HEALTH

Drug-resistant bacterial infections reported in 20 states, worldwide

BY Michael Johnsen

ARLINGTON, Va. Drug-resistant bacterial infections recently have been reported in more than 20 states across the United States, and now are responsible for an outbreak in Tel Aviv, Israel, according to a report in USA Today on Thursday, citing information from the Society for Healthcare Epidemiology of America.

The bacterial infections prove fatal in as many as 60% of all cases.

The outbreak in Tel Aviv has been traced to northern New Jersey, Neil Fishman, director of SHEA, told the national daily. The bacteria in question are equipped with a gene that enables them to produce an enzyme that disables antibiotics. The enzyme is called Klebsiella pneumoniae carbapenamase, or KPC. It disables carbapenem antibiotics, or last-ditch treatments for infections that don’t respond to other drugs.

The infections are taking place primarily in hospital settings and have not yet spread to the general community.

The problem may be of greater concern than methicillin-resistant Staphylococcus aureus, or MRSA, given the number of alternative treatments that are available. The only drug that appears to make any headway against carbapenem-resistant germs is polymyxin, a medicine that has fallen out of favor with doctors given the toxicity to the kidneys, Fishman said.

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House committee to hold hearing over J&J recall

BY Michael Johnsen

WASHINGTON House Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Thursday announced that the committee will hold a hearing Sept. 30 at 10 a.m. to examine the circumstances surrounding Johnson & Johnson’s recall of more than 135 million bottles of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare, including children’s Tylenol, infant’s Tylenol, children’s Motrin and children’s Benadryl.

 

The hearing also will examine the circumstances surrounding a “phantom recall” of a particular Motrin product, which became public as a result of the committee’s hearing on May 27.

 

 

“This is about the safety of trusted medication that our children and grandchildren use,” Towns stated. “The evidence we have uncovered since our first hearing is extremely troubling.” 

 

 

Witnesses invited to testify include Bill Weldon, J&J chairman and CEO, and Colleen Goggins, J&J worldwide chairman, consumer group.

 

 

The hearing will be webcast on the committee’s website, Oversight.house.gov. 

 

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Forest Pharmaceuticals pays $313 million in settlement deal

BY Alaric DeArment

SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.

The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.

One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.

 

The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.

 

 

“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”

 

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