Current Events

U.S. health regulators on Friday allowed Pfizer Inc to remove a serious warning from the label of its smoking cessation treatment, Chantix, giving a new lease of life to the controversial drug that was approved a decade ago.

The U.S.
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Agios Pharmaceuticals Inc. said Thursday it has halted development of an experimental drug to treat a form of anemia after regulators, concerned about a safety issue surfacing in an early-stage clinical study, put a hold on clinical testing of the compound.

Agios disclosed for the first time Thursday that the Food and Drug Administration had ordered it to suspend testing of the drug after a healthy volunteer in a British clinical trial was diagnosed with drug-induced cholestatic hepatitis, the obstruction of bile secretion. Agios said the patient is being monitored and no other adverse events have been reported. Nonetheless, the company has stopped the British study and a separate palability study with US volunteers.
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The Food and Drug Administration this week announced that it was requiring new warnings about the repeated or lengthy use of general anesthesia and sedative drugs in pregnant women and children under age 3 because of their possible effect on the developing brain.

But one doctor I contacted for this story expressed concern that the new warning might spur patients and parents to delay potentially lifesaving surgery.

"The (scientific) literature is so murky right now that I believe that the FDA has done a disservice to the population by putting out these warnings," Dr. Rita Agarwal, chair of the American Academy of Pediatrics' Section on Anesthesiology and Pain Medication, told me.

Agarwal and the other physicians I asked about the new warning said that, when possible, they and their colleagues already try to minimize or postpone procedures requiring anesthesia or sedatives because of animal studies that suggest a possible adverse effect.
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Four New Jersey residents -- including two teenagers -- who suffered third-degree burns when their e-cigarette batteries ignited "like a rocket" are suing the shops that sold the "defective" devices, their attorneys announced Thursday.

The manufacturers of the lithium ion batteries that power the vaping devices are also the targets of the litigation, although the attorneys acknowledged it would be tougher to hold them accountable. The batteries are made in China.

But with the burgeoning $10 billion e-cigarette industry operating without meaningful oversight yet by the U.S.
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A 17-year-old died on a Texas highway last month after a minor automobile accident, one that local police said she should have walked away from.
Instead, Huma Hanif died within a matter of seconds as the Takata airbag inflator inside the steering wheel of her 2002 Honda Civic exploded, launching shrapnel at her from mere feet away. A piece of metal cut her neck causing her to bleed to death shortly after the low-speed collision.

Hanif is the 11th person to die from injuries suffered as a result of a defective Takata airbag. Hundreds more around the world have been injured by the exploding inflators.
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From the air, the Pearl River Delta in southern China’s Guangdong province resembles a mass of human cells under a microscope. Hundreds of thousands of tiny rectangular blocks, all of them shades of green, are clustered between cities and waterways. Livestock pens are scattered among the thousands of seafood farms that form the heart of the country’s aquaculture industry, the largest in the world.

Beside one of those fish farms near Zhaoqing, on a muggy day in June, a farmhand wearing a broad-brimmed straw hat hoses down the cement floor of a piggery where white and roan hogs sniff and snort. The dirty water from the pens flows into a metal pipe, which empties directly into a pond shared by dozens of geese.
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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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