Formulary Watch |

FDA safety efforts target counterfeiting, unapproved products, and confusing abbreviations; enrollment in Medicare Part D rises above 38 million

FDA has announced further steps it plans to take to target the sales of counterfeit medications. The agency also rolled out a joint campaign with the Institute of Safe Medication Practices (ISMP) to discourage the use of confusing abbreviations that can potentially cause medication errors.

New ALLHAT findings: Diuretic most effective antihypertensive for preventing heart failure

Diuretics are superior to both calcium channel blockers (CCBs) and, at least in the short term, angiotensin-converting enzyme (ACE) inhibitors in preventing heart failure (HF) in hypertensive patients, according to a follow-up analysis of the largest clinical trial on hypertension to date.

SSRIs demonstrate risk reduction for colorectal tumors dependent on dose level in case-control study

Investigators conducting a population-based, nested case-control study observed an association between the daily dose level of selective serotonin reuptake inhibitors (SSRIs) and a decreased risk of colorectal cancer among patients aged 5 to 85 years old. No consistent association was found between colorectal cancer risk and the use of tricyclic antidepressants (TCAs).

TELICAST trial of telithromycin produces split results in asthma treatment

A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.

Scientific support for off-label prescriptions absent in 73% of cases

In 2001, off-label drug prescriptions accounted for 150 million (21%) of the estimated 725 million prescriptions written in the United States, according to the 2001 IMS Health National Disease and Therapeutic Index (NDTI). However, according to a study published in the Archives of Internal Medicine, 73% of the off-label medication prescriptions the authors researched (95% CI, 61%–84%) had little or no scientific backing.

Estrogen alone does not raise risk of breast cancer in hysterectomy patients

Postmenopausal women with prior hysterectomies do not increase their risk of breast cancer incidence with the use of conjugated equine estrogen (CEE), according to a study published in the Journal of the American Medical Association (JAMA).

Digestive Disease Week 2006: Pharmacologic studies review findings on ACE inhibitors, treatment of Crohn's disease

Focused on a diverse number of areas in the study of gastrointestinal health, Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, yielded important information about the pharmacologic treatment of certain GI cancers and Crohn's disease.

Abatacept: The first T-lymphocyte co-stimulation modulator; for use in rheumatoid arthritis

Abatacept (Orencia, Bristol-Myers Squibb) is the first T-lymphocyte co-stimulation modulator to be approved by FDA. The agent is indicated for use in patients with moderate-to-severe, active rheumatoid arthritis who have not had an adequate response to methotrexate, tumor necrosis factor (TNF) inhibitors, or other disease-modifying anti-rheumatic drugs (DMARDs).

Indiplon: A short-acting GABA-A receptor agonist sedative hypnotic for the treatment of insomnia

A number of clinical approaches are utilized in managing insomnia. Indiplon (Pfizer) is a selective non-benzodiazepine sedative hypnotic under consideration by FDA for the treatment of insomnia. Like other agents in its class, indiplon binds selectively to the GABA-A receptors in the brain, promoting sleep.

First-time generic approvals (July 2006)

Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)

Pipeline Preview (July 2006)

Approvable designations

FDA actions in brief

FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.

Gardasil

Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine

Drug Watch: Agents in late-stage development for the treatment of depression (July 2006) (PDF)

A review of agents in late-stage development for the treatment of depression (July 2006).

Tiotropium use in patients with COPD exacerbation improves airflow limitation and decreases health resource utilization

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

Drug Watch: Agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006) (PDF)

A review of agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006).

Varenicline

The activity of varenicline in the aiding of smoking cessation is believed to be the result of the agent's action at a sub-type of the nicotinic receptor where it acts as an agonist while simultaneously preventing nicotine binding to alpha 4 beta 2 receptors. Varenicline was approved on May 10, 2006, as an aid to smoking cessation treatment.

Deal limitations, promotion of generic medications aim to stem rising drug costs, but threaten access

Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.

Planning for a paradigm shift in the realm of over-the-counter medications

The blockbuster drugs of the 1990s came off-patent, became generic, and now several of them have become available OTC. Others are expected to join the ranks in the next few years.

Lower oral retinoid dose effective for psoriasis

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.

New monoclonal antibody effective for plaque psoriasis

CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.

Entecavir demonstrates higher rates of improvement than lamivudine in patients with Hepatitis B

A phase 3 study evaluating the histologic and virologic improvement of hepatitis B antigen positive (HBeAg) patients randomized to either lamivudine or entecavir demonstrated that patients treated with entecavir had a significantly higher rate of histologic, virologic, and biochemical improvement. Researchers also observed less viral resistance with entecavir.

Tiotropium use in patients with COPD exacerbation improves airflow limitation and decreases health resource utilization

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

Conflict of interest disclosures common at FDA advisory meetings, rarely result in recusals

A cross-sectional study of the agendas and transcripts of FDA drug advisory committee meetings from 2001 to 2004 found that conflict of interest disclosures occurred at 73% of the meetings examined, but that the recusal of advisory committee members from decision-making as a result of those conflicts occurred only 1% of the time.

ACE inhibitors versus ARBs: comparison of practice guidelines and treatment selection considerations

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) play a role in the treatment of hypertension (HTN) and heart failure (HF). The literature shows that in patients with HTN with comorbidities, such as HF, myocardial infarction (MI), diabetes mellitus, chronic kidney disease, and stroke, ACE inhibitors and ARBs appear to provide added benefit beyond solely lowering blood pressure. In addition, clinical trials have also demonstrated that ACE inhibitors and ARBs may be beneficial in the prevention of diabetes, atrial fibrillation (AF), and recurrent stroke. This review evaluates the practice guidelines and current literature to assess the implications for the use of ACE inhibitors or ARBs in HTN and HF.

Meta-analysis of anti-TNF agents in RA treatment trials suggests increased risk of infection, malignancies

A meta-analysis of 9 randomized, placebo-controlled studies of rheumatoid arthritis (RA) patients treated with the anti-tumor necrosis factor (anti-TNF) agents infliximab and adalimumab suggests an increased risk of malignancies dependent on dose and an increased risk of serious infections.

Varenicline: An oral partial nicotine agonist for smoking cessation

Varenicline (Chantix, Pfizer) is a partial nicotine receptor agonist with a high affinity for the alpha-4 beta-2 nicotinic acetylcholine receptors, modulating dopamine levels associated with nicotine addiction and aiding in smoking cessation. Clinical studies have demonstrated favorable cessation rates compared with placebo and sustained-release bupropion, with an encouraging safety profile. The most common adverse effect seen in clinical trials was mild-to-moderate nausea. In November 2005, a New Drug Application (NDA) was submitted for varenicline, and the drug was subsequently granted a 6-month priority review. On May 10, 2006, varenicline became the first oral medication approved for smoking cessation since bupropion, representing an agent with a novel mechanism of action for smoking cessation.

Pipeline Preview (June 2006)

Human papillomavirus (HPV) (types 6, 11, 16, 18) vaccine (Gardasil, Merck) for female patients aged 9 years or older

FDA actions in brief

Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

Rasagiline

Rasagiline is an irreversible monoamine oxidase (MAO) inhibitor that is thought to exert its effect by specifically inhibiting MAO-B, thereby causing an increase in the extracellular levels of dopamine in the striatum.