Study: Breastfeeding Mothers Do Not Pass Tacrolimus On To Babies.

Medwire  (1/29) reports that a study  published in the Clinical Journal of the American Society of Nephrology found that "breastfeeding mothers taking tacrolimus do not pass the immunosuppressant on to their babies when breastfeeding." Researchers said that "the good news for breastfeeding mothers is that ingestion of tacrolimus by infants via breast milk is 'negligible.'"

FDA approves OTC overactive-bladder treatment.

Reuters (1/26, Berkrot) reported that the US Food and Drug Administration on Friday announced it has approved an over-the-counter version of Merck's Oxytrol (oxybutynin) as a treatment for overactive bladder in women ages 18 years and older. The agency noted that findings from nine trials involving 5,000 study participants, showed that consumers readily understand information on the drug-product's labeling and that they are able to use oxybutynin appropriately. The Whitehouse Station, New Jersey-based pharmaceutical company said it expects to launch the OTC version on the market in the fall. However, the FDA said that for men with overactive bladder, only the prescription version of Oxytrol will be available.

        According to MedPage Today (1/26, Gever), Merck "did not seek OTC status for the product in men." The nine studies showed that men were "relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems. A key worry is that incorrect self-diagnosis in men could delay detection of prostate cancer."

        The Triangle Business Journal (1/26, Ohnesorge, Subscription Publication) noted that the FDA's approval made Oxytrol the first, overactive bladder treatment in the anticholinergics class to become available OTC. Oxytrol is a "patch applied to the skin every four days."

        WebMD (1/26, Doheny) also covered the story, noting that according to Merck, "more than 20 million American women" have overactive bladders.

FDA panel begins hearing on hydrocodone.

ABC World News (1/24, story 5, 2:15, Sawyer, 7.43M) reported, "Now, to the crackdown on the epidemic use of prescription pain killers in America. Consider this, the US, just 4.5% of the world's population, consumes 99% of the world's hydrocodone." ABC (Kerley) added, "The Drug Enforcement Administration can't win the battle, and is pleading to make it harder" to get prescription drugs containing hydrocodone. Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section was shown saying, "If it [hydrocodone] has more restrictive manners tied to it, it could help reduce the abuse potential." Kerley added that there is some concern that if hydrocodone is "classified as a more dangerous drug, that could drive up costs" for drug makers and healthcare providers, and patients "would have to make more visits to the doctor for refills, spending more in co-pays."

        Bloomberg News (1/25, Edney) reports that an FDA advisory panel began its two-day meeting Thursday to contemplate the DEA's request that the agency consider tightening prescribing and other rules on hydrocodone drug products. For one, the Drug Safety and Risk Management Advisory Committee is "debating the DEA's request to limit prescriptions of hydrocodone combination pills and cough suppressants to a 90-day supply instead of the current five refills within six months. The proposal also would strip physician assistants and nurse practitioners of their authority to prescribe the products." In addition, the DEA has asked the agency to move hydrocodone-combination products - such as Vicodin (acetaminophen and hydrocodone) - from the schedule III designation to the highly regulated schedule II class under which narcotics - such as OxyContin (oxycodone) and pure hydrocodone - fall.

        HealthDay (1/25, Gardner) notes that advocates of a "move to Schedule II status point to tragic deaths and suicides that have been the result of misuse of these prescription drugs" whereas opponents have expressed concern "that tightening access to the drugs would mean that people who really need them to ease pain will not be able to get them." Meanwhile, an FDA spokesperson "said the advisory panel would most likely vote on the issue Friday afternoon."

FDA Advisory Panel Recommends New Restrictions On Hydrocodone Products.

An FDA advisory panel's recommendation regarding hydrocodone restrictions received a substantial amount of coverage in print, online, and on two of last night's national news broadcasts. Some sources pointed out that the FDA was likely to adopt the recommendations. Additionally, many sources pointed out that the recommendations did face some criticism, particularly from pain patient advocacy groups.

        The CBS Evening News (1/25, story 9, 0:15, Pelley) reported that "an FDA advisory panel" has "recommended new restrictions on prescriptions and refills" of products containing hydrocodone.

        ABC World News (1/25, story 8, 0:30, Sawyer) reported, "The FDA is expected to follow the recommendation making it more difficult to get those drugs prescribed because of all the abuse."

        The Los Angeles Times  (1/26, Girion) reported that the panel "recommended Friday that the agency reclassify hydrocodone...as a Schedule II narcotic, placing it in the same category as other widely abused medications, including OxyContin and fentanyl." Should the agency approve "the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills. In addition, pharmacies would have to follow stricter procedures for handling and storing the drug."

        The New York Times  (1/26, Tavernise, Subscription Publication) reported, however, that "at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse." Still, the Times points out that "the drug agency is likely to follow" the recommendation.

        The AP  (1/25) reported, "FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them." Douglas Throckmorton, the agency's deputy director for regulatory programs, said, "There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society."

CDC: New strain of norovirus has reached US.

National media outlets, including some major dailies, as well as health-related sources offer notable coverage of this week's Morbidity and Mortality Weekly Report from the CDC that revealed a new strain of norovirus has reached the US from Australia. Nearly all reports noted how the CDC credited the new strain for 141, or 58%, of the 266 norovirus outbreaks reported since September, with many sources describing the norovirus as a highly contagious "bug."

