Formulary Watch |

FDA limits use of tolvaptan; irreversible liver damage possible

FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.

FDA warns of retinal abnormalities with Potiga use

FDA issued a warning April 26 that the anti-seizure drug, ezogabine (Potiga) may cause pigment changes in the retina as well as blue skin discoloration. It is not known if the changes are permanent, according to an FDA drug safety communication.

NIH halts AIDS vaccine trial

The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has halted a phase 2b clinical trial, HVTN 505, evaluating a sequential regimen of 2 HIV vaccine candidates.

Actavis to sell generic reformulated OxyContin in 2014

Actavis will be able to sell defined quantities of a generic version or an authorized generic version of reformulated OxyContin as early as next year, according to a prepared statement from Purdue Pharma L.P., the manufacturer of the opioid analgesic

Negative perceptions of statins lead to abandonment of initial Rx fill

Patients who fail to fill a new prescription for statin therapy have a number of reasons, including negative perceptions about the medication, a preference for lifestyle modifications, concerns about side effects, drug interactions, polypharmacy, and a perception that they do not need the drug, according to a study published by The American Journal of Managed Care.

L-carnitine therapy boosts cardiac health following heart attack, study reports

L-carnitine significantly improves cardiac health in patients after a heart attack, according to a multicenter team of investigators in a study published in Mayo Clinic Proceedings.

Progress in PCV uptake seen since 2000, WHO reports

Global progress has been made since the introduction of pneumococcal conjugate vaccines (PCVs) 13 years ago, according to a report published in the April 26 Morbidity and Mortality Weekly Report (MMWR).

FDA approves combination glaucoma drop without beta-blocker

FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

FDA approves first oral agent for OIC in adults with chronic noncancer pain

FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.

ASHP offers recommendations for opioid drug labeling

As FDA takes an increased interest in the prescribing of narcotic medications, due to higher levels of prescribing and increased overdoses over the recent years, the American Society of Health-System Pharmacists (ASHP) stressed the importance of understanding the causes of pain and issues of patient access to appropriate drug therapy.

FDA nixes generic OxyContin, approves abuse-deterrent labeling for reformulated OxyContin

FDA announced April 16 that it will not approve any generic versions of the original OxyContin formulation as the benefits no longer outweigh its risks. The original OxyContin was withdrawn from sale for reasons of safety, as it could be easily misused and abused by crushing and snorting. The original formulation was approved in 1995.

Physicians in ACOs believe pharma companies could help reduce the cost of healthcare-but suspect they won’t

Healthcare providers believe that the pharmaceutical industry could play an important role in helping value-based healthcare providers such as accountable care organizations to deliver better care at lower cost. But pharma companies currently do a poor job of delivering the kind of data needed to accomplish that goal, according to a survey of physicians in value-based delivery models, conducted by Oliver Wyman, a New York-based management consulting firm.

Women at highest risk for breast cancer benefit most from preventive therapy

Women at the highest risk for breast cancer benefit the most from preventive drug therapy, including tamoxifen and raloxifene, according to a study, published in the April 16, 2013, issue of the Annals of Internal Medicine.

Generics help to balance specialty pharmacy costs, report states

The increase in utilization of generic drugs is driving costs down, while the increase in specialty pharmacy utilization is driving costs up, according to the 2013 CVS Caremark annual Insights Report.

ApotheCure and NuVision compounding pharmacies recall all lots of sterile products

On April 15, 2013, 2 pharmaceutical compounders recalled their sterile products following an alert issued by FDA.

Greater awareness fuels increase in self-reported hypertension, use of antihypertensive medications

Thanks to consumer education efforts on heart disease and hypertension, self-reported hypertension and use of antihypertensive medications has increased in the United States according to the Centers for Disease Control and Prevention (CDC).

Health gains, cost savings seen with generic HF drugs

Guideline-directed medical therapy for heart failure (HF) is highly cost-effective and able to produce significant health gains for individuals with mild to moderate disease, according a study published April 2 in the Journal of the American College of Cardiology.

Age restriction on emergency contraception lifted

On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.

FDA approves Diclegis for treatment of pregnancy morning sickness

FDA has approved doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg (Diclegis, Duchesnay) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management, including dietary and lifestyle modifications. These modifications include eating several small meals instead of 3 large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.

Guideline recommendations issued for molecular testing, targeted therapies in lung cancer

The College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) recently issued evidence-based guidelines on molecular testing in lung cancer, and support the recommendation that physicians conduct testing in advanced non-small cell lung cancer patients at the time of diagnosis or at the time of recurrence or progression.

Men taking amiodarone at increased risk for cancer

The antiarrhythmia drug amiodarone appears to be linked to a higher risk of cancer in men, specifically those who receive higher cumulative defined daily doses within the first year of treatment, according to a retrospective study published online April 8 in Cancer.

Judge orders FDA to make emergency contraceptive available without prescription for all ages

A New York federal judge has struck down the restrictions on levonorgestrel-based emergency contraceptives and ordered the FDA to make the drugs available without a prescription and without point-of-sale or age restrictions within 30 days, according to an April 4th memorandum and order

Researchers find small benefit from antibiotics for patients with respiratory infections

Physicians would need to prescribe antibiotics to more than 12,000 patients diagnosed with common colds to prevent 1 hospital admission for pneumonia, according to a study published in the March/April issue of the Annals of Family Medicine.

AMCP changes name of foundation, appoints new board members

The Academy of Managed Care Pharmacy has changed the foundation’s name to the Academy of Managed Care Pharmacy Foundation. In addition, it has elected four new members to its board of trustees, during the AMCP’s 25th annual meeting and exposition in San Diego.

Shifting patients to Managed Medicaid affects preventive care, costs

The shift of Medicaid patients from fee-for-service to Managed Medicaid during 2011 resulted in a massive shift of prescriptions nationally, with nearly half of all Medicaid prescriptions now filled by Managed Medicaid, according to a recent study released by the IMS Institute for Healthcare Informatics. It was presented April 4 during the Academy of Managed Care Pharmacy Annual Meeting in San Diego.The number of monthly prescriptions dispensed through Managed Medicaid increased from 4.9 million in September 2011 to 12.5 million in June 2012, as reported in the IMS Institute study, “Impact on Patient Care of Shift From Fee-For-Service to Managed Medicaid.”

Medicare care delayed in states with Medicaid restrictions

States with restrictive Medicaid policies need to alter those policies because of delayed medical care, according to a recent New England Journal of Medicine letter to the editor.

Novartis disappointed by loss of India patent case for Glivec

On April 1, the Indian Supreme Court denied Novartis’ appeal challenging the rejection of a patent for its cancer drug Glivec (imatinib mesylate), which has been patented in almost 40 countries including China, Russia, and Taiwan. This landmark ruling ends a 7-year legal battle by Novartis, which never has been granted an original patent for Glivec in India. The ruling will hinder medical progress and innovation, the manufacturer said.

Canagliflozin approval ushers in new approach to T2DM

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) for adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

Sublingual immunotherapy for allergic rhinitis and asthma effective, JAMA reports

In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.

Canagliflozin approval ushers in new approach to T2DM

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) tablets to be used with diet and exercise, to improve glycemic control infor adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.