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1 July 2014 page 1 / 27

2 Cardiology Advising on this article: Eric MacLaughlin July 1, 2014 Spironolactone: Unimpressive results in some patients with heart failure Key Point Spironolactone in patients with heart failure (HF) with preserved ejection fraction (HFpEF) failed to reduce risk of death, according to results of the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial. However, spironolactone did significantly reduce the secondary outcome of rate of hospitalizations for HF. page 2 / 27

3 Focus on Diabetes Care Advising on this article: Charles D. Ponte July 1, 2014 Higher-potency statins increase diabetes risk Key Point Observational data analyzing approximately 137,000 patients suggested that use of higher-potency statins may be associated with an increased risk of new-onset diabetes as compared with lower-potency agents. page 3 / 27

4 Focus on Immunizations Advising on this article: John D. Grabenstein July 7, 2014 CDC: Intranasal vaccine preferred over flu shot in younger children Key Point CDC s Advisory Committee on Immunization Practice (ACIP) recently voted to preferentially recommend the intranasal live-attenuated influenza vaccine (LAIV) in children aged 2 years to 8 years when it is available. Committee members stressed that vaccination should not be delayed to await LAIV when injectable inactivated influenza vaccine (IIV) is available. page 4 / 27

5 Rheumatology Advising on this article: Arthur A. Schuna July 7, 2014 Tofacitinib outperforms MTX as initial RA treatment Key Point Initial treatment with tofacitinib (Xeljanz Pfizer) monotherapy was superior to methotrexate (MTX) in patients with active moderate-to-severe rheumatoid arthritis (RA) who had not previously received MTX or therapeutic doses of MTX. page 5 / 27

6 Cardiology Advising on this article: Eric MacLaughlin July 15, 2014 Omega-3s: No benefit in reducing cardiac risk Key Point Daily dietary supplementation of long-chain omega-3 fatty acids or lutein plus zeaxanthin was not associated with any reduction in cardiovascular (CV) events, according to a study published in the May issue of JAMA Internal Medicine. page 6 / 27

7 Infectious Diseases Advising on this article: Allana Sucher July 15, 2014 Dalbavancin: Once-weekly option for skin and skin-structure infections Key Point Once-weekly intravenous dalbavancin (Dalvance Durata Therapeutics) was noninferior to twice-daily intravenous vancomycin followed by oral linezolid for treatment of bacterial skin or skin structure infections, according to a recent study. Dalbavancin was approved by FDA in May s page 7 / 27

8 Gastroenterology Advising on this article: C. Wayne Weart, M. Lynn Crismon, Arthur A. Schuna July 21, 2014 SSRIs + NSAIDs: Increased risk for GI bleeding Key Point Selective serotonin reuptake inhibitors (SSRIs) were associated with a modestly increased risk of upper gastrointestinal (GI) bleeding in a recent study. This risk was further elevated in patients taking concomitant NSAIDs. page 8 / 27

9 Focus on Lipids Care Advising on this article: Amber Briggs, Eric MacLaughlin July 21, 2014 Cholesterol guidelines: Risk calculation controversy persists Key Point A recent analysis applied risk prediction and statin eligibility criteria to a healthy patient population aged 55 years and older for three recent guidelines: the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, the Adult Treatment Panel III (ATP III) recommendations, and the European Society of Cardiology (ESC) guidelines. The ACC/AHA guidelines qualified nearly all men and two-thirds of women for statin therapy, as compared with much lower proportions recommended by the other two guidelines. page 9 / 27

10 Focus on Diabetes Care Advising on this article: Charles D. Ponte July 29, 2014 Insulin-related hypoglycemia: Did we cause this problem? Key Point Approximately 100,000 emergency department (ED) visits and 30,000 hospitalizations occur annually as a result of insulin-related hypoglycemia and errors, with the greatest risk occurring in patients aged 80 years or older. page 10 / 27

