Uloric Heart Attacks, Deaths Likely To Result in Failure to Warn Lawsuits

A number of product liability attorneys are now looking into potential Uloric lawsuits, suggesting that the controversial gout medication may be the target of mass litigation following recent revelations of that users were not adequately warned about the risk of heart problems and death.

In late February, the FDA announced it would require a new boxed warning be added to all Uloric labels, alerting consumers and the medical community about the risk of cardiovascular injury and overall death from combining medications or existing health problems while taking Uloric. It is the strongest warning the agency can require a drug maker to place on their product.

Uloric (febuxostat) is a Takeda Pharmaceuticals medication that is designed to lower the blood uric levels among adults diagnosed with gout, which has rapidly become a blockbuster drug since it was introduced in 2009. However, recent research suggests that side effects of Uloric may carry serious heart risks when compared to alternative drug treatments.

In the wake of the warning, concerns are being raised that the manufacturer failed to adequately warn the medical community and patients about the true side effects of Uloric, despite warning signs that have existed for several years.

A few different plaintiffs’ attorney groups have organized meetings or conferences in the coming months about the potential Uloric litigation, to discuss criteria for claims that can be maintained and develop plans for the litigation.

While there were some warning signs and even FDA concerns when Uloric was first released, it appears that the agency did not understand the true scope of Uloric heart problems until Takeda released the results of a post-marketing clinical trial the FDA required the drug maker to complete when approving Uloric in 2009. However, growing evidence suggests that Takeda knew or should have known about the risks, yet continued to market the drug without adequate warnings.

The FDA has now required that a prominent label warning be placed on Uloric, and doctors are advised to only consider use of the drug if patients are not able to tolerate allopurinol, an older and safer gout treatment.

Result from the Takeda clinical trial compared Uloric and allopurinol, finding that for every 1,000 patients treated for a year with Uloric there were 26 deaths, compared to only 22 with allopurinal. However, when examining the risk of heart-related deaths, there were 15 Uloric deaths for every 1,000 patients treated for a year, compared to 11 with allopurinol.

Although a Uloric recall was urged by some critics, the FDA decided to allow the drug to remain on the market, with severe limitations approved uses.

Plaintiffs lawyers suggest that if Takeda has provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.

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Sleep Walking Risks with Ambien, Lunesta, Sonata Draw FDA “Black Box” Warning

Federal health officials are requiring the manufacturers of Ambien, Lunesta and other insomnia medications to add the strongest label warning available, following continuing reports of injuries and deaths resulting from complex sleep behaviors while under the influence of the drugs, including sleep walking, sleep driving and other activities that pose serious risks when not fully alert.

The U.S. Food and Drug Administration (FDA) announced the new “boxed” warning on Tuesday, indicating that new information will be placed in a black box placed prominently on the label.

The move comes after dozens of serious injuries and at least 20 deaths linked to patients engaging in activities while in a sleep-state following use of the popular sleep aid drugs.

The warnings will be added to eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist), which are commonly prescribed to adults to treat insomnia and help individuals sleep at night. These drugs are categorized by officials as sedative-hypnotic medications and have been approved by the FDA for patient use for many years.

Over the last decade, a growing body of evidence has confirmed dangerous sleep activity linked to Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist. These incidents have resulted in injuries, fatalities, and in at least two scenarios individuals who committed murder of their spouses had no memory after mixing sleep aid medications.

Officials indicate that the black box warning represents an accumulation of research, which has shown patients using sleep aid prescription medications were found to experience complex sleep behaviors including sleepwalking, sleep driving, using a stove or oven while asleep and having no recollection of the dangerous activities they were involved in.

The FDA has become aware of at least 46 non-fatal serious injuries after patients began actively using a prescription sleep drug. Of the injuries recorded patients have reportedly injured themselves by accidental overdoses, falls, burns, near-drowning, over-exposing themselves to cold temperatures, loss of limbs, gunshot wounds, and apparent suicides.

Of the 20 fatalities recorded from patients using prescription sleep aids, causes of death included carbon monoxide poisoning, drowning, fatal falls, hypothermia and severe automobile accidents.

According to the U.S. Centers for Disease Control, an estimated 50 million Americans are believed to suffer from some sort of sleep disorder, and roughly 4% adults consistently use a prescription insomnia aid to sleep at night.

Previous research has found many users of these prescription sleep aids do not adhere to the FDA’s recommended safety guidelines designed to prevent injuries and accidents due to drowsiness caused by the drug.

