FDA Adds Boxed Warning to Ocaliva Following Dosing Errors
The U.S. Food and Drug Administration (FDA) has ordered a boxed warning and dosing table be added to the liver disease drug Ocaliva (obeticholic acid) following reports that the medication is being incorrectly dosed daily instead of weekly to patients.
About the Ocaliva Black Box Warning
Medscape reports that Ocaliva is prescribed to patients with moderate to severe primary billary cholangitis (PBC) and that the incorrect dosing results in an significantly increased risk of serious liver injury.
In a safety communication, the FDA addressed the issue saying that the dosing errors have resulted in cases of liver decompensation, liver failure, and death. In order to correct the issue, the FDA is clarifying current recommendations for screening, dosing, monitoring, and managing PBC in patients with moderate to severe liver disease taking Ocaliva.
In addition to the boxed warning and dosing table, the FDA said that it will also require Ocaliva carry a medication guide for patients that informs them about the past dosing issues and the risk of such errors.
Additional Guidelines Issued to Healthcare Professionals and Patients
Beyond packaging and label changes, the FDA advises clinicians to take the following actions when treating a patient with Ocaliva:
- Routinely monitor patients for biochemical response, tolerability, and PBC progression.
- Closely monitor patients who are at an increased risk of liver decompensation.
- Make sure both patients and caregivers are educated on the symptoms of worsening liver function.
- Temporarily stop treatment with Ocaliva if the patient displays evidence of worsening liver function.
- Consider stopping treatment in patients who have experienced clinically significant liver-related adverse reactions.
Contact an Experienced Drug Recall Attorney
Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.
New York City Files $500 Million Lawsuit Against Opioid Drug Companies
New York City has filed a $500 million lawsuit against prescription opioid manufacturers and distributors in an effort to hold them accountable for their alleged part in New York’s opioid epidemic.
About the New York Opioid Lawsuit
According to the lawsuit, the current opioid epidemic was caused, at least in part, by manufacturers’ marketing of the drug.
Additionally, New York City alleges that crises has placed a burden on the city as it must cover increased substance use treatment services, ambulatory services, emergency department services, inpatient hospital services, medical examiner costs, criminal justice costs, and law enforcement costs.
New York City is not the first to file such a lawsuit. More than 200 lawsuits have been filed against drug companies by local communities across the nation, including communities and cities in California, Illinois, Kentucky, Ohio, New Jersey, and West Virginia.
The vast majority of the lawsuits have already been consolidated into multidistrict litigation. It is unclear if New York City’s lawsuit would join the MDL.
Dangers of Opioid Painkiller Abuse
- The U.S. Centers for Disease Control and Prevention records about 14,800 prescription painkiller deaths every year – this is more deaths than those attributed to car accidents or gunshot wounds
- Perhaps more alarming is that the rate of painkiller abuse has increased by 300 percent between 1999 and 2010. The rate of abuse is especially high among women, increasing 400 percent during the same time span.
- When used during pregnancy, opioid painkillers can lead to birth defects including:
- Spina Bifida
- Conoventicular septal defect
- Hypoplastic left heart syndrome
- Atrial septal defect
- Tetralogy of fallot
- Nearly 1 in every 33 babies is born with a birth defect according to the CDC. Birth defects are the leading cause of death in infants, and account for more than 20 percent of all 5,600 infant deaths each year.
FDA Issues Safety Alert for Zoll LifeVest Wearable Defibrillator
The FDA has issued a safety alert for the Zoll LifeVest 4000, an external, wearable cardioverter defibrillator, saying it may fail to deliver appropriate therapy for potentially fatal arrhythmias.
About the Zoll LifeVest Defibrillator Safety Alert
According to Medscape, the LifeVest 400 may deliver appropriate shocks as a result of “a fault that prevents the device from charging its high-energy capacitors.”
The defect can occur when the device displays a warning to “Call ZOLL for service, Message Code 102.” The FDA says that the warning “does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.”
The company reports that 33,670 device have been distributed as of November 2017. The above message has displayed on roughly 0.1% of the devices.
Zoll says it is aware of one death associated with the device’s failure to deliver treatment after the message appeared.
What Are Common Causes of Medical Device Defects?
Recalls occur when a medical device is defective or a risk to a patient’s health (or both). A device is considered to be recalled if the manufacturer takes actions to correct or remove the device that violates FDA law. In some cases, the recalled device may not necessarily need to be removed from a patient, or the risks of removal outweigh the risk of leaving it in place.