11 Endocrinology Advising on this article: Frank Pucino July 29, 2014 Hot flashes: Nonhormonal therapies work as well as estrogen Key Point Low-dose venlafaxine and low-dose estradiol were both shown to be effective at reducing vasomotor symptoms (VMS) in perimenopausal and postmenopausal women in a recent study. page 11 / 27

12 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes July 1, 2014 Warfarin sodium Bristol-Myers Squibb has issued a voluntary recall of six lots of warfarin sodium for injection (5-mg single-use (Coumadin Bristol-Myers Squibb) vials) in the United States. Visible particulate matter was found in a small number of unreleased samples. Particulate matter found in unreleased samples prompts recall Injected particulate metallic and nonmetallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue. The product is packaged in cartons of six vials and includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: , , , , , Warfarin sodium for injection was discontinued in early April The oral formulation is not affected by this recall. page 12 / 27

13 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes July 1, 2014 Injectable nutritional supplements FDA is alerting health professionals not to use injectable vitamin drug products distributed by Medical (No trade name Medical Supply Supply Liquidators in Clive, Iowa, with Sunshine Labs Liquidators/Compound Brothers on the label. These products are manufactured by Dominicana) Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic and sold as prescription Products with "Sunshine Labs" label not FDA injectable nutritional supplements. FDA has not approved approved these products and cannot be assured of their safety, effectiveness, or quality. All lots of nonexpired products from Compound Brothers Inc. and labeled as Sunshine Labs are being recalled by Medical Supply Liquidators. See the FDA Statement for a listing of all affected products. page 13 / 27

14 New Drug Approvals Generic Name (Trade Name Company) Uses/Notes July 3, 2014 Belinostat FDA has approved belinostat for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare (Beleodaq Spectrum Pharmaceuticals) and fast-growing type of non-hodgkin lymphoma (NHL). The action was taken under the agency s accelerated New drug treats rare, aggressive form of approval program. non-hodgkin lymphoma PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,990 will die. PTCL represents about 10% to 15% of NHLs in North America. Beleodaq works by stopping enzymes that contribute to T-cells becoming cancerous. It is intended for patients whose disease returned after treatment or did not respond to previous treatment. The drug's safety and effectiveness were evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL. All participants were treated with belinostat until their disease progressed or adverse effects became unacceptable. Results showed 25.8% of participants had their cancer disappear or shrink after treatment. The most common adverse effects were nausea, fatigue, fever, anemia, and vomiting. page 14 / 27

15 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes July 16, 2014 Lactated ringers and 5% dextrose injection Hospira, Inc. announced a voluntary nationwide user-level recall of one lot (# JT) of lactated ringers and 5% dextrose injection packaged in 1,000-mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper lefthand side of the primary container. This action is due to one confirmed customer report in which particulate was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of mold. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak. I.V. administration of a nonsterile product may result in life-threatening infections and in prolonged hospitalization or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date and has not identified any quality issues with retention samples for this lot. Hospira has investigated and determined the root cause of the event and has implemented corrective actions to address this issue. In general, a defect in a container leading to a leak may create a breach in sterility since an open pathway exists for contamination of fluid. If the leak is not detected, and the solution becomes contaminated and it is not identified prior to administration, contaminated solution could be administered to the patient. The product is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by a patient's clinical condition. This lot was distributed nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers and distributors. This recall is being conducted as a precautionary measure. Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call page 15 / 27

16 (No trade name Hospira) Possible mold contamination prompts recall Stericycle at between the hours of 8:00 am to 5:00 pm EST, Monday through Friday, to arrange for the return of the product. page 16 / 27

17 Supplemental Approvals Generic Name (Trade Name Company) Uses/Notes July 16, 2014 Immune globulin I.V. (human) 10% (100 mg/ml) liquid preparation (Octagam 10% Octapharma USA) Immune therapy approved for treatment of chronic ITP in adults Octapharma USA announced FDA approval of immune globulin I.V. (human) 10% (100 mg/ml) liquid preparation for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding. Approval was based on the results of an Octapharma-sponsored clinical trial to evaluate the safety and efficacy