In May 2016, the U.S. Food and Drug Administration (FDA) warned about the risks of fluoroquinolone antibiotics, which include Levaquin, Avelox and Cipro. The agency said that, given the risk of potentially permanent side effects, these medications should only be used in situations where no other treatment options are available for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections.
Fluoroquinolones are the subject of a multidistrict litigation (MDL) underway in Minnesota. A court recently ruled that plaintiffs can amend the Master Complaint to include this most recent FDA announcement. At least 484 lawsuits have been filed over Levaquin, Cipro and Avelox in the District of Minnesota. An additional 40 lawsuits have been filed in state courts. Continue reading
Zithromax, a widely prescribed antibiotic, has been linked to a number of severe side effects, including the serious allergic skin reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Stevens-Johnson is “a rare, serious disorder” of the skin and mucous membranes. SJS is usually a reaction to a medication or an infection. SJS frequently begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. Continue reading
The U.S. Food and Drug Administration (FDA) has updated the warning label on Abilify, Abilify Maintena, Aristada and generic aripiprazole to include information about compulsive behavior. According to the safety announcement, there have been reports of uncontrollable urges to gamble, binge eat, shop and have sex in patients taking these drugs. According to the FDA announcement, the compulsive behaviors generally stopped when the dosage was lowered or drug discontinued.
The current label included pathological gambling as a reported side effect, but the FDA stated that this was not an accurate description of impulse-control problems identified. Additionally, the label did not include information about compulsive behaviors other than gambling. As a result, the agency is updating the warning label. Continue reading
The U.S. Food and Drug Administration (FDA) has approved labeling changes on fluoroquinolone antibiotics, which include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive). In a news release issued Tuesday, the agency said the Boxed Warning and the Warning and Precautions section of the label would be revised to warn of “disabling and potentially permanent side effects” affecting tendons, muscles, joints, nerves and the central nervous system.
Fluoroquinolones fight bacterial infections by preventing growth or killing bacteria. In November 2015, an FDA Advisory Committee reviewed new safety information involving two or more side effects that occur simultaneously, and the potential to lead to permanent damage. The committee concluded that the risks of fluoroquinolones generally outweighed the benefits in patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. In May, the FDA released a drug safety communication stating that use of fluoroquinolones should be limited to situations where no alternative treatments are available.
The new safety label will reflect current information showing that both oral and injectable fluoroquinolones were associated with “disabling side effects” that can affect the tendons, muscles, joints, nerves and the central nervous system, the FDA said. The agency’s news release stated that the side effects may be permanent, and occur anywhere from hours to weeks after treatment. Continue reading
Plaintiffs in more than 200 birth defect lawsuits have raised concerns over the pharmaceutical company GlaxoSmithKline’s (GSK) new proposal for Sequenced Discovery. Parents say the company neglected to warn patients and health experts of its anti-nausea drug Zofran’s alleged potential to cause serious birth defects, according to The Legal Examiner.
On June 3, 2016, GSK suggests possible order, or “sequence” in the document’s language, for how discovery should proceed. In the discovery phase, both parties are allowed to demand evidence from one another. For its part, GSK wants this litigation to turn to two major questions: Continue reading
Dilantin, the anti-epileptic drug that has been in use for decades is one of many drugs associated with the related skin conditions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Though these conditions are rare, when they do occur they put the patient at risk for permanent skin and organ damage and blindness. SJS/TEN can be fatal, Top Class Actions reports. Continue reading
Hundreds of product liability lawsuits involving the fluoroquinolone antibiotics Levaquin, Cipro and Avelox are moving toward trial in a multidistrict litigation (MDL) in the U.S. District Court, District of Minnesota.
In June 2016, the court granted a motion from the plaintiffs to amend the master complaint to include information about the U.S. Food & Drug Administration’s (FDA) May 2016 safety announcement for fluoroquinolone antibiotics. The court said that doing so would not greatly expand the scope of the proceedings. Continue reading
The makers of Xarelto, an anticoagulant that was credited as a breakthrough in blood clot prevention, is battling numerous lawsuits. An alleged connection between an elevated risk for serious hemorrhages and Xarelto are now being lent possible increased credibility through recent studies, reports the Digital Journal.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. It is manufactured by Bayer AG and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The initial purpose of the medication was to prevent blood clots in patients with pulmonary embolisms, deep vein thrombosis, and those recovering from knee and hip replacement surgeries. A short while after it was approved, Xarelto’s uses were expanded to treat atrial fibrillation, a heart condition that increases the risk of stroke. Continue reading