Types of actions that result in a medical device recall include:
- Inspecting the device for issues
- Adjusting settings
- Destroying the device
- Notifying patients of a problem with the defective device
- Monitoring patients for issues
The FDA is in charge of monitoring all medical devices and drugs available for consumer use. In most cases, a company, including manufacturers and/or distributors, will usually recall their medical devices on their own or voluntarily. However, if a medical device is associated with significant health problems or death, the FDA can legally require a company to recall a device immediately.
When a company recalls a medical device, they will:
- Contact the customers who received the product from them, and takes steps to reach others who need to be notified usually by press release.
- Supply information to help users identify the product and take steps to minimize health consequences.
- Take action to prevent the problem from happening again.
Texas Girl, 6, Experiences Hallucinations, Rare Side Effects from Tamiflu Medication
According to CBS 11, a six-year-old girl in Allen, Texas, suffered from hallucinations after taking Tamiflu to treat her influenza diagnosis. The girl’s parents say she ran away from her school and believe that she tried to crawl out of her second-story bedroom window in an attempt to harm herself.
After bringing the girl to the hospital following the incident, a doctor told them that rare side effects are possible with Tamiflu (oseltamivir), including nervous system problems such as psychosis. One emergency room physician says less than one percent of patients taking Tamiflu experience these kind of severe adverse events.
The Tamiflu drug label contains several warnings, including neuropsychiatric events, particularly in pediatric patients. The label states that these patients may be at an increased risk of confusion or abnormal behavior early in their illness and to monitor for signs of this type of behavior.
In addition, the warning label describes additional postmarketing reports of delirium and abnormal behavior that lead to injury, and in some cases fatal outcomes, in flu patients receiving Tamiflu. These reports were mostly from pediatric patients taking the drug in Japan, however, the label states that the contribution of Tamiflu to these injury events have not been established.
Serious skin or hypersensitivity reactions can also occur when taking Tamiflu. Tamiflu’s indicated usage is for patients who have exhibited symptoms of the flu for no more than 48 hours.
The six-year-old girl’s family told CBS 11 that they will be filing a report with the Food and Drug Administration (FDA) regarding the event.
Other Cases of Severe Side Effects while Taking Tamiflu
Forbes notes that this is not the first time a report of Tamiflu-induced hallucinations reached national news.
- In 2009, an article in the Daily Mail described the experiences of two children who were administered Tamiflu for a swine flu diagnosis. The children suffered from hallucinations, high fever, and vomiting.
- In 2012, a woman wrote an article in Time regarding her son’s behaviors after taking the drug. Her nine-year-old son experienced nightmares, babbling, and was convinced he was being chased as he ran around their house.
- In 2015, a case report in Clinical Pscyhopharmacology and Neuroscience described a patients severe symptoms, including mood swings, suicidal feelings, auditory hallucinations, and insomnia.
In 2005, a massive string of incidents in Japan involving Tamiflu garnered the FDA’s attention. More than 100 cases of neuropsychiatric events were reported, including the deaths of 12 children who had taken Tamiflu. The potentially harmful drug was banned for use in teenagers after multiple incidents of teens jumping from second-story windows and other suicidal behaviors.
Tamiflu’s manufacturer said that the available data did not suggest that the incidents in patients taking the drug were higher than those who were not. The FDA conducted a review and did not conclude that there was a causal relationship between Tamiflu and pediatric deaths.
Although the severe side effects of Tamiflu are rare, some believe that the true efficacy of the drug is still unclear. According to Forbes, reviewers of the drug’s trials found evidence of publication and reporting biases, and all of the trials were sponsored by the drug’s manufacturer. No placebo-controlled trials were conducted by an independent source. Although a review of the studies found that Tamiflu reduced the duration of symptoms by about a day, the drug was not found to reduce the risk of hospitalization or transmission of the influenza virus.
According to the six-year-old girl’s parents, the approximately one day of symptom relief from the flu is not worth the possible side effects that their child encountered.
Injured by a Dangerous Pharmaceutical Drug?
If you or a loved one have suffered severe side effects or were injured after taking a pharmaceutical drug, contact Thomas J. Henry immediately. Our attorneys have experience handling cases involving dangerous drugs and medical devices. You may be entitled to compensation for your injuries, medical costs, lost wages, and other damages caused by an unsafe medication. Call us today and speak with an attorney. We are available 24/7, nights and weekends to evaluate your claim and provide you with a free case review.
Study: Most Clinical Trials are Unjustified, Unethical
What is a Clinical Trial?
