Formulary Watch |

Use of SSRIs in early pregnancy not associated with increased risk of most birth defects

In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.

Focus on 2007: A year of novel pharmacologic agents in review; arformoterol, pramipexole, CERA, sitaxsentan, bifeprunox, vernakalant, telavancin, maraviroc, and rotigotine

Throughout 2007, Formulary's "Focus on" articles have examined 9 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members. Because many readers have said that they frequently reference this column when making formulary decisions for their hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each. Of the 9 agents reviewed in 2007, 4 have received final FDA approval; the remaining 5 agents have not yet been approved by FDA.

FDA actions in brief

FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)

First-time generic approvals, November 2007

First-time generic approvals: oxcarbazepine tablets; risedronate tablets; clarithromycin for oral suspension

FDA pipeline preview, November 2007

The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine

Raloxifene: Selective estrogen receptor modulator approved by FDA for reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk for invasive breast cancer

Raloxifene was approved on September 13, 2007, for the additional indication of the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

Doripenem: New molecular entity/carbapenem antibiotic approved by FDA for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis

FDA has approved doripenem, a carbapenem antibiotic, for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis

EARLY and BENEFIT: Bosentan beneficial in patients with early PAH and in patients with inoperable disease

Patients with early-stage pulmonary arterial hypertension (PAH) and those with either inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or inoperable or post-pulmonary endarterectomy pulmonary hypertension can benefit from treatment with bosentan, according to study results presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.

FINESSE: Study results could bring an end to facilitated PCI following ST-elevation myocardial infarction

Thrombolytic therapy with reteplase/abciximab before percutaneous coronary intervention (PCI) (facilitated PCI) has no effect on post-myocardial infarction (MI) complications, including death, but the treatment significantly increases the risk of bleeding compared with primary PCI performed with in-lab abciximab in patients with ST-elevation MI, according to the results of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study.

ADVANCE: Perindopril plus indapamide reduces vascular events in patients with type 2 diabetes

In a multicenter, multinational, randomized controlled study, a fixed-dose combination of perindopril/ indapamide was associated with a reduced risk of death and vascular events in patients with type 2 diabetes, many of whom were already taking antihypertensive drugs.

European Society of Cardiology: 2007 Congress covers a wide variety of research

The 2007 Congress of the European Society of Cardiology attracted nearly 30,000 attendees to Vienna, Austria, from September 1 to 5, 2007. The congress offered details of the latest research in various fields of cardiology

Maraviroc: The first CCR5 antagonist for the treatment of HIV

Maraviroc is the first CCR5 antagonist approved for the treatment of HIV-1 infection. The use of maraviroc is associated with significant decreases in HIV viral load and increases in CD4 counts in antiretroviral treatment-experienced patients with CCR5-tropic virus when used as an add-on to optimized antiretroviral treatment. In clinical trials, patients with dual- or mixed-tropic virus (which can infect cells using CXCR4 and/or CCR5 receptors) who were treated with maraviroc demonstrated no difference in HIV viral load compared with patients who received placebo. A recent study compared maraviroc plus lamivudine/zidovudine with efavirenz plus lamivudine/zidovudine; maraviroc did not demonstrate noninferiority when undetectable virus was defined as <50 copies/mL; however, maraviroc did meet noninferiority criteria when undetectable virus was defined as <400 copies/mL. Maraviroc is not recommended for patients with CXCR4-tropic, dual-tropic, or mixed-tropic virus; for antiretroviral-naive patients; or for..

Older agents for type 2 diabetes equal or superior to newer agents for glycemic control, lipid levels, body weight

An extensive systematic review published in the Annals of Internal Medicine demonstrated that older oral drugs for type 2 diabetes are just as, if not more, effective than newer agents for gylcemic control, lipid control, and other intermediate end points.

The impact of angiotensin II receptor blocker potency on the clinical outcomes of stroke, acute myocardial infarction, or death

Angiotensin II receptor blockers (ARBs) have been demonstrated to reduce morbidity and/or mortality in patients with chronic heart failure (CHF), acute myocardial infarction (AMI), type 2 diabetes, and hypertension. Although as a class ARBs share a common mechanism of action, potency among the agents varies. Higher-potency ARBs (candesartan, irbesartan, olmesartan, and telmisartan) may demonstrate improved 24-hour blood pressure control, suggesting that these agents may have superior clinical event reduction potential versus lower-potency agents (eprosartan, losartan, and valsartan). We conducted a meta-analysis of randomized, controlled trials that evaluated the effect of ARBs on clinical outcomes. A systematic literature search of MEDLINE from 1966 through December 2006 was conducted using specific search terms. Studies that met the following criteria were included: randomized; not angiotensin-converting enzyme (ACE) inhibitor-controlled; incorporation of monotherapy with ARBs in 1 or more of the treatment..

