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FDA Questions Xarelto Approval due to Faulty Blood Monitors

The results of a clinical trial for the approval of Xarelto (rivaroxaban) are being questioned by the U.S. Food and Drug Administration (FDA)  after it was revealed that a faulty blood testing device  may have compromised the results. Xarelto, an anti-clotting drug has been on the market since 2011 as an alternative to warfarin (Coumadin), an anti-coagulant that has been in use for over 60 years, reports The New York Times.

Warfarin requires careful, frequent monitoring of a patient’s diet, drug regimen, with frequent blood tests. If there is too little of the blood-thinner, a patient could suffer a stroke; too much, there may be life-threatening bleeding, according to the Times. Xarelto has been advertised to be more convenient for the patient, but where warfarin has an antidote in case of internal bleeding, Xarelto has no known antidote. In the case of a Xarelto user, an internal bleeding event could be catastrophic. More FDA Questions Xarelto Approval due to Faulty Blood Monitors

Drug Treatment for MS Tysabri Linked to Fatal Brain Disorder

Scientists have reported that recent findings show that the use of the multiple sclerosis drug Tysabri can cause a patient to contract the John Cunningham (JC) virus, which can lead to multifocal leukoencephalopathy (PML), a potentially fatal brain disease, with no known cure. Tysabri is used for patients with relapsing multiple sclerosis (MS) to reduce the frequency of flares and slow the progression of physical disabilities, as reported in Newsday.

Tysabri works by keeping white blood cells of the immune system from entering the spinal cord and the brain. Doctors believe they cause much of the damaging effects of MS. Tysabri is administered intravenously every four weeks, but can have serious side effects. They include infections, headache, fatigue, depression, joint pain, menstrual problems, and liver damage. More Drug Treatment for MS Tysabri Linked to Fatal Brain Disorder

Kidney Problems Possibly Tied to Heartburn Medications

A study involving heartburn sufferers and their medications has revealed a possible connection to an increased risk in kidney disease. Previous studies had linked the use of heartburn medication with increases in bone fractures, pneumonia, and a potentially serious bacterium infection called Chlostridium difficile.

The study involved 10,482 patients over 13 years, according to The New York Times. The researchers monitored proton pump inhibitor (PPI) use. PPIs are a type of heartburn medication. Some patients were taking PPIs such as the brands Nexium, Prilosec, and Prevacid. Other patients were taking non-PPI medications, known as H2 receptor antagonists, such as Pepcid, Zantac, and Tagamet. The study appeared in the American Medical Association’s JAMA Internal Medicine. More Kidney Problems Possibly Tied to Heartburn Medications

Las Vegas Jury Hearing Evidence in Actos Bladder Cancer Case

In a trial that began on August 27, a Las Vegas jury is hearing evidence that Takeda Pharmaceuticals hid the bladder cancer risk of its type 2 diabetes medication, Actos.

The case is being heard before Judge Jerry Wiese in the Supreme Court of the State of Nevada, and it is a consolidated case on behalf of a living plaintiff and the widow of a deceased man. Both men had been taking Actos (pioglitazone) and both of them developed bladder cancer, which they allege was caused by the drug. Counsel for the plaintiffs is expected to seek $2 billion in damages for the living man and for the widow. More Las Vegas Jury Hearing Evidence in Actos Bladder Cancer Case

Similarities in the Names of Two Drugs Leads to Drug Errors

Similarities in the Names of Two Drugs Leads to Drug Errors

Similarities in the Names of Two Drugs Leads to Drug Errors

Brintellix and Brilinta are two drugs used for vastly different purposes. Brintellix is an antidepressant drug, while Brilinta is a blood-thinner intended to prevent death after a heart attack or severe chest pain or to prevent a second heart attack. Due to the similarity of their names, however, doctors and pharmacists are getting them confused.

On Thursday, the U.S. Food and Drug Administration (FDA) said the agency had been receiving medication error reports since Brintellix was approved in September 2013 – 50 reports in all. The mix-ups occurred when doctors prescribed the wrong drug or pharmacies dispensed the wrong one. Both drugs come in tablet form and have the letter T stamped on them. In some cases, both drugs are yellow. Brintellix is manufactured by Takeda Pharmaceuticals; Brilinta is made by AstraZeneca PLC, according to CBS News. More Similarities in the Names of Two Drugs Leads to Drug Errors

Levaquin Linked to Mitochondrial Toxicity in FDA Report

The antibiotic Levofloxacin, sold under the brand names Levaquin and Cipro, is in the flouroquinolone family and widely used to treat serious infections such as pneumonia and kidney infections. Recent reports, however, suggest that the drug is linked to a condition known as mitochondrial toxicity. ABC5 in Cleveland, Ohio, indicated that a 2013 report by the U.S. Food and Drug Administration (FDA) identified this risk but, has not publicly disclosed it. A review of the FDA’s adverse event database revealed that Levofloxacin has been linked to 3,000 deaths and 200,000 complaints, ABC5 reports.

