Formulary Watch |

FDA study helps provide understanding of rising rates of whooping cough, response to vaccination

A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by FDA and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.

Metformin improves outcomes for cancer patients with type 2 diabetes

In cancer patients with concurrent type 2 diabetes, metformin alone or in combination with other regimens was associated with 34% reduction in overall death risk and 38% reduction in cancer-specific death risk, according to a study in the December issue of The Oncologist.

Sodium levels in “fizzy” medications may increase cardiovascular risks

Taking effervescent, dispersible, and soluble medications that contain sodium long term increase the risk of cardiovascular events, including heart attacks and strokes, according to a study published in the British Medical Journal.

FDA approves Xiaflex for Peyronie’s disease

FDA approved a new use for collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

CDC provides tool kit to help with collaborative practice agreements

The Centers for Disease Control and Prevention (CDC) with the help of the American Pharmacists Association (APhA) Foundation has developed a tool kit for instituting collaborative practice agreements between healthcare providers and pharmacists, which is intended to improve healthcare quality.

PTSD patients most likely to skip hypertension medications

Among primary care patients with uncontrolled hypertension, medication nonadherence was more than twice as common in patients with post-traumatic stress disorder (PTSD) (68%) as compared to patients without PTSD (26%), according to a study reported online in JAMA Internal Medicine.

Diabetes patients who use mail order pharmacy less likely to visit emergency rooms

Patients with diabetes who received prescribed heart medications by mail were less likely to visit the emergency room than those who picked up prescriptions in person, according to a new Kaiser Permanente study published in the American Journal of Managed Care.

Muscle pain that turns off statin users can result from interactions with other drugs

Many patients who stopped taking cholesterol-lowering statin drugs were also taking an average of 3 other drugs that interfered with the normal metabolism of statins, according to a study published in the Journal of Clinical Lipidology.

Phthalate exposure during pregnancy increases odds of preterm delivery

Pregnant women exposed to environmental phthalates are at an elevated risk of preterm delivery, according to a recent study in JAMA Pediatrics.

Nurse navigators help cancer patients cope early in care

When Group Health patients received support from a nurse navigator, or advocate, soon after a cancer diagnosis, they had better experiences and fewer problems with their care-particularly in health information, care coordination, and psychological and social care-according to a randomized controlled trial in the Journal of Clinical Oncology.

Investigational tiotropium shown to improve symptoms of moderate asthma

Data for tiotropium show improved lung function, sustained bronchodilation in patients with moderate asthma severity.

FDA lifts some restrictions on diabetes drug Avandia

FDA has eased restrictions on patient access to the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). The agency made its determination after an FDA Advisory Committee reviewed the drug in June 2013 and voted to lift its restrictions, and new information was released indicating that the drug carries no heightened cardiovascular risk.

FDA approves simeprevir for hepatitis C virus

FDA has simeprevir (Olysio, Janssen Therapeutics, Division of Janssen Products, LP) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

FDA approves Nexavar to treat metastatic differentiated thyroid cancer

FDA has expanded the approved uses of sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals) to treat late-stage (metastatic) differentiated thyroid cancer.

FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza for National Stockpile

FDA approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people aged 18 years and older who are at increased risk of exposure to the H5N1 influenza virus.

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.