FDA Updates Kidney Failure Warning on Bone-Building Drug
The U.S. Food and Drug Administration on Thursday issued an updated warning that doctors should screen patients for kidney problems before prescribing Reclast, a bone-building drug that has been linked to an increased risk of kidney failure in certain patients.
In a statement posted on its website, the agency said kidney failure "was a rare but serious condition associated with the use of Reclast in patients with a history of or risk factors for [kidney] impairment."
The agency said it has added instructions to the medication's labeling that tell doctors to test patient's kidney function with a blood test and to monitor patients who already take Reclast (zoledronic acid). Patients who have acute kidney impairment should not be prescribed Reclast, the FDA noted.A warning about possible kidney failure was first added to the drug's labeling back in 2009, after the FDA received five reports of kidney failure, some of which were fatal, following Reclast infusion. Since then, the agency has received 11 reports of fatal kidney failure and nine reports of non-fatal kidney injury in similar patient settings.-----New Laws Forcing Florida Pill Mills to CloseWith new laws at their disposal, Florida officials this year have taken aggressive action against so-called "pill mills" in the state.The state has long been the hub of illegal sales of prescription drugs in the United States. For example, doctors in Florida last year bought 89 percent of all oxycodone (an often-abused prescription painkiller) sold in the U.S. and at one point the state had more than 1,000 pain clinics, The New York Times reported.But in the past year, more than 400 clinics were either shut down or closed, prosecutors have indicted dozens of pill mill operators, and nearly 80 doctors have had their licenses suspended for prescribing large amounts of pills without verified medical need.A new law that took effect in July forbids Florida doctors, with some exceptions, from dispensing narcotics and addictive medicines in their clinics, The Times reported.-----ER Visits Due to Air Gun, Paintball Injuries DecliningAir and paintball gun injuries accounted for more than 20,000 emergency department visits in the United States in 2008, a federal government report says.While a large number, it's a 20 percent decrease from 2006, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.Children and teens 17 and younger accounted for about 60 percent of air and paintball gun injury emergency department visits in 2008, and more than 25 of the visits were for children ages 10 to 14.Males accounted for five times more visits than females. Visits for air and paintball gun injuries were higher in rural areas (92 per 1 million population) than in urban areas (61 per 1 million), and were nearly three times higher among low-income children (93 visits per 1 million people) than among children from higher income families (34 per 1 million).-----U.S. Ranks 41st in Newborn Survival: StudyNewborn babies in countries such as Cuba, Poland and Malaysia now have a better chance of survival than newborns in the United States, according to a study that looked at 20 years of data from all 193 member nations of the World Health Organization.The figures also show that newborns in Qatar, Croatia and the United Arab Emirates now die at about the same rate as newborns in the United States, the Associated Pressreported.With a newborn death rate of 4.3 per 1,000 live births, the United States now trails 40 other countries in terms of newborn death risk. The U.S. had the 28th lowest risk in 1990."It's not that things are worse in the United States than before, it's that the U.S. isn't making progress like other countries," Dr. Joy Lawn, a pediatrician who works for Save the Children, told the AP.Lawn conducted the study with researchers from WHO and the London School of Hygiene and Tropical Medicine in England. They found that babies under 4 weeks old account for 41 percent of child deaths worldwide and that the three leading causes of newborn death are preterm delivery, asphyxia and severe infections.Proper care can prevent all three problems, Lawn told the AP.The study was published Tuesday in the journal PLoS Medicine.