FDA action related to medication safety and reliability, October 2007

Briefs of FDA actions related to medication safety and reliability

Use of SSRIs could lead to brittle bones in older patients

In 2 prospective cohort studies published in the Archives of Internal Medicine, researchers demonstrated that selective serotonin-reuptake inhibitor (SSRI) use, but not the use of other common antidepressants, was associated with a significant decrease in total hip and lumbar spine bone mineral density (BMD) among older patients compared with nonuse of antidepressants.

First-time generic approvals, October 2007

First-time generic approvals: Carvedilol tablets; famciclovir tablets

FDA pipeline preview, October 2007

The latest FDA action (through October 2007) related to valrubicin (Valstar), pancrelipase (Creon), raltegravir (Isentress), mifamurtide (L-MTP-PE, formerly Junovan), recombinant human antithrombin (Atryn), picoplatin, T4N5 liposome lotion (Dimericine), oral azacitidine, ANX-510 (CoFactor), vincristine (Marqibo), sorafenib (Nexavar), bendamustine (Treanda), MB07133, ALS-357, and MGCD0103

Risperdal: Psychotropic agent recently approved by FDA for the treatment of schizophrenia in adolescent patients and for the short-term treatment of bipolar I disorder in pediatric and adolescent patients

FDA has approved a new indication for risperdal. The drug is now indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years and for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in children and adolescents aged 10 to 17 years.

Somatuline Depot: New molecular entity recently approved by FDA for the treatment of acromegaly

FDA has approved Somatuline Depot, an analog of natural somatostatin, for the treatment of acromegaly

Drug Watch: Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis (September 2007) (PDF)

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Telavancin: A novel lipoglycopeptide antibiotic with dual mechanisms of action

Telavancin is a novel semisynthetic lipoglycopeptide antibiotic undergoing FDA review for complicated skin and skin-structure infections; this agent is also in phase 3 clinical trials for the treatment of hospital-acquired pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Streptococcus pneumoniae. Telavancin exerts its antibacterial action via a dual mode of action involving both inhibition of peptidoglycan synthesis and disruption of the bacterial cell membrane; the latter of these effects is believed to improve the rate of killing observed with telavancin compared with other glycopeptides. In vitro, telavancin exhibits good activity against a variety of gram-positive organisms, including drug-resistant S pneumoniae, MRSA, vancomycin intermediate-susceptible and vancomycin-resistant S aureus, and vancomycin-resistant enterococci. Clinical data have demonstrated that telavancin is at least as effective as comparator agents for a variety of infectious processes...

Researchers say benefits of antidepressants among pediatric patients outweigh risk of suicide

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

PDUFA legislative proposals call for increased fees to help improve drug safety

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) IV has been expanded, as expected, via a host of provisions designed to shape drug development and ensure the safe use of medications.

Initial sitagliptin plus metformin demonstrated to be effective in patients with type 2 diabetes

Initial combination therapy with sitagliptin and metformin is more effective than either agent alone in lowering glucose values in patients with type 2 diabetes, according to the results of a recently published study.

Statin pill-splitting has no significant effect on adherence or lipid outcomes, regardless of financial incentive

Splitting statin tablets does not negatively affect patient satisfaction, medication adherence, or lipid level control, according to the authors of a randomized, controlled study

Topiramate: An effective add-on treatment in obese, drug-naïve patients with type 2 diabetes

In a randomized, placebo-controlled trial, topiramate was demonstrated to be an effective add-on treatment to lifestyle changes in obese patients with type 2 diabetes.

Use of broad-spectrum antibiotics during infancy associated with increased risk of pediatric asthma

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Patients treated with proton-pump inhibitors at increased risk for community-acquired pneumonia

Proton-pump inhibitor (PPI) use moderately increases the risk of community-acquired pneumonia (CAP), particularly among younger patients and those who recently initiated treatment, according to the results of a population-based, case-control study.

Management of Parkinson disease: Current treatments, recent advances, and future development

Parkinson disease (PD) is a chronic progressive neurodegenerative disorder that affects >1 million people in the United States. PD causes both motor and nonmotor disturbances; common symptoms include resting tremor, rigidity, and bradykinesia. The current goals of treatment are to slow disease progression and to reduce disability without inducing long-term complications. The classes of agents currently approved for the treatment of PD include levodopa/carbidopa, dopamine agonists, catechol-O-methyl-transferase (COMT) inhibitors, monoamine-oxidase type B (MAO-B) inhibitors, anticholinergics, and agents/ combinations from other drug classes. Newer agents, such as rasagiline and rotigotine, offer additional treatment options to healthcare professionals. Despite these advances in the treatment of PD symptoms, current therapies do not prevent neuron degeneration. Research into new treatments is focused on neuroprotective drugs, new dopamine agonists, and nondopaminergic agents; the goal of these investigative..