In 2008, the FDA placed a black box warning–the agency’s most serious–on the drug in 2008 warning of nerve damage and ruptured tendons. More Levaquin Linked to Mitochondrial Toxicity in FDA Report

Medication Given to Infants and Newborns for Low Blood Sugar can Cause Pulmonary Hypertension

Medication Given to Infants/Newborns Cause Hypertension

Medication Given to Infants/Newborns Cause Hypertension

In a July 16 Safety Alert published to its website, the U.S. Food and Drug Administration (FDA) warned that giving Proglycem (diazoxide) to infants and newborns to treat low blood sugar can cause a serious lung condition called pulmonary hypertension.

Proglycem is given to babies who have low blood sugar levels due to certain medical conditions that cause the release of too much insulin from the pancreas. Proglycem increases blood sugar by blocking the pancreas from releasing excess insulin. The medication is typically given the hospital, and the FDA urges healthcare professionals to closely monitor infant and newborn patients receiving it, particularly those with meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease. The use of Proglycem should be stopped if pulmonary hypertension is identified, the FDA said in the Safety Alert. More Medication Given to Infants and Newborns for Low Blood Sugar can Cause Pulmonary Hypertension

New Study Finds a Link Between Using Both Antidepressants and NSAIDs and Intracranial Bleeding

Link Between Antidepressants, NSAIDs & Bleeding

Link Between Antidepressants, NSAIDs & Bleeding

Many individuals with depression also suffer from chronic pain, and take a combination of antidepressants and nonsteroidal anti-inflammatory drugs (NSAIDs) to treat both conditions. A new Korean study published in The BMJ shows that taking these medications together increases the risk of intracranial bleeding. Commonly used NSAIDs include aspirin and ibuprofen.

A team of Korean researchers set out to determine the risk of intracranial bleeding caused by a combination of antidepressants and NSAIDs due to ongoing concern about possible drug reactions. The researchers used the Korean nationwide health insurance database to analyze the records of over four million people who were first prescribed antidepressants and NSAIDs between 2009 and 2013. The team analyzed the timing of both NSAID prescriptions and hospital records to identify individuals admitted to the hospital for the first time for intracranial hemorrhage within 30 days of a new prescription, taking into consideration age, sex and use of other medications, according to PsychCentral.com. More New Study Finds a Link Between Using Both Antidepressants and NSAIDs and Intracranial Bleeding

FDA to Meet Today to Discuss Safety Concerns Surrounding Proposed New Lung Cancer Drug

FDA to Meet Today to Discuss Safety Concerns

FDA to Meet Today to Discuss Safety Concerns

Eli Lilly & Co. is trying to gain the U.S. Food and Drug Administration’s (FDA) approval for its new experimental lung cancer drug, necitumumab, but in a staff report released on Tuesday that was obtained by Bloomberg, the agency said the medication may increase patients’ risk of suffering deadly blood clots.

Lilly company wants to sell necitumumab as an accompaniment to chemotherapy to treat squamous non-small cell lung cancer, which is one of the most common types of the disease. The FDA is scheduled to meet today to discuss the risks and benefits of the drug when used in combination with chemotherapy. Lilly is expected to have an answer from the agency concerning approval of the drug by the end of the year, according to Bloomberg. More FDA to Meet Today to Discuss Safety Concerns Surrounding Proposed New Lung Cancer Drug

Public Advocacy Groups Sue the FDA Over Failure to Release Clinical Trial Data for Two Hepatitis C Treatments

Public Advocacy Groups Sue the FDA

Public Advocacy Groups Sue the FDA

The U.S. Food and Drug Administration (FDA) is facing a lawsuit filed by a pair of public advocacy groups that claim the agency failed to release clinical trial data for Gilead Sciences hepatitis C treatments on a timely basis.

Treatment Action Group and Global Health Justice Partnership late last year asked Gilead for patient-level trial data for the Sovaldi and Harvoni hepatitis C drugs. The groups sought the data because high cure rates have led to the drugs being widely prescribed, and because the FDA approved the medications as part of its “breakthrough designation” regulatory process, which accelerated review of the drugs, according to The Wall Street Journal (WSJ). More Public Advocacy Groups Sue the FDA Over Failure to Release Clinical Trial Data for Two Hepatitis C Treatments