Health Highlights: June 8, 2006
FDA Cracks Down on Unapproved Antihistamines CDC Pushes Compliance With Vehicle Safety for Kids Health Official Urged Halt of Kids' Antibiotic Trial Informed Consent Takes Back Seat in Public Crisis: FDA Guidant Considered Warning Docs on Heart-Device Defects: Report
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Cracks Down on Unapproved Antihistamines
Makers of unapproved cold, cough and allergy medicines that contain the antihistamine carbinoxamine have 30 to 90 days to stop production, the Food and Drug Administration said Thursday.
Some 120 such medicines now being sold pose safety risks to children under 2 years of age, according to the Associated Press. The estimated 26 manufacturers of the unapproved drugs must seek FDA permission if they want to continue selling the medicines.
Since 1983, the FDA has received reports of 21 deaths of children 2 and younger associated with the unapproved products, including those with carbinoxamine tannate and maleate. The only two FDA-approved medicines that contain carbinoxamine are both made by Mikart Inc. of Atlanta, AP reported.
The crackdown is part of a continuing push by the FDA to encourage companies to comply with the approval process. The agency said there are several hundred unapproved drugs contained in several thousand different products sold today in the United States.
CDC Pushes Compliance With Vehicle Safety for Kids
Efforts to promote helmet use to reduce injuries to off-road motorcyclists under age 16 need to be strengthened, and parents should be encouraged to use restraints for children in cars, a federal agency tracking youth injuries reported Thursday.
An estimated 23,800 children ages 19 and younger were treated for off-road motorcycling injuries in U.S. hospital emergency departments each year from 2001-2004, according to the National Center for Injury Prevention and Control, an arm of the U.S. Centers for Disease Control and Prevention. Nearly seven out of 10 of those injured were less than 16 years of age, and 88 percent were male.
A second report showed that 635 children up to 12 years old were injured in motor vehicle crashes and treated in emergency departments in 2004. Almost 45 percent were either inappropriately restrained or not restrained, and among the 36 percent of children who were inappropriately restrained, most were four to eight year-olds who had been prematurely placed in seatbelts rather than booster seats.
The percentage of unrestrained children requiring hospitalization for their injuries was three times that of restrained children, the report said.
Both findings are published in the June 9 issue of the CDC'S Morbidity and Mortality Weekly Report.
Health Official Urged Halt of Kids' Antibiotic Trial
A U.S. Food and Drug Administration official last month called for a halt in clinical trials of an antibiotic for children because the drug could be deadly, according to internal memorandums from the agency.
The drug, Ketek, made by Sanofi-Aventis, is currently approved only for use in adults as a treatment for sinusitis, bronchitis and pneumonia. The company is testing the drug as treatment for ear infections and tonsillitis in almost 4,000 infants and children in more than a dozen countries, including the United States, The New York Times reported Thursday.
According to a recent review by FDA safety officials, there is growing evidence that Ketek is unusually toxic -- 12 adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury. Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often, the officials concluded in the review, the newspaper reported.
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the FDA's Office of Drug Safety at the agency, wrote in one of the memorandums obtained by the Times. Other safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects, the paper said.
FDA spokeswoman, Susan Bro, asked about the Johann-Liang memorandum, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact."
Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said the company was in discussions with the FDA about the drug.
Informed Consent Takes Back Seat in Public Crisis: FDA
Victims of a future terrorist attack or public health emergency would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts immediately condemned the ruling as unnecessary and ripe for abuse.
The rule, issued by the U.S. Food and Drug Administration, would allow health care workers to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, the Associated Press reported. In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.
Dr. Deborah Peel, chairwoman of the Patient Privacy Rights Foundation, a watchdog group, told AP, "This sounds like they're taking for themselves the right to test individuals every time they declare a public health emergency. There is no way getting consent would delay testing."
The rule is subject to public comment until Aug. 7. The FDA said it published the rule without first seeking comments because it would hinder the response to an outbreak of bird flu or other public health emergency. The agency said the lack of such an exemption impeded the public health response to the SARS epidemic of 2003, AP reported.
Guidant Considered Warning Docs on Heart-Device Defects: Report
Guidant Corporation, which last year defended its decision not to tell physicians about significant heart-device defects, had drafted a "Dear Doctor" letter to disclose the hazards but decided not to send it, The New York Times reported Wednesday.
The proposed letter and other company records, released this week by a Texas state judge, may have significant legal and financial consequences. Since last fall, the U.S. Department of Justice and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators.
A spokeswoman for the United States attorney's office in Minneapolis that's heading the federal inquiry declined to comment on the investigation, according to the paper's report.
At least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of an electrical defect. But many experts believe that the number is probably higher because implanted heart devices are rarely examined after a patient's death to see if they were working properly, the newspaper said.
A defibrillator is an implanted device that senses potentially fatal heart rhythms and corrects them with a timed electrical shock to restore a normal heartbeat.