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Eli Lilly & Co. is halting the development of semagacestat, an experimental treatment for Alzheimer’s disease, because two late-stage studies showed the drug may have worsened the condition in patients and increased their risk of skin cancer.
The Food and Drug Administration (FDA) wants to withdraw its approval of midodrine hydrochloride, a medication used to treat the low blood pressure condition orthostatic hypotension, because post-approval studies that verify the clinical benefit of the drug have not been done. This is the first time the agency has issued a withdraw proposal for a drug approved under the FDA’s accelerated approval regulations.
The U.S. Department of Justice is seeking to permanently shut down a Brooklyn, New York-based maker of ready-to-eat deli salads, seafood, and cream cheeses. Food and Drug Administration inspectors say that NY Gourmet Salads Inc. has a history of serious non-compliance with federal food safety standards and the presence of potentially deadly bacteria in its processing facilities and foods.
It seems China can’t stop producing tainted products. This time, pediatricians in the central province of Hubei are expressing concern over premature development of breasts in three infant girls, and are suggesting that milk powder manufactured by Synutra International is the culprit. The infants who were affected had levels of estradiol and prolactin, hormones that stimulate the production of breast milk, that were as high as those in adult women. One father in Beijing said his daughter not only had grown breasts but was also releasing vaginal discharge.
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.
The Federal Aviation Administration (FAA) has been cracking down on shipments of hazardous materials and has published a notice of civil penalties issued against 11 companies. The FAA issued the fines in response to improperly packaged, marked, classed, described, or labeled hazardous materials. The penalties total $720,000 and range from $54,000 to $91,000.
The Food and Drug Administration (FDA) is alerting emergency medicine and surgery professionals of serious adverse events that may result from the long-term use of inferior vena cava (IVC) filters. IVC filters are a type of catheter that is implanted into the inferior vena cava, a large vein that carries de-oxygenated blood from the lower half of the body into the right atrium of the heart, to prevent fatal pulmonary emboli.
The Food and Drug Administration (FDA) is warning the public about Solo Slim and Solo Slim Extra Strength, more dietary supplements that contain the undeclared drug ingredient Didesmethyl Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss that can cause serious health complications in some people, including life-threatening cardiovascular events.
Americans take dietary supplements to help them lose weight, be more aware, and for general well being, but according to a recent Consumer Reports story, those “healthy pills” may be making them sick. The consumer magazine identified 12 ingredients in readily available dietary supplements that should be avoided because they have been linked to serious cardiovascular, liver and kidney problems. These dietary supplements aren’t regulated by the Food and Drug Administration (FDA) and thus manufacturers of these products don’t have to provide evidence that they are safe and effective.
Two mothers who watched their young children die after becoming trapped in the powerful suction at the bottom of a pool are now fighting to prevent tougher pool safety regulations from being further undermined by the swimming pool industry.
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