From Our 2012 Archives
Health Highlights: Jan. 16, 2012
Latest MedicineNet News
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
'Totally Drug-Resistant' TB Reported in India
The first cases of "totally drug-resistant tuberculosis" in India have been reported by doctors. A dozen medicines were tested and none of them worked.
"It is concerning," Dr. Kenneth Castro, director of the U.S. Centers for Disease Control and Prevetion's Division of Tuberculosis Elimination, told the Associated Press. "Anytime we see something like this, we better get on top of it before it becomes a more widespread problem."
However, no one anticipates a rapid spread of such TB. Most of the cases were the result of mutations that occurred in poorly treated patients, and not caused by person-to-person transmission.
This is not the first occurrence of highly drug-resistant TB. Since 2003, patients have been documented in Italy and Iran. The cases have mostly been restricted to poor areas and the TB has not spread widely, the AP reported.
New Fees Would Accelerate Generic Drug Reviews: FDA
Drug makers could pay hundreds of millions of dollars a year in new fees in order to speed up the review of generic drugs, the U.S. Food and Drug Administration says.
An agreement with drug makers was released Friday by the FDA, which will submit the proposal to Congress for approval, the Associated Press reported.
Most new drugs are reviewed in 10 months, but the typical review time for a generic drug is 30 months. The FDA's backlog of generic drug applications awaiting review is more than 2,000, according to the Generic Pharmaceutical Association.
If approved, generic drug makers would pay $299 million a year so that the FDA could hire more generic drug reviewers starting in fiscal year 2013. With the new reviewers, the FDA's goal would be to review 90 percent of generic drug applications within 10 months, the AP reported.
Lymphoma Drug Adcetris Gets New Warning About Brain Infection
Two additional cases of a rare but serious brain infection have led to a new boxed warning on the lymphoma drug Adcetris (brentuximab vedotin), the U.S. Food and Drug Administration said Friday.
Adcetris is used to treat Hodgkin lymphoma and a rare lymphoma called systemic anaplastic large cell lymphoma. When the FDA approved Adcetris in August 2011, one case of the potentially deadly brain infection progressive multifocal leukoencephalopathy (PML) was described in the Warnings and Precautions section of the drug's label.
Along with the new boxed warning about the risks of PML, the drug will also carry a new contraindication warning against the use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity, the FDA said.
Signs and symptoms of PML can develop over several weeks or months and may include mood changes, unusual behavior, confusion, memory loss, thinking problems, weakness on one side of the body, and changes in vision, speech or walking.
Patients who develop any signs or symptoms of PML should immediately notify their doctor, the FDA said.
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