A clinical trial involves researching human participants and is intended to add to medical knowledge. Most clinical trials fall into two types of study:
- Interventional studies
- Observational studies
For interventional studies, participants receive specific interventions according to the research plan or protocol developed by the investigators. Interventions may be medical protocols (like drugs or devices) changes to behavior, changes to diet, or a medical procedure.
Results from the intervention group are then compared against a placebo or control group to gauge the interventions safety and efficacy.
What Makes a Clinical Trial Scientifically and Ethically Justified
There are not stringent guidelines when determining what criteria make a clinical trial justified. So the team responsible for the study created their own, very simple criteria:
- Is there a specific hypothesis responding to a clear question? – The clinical trial should be hypothesis-driven, addressing a specific medical need. For example, Drug A should improve the lives of individuals suffering for Disease X. Trying to give participants Drug A to see is it does some random good does not meet this criteria.
- Is there uncertainty around the central question? – There should be an unanswered question or questions about the efficacy of the intervention. If you already know the answer to the hypothesis being tested and have the evidence necessary to demonstrate that answer, there is no reason to have the study.
- Has this uncertainty been established through a systematic review of the literature? – Scientists proposing the trial should have studied all available literature to know the potential of their intervention (such as Drug A above) and to ensure their questions have not been answered by another trial.
Findings of the Clinical Trial Study
The researchers applied the about criteria to more than 200 clinical trial and found that only 44% of the clinical trials met all three criteria.
Results for the individual criterion were as follows:
- 76% of trials satisfied criterion 1
- 99% of trials satisfied criterion 2
- 54% of trials satisfied criterion 3
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry Injury Attorneys are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.
Study Links Acetaminophen Use During Pregnancy to Language Delay in Girls
A new study found that two-year-old girls whose mothers took acetaminophen during their pregnancies had higher rates of language delays than those whose mothers did not take the medication during pregnancy.
About the Acetaminophen Study
The study was published in the journal European Psychiatry and involved 754 Swedish women who were interviewed between weeks 8 and 13 of their pregnancies. Interviewers asked the women questions about how often they had used acetaminophen (Tylenol) since they had conceived.
The women also provided urine samples to be tested for acetaminophen concentration.
Acetaminophen use was fairly common during early pregnancy, with about 59% of women reporting taking the drug at least once in their first trimester. Others reported taking 100 pills in that time.
At 30 months, all of the children were given a language-development screening. Those who used fewer than 50 words were considered to have a language delay.
Findings of the Acetaminophen Study
Overall, about 10% of children were found to have a language delay at 30 months with delays being more common in boys. However, girls born to mothers in the high-acetaminophen group were nearly 6 times more likely to have language delays than mothers in the no-acetaminophen group.
According to the authors, taking acetaminophen seemed to diminish the “well-recognized femal advantage” generally noted in the vocabularies of children at 30 months.
Previous studies on acetaminophen during pregnancy have reported other instances in which prenatal exposure to the drug seems to narrow the gap in gender-specific developmental difference. Acetaminophen use during pregnancy has also been associated with higher rates of ADHD.
The Swedish study will continue to follow the children tested at age 2 and will re-examine their language development at 7 years.
Study Links Ibuprofen to Male Infertility
A new study published in the journal Proceedings of the National Academy of Sciences found that taking ibuprofen in doses commonly used by athletes was associated with infertility in men.
About the Ibuprofen and Male Infertility Link
According to CNN, the study was a continuation of research that began with pregnant women. In their original study, the researchers determined that three popular over the counter pain killers, aspirin, acetaminophen, and ibuprofen, affected the testicles of male babies.
The first study provided evidence that all three drugs are “anti-androgenic,” meaning they disrupt male hormones. The drugs were also linked to an increased likelihood of male babies being born with congenital malformations.
With the first study’s findings, the researchers wondered if the drugs had similar affects on adult males.
The research team gathered 31 male volunteers between the ages of 18 and 35, 14 of whom were given a daily dosage of ibuprofen consistent with a dosage taken by professional and amateur athletes: 600 milligrams twice a day. The remaining 17 participants were given a placebo.
Within 14 days, the volunteers taking ibuprofen experienced changes in their luteinizing hormones, with the ration of testosterone to luteinizing hormones decreasing, a common sign of dysfunctional testicles. This imbalance also produced compensated hypogonadism, a condition associated with infertility, depression, and increased risk of cardiovascular events, including stroke and heart failure.
