Current Events

A Tennessee pharmacy believed to be the source of a second outbreak of fungal infections linked to pain shots was a mess when Food and Drug Administration inspectors went in last month, with stray spiders in a clean room and few written procedures for making sure products were sterile, the FDA says.

The FDA has found fungus and bacteria in at least two vials of steroid distributed by Main Street Pharmacy of Newbern, Tenn. So far, 25 patients in four states have developed abscesses after getting injections of the pharmacy’s product.

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New York State regulators are calling for a nationwide moratorium on transactions that life insurers are using to alter their books by billions of dollars, saying that the deals put policyholders at risk and could lead to another taxpayer bailout.

Insurers’ use of the secretive transactions has become widespread, nearly doubling over the last five years. The deals now affect life insurance policies worth trillions of dollars, according to an analysis done for The New York Times by SNL Financial, a research and data firm.

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Walgreens has been handed the largest fine in the history of the U.S. Controlled Substances Act.

Walgreens, the nation's largest drugstore chain, will pay $80 million in fines to end a DEA probe into allegations it allowed millions of controlled substances, including the highly addictive painkiller oxycodone, to reach the black market.

The settlement is the largest civil penalty paid under the Controlled Substances Act in Drug Enforcement Administration history, U.S. Attorney Wifredo Ferrer said Tuesday.

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The nationwide outbreak of hepatitis A linked to frozen berries grew to 79 Friday, but it is sparing children.

Of the people in seven states who have become ill with the deadly liver disease, only one was a child. Health officials initially feared that the youngest would be hit hardest because the contaminated frozen berries are used in smoothies, ice pops and other warm-weather treats popular with children.

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A federal judge intervened Thursday to improve the odds that a second dying child could get a lung transplant from an adult donor in a fast-moving drama that has tugged at the public's heartstrings while raising concerns among ethicists.

Just a day earlier, lawyers had persuaded U.S. District Judge Michael M. Baylson to suspend rules they said discriminated against children like Sarah Murnaghan of Newtown Square, a 10-year-old with end-stage cystic fibrosis. They returned to federal court Thursday and successfully argued for Javier Acosta, 11, of New York City, who suffers from the same progressive disease. He has been waiting for lungs since 2010, the lawsuit said.

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President Obama defended National Security Agency surveillance programs Friday, saying they are designed to promote public safety and protect civil liberties.

"They help us prevent terrorist attacks," Obama said, and are valuable despite what he called "modest encroachments on privacy."

Speaking after delivering a health care speech in San Jose, Calif., Obama denounced the "hype" surrounding recent news reports, and said "nobody is listening to your telephone calls" or "reading the e-mails" of U.S. citizens.

People can "complain about Big Brother" and the potential of a "program run amok," Obama said, "but when you actually look at the details, then I think we've struck the right balance."

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In the largest drug safety settlement the Department of Justice has ever executed with a generic drug manufacturer, Ranbaxy USA pleaded guilty to seven felony counts and agreed to pay a total of $500 million in fines and forfeitures. The DOJ alleged that Ranbaxy knowingly produced adulterated drugs at two plants in India that were later distributed in the United States and that Ranbaxy officials failed to notify the FDA of tests that showed numerous drugs it produced were out of specification, impure, and did not meet shelf life standards.

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DETROIT — In an escalating confrontation with regulators, Chrysler said on Tuesday that it would not recall 2.7 million Jeeps that the government contends are defective and prone to fires in the event of rear-impact collisions.

It is unusual for a car company to refuse a recall request made by the National Highway Traffic Safety Administration, which regulates the safety of vehicles.

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High doses of painkillers such as ibuprofen raise the risk of heart disease, according to a review of 639 studies that draws a parallel with the potential danger from newer pain drugs including Pfizer Inc. (PFE)’s Celebrex and Merck & Co.’s withdrawn Vioxx.

Over a year of treatment, for every 1,000 patients with moderate heart disease risk who took 2,400 milligrams of ibuprofen or 150 milligrams of diclofenac, both daily doses standard for arthritis, three patients would experience an avoidable heart attack, the analysis showed. Ibuprofen is sold as a generic and under brand names such as Advil and Nurofen.

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Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner delivery catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.  This recall includes all sizes, diameters and lot numbers prior to April 16, 2013.

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General Motors Co. is recalling more than 27,000 Cadillac SUVs worldwide because the wheels can fall off.

The company says the recall affects the 2013 Cadillac SRX with 18-inch wheels. Canadian safety regulators say the wheel nuts may not have been tightened enough at the factory.

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