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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.
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 H1N1 pandemic is over, the World Health Organization (WHO) announced this week. The strain of influenza killed about 18,500 worldwide since it emerged during the spring of 2009, and spurred a flurry of mass vaccination programs. The organization warns that the announcement doesn’t mean the H1N1 virus has gone away. Rather, it is expected to take on the behavior of a seasonal flu virus and circulate primarily during the winter months over the next several years. During the pandemic, the H1N1 virus spread into other seasons, dominating other seasonal influenza viruses.
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.
Patients who received massive overdoses of radiation to the head during tests for strokes at hospitals in California and Alabama may face long-term risks of cancer and brain damage, according to the New York Times. The newspaper launched an investigation into the overdoses that were first reported by the Food and Drug Administration (FDA) in October.
At that time, the agency said it had received reports of more than 200 patients at one hospital receiving excessive doses of radiation to the head, which resulted in hair loss and erythema, or redness of the skin. The Times has since found that the radiation overdoses were larger and more widespread than originally thought – exceeding 400 from eight different hospitals – and that some patients reported symptoms far worse than hair loss, including memory loss and confusion.
Vaccines for the 2010-2011 flu season in the United States have been approved by the Food and Drug Administration (FDA), but they also include a warning of fever and febrile seizures in young children.
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