Other Adverse Events Associated with Ibuprofen
Like all medications, ibuprofen can result in adverse events, some of which are serious. Common side effects include:
- Upset stomach
- Impaired vision
- Irregular breathing
- Increased blood pressure
- Chest pain
- Severe allergic reactions
Medical professionals also agree that taking ibuprofen within the last 3 months of pregnancy may harm the unborn baby. As such, pregnant women are urged to not use the medicine without a doctor’s advice.
FDA Issues Class 1 Recall for Johnson & Johnson Heart Device
About the Johnson & Johnson Heart Device Recall
According to the CNBC, the recall was issued Tuesday and involves the Agilis Steerable Introducer Sheath, a device used to insert and position cardiovascular catheters in the heart.
The FDA states that a valve on the device which is meant to prevent blood from flowing back through the device may be faulty and not fulfill its function.
Recalled units were manufactured and distributed between January 1 and May 5, 2017.
What Is a Class 1 Recall?
Recalls issued by the FDA fall under three classifications:
- Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The FDA also recognized two other safety actions:
- Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
- Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
Bayer, J&J to Pay $28 Million in Xarelto Lawsuit
Bayer and Johnson & Johnson have both been ordered by a Philadelphia state court jury to pay $27.8 million to an Indiana couple after the jury determined the drugmakers failed to warn of internal bleeding risks associated with the blood thinner Xarelto.
Details of the Xarelto Lawsuit
According to Reuters, the lawsuit was filed by Lynn Hartman and her husband in 2015 and marks the first successful trial verdict in litigation against Bayer and J&J over Xarelto. The drugmakers won three previous cases in federal court.
The lawsuit claimed Hartman was prescribed Xarelto to prevent strokes as a result of atrial fibrillation. She took the drug for roughly one year before being hospitalized in June 2014 with severe gastrointestinal bleeding.
The trial was the first of roughly 1,400 Xarelto cases pending in the Philadelphia court and more than 18,500 cases are pending in federal court.
The jury awarded Hartman $1.8 million in compensatory damages and $26 million in punitive damages.
Side Effects of Xarelto
Xarelto is associated with several common side effects, including:
- Nose bleeds
- Coughing up blood
- Back pain
- Difficulty breathing
Since its introduction to the market, Xarelto has been mired in controversy. Currently, there are tens of thousands of lawsuits pending against Johnson & Johnson, Bayer, and Janssen Pharmaceuticals regarding Xarelto and its link to uncontrollable bleeding. In addition, there is currently no FDA-approved antidote to Xarelto — there is no reversal agent for uncontrolled bleeding caused by the blood thinner.
Because there is no reversal agent, bleeds caused by Xarelto are oftentimes catastrophic and sometimes fatal. The lawsuits state that these pharmaceutical giants failed to sufficient warning of the deadly dangers associated with Xarelto.
Signs and symptoms of a serious bleed include:
- Nose bleeds that happen often
- Unusual gum bleeds
- Heavier than normal menstrual bleeding
- Red, pink or brown urine
- Bright red or black stools
- Coughing up blood or blood clots
- Vomiting blood (vomit looks like coffee grounds)
- Pain and swelling at wound sites
FDA Pushes for Limbrel Recall Following Reports of Liver and Lung Injury
The U.S. Food and Drug Administration (FDA) is urging Primus Pharmaceuticals to recall its product Limbrel after reports of liver and lung injuries.
What is Limbrel?
Limbrel was initially marketed by Primus as “medical food” meant to address “the metabolic processes associated with osteoarthritis.” However, the FDA announced this week that it considers Limbrel to be an unapproved drug that comes with the risk of liver injury and an adverse lung condition.
Still, the FDA is powerless to remove the product from market as it lacks the authority to require Primus to recall Limbrel.
In November, the FDA issued a warning urging anyone taking Limbrel to immediately discontinue treatment with the drug. The FDA cited 194 adverse event reports, acknowledging that at least 30 were already found to be likely associated with the product.
Among the adverse events associated with Limbrel were:
- Liver injury
- Hypersensitivity pneumonitis
- Trouble breathing
What is Medical Food?
Medical food is a strictly defined regulatory category which includes products recommended by doctors because of certain nutritional components shown to help manage aspects of a disease or condition. The FDA has ruled that Limbrel does not meet the criteria necessary to be designated a medical food.
That has not stopped Primus Pharmaceuticals from advertising Limbrel as a medical food with it’s website claiming “unlike drugs, prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.”
Limbrel is currently only available by prescription.