According to a sleep aid study issued by the Institute for Safe Medication Practices (ISMP) in 2018, approximately 77% of users of Ambien, Edluar and Zolpimist, which all use the active ingredient zolpidem, failed to follow two or more FDA recommendations on using the drug safely. Most common unsafe use of the drugs involved taking two or more types at once, long-term use, and taking higher than recommended doses; particularly among women and older patients.

According to the ISMP report, the U.S. Centers for Disease Control and Prevention found that Ambien and its generic zolpidem equivalents were the drug most linked with emergency room visits, according to adverse event data received by the FDA. According to the report, there are an estimated 10,212 emergency department visits each year linked to Ambien use, with 25% of those requiring the person be hospitalized.

In 2014, the FDA received 1,030 serious adverse event reports where Ambien was the primary or secondary drug suspected of causing the problem.

A black box warning issued by the FDA is the strictest warning put on the labeling of prescription drugs and drug products, indicating there is reasonable evidence that the use of the products may cause a serious hazard to consumers.

Patients using sleep medications such as Ambien and Lunesta or other prescription drugs with the active ingredients eszopiclone, zaleplon, and zolpidem are being encouraged to stop taking the medication if they experience complex sleep behaviors where you engage in activities while you are not awake or you do not remember. Those who experience these situation should contact their health care professional right away.

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Amid Zostavax Concerns, Demand for Newer Shingles Vaccine Shingrix Soars

As a growing number of doctors move away from Zostavax, due to concerns about the side effects of the shingles vaccine, GlaxoSmithKline indicates that it plans to spend $100 million to boost the production of Shingrix, as demand for the newer shingles vaccine skyrockets.

The drug manufacturer issued a press release on April 24 announcing it was making a massive investment into a Hamilton, Montana facility to increase production of Shingrix. The decision comes after company officials announced in December that Shingrix vaccine shortages may occur throughout 2019.

Shingrix (recombinant zoster vaccine; RZV) was the second vaccine approved for prevention of shingles among adults, which involves two doses for inoculation. When it was introduced, Zostavax (varicella zoster vaccine; VZV) was the only shingles vaccine on the market, involving a single dose. However, unlike Zostavax, Shingrix does not involve the use of a live virus, which has been linked to reports of problems among patients who received Zostavax.

Merck now faces hundreds of Zostavax lawsuits brought by individuals nationwide who experienced severe shingles outbreaks or auto-immune disorders after receiving their version of the shingles vaccine, involving allegations that the live virus was “under-attenuated” and not sufficiently weakened to avoid the risk of reactivating the dormant virus in many individuals.

Amid rising Zostavax concerns, CDC researchers have indicated that the Shingrix success rate is above 90%, which has led to increasing demand. The success rate with Shingrix is in line with most vaccines, leading doctors to conclude it is safer.

In November 2018, a study published in The BMJ, which found that Shingrix is 85% more effective at preventing shingles than Zostavax, further accelerating the move away from Zostavax by many doctors.

“For more than a decade, our Hamilton facility has supported GSK’s adjuvant system development program,” Jack Bailey, President, US Pharmaceuticals, GSK, said in the press release. “By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including SHINGRIX.”

The relative safety of Shingrix compared to Zostavax is likely to be a main focus of the litigation filed against Merck, which also includes allegations that the drug maker knew about the safer alternative design, but placed desire for profits before consumer safety.

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Unsafe Sleeping Environments Still Cause Significant Percentage Of Infant Deaths: Study

Despite years of warnings about the importance of creating safe sleeping environments for infants, babies continue to suffocate and die after parents place them to sleep on their stomach, or in a crib with soft bedding, according to the findings of new research.

In a study published in the medical journal Pediatrics, researchers from the U.S. Centers for Disease Control and Prevention (CDC) analyzed data from the Sudden Unexpected Infant Death Case Registry from 2011 to 2014, and concluded that placing infants to sleep on their stomaches or sides was linked to 92% of incidents.

The data included sudden infant deaths (SIDs) stemming from all causes, and researchers specifically focused on cases categorized as suffocation with unsafe sleep factors. These cases were then assigned a method of suffocation, including soft bedding, overlay, or wedging.

Of the SIDs deaths classified as suffocation, nearly 70% were attributed to soft bedding, such as blankets, pillows, crib bumpers, sleep positioners, or couch cushions. In nearly all of the deaths, the infants were not sleeping on their back, but instead placed on their stomach or side to sleep.

Another 19% of deaths were attributed to overlay, which is when someone was on top of the infant when they died. This can include inadvertently rolling onto the infant during sleep. In most cases, it was a parent; however, in 22% of cases it was a sibling. Two-thirds of overlay deaths occurred in an adult bed.

