Current Events

When teenage Eddie Bible looked in the mirror, he didn't see a boy. It was too difficult for him to look past the large breasts on his chest.

"I had bigger boobs than the girls in (high) school," he said. "I thought, 'Am I going to have to get a training bra?' "
At 13 years old, Bible was suffering a side effect -- not disclosed at the time -- of medication he was taking for anxiety and bipolar disorder.
"They put me on this Risperdal.
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The Food and Drug Administration warned Wednesday that repeated or lengthy use of general anesthesia or sedation drugs for children younger than 3 or pregnant women in their third trimester may affect youngsters' developing brains.

The agency, which said its warning is based on a comprehensive analysis of the latest research, issued a “drug-safety communication” to inform health-care providers, parents and pregnant women about the risks of using the drugs repeatedly or for more than three hours at a time. It also ordered manufacturers to add warnings to their products' labels.

“We recognize that in many cases these exposures may be medically necessary,” Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. The new data on potential harms, she said, “must be carefully weighed against the risk of not performing a specific medical procedure.
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A French association of people affected by an epilepsy drug that caused birth defects launched a class action against pharmaceutical company Sanofi on Tuesday.

APESAC President Marine Martin told The Associated Press that Sanofi now has four months to acknowledge its responsibility before a judge takes up the case.

The global drug company has been selling Depakine, the anticonvulsant drug at the center of the class action, in France since 1967.

Depakine, which contains sodium valproate, is usually prescribed to treat epilepsy.

Sanofi said in an email to the AP that it had received notification of the proceedings.
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[NEWARK, New Jersey] Wells Fargo & Co is under investigation by regulators in California and New Jersey to determine whether the bank signed up customers for Prudential Financial Inc life policies without their permission.

The announcements Monday by regulators followed fraud and misconduct allegations raised last week in a whistle-blower lawsuit claiming the insurer covered up an internal inquiry that found San Francisco-based Wells Fargo may have fraudulently opened Prudential's low-cost MyTerm policies.

California Insurance Commissioner Dave Jones said that his department will work with New Jersey watchdogs to examine "all aspects" of the allegations, and that Prudential's practices will be investigated as well.

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Centurion recalled 1,000 of its convenience kits containing Multi-Med single lumen catheters, according to an FDA news release on Dec. 9.

The FDA said the action was a Class 1 recall, which means use of the devices could cause serious injuries or death.

Centurion found that excess material could remain at the tip of the catheters, separate from the catheters and enter the patient’s bloodstream. If that happens, patients could develop blood clots, embolism of the excess material to vital organs or death.
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The FDA recently issued a press release that confirms medication containing pioglitazone could be associated with an increased risk of developing bladder cancer. Affected medications include Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni, the FDA reported.

While these medication labels already contain warnings about the risk of bladder cancer, new label updates that include data from additional studies were approved by the FDA. 

The original alerts were made public in September 2010 and June 2011 based on interim results from a long-term safety study. In August 2011, the labels of pioglitazone-containing medications were changed to inform individuals about the increased cancer risk.
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Prudential Financial Inc. was accused of covering up fraudulent sales of life insurance policies through Wells Fargo & Co. to low-income customers, marking the latest flareup of the fake-accounts scandal plaguing the third-largest U.S. lender by assets.
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As healthcare leaders and policy experts come together for the annual Food and Drug Administration (FDA) CMS Summit in Washington this month, much of the focus will be on how quickly both agencies are evolving to meet the needs of patients. By most accounts, 2017 is gearing up to be a year in which the voice of the individual patient will be front and center in historically bureaucratic and highly-technical environments. 

Case in point is the discussion surrounding the first-ever FDA-approved drug to treat patients with Duchenne muscular dystrophy (DMD) — Eteplirsen, now known as Exondys 51.

The FDA made its decision in September, but there is a lingering debate as to whether the clinical trials used were sufficient for approval. Despite numerous DMD experts weighing in (not to mention patients and families who were directly part of the trials), the evaluation of the medicine came about at a unique time in biomedical innovation.
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Sanofi Pasteur, one the world's leading vaccine makers, had a potentially serious and costly problem on its hands: Its Monroe County plant discovered tiny pieces of glass in batches of a vaccine intended for babies.

The glass was first detected in April 2013 in samples of a vaccine that had already been distributed to customers and which would not expire until September 2014.

Sanofi sent the samples to an outside laboratory for analysis. The lab found evidence of delamination — which occurs when vaccine vials shed flakes of glass called lamellae.

The health risks posed to any individual by vaccine vial delamination are widely believed to be minuscule.
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Dementia patients who get prescriptions from multiple health systems may face a higher risk of drug mix-ups or unsafe interactions than people with cognitive problems who get all their medications from one place, a study of U.S. veterans suggests.

Researchers examined data on more than 75,000 veterans with dementia and found that among patients who received all of their care at Department of Veterans Affairs (VA) facilities, 39 percent had potential safety issues with prescribed medications.

Among those who got some care at the VA and some treatment elsewhere, however, 59 percent had possible drug safety issues, the study found.
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Antibiotics and narcotics are often prescribed when they aren’t the best option for patients and may do more harm than good, a survey of U.S. physicians suggests.

The survey asked doctors to identify treatments that they see routinely used despite guidelines recommending against the interventions and little or no value for patients.

Overuse of antibiotics topped the list, with 27 percent of doctors identifying this as a common problem.
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