The Food and Drug Administration is warning that a popular antibiotic marketed under the name Ketek can cause acute liver failure, and it's advising physicians to monitor patients on the drug closely.
The FDA says the problems can develop after taking only a few doses of Ketek, and can progress rapidly to acute liver failure.
Over two years, through April 2006, 12 cases of acute liver failure, and 23 cases of serious liver injury were reported to the FDA. Four of those patients died and one required a transplant. The agency is investigating two more cases of acute liver failure that have been reported since April.
Ketek was approved for the treatment of sinusitis, bronchitis and certain kinds of pneumonia in 2004. A key safety study of the drug was riddled with fraud, and Sen. Charles Grassley (R-Iowa), who is investigating the FDA's handling of Ketek, said today there are legitimate questions about whether Ketek should be on the market. — Snigdha Prakash
CDC Recommends HPV Vaccine for Girls
June 28, 2006 — The Centers for Disease Control and Prevention is recommending that pre-adolescent girls be vaccinated against a sexually transmitted virus that can cause cervical cancer. The idea is to vaccinate them before they become sexually active.
Several strains of the sexually transmitted human papilloma virus (HPV) cause cervical cancer and genital warts. The Advisory Committee on Immunization Practices voted unanimously to recommend administering a vaccine to 11- and 12-year-old girls. The committee says it's also OK to give the vaccine to girls as young as 9. The vaccine doesn't protect against all cancer-causing strains of HPV, so regular cervical cancer testing is still necessary.
The committee's recommendations are almost always adopted by state governments and insurance companies. But getting 11- and 12 year olds into the doctor's office for the series of three shots may be difficult. And the vaccinations cost several hundred dollars. — Joanne Silberner
New Restrictions on Diet Supplements
June 28, 2006 — A Senate committee has approved compromise legislation that will require makers of diet supplements to report bad reactions to the federal government.
A 1994 law specifically exempted makers of diet supplements from having to meet the same safety and effectiveness requirements as prescription drugs. That's caused a lot of complaints from consumer advocates, particularly after serious health problems linked to the supplement ephedra.
The new bill breaks a years-long deadlock — in a way. Supplements still won't have to prove they're safe and effective, but makers will have to report so-called "adverse reactions" to the Food and Drug Administration. The reports won't necessarily mean the supplements are unsafe, but they will let the agency see if a pattern emerges.
With support from Republicans, Democrats, the industry and consumer groups, the bill is expected to win swift passage. — Julie Rovner
Report Accuses FDA of Neglecting Field Complaints
June 27, 2006 — A new report accuses the Food and Drug Administration of not doing its job.
After the FDA failed to respond to reports by its own investigators of major problems at a vaccine manufacturer, Democratic staffers of the House Committee on Government Reform decided to take a closer look.
They asked the FDA for internal documents showing how well or how badly the agency was enforcing its rules and regulations.
The staffers found that the FDA issued half the number of warning letters in 2005 as it did in 2000. Over those years its inspectors were reporting the same number of violations, or more.
The staff report concludes that in many cases, FDA headquarters rejected recommendations from field officers. In a written statement, the FDA said it shouldn't be judged on numbers, that it's been focusing instead on the biggest problems. — Joanne Silberner
Medical Journal Corrects Vioxx Study
June 26, 2006 — The New England Journal of Medicine has issued an unusual correction to a paper it published last year on the painkiller, Vioxx. The change undermines a key feature of drug maker Merck's defense against thousands of product-liability lawsuits.
Vioxx was withdrawn from the market in 2004 after a study called APPROVe showed that the painkiller doubled the risk of heart problems.
In court, Merck has argued that the risk to patients didn't begin until 18 months of use, and that short-term use of Vioxx was safe. Many experts disputed that, but Merck's position was strengthened by a carefully worded statement in the New England journal, which said the risks "became apparent" 18 months after the study began.
The journal corrected those statements today. It said that a statistical error by Merck undermined the evidence for them. The journal deleted two references to the 18-month delay, and weakened two others. — Snigdha Prakash