other Side Effects Associated With Invokana

Aside from the correlation with amputations, the drug also has other negative effects. These negative side effects include decreased cardiovascular health and an increased chance of bone fractures and urinary tract infections. Researchers encourage doctors to look at pre-existing conditions that could be exacerbated when patients take the drug. The potentially exacerbated pre-existing conditions include peripheral vascular disease, neuropathy, diabetic foot ulcers, and previous amputations.

An announcement of this magnitude has many industry insiders wondering what this could mean for Invokana’s competitors. The competing drugs that fall into this specific class of diabetes treatments are known as sodium-glucose cotransporter 2 inhibitors. This class of diabetes drugs includes well-known names like Farxiga and Jardiance. Seamus Fernandez, an analyst at the healthcare-specialized investment bank Leerink Partners, has predicted that Jardiance in particular will benefit from the market losses that are projected for Invokana. Mr. Fernandez believes that many doctors will likely switch patients away from Invokana immediately.

Investors in Johnson & Johnson (J&J) are also wondering if they should be worried about this new research. Janssen is the pharmaceutical arm of the American multinational manufacturer. However, Fernandez believes that they do not have much cause for concern. He doubts that the class of drugs overall will suffer a substantial setback. Regardless, adding the FDA’s strongest safety warning to Invokana’s packaging will undoubtedly create issues for this J&J company.