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Lamictal (lamotrigine), a medication commonly used for seizures in children 2 years old and older, and bipolar disorder in adults, can cause aseptic meningitis, according to a Drug Safety Communication issued by the Food and Drug Administration (FDA). The warning will be added to the drug’s Warnings and Precautions section of the drug safety label as well as the patient Medication Guide.
Consumers should not take the oral mineral supplement Miracle Mineral Solution because when used as directed, it produces an industrial bleach that can cause serious health problems. The Food and Drug Administration (FDA) issued the warning after receiving several reports of injuries from consumers who had used the product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration. Consumers are advised to shop using the solution immediately and throw it away.
The Food and Drug Administration (FDA) is warning health care professionals and patients about the potential for developing a type of pneumonia when treated with Cubicin (daptomycin), an intravenous antibacterial drug used to treat MRSA and MSSA, serious difficult-to-treat staph infections of the skin and bloodstream. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms include fever, cough, shortness of breath, and difficulty breathing. If not quickly recognized and appropriately managed, esoinophilic pneumonia may lead to progressive respiratory failure and death.
The Food and Drug Administration (FDA) is investigating a recently published study that suggests medications used to treat high blood pressure and other conditions, known as angiotensin receptor blockers (ARBs), may increase cancer risk. Brand name ARBs include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.
Tests conducted by the Food and Drug Administration (FDA) on a product known as “Generic Tamiflu” and sold on the Internet has found that the product contains an ingredient that could cause serious injury in some consumers. The fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin are at risk of experiencing similar reactions from cloxacillin. Such reactions include sudden, potentially life-threatening reactions called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
The Food and Drug Administration (FDA) is reviewing data from two clinical trials that suggest the blood pressure medication Benicar (olmesartan) may increase the risk of death from cardiovascular causes in patients with type 2 diabetes, according to an FDA safety announcement. The agency is continuing to review the data from two studies, ROADMAP and ORIENT, and is considering additional ways to asses the cardiovascular effects of Benicar.
U.S. District Judge Berle M. Schiller has ruled that manufacturers of generic drugs are not protected from lawsuits even if the Food and Drug Administration (FDA) certifies them as the “bioequivalent” of their brand name predecessors. The lawsuit involved consumers who were previously taking the brand name antidepressant Wellbutrin.
The defendants allege after switching to a generic version of the drug, buproprion, made by Teva Pharmaceuticals and Impax Laboratories, they experienced side effects. The lawsuit contends Teva and Impax became aware of the side effects but failed to warn consumers. While the active ingredient in Wellbutin and buproprion is the same, the two have differing release rates, which the defendants say caused adverse events when they switched to bupropion.
A weight loss dietary supplement is being recalled by the Food and Drug Administration (FDA) after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.
A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.
External biphasic defibrillators, monitor/defibrillators and automated external defibrillators (AEDs) used to provide cardioversion therapy to patients are being investigated by the Food and Drug Administration following reports that the devices designed to deliver 200 J (joules) were ineffective during use.
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