ACE inhibitors versus ARBs for ischemic heart disease: comparative effectivenessJanuary 1st 2010
A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.
Pralatrexate injection (Folotyn): Folate analogue metabolic inhibitor approved for treatment of relapsed or refractory peripheral T-cell lymphomaJanuary 1st 2010
New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
Drug pricing, safety, access to dominate agenda in the year aheadJanuary 1st 2010
The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:
Dabigatran compared to warfarin when given to patients with atrial fibrillationJanuary 1st 2010
Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
FDA actions in brief, January 2010 (Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate)January 1st 2010
Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate
Telmisartan (Micardis): Angiotensin II receptor blocker tablets approved for cardiovascular risk reduction for patients unable to take an ACE inhibitorDecember 1st 2009
New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.
Generic drugs dominate market, look to expand into biologicsDecember 1st 2009
Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.
Fibromyalgia: A review of management optionsDecember 1st 2009
Evidence-based recommendations utilize an integrated approach that combines nonpharmacologic approaches (specifically patient education, exercise, and cognitive behavioral therapy) and pharmacologic approaches in the management of fibromyalgia.
Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasisNovember 1st 2009
New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Thiopurines increase lymphoproliferative disorder risk in IBD patientsNovember 1st 2009
Patients with inflammatory bowel disease receiving thiopurines are at increased risk of developing lymphoproliferative disorder, according to a French prospective observational cohort study, which was published online in The Lancet.
Bloodstream infections and contaminated prefilled syringes: issues of medication safetyNovember 1st 2009
An investigation into a multistate outbreak of Serratia marcescens bloodstream infections (BSIs) published in the Archives of Internal Medicine found an association between the BSIs and contamination of prefilled syringes.
Valsartan and aliskiren (Valturna): Combination of an angiotensin receptor blocker with direct renin inhibitor approved for the treatment of hypertensionNovember 1st 2009
New combination: Valturna was approved on September 16, 2009, for the treatment of hypertension in patients not adequately controlled on either aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
Development of an adverse drug reaction bulletin in a teaching hospitalNovember 1st 2009
Bulletins that focus on drugs and therapeutic matters are often distributed by hospitals and other health systems that have programs for reporting adverse drug reactions.
Travoprost: A prostaglandin analogue for the treatment of glaucoma
In August 2003, the US Department of Veterans Affairs (VA) awarded a contract for prostaglandin ophthalmic agents with travoprost as the agent of choice. Although there was no national mandate to switch patients from existing therapy, many VA facilities had agreements from their local ophthalmology and optometry departments to conduct a therapeutic interchange of patients from existing prostaglandins (eg, latanoprost) to travoprost.
Two antimalaria drugs are tolerated regimens in regions with resistanceNovember 1st 2009
In a review published in The Cochrane Library, researchers determined that atovaquone-proguanil and doxycycline were well tolerated by most travelers and are less likely than mefloquine to cause adverse neuropsychiatric outcomes.
FDA actions in brief, October 2009 (Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, Bepreve)October 1st 2009
Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve
Morphine/naltrexone extended-release capsules (Embeda): Combination of mu-opioid agonist and mu-opioid antagonist approved for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time periodOctober 1st 2009
New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period
FDA Pipeline preview, October 2009 (doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, quinazoline495)October 1st 2009
Recent FDA action (through October 2009) related to doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, and quinazoline495
First-time generic drug approvals, October 2009October 1st 2009
Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension
Guanfacine extended-release tablets (Intuniv): Selective alpha2a-adrenergic receptor agonist approved for the treatment of ADHDOctober 1st 2009
New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)