Raltegravir tablets (Isentress, Merck) have been approved for the treatment of human immunodeficiency virus drug (HIV)-1 infection, in combination with other anti-retroviral agents, in patients who have received other therapies and who have evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.
Studies have shown that formulary restrictions can be an effective means of controlling drug use, but concerns have arisen about clinical consequences, say researchers from Canada. One retrospective study, for example, suggested that restricting fluoroquinolones drug could lead to more hospitalizations for pyelonephritis and bronchitis. To confirm these findings, the researchers conducted a study using a database of 1.4 million older adults.
The anticonvulsant agent topiramate (Topamax drug, Ortho-McNeil) might also be a promising therapy for alcohol dependence, according to findings from a 14-week study involving 371 adults.
The Topiramate for Alcoholism Study Group reported that generic topiramate, up to 300 mg/day, reduced the percentage of heavy drinking days from a mean of 81.91% to 43.81%; the reduction for plai cebo subjects ranged from 81.97% to 51.76%.
In an international study, tadalafil (Cialis drug, Eli Lilly) improved erectile function in men with spinal cord injury.
After a four-week run-in period, 186 men (mean, 38 years of age) were randomly assigned to receive ondemand tadalafil or placebo for 12 weeks. The tadalafil dose was maintained at 10 mg/day or was titrated to 20 mg/day.
Most of the patients had had erectile dysfunction (ED) for at least one year; 69% had moderate-to-severe ED. The majority of men (78%) had a neurological injury at or above the T11 level. Yet despite serious baseline conditions, all primary efficacy variables improved significantly with tadalafil treatment improved ED from moderate at baseline to mild.
The use of no-rinse 2% chlorhexidineimpregnated cloths to bathe patients in the medical intensive-care unit has been found to reduce primary bloodstream infections by 61%, compared with soap and water.
In a 12-month study from Rush Medical Center and Cook County Bureau of Health Services in Chicago, 391 patients were assigned to receive antiseptic skin preparation with chlorhexidine gluconate, and 445 received daily baths with soap and water. The researchers found 31 primary bloodstream infections in 27 patients. Using central-line (IV catheter) days as the denominator, patients in the chlorhexidine arm were at lower risk for primary catheter-associated bloodstream infections (6.4), compared with patients bathed with soap and water (16.8) per 1,000 central-line days.
The FDA and Novartis have informed health care professionals and patients about a link between delayed-release mycophenolic acid (Myfortic, Novartis) and an increased risk of pregnancy loss and congenital malformations during pregnancy. This medication is indicated for preventing organ rejection in patients receiving allogeneic renal transplants.
The FDA has informed health care professionals and consumers that the Cochlear Implant device used by deaf and hearing-impaired patients has been associated with an increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children with these implants that have a positioner component are considered to be at a greater risk.
Within the past year, two children, 9 and 11 years of age, died as a result of meningitis. Neither child had received a full round of vaccinations, and the cause of death was attributed to this omission in one of the children.
(Source: FDA, October 10, 2007.)
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