        For example, USA Today (1/24, Weise, 1.71M) says that, according to the CDC report, "Last month, the bug, which causes nausea, forceful vomiting, diarrhea and abdominal pain, accounted for 58% of outbreaks of norovirus nationally." CDC epidemiologist Aron Hall said "it's not clear whether this strain is more likely to infect people or make them more ill than previous strains, but...any time a new strain emerges, it has the potential to increase disease 'because people haven't been exposed to it before, so they're more susceptible.'" He said this year's norovirus season, which normally peaks in January, "unfortunately coincides with an early increase in flu season," adding that, besides timing, there was no link between the norovirus and the stomach flu.

        The Washington Post (1/25, Brown, 489K) adds, "About two-thirds of this season's outbreaks occurred in long-term care institutions and 13 percent involved restaurants," according to the Morbidity and Mortality Weekly Report. For its part, Virginia "has identified six outbreaks caused by GII.4 Sydney this season - four in 2012 and two this month, said Michelle Stoll, a spokeswoman for the state health department. ... Information about outbreaks in Maryland and the District caused by the new strain was not immediately available."

        The AP (1/25, Stobbe) cites Ian Goodfellow, a prominent researcher at England's University of Cambridge who "calls norovirus 'the Ferrari of viruses' for the speed at which it passes through a large group of people. 'It can sweep through an environment very, very quickly."

        CQ (1/25, Subscription Publication) quotes Aron Hall in a news release, "The new strain spread rapidly across the United States from September to December 2012. The proportion of reported outbreaks caused by this strain increased dramatically from 19 percent in September to 58 percent in December." The CDC "says the 2009 launch of CaliciNet was a 'milestone' in monitoring norovirus that permitted 'identification of new strains in real time.'" In this connection, the Milwaukee Journal Sentinel (1/25, Herzog, 221K) notes the lab at the Milwaukee Health Department is connected to CaliciNet.

        Dubbing the new strain "a highly contagious gut bug," the NBC News (1/25, Aleccia) in its "Vitals" blog adds that CDC officials "advised health workers to be vigilant for increases in norovirus outbreaks this winter because of the new GII.4 Sydney strain. They should follow standard infection control practices to prevent norovirus. In addition, the general public ought to be aware that the new bug is out there and take precautions including washing hands with soap and water, disinfecting surfaces, rinsing fruits and vegetables, cooking shellfish thoroughly and not preparing food or caring for others while ill."

        The Louisville (KY) Courier-Journal (1/25, Ungar, 150K) adds many local physicians "say they've seen a spike in gastroenteritis cases in recent months that may be related. The emergency room at Sts. Mary and Elizabeth Hospital, for example reported 66 cases between late November and early December, and in the past week saw nine cases of vomiting or gastroenteritis, seven cases of diarrhea and 14 cases of gastroenteritis."

        Further coverage of the CDC's Morbidity and Mortality Weekly Report can be found in reports from HealthDay (1/25, Preidt),Medscape (1/25, Lowes), WebMD (1/25, Boyles), and Modern Healthcare (1/25, Barr, Subscription Publication, 71K).

Blacks, Hispanics With Hypertension May Not Receive Adequate Diuretic Treatment.

MedPage Today  (1/25, Kaiser) reports, "Blacks and Hispanics who are hypertensive may not be receiving adequate diuretic treatment," according to two studies published in the American Journal of Hypertension. "In the first study  (PDF), which included black patients with uncontrolled hypertension, only 46% of them were prescribed a diuretic, according to Linda M. Gerber, PhD, of Weill Cornell Medical College in New York City, and colleagues." Meanwhile, "in the second study  (PDF), blacks, Hispanics, and other ethnic minority patients with hypertension and on dialysis were about 25% less likely to have 'exposure' to each of four common classes of blood pressure medications such as beta-blockers and calcium-channel blockers compared with whites, reported Theresa I. Shireman, PhD, of the University of Kansas School of Medicine in Kansas City, Kans., and colleagues."

Researchers Say They Have Used Stem Cells To Grow Human Kidney Tissue.

AFP-Relaxnews  (1/25) reports, "Researchers in Japan said Wednesday they have succeeded in growing human kidney tissue from stem cells for the first time in a potential breakthrough for millions with damaged organs who are dependent on dialysis." One of the researchers, "Kenji Osafune of Kyoto University, said his team had managed to take stem cells...and nudge them specifically in the direction of kidney tissue." He "said they had succeeded in generating intermediate mesoderm tissue from the stem cells, a middle point between the blank slate and the finished kidney tissue."

Kidney Disease Linked To Higher Risk Of Early Death In Patients With Diabetes.

BBC News  (1/25) reports, "Keeping your kidneys healthy could be one of the best ways to extend your life if you have diabetes," according to a study published in the Journal of the American Society of Nephrology. Researchers "found that having kidney disease meant a much higher risk of early death."

        Medscape  (1/25, Nainggolan) reports that investigators "examined 10-year mortality by diabetes and kidney-disease status for 15046 participants in the third US National Health and Nutrition Examination Survey (NHANES III) by linking baseline data with the National Death Index."

        HealthDay  (1/25, Gordon) reports, "The study found that 10-year mortality rates for people with both type 2 diabetes and kidney disease is more than 31 percent." However, "for people with only type 2 diabetes, the death rate after a decade was 12 percent." Meanwhile, "for those with neither condition, the 10-year death rate was about 8 percent."

        According to EverydayHealth  (1/25, Hauser), "This is the first study to determine the strength of the link between kidney disease and mortality among people with type 2 diabetes, though diabetes has long been associated with an overall increased mortality risk, particularly due to cardiovascular disease."