In addition, 12% of suffocation deaths were due to wedging. This is when the infant becomes trapped between the mattress and the wall or the bed frame. Three-quarters of these types of deaths occurred in an adult bed, not a crib.

Soft bedding deaths occurred most often in an adult bed, nearly half the time, and 82% of deaths attributed to soft bedding occurred when the infant was on their stomach. One-third of the time a blanket was obstructing the infant’s airway.

The average age of infants who suffered sudden deaths due to soft bedding was 3 months, 2 months for overlay deaths, and 6 months for wedging.

Researchers said two factors played a significant role in infant deaths: Infants being put to sleep on his or her stomach or side and infants sleeping in adult beds.

Nearly 90% of babies between 0 and 4 months and 70% of babies 5 to 11 months who died of suffocation were found on their stomach. If safe sleep habits were followed during the study period, the death rate would have dropped from 87 infants per 100,000 deaths to 75 infants per 100,000 deaths.

Infant Suffocation Risks

Unintentional suffocation is the leading cause of injury death among infants under one year old in the U.S. More infants die each year from accidental suffocation than any other type of injury.

A study published in 2018 indicated despite national campaigns to advocate safe sleeping positions, many infants are still placed in dangerous conditions, including on the stomach and with blankets.

Researchers recommend parents follow the American Academy of Pediatrics infant sleep recommendations, which emphasize placing a baby on his or her back to sleep, using a firm mattress or surface, and keeping pillows, crib bumpers, blankets, and soft toys out of the baby’s sleeping area.

Many parents want to keep their baby near them when they are still infants. The AAP recommends when infants sleep in the parent’s room, they sleep in a crib, not in the parent’s bed.

Earlier this month, nearly 5 million Fisher-Price Rock’n’Play Sleepers were recalled after the U.S. Consumer Product Safety Commission received reports of 32 infant deaths. Babies placed in the sleeper rolled onto their stomach, leading to suffocation on the soft cushion covering the device.

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Core Discovery Underway in Lawsuits Over Valsartan Contamination

The U.S. District Judge presiding over all valsartan contamination lawsuits has issued an order establishing the rules for core discovery in the litigation, which involves claims brought by individuals nationwide who say they developed cancer after receiving recalled versions of the generic hypertension drugs that were tainted with carcinogenic impurities.

There are currently about 50 product liability lawsuits filed against various generic drug manufacturers and distributors, each raising similar claims that versions of the hypertension drug valsartan were distributed for years with cancer-causing contaminants, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which appear to be a by-product of the generic drug manufacturing process.

Many of the complaints involve allegations that users of the recalled valsartan drugs developed liver cancer, kidney cancer, colon cancer, stomach cancer and other digestive tract cancers, pursuing damages against Zhejiang Huahai Pharmaceutical Company of China and other defendants that manufactured and sold the tainted pharmaceutical ingredients, which were widely distributed throughout the United States in recent years.

Given common questions of fact and law presented in lawsuits filed in various different U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for the valsartan contamination lawsuits in February, which resulted in the transfer of cases pending throughout the federal court system to U.S. District Judge Robert B. Kugler in the District of New Jersey. The process is designed to reduce duplicative discovery, avoid conflicting pretrial schedules and serve the convenience of the parties, witnesses and the judicial system.

Following a status conference last week, Judge Kugler issued an order (PDF) on April 29, setting rules for the production of “core” discovery documents for the litigation.

The order calls for defendants to produce information concerning the facilities that manufactured the active ingredient for generic valsartan, or which produced finished products linked to the litigation. It also limits the production of core discovery to valsartan; meaning the discovery will not include other hypertension drugs that have been recalled due to tainted ingredients, such as generic losartan and irbesartan.

The order lays out which specific documents responding defendants will produce and indicates core discovery will run until June 17.

As more individuals discover that they may have received contaminated valsartan pills, a growing number of lawsuits are likely to be filed by individuals nationwide.

Following coordinated discovery and any early “bellwether” trials held in the MDL, if the manufacturers fail to negotiate valsartan settlements or another resolution for the litigation, each individual case may ultimately be remanded back to the U.S. District Court where it was originally filed for a future trial date.

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Prolia Discontinuation Increases The Risk Of Vertebral Fractures, Study Found

The side effects of Prolia may increase the risk of vertebral fractures when consumers stop using the osteoporosis drug, according to the findings of a study by Israeli researchers.

In research published in the journal Calcified Tissue International last year, serious concerns were raised about the impact of Prolia discontinuation, adding to a growing body of evidence about the fracture risk associated with the medication.

