Latest Fda Approved Drugs Information Systems

By Ransdell Pierson NEW YORK (Reuters) Jun 14 - For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, whose hardships and risks have deterred many from using the stroke-prevention medicine. But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used. Most concerns revolve around Pradaxa (dabigatran), a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s. "The good news is you now have an alternative to warfarin," said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare syst...

June 11, 2012 — Drug–drug interactions (DDIs) are frequent occurrences in the medical intensive care unit (MICU). The severity of the condition and the drug combinations used in the MICU are distinct from those of the DDIs published in other ICU settings (eg, cardiac ICU). Prevention of these DDIs is an important aspect of patient safety. Pamela L. Smithburger, PharmD, from the Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pennsylvania, and colleagues presented the results of a 4-week, prospective, observational study in an article  published online  June 7 in the  International Journal of Pharmacy Practice . This is the first study that evaluates drug interactions specifically in a MICU population with a variety of diagnoses and comorbid disease states. The authors conclude with the suggestion that patient characteristics and location should be considered when developing a DDI alerting system. The study included 240 patient ...

By David Douglas NEW YORK (Reuters Health) Jun 11 - An apparent association between some common medications, including antihistamines and angiotensin II receptor blockers (ARBs), and urinary incontinence (UI) suggests a need for further study, researchers say. Dr. Susan A. Hall of the New England Research Institutes, Watertown, Massachusetts, lead author of a report online May 15 in the Journal of Urology, told Reuters Health by email that her team found some associations that were not previously documented. But, she added, the cross-sectional design of the research can't prove causality. The population-based epidemiological study involved more than 5,500 men and women aged 30 to 79 years. Nine percent of women and 4.6% of men had urinary incontinence -- and these individuals were significantly older than those without such symptoms. The prevalence of UI was then examined in users of 25 medication groups after adjustments for known urinary incontinence risk factors. ...

Question: What can I do to make oral medications taste better for children? Response from Jessica C. Stovel, RPh Adjunct Assistant Professor, Department of Psychiatry, Division of Child and Adolescent Psychiatry, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada Most children will need to take medications during childhood, whether it involves short-term treatment of an ear infection or long-term treatment of a chronic disease. Ensuring that the child gets the full dose can be a significant challenge for caregivers because most medications inherently have a bitter taste that can be very difficult to mask, even when pharmaceutical companies have developed a flavored liquid formulation. The texture of a commercially available liquid may also be problematic and unacceptable to a child (eg, it may be gritty). [1,2]  An even greater challenge arises when no commercial liquid formulation is available and the child cannot swallow pi...

June 15, 2012 — Vismodegib ( Erivedge ) "is the greatest advance in therapy yet" for the treatment of basal cell carcinoma (BCC), according to an  editorial published  in the June 7 issue of the  New England Journal of Medicine . "It is a landmark day for patients with basal cell carcinoma and all those involved in their care," writes John T. Lear, MD, from the University of Manchester, United Kingdom. His editorial accompanies 2 studies reporting the "remarkable effects of vismodegib." One of the studies  provides final results from a clinical trial of patients with metastatic and locally advanced BCC. These results led to the  approval of vismodegib  earlier this year. Earlier results from this study, showing a "substantial benefit in BCC," were presented at the 2011 European Multidisciplinary Cancer Congress, as  reported at that time  by  Medscape Medical News . The other study  showed that vismodegib decreases the in...

June 15, 2012 — The American Academy of Neurology and the Child Neurology Society have released new guidelines on the medical management of infantile spasms in children. The guideline updates the last version, released in 2004. Among the major changes are a recommendation that low-dose adrenocorticotrophic hormone (ACTH) may be considered for use, and that both ACTH and vigabatrin can be useful short-term treatment options, although ACTH is preferred to vigabatrin. "We also want to highlight that early diagnosis and treatment of infantile spasms could lead to better long-term development outcomes," first author Christine Y. Go, MD, from the Hospital for Sick Children in Toronto, Ontario, Canada, told  Medscape Medical News . "I think that's one of the more important messages, because a lot of families, sometimes they're not sure if it's a seizure or not, and they kind of miss the boat," she said. "The child doesn't get treated until 3 t...

June 11, 2012 (Miami Beach, Florida) — Half of HIV-positive drinkers receiving antiretroviral therapy (ART) intentionally skipped or stopped taking their medications when they consumed alcohol, in the mistaken belief that combining ART drugs and alcohol is somehow toxic, according to a prospective cohort study. The study, which monitored patients' beliefs about mixing alcohol and ART medicines, was presented here at the 7th International Conference on HIV Treatment and Prevention Adherence. "It's really a bad idea for people to stop taking their HIV medications, but we found that there was a substantial number of people with HIV who are choosing to stop taking their medication when they are drinking," lead author Seth Kalichman, PhD, from the University of Connecticut, in Storrs, told  Medscape Medical News . "There are many who hold the belief, not only those with HIV infection but those with other chronic diseases, that if they mix their medications wi...

NEW YORK (Reuters Health) Jun 11 - Researchers who reviewed "all available evidence" on the safety of the antiarrhythmic dronedarone (Multag, Sanofi SA) found it increases cardiovascular risk, regardless of duration of use and across a wide spectrum of clinical cardiovascular conditions. Dronedarone should be used with caution, particularly in patients with cardiovascular risk factors, the research team advised in a report online May 21 in the American Journal of Cardiology. The FDA has already put out a warning about the drug. In the new paper, Dr. Saurav Chatterjee and colleagues explain that dronedarone is a new antiarrhythmic, with an electropharmacologic profile closely resembling that of amiodarone, but with a shorter half-life and structural differences intended to minimize the adverse effects seen with amiodarone. The U.S. Food and Drug Administration approved dronedarone in July 2009 to reduce rehospitalizations in patients in sinus rhythm who have a histo...

WASHINGTON (Reuters) Jun 07 - Clinicians seeking to replenish their supply of injectable ibandronate (Boniva) in the next few weeks may be out of luck because the company did not accurately forecast demand, federal officials said. A mismatch between company forecasts and actual demand is one of the many reasons medicines can go into shortage, especially when there is only one company making them. The number of cancer, anesthetic and other drugs in short supply in the United States hit a record high last year with 250 medicines, largely due to manufacturing problems. The Boniva shortage does not affect the more widely used oral version of the drug which became available generically earlier this year. Genentech, the Roche unit that makes Boniva, used to prevent and treat osteoporosis, could not immediately say why demand forecasts for injectable Boniva were not accurate. "Patient safety is of the utmost importance to Genentech, and we are working as fast as we can to ad...

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine ( Truvada , Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed. In early May, the FDA's Antiviral Drugs Advisory Committee  strongly backed  approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection. However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended. According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug. The committee's recommendation for supplemental approval of tenofovir/emtricit...

June 14, 2012 — The US Food and Drug Administration (FDA) has approved a combination meningitis vaccine for infants and children aged 6 weeks through 18 months, the agency announced today. The FDA said this is the first meningococcal vaccine that can be taken by children as young as 6 weeks of age. The vaccine, called  Menhibrix  (GlaxoSmithKline Biologicals), immunizes against 2 types of bacteria:  Neisseria meningitidis  (serogroups C and Y) and  Haemophilus influenzae  type B (Hib). Each bacterium can infect the lining that surrounds the brain and spinal cord, according to the FDA. Both meningococcal and Hib diseases can cause death or serious and permanent damage such as mental retardation and blindness. The diseases can progress rapidly, and their symptoms are hard to distinguish from those of other common childhood conditions, making them particularly dangerous for children younger than 2 years of age. The FDA determined that Menhibrix is e...

CLINICAL CONTEXT Several studies have evaluated the risk for venous thrombosis, including deep vein thrombosis and pulmonary embolism, in women using oral contraceptive pills. However, few data are available regarding the risk for venous thrombosis in users of nonoral hormonal contraceptives. To prevent pregnancy, nonoral hormonal contraceptives continuously release hormones into the body. The objective of this study by Lidegaard and colleagues was to determine the risk for venous thrombosis in current users of nonoral hormonal contraception. STUDY SYNOPSIS AND PERSPECTIVE Women who use transdermal patches or vaginal rings for contraception may be at significantly increased risk for venous thromboembolism compared with women who do not use hormonal contraception, according to a national registry-based Danish study  published online  May 10 in the  BMJ . Women using transdermal patches had a relative risk (RR) of 7.9 (95% confidence interval [CI], 3.5 - 17.7) ...

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. As explained in a November 8, 2011 statement, in October 2011, FDA received information from Makena’s sponsor, K-V Pharmaceuticals, regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products. The Agency explained that FDA had carefully reviewed the data K-V submitted and would conduct an on-site review of the laboratory analyses. The Agency also stated that FDA had begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk APIs used ...