Calif. health officials address ‘whooping cough’ outbreak
SACRAMENTO, Calif. California health officials and healthcare professionals are urging Californians to get vaccinated, as the state is on pace for the worst epidemic of pertussis, more commonly known as whooping cough, in more than 50 years. The disease already has claimed the lives of nine infants in the state.
"Whooping cough is now an epidemic in California. Children should be vaccinated against the disease, and parents, family members and caregivers of infants need a booster shot," stated Mark Horton, director of the California Department of Public Health.
As of Sept. 14, there were 4,017 cases of the illness reported for a state rate of 10.3 cases for every 100,000 people. Of that number, 3,985 of the reported cases experienced disease onset in 2010, according to the California Department of Public Health.
This marked the most cases reported in 55 years, when 4,949 cases were reported in 1955, and the highest incidence in 48 years, when a rate of 10.9 cases per 100,000 people was reported in 1962. Previously, the peak was in 2005, when there were 3,182 cases reported, according to the CDPH.
Pertussis is a highly contagious disease. Unimmunized or incompletely immunized young infants are particularly vulnerable. Since 1998, more than 80% of the infants in California who have died from pertussis have been Hispanic.
The vaccine begins at 2 months of age, but young infants are not adequately protected until the initial series of three shots is complete at 6 months of age. The series of shots that most children receive wears off by the time they finish middle school, according to the CDPH.
In response to the epidemic, Walgreens announced that its pharmacists in California were offering pertussis immunizations (tetanus/diphtheria/pertussis-Tdap vaccine) at more than 150 select stores throughout the state. Walgreens pharmacists in the state can administer immunizations to anyone age 9 years and older. With more than 575 stores throughout California, Walgreens will continue to add locations that can administer the whooping cough vaccine.
"We share in the recommendations of state and federal health officials that the best thing people can do to keep themselves and their families healthy during this epidemic is to get vaccinated," stated Bill Hose, California market VP for Walgreens. "In addition to children, who are the most vulnerable, those who care for or are in contact with children should also be immunized, and we’re continuing to stress these important statewide recommendations to our patients, customers and the general public."
House committee to hold hearing over J&J recall
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.
Forest Pharmaceuticals pays $313 million in settlement deal
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.”