Prolia (denosumab, or DMAB) was introduced by Amgen in 2010, and was the first drug approved by the FDA for the treatment of postmenopausal osteoporosis.

According to the researchers, the drug was approved after showing a reduction in vertebral and hip fractures over the course of three years, and keeping the risk reduced up to 10 years. However, they noted that a number of reports raised concerns about the risk of fractures once users discontinued the drug, due to rapid bone density declines and reports of multiple vertebral fractures.

The researchers conducted a phone survey of doctors engaged in bone metabolism in nine Israeli hospitals. They looked at clinical data on patients with vertebral fractures after Prolia discontinuation and found nine elderly female patients, most of who had prolonged exposure previously to Fosamax or another bisphosphonate drug.

According to the findings, the women collectively suffered 36 vertebral fractures, eight of whom had multiple fractures; most of which were spontaneous.

“In line with previous reports, the timing and severity of the fractures raise concern of DMAB discontinuation effect,” the researchers concluded. “Care providers, patients, and regulatory authorities should be aware of the possible risk of DMAB treatment interruption.”

Prolia Bone Fracture Concerns

In 2013, the prominent consumer watchdog group Public Citizen raised concerns about the Prolia fracture risks, noting that the drug has been linked to reports of bone brakes following little or no trauma. The group indicated that Prolia appears to interfere with bone metabolism and the body’s immune system, resulting in breaks that may occur in situations that would not typically result in such an injury.

Although Amgen issued warnings about the link between Prolia and bone fractures in Canada as early as 2012, concerns have been raised that insufficient warnings are still being provided in the United States.

Earlier this month, Public Citizen filed a petition with the FDA calling for the agency to require a “black box” Prolia fracture warning, which would be the strongest warning the drug maker could be required to add to the label.

As more consumer learns that problems suffered in recent years may have been avoided with stronger warnings, it appears likely that Amgen may face Prolia bone fracture lawsuits, raising allegations similar to those presented in several thousands Fosamax lawsuits in prior years.

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Superbug Evolution Outpacing Antibiotic Development, U.N. Warns

Overuse of antibiotics is leading to a worsening problem of drug-resistant bacteria and infections, resulting in hundreds of thousands of deaths globally each year, according to the findings of a new international report.

The Interagency Coordination Group on Antimicrobial Resistance put together the report, “No Time to Wait: Securing the Future From Drug-Resistant Infections”, for the secretary general of the United Nations and released the findings this month, warning that widespread drug resistance is becoming a global crisis.

Antibiotics, antivirals, and antifungals are critical tools used to fight infection, but these methods are becoming ineffective because of their overuse in humans and animals, researchers warn. One recent study found that more than half of antibiotics are prescribed without an infection diagnosis.

There are high levels of antibiotic resistance reported in countries around the world at all income levels. Infections once easily treated are now becoming untreatable, such as antibiotic resistant tuberculosis and gonorrhea. Additionally, lifesaving medical procedures, like surgery, are becoming riskier due to the chance of contracting antibiotic resistance infections.

Drug resistant diseases cause nearly 700,000 deaths globally each year. More than 230,000 people die from drug resistant tuberculosis alone yearly. In the U.S., roughly 2 million Americans develop antibiotic resistant infections each year, leading to 23,000 deaths.

The report emphasizes the One Health concept which focuses on the interconnection of the health of people, animals, and the environment. This concept aims to work to focus on interconnected health to achieve optimal health for the globe.

The findings indicate the concept is especially important because six out of 10 infectious diseases found in humans are spread from animals. The interconnected nature of humans, animals, and the environment is how drug resistance worsens and spreads.

Emerging Threats

The report highlighted three urgent threats of antibiotic resistance: C. difficile (C. diff), Carbapenem-resistant Enterobacteriaceae (CRE), and N. gonorrhoeae.

C. diff infects more than 500,000 people yearly and leads to life-threatening cases of diarrhea and colitis. It often poses a high risk of infection for other patients. CRE is one of the most drug resistant bacteria and is typically acquired in healthcare settings. It causes nearly 9,000 infections each year leading to 600 deaths. Gonorrhea is a sexually transmitted disease. Many strains have become nearly untreatable with antibiotics.

Other things that spread the development of drug resistance include inadequate access to clean water, sanitation and hygiene; poor infection and disease prevention; and lack of access to affordable antibiotics and vaccines.

The report warns that the number of drugs in development to combat resistant bacteria simply is not enough. To that end, the group offered five recommendations: accelerate progress of the One Health National Antimicrobial Resistance Action Plan, focus on innovating new antibiotics, collaborate for better action plans to treat disease, invest in sustainable response plans, and strengthen accountability and global governance.

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