New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis
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New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients
Febuxostat (Uloric): Xanthine oxidase inhibitor approved for chronic management of hyperuricemia in patients with gout
Agents in late-stage development for the treatment of asthma, COPD, and PAH
At a joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees on January 30, 2009, advisors voted 14 to 12 that propoxyphene and propoxyphene-containing products should be removed from the market. Propoxyphene (Darvon, Xanodyne; generic propoxyphene) and propoxyphene combinations, including Darvocet (Xanodyne), are used for the treatment of mild-to-moderate acute pain.
In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.
Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.
Tom Daschle's (D?SD) withdrawal of his nomination for Secretary of Health and Human Services (HHS) has some speculating whether or not healthcare reform will be derailed. Daschle withdrew after saying that his failure to pay more than $120,000 in taxes could be a "distraction."
Pfizer is discontinuing a phase 3 study of axitinib for the treatment of advanced pancreatic cancer. An analysis by an independent data safety monitoring board demonstrated that there was no improvement in survival among patients treated with axitininb plus gemcitabine versus those treated with gemcitabine alone.
On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
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Review of ARV agents for the treatment of HIV infection; Focus on dronedarone; Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS
Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS (February 2009) (PDF)
Agents in late-stage development for the treatment of HIV and AIDS
Recent FDA action (through February 2009) related to asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, and vigabatrin
Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.
Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.
Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.
The challenge of controlling HIV in patients with resistance to antiretrovirals has contributed to accelerated research into treatments with novel antiretroviral activity.
Recent FDA approvals (through Feburary 2009) related to Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, and AllerNaze
New molecular entity: Plerixafor (Mozobil), a hematopoietic stem cell mobilizer, was approved on December 15, 2008, for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM
New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer
New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia
For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.
In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.
After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.
A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).
Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.
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