Current Events

The Food and Drug Administration issued a final rule Dec. 19, banning the use of most powdered medical gloves.

The rule, which goes into effect Jan. 18, applies to patient examination gloves, powdered surgeon's gloves and absorbable powder for lubricating a surgeon's glove. 

"While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling," the agency said in a March news release.
Read more . . .

There are a lot of things you don’t want to happen to your car, but having it go up in flames for no apparent reason is likely close to the top of the list. Yet, that’s apparently occurred to eight Smart vehicles in the last two years. 

As a result, the National Highway Traffic Safety Administration announced this week that it had opened a preliminary investigation into 42,875 model year 2008 to 2009 Fortwo vehicles.

According to NHTSA’s preliminary evaluation notice [PDF], the agency’s Office of Defects Investigation has received eight complaints from consumers related to incidents in which the engine compartment – located in the back of the vehicle – caught fire.

The owners reported that the fires occurred both when the car was in use and while it was parked.
Read more . . .

The U.S. National Highway Traffic Safety Administration is launching an investigation into about 1 million newer Fiat Chrysler Ram pickup trucks and SUVs after receiving complaints the vehicles rolled away after being parked, it said on Tuesday.

Fiat Chrysler Automobiles NV said it is cooperating with the government investigation that covers the 2013-2016 model year Ram 1500 pickup truck and 2014-2016 Dodge Durango SUV. The government said it has reports of 25 crashes from owners alleging vehicle roll-away and 9 injuries and urged drivers to set the parking brake before exiting the vehicles.
Read more . . .

Volkswagen Group has agreed to yet another compensation and buyback package to buyers of its polluting diesel-powered vehicles, this time involving owners of VW, Audi and Porsche cars and SUVs with six-cylinder engines.

Under the agreement announced Tuesday, the automaker will buy back another 20,000 polluting diesel vehicles with 3-liter, six-cylinder diesel engines in the U.S., fix about 63,000 vehicles and pay $225 million in environmental remediation.

The company agreed to the sweeping settlement with the U.
Read more . . .

Lawyers, companies and researchers now have valuable access to complaints of harm associated with FDA-regulated food, dietary supplements and cosmetics.

The new public-facing Food and Drug Administration database compiles adverse-event reports that consumers, doctors and companies send the FDA. These reports were previously available only through specific Freedom of Information Act requests.

The agency uses the reports to identify harmful products that may need further investigation.

Both consumer and industry groups say the database will prove helpful to a variety of users about potential product problems.
Read more . . .

The FDA has formally banned two types of powdered gloves and a glove lubricant Friday, issuing its final ruling on a proposal first announced in March.
The agency outlawed powdered surgeon's gloves and powdered patient examination gloves -- in addition to banning absorbable powder used to lubricate surgeon's gloves -- because they "present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling." The ruling will go into effect 30 days after the ban notice is published in the Federal Register (scheduled for Monday).

The ruling does not apply to powdered radiographic protection gloves, nor to powder used to manufacture non-powdered gloves, or to use with other medical devices (such as condoms).

Read more . . .

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.
Read more . . .

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.
Read more . . .

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.
Read more . . .

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.
Read more . . .

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.
Read more . . .