Formulary Watch |

FDA warns of MI with cardiac nuclear stress test agents

FDA is warning healthcare professionals of the rare but serious risk of heart attack and death with use of cardiac nuclear stress test agents regadenoson (Lexiscan) and adenosine (Adenoscan).

Label, packaging changes requested for some OTC topical antiseptic products

FDA has requested label and packaging changes for certain over-the-counter (OTC) topical antiseptic products to decrease the risk of infections from these products, which in rare cases have resulted in deaths.

FDA approves luliconazole for tinea pedis

FDA has approved luliconazole (Luzu Cream, 1%, Valeant Pharmaceuticals) for the 1-week, once-daily treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients aged 18 years and older.

Analgesic overuse can exacerbate chronic post-traumatic headaches in adolescent concussion patients

Excessive analgesics use can contribute to the chronic headache associated with concussion in some adolescent patients and discontinuing these drugs can improve symptoms, according to researchers at the 42nd Annual Meeting of the Child Neurology Society, in Austin, Texas.

Long-term oral contraceptive users at risk for glaucoma

Women using oral contraceptive for 3 years or more may be at risk for developing glaucoma and should be screened for the eye disease if they have additional risk factors, according to researchers at the American Academy of Ophthalmology annual meeting in New Orleans.

Studies: Lurasidone effective for treating depression associated with bipolar disorder

Lurasidone HCl (Latuda) reduces depressive symptoms in adult patients with bipolar depression as monotherapy and adjunctive therapy to lithium or valproate. This flexibility is important given the multiple unmet needs of patients with bipolar depression, according to 2 phase 3 studies published recently in The American Journal of Psychiatry.

FDA approves rare blood cancer drug under breakthrough therapy designation

FDA has approved ibrutinib (Imbruvica, Pharmacyclics and Janssen) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. It is the second drug with breakthrough therapy designation to receive FDA approval.

Statin use urged for 33 million Americans

Statin therapy is now recommended for approximately 33 million Americans who don’t have cardiovascular disease (CVD), but have an estimated 10-year CV risk of 7.5% or higher. These individuals also have LDL cholesterol between 70 mg/dL and 189 mg/dL, according to new guidelines issued Nov. 12 by the American College of Cardiology and the American Heart Association.

PODCAST: Hepatitis C overview

Hepatitis C discussion with Eliav Barr, MD, vice president, infectious disease project and pipeline lead at Merck Research Laboratories in West Point, Pa.

Vertex shifts focus to cystic fibrosis R&D

Vertex Pharmaceuticals is shifting its investment strategy to focus on opportunities in cystic fibrosis, according to Ian Smith, chief financial officer, who spoke at the Credit Suisse 2013 Healthcare Conference in mid November.

Address critical care area weaknesses to help reduce healthcare-associated infections

Healthcare-associated infections (HAIs) are less likely to occur in favorable critical care work environments, according to a study in the November issue of American Journal of Critical Care.

Rivaroxaban may help prevent VTE in patients after orthopedic surgery

New data looking at the safety and efficacy of rivaroxaban (Xarelto, Janssen) for the prevention of venous thromboembolism (VTE) following major orthopedic surgery has been published online ahead of print in Thrombosis and Haemostasis.

FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD

FDA has approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (aged 12 years and up).

FDA approves Aptiom to treat seizures in adults

FDA approved antiepileptic drug eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) for use as adjunctive treatment of partial onset seizures, the most common type of seizure seen in people with epilepsy.

Off-label use of atypical antipsychotics: Lack of evidence for their use in primary insomnia

Atypical antipsychotics are some of the most commonly prescribed psychotropic medications in the United States. There is increasing off-label use despite lack of evidence to support its use in some of these medical or psychiatric conditions. One of these growing uses is for the management of primary insomnia. This article discusses the literature on using atypical antipsychotics for managing primary sleep disturbances. Much of the research targeting insomnia is related to using antipsychotics for comorbid psychiatric or medical problems and secondary sleep complaints. For pharmacologic management of primary insomnia in the absence of other psychiatric or neurologic conditions for which atypical agents are helpful, other hypnotic agents should be tried. More research is required before expanding the prescribing of antipsychotics for insomnia.

Strep throat risk score brings together patient data and big data to potentially reduce unnecessary doctors' visits

A new risk measure called a "home score" could potentially prevent 230,000 trips to US doctors' offices every year for suspected strep throat, according to a study online in Annals of Internal Medicine.

A prescription for specialty pharmaceuticals: Transparency and collaboration for improving drug and diagnosis coding on medical claims

Emerging therapies for treating type 2 diabetes

Type 2 diabetes mellitus presents multiple treatment dilemmas for prescribers and healthcare clinicians. The number of oral agents for treating diabetes has increased over the past decade, and the best treatment regimen for each patient often varies based on comorbid conditions and treatment goals. Hence, understanding the risks and benefits of each agent is vital. While the number of agents for treating type 2 diabetes mellitus continues to increase, prescribers and clinicians may struggle with the need to individualize care as a means to improve treatment outcomes.

Pipeline preview

FDA actions in brief

Data from HCV clinical trials presented at Liver Meeting in D.C.

New data evaluating the investigational protease inhibitor faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV), studied in genotype 1 (GT1) patients with hepatitis C (HCV), were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting, in Washington, DC.

Investigational tiotropium reduces exacerbations in severe asthma cases

Once-daily dosing of the investigational drug tiotropium helped to improve lung function over 24 hours in individuals with severe asthma, according to data presented at the 2013 American College of Chest Physicians annual meeting (CHEST 2013) in Chicago.

Statins may lower prostate cancer-related mortality risk

Patients with prostate cancer who use statins may have a lower risk of death from their disease, according to a study published online ahead of print in the Journal of Clinical Oncology.

Antibiotics overprescribed for sore throats, bronchitis

J&J fined $2.2 billion for fraudulently marketing Risperdal, Invega

Healthcare giant Johnson & Johnson has agreed to pay more than $2.2 billion to settle charges it fraudulently promoted drugs and used kickbacks to spur sales, the U.S. Justice Department announced Monday.

Anti-seizure drug gets boxed warning of potential vision loss

FDA has approved a new boxed warning for the anti-seizure drug ezogabine (Potiga) because of the potential risk of vision loss, retinal abnormalities, as well as skin, nail, mucous membrane, and sclera discoloration. The agency recommends that ezogabine use be limited to individuals who have not responded to alternative therapies for seizure control, and when the benefits of treatment are greater than the risks.

Sales of leukemia chemotherapy drug suspended

Citing the risk of life-threatening blood clots and severe narrowing of blood vessels, FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of ponatinib (Iclusig).

Under breakthrough therapy designation, FDA approves chronic lymphocytic leukemia drug

FDA has approved obinutuzumab (Gazyva, Genentech, a member of the Roche Group), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

BLOG: Optimize antibiotic stewardship

Now is the time to dedicate resources in the inpatient and outpatient world to optimize antimicrobial stewardship.

Allopurinol alone found inadequate for gout control

Allopurinol, considered the standard of care for gout, may be inadequate to lower uric acid levels in patients with gout, according to new safety and efficacy data from a large study presented at the American College of Rheumatology (ACR) 2013 annual meeting recently in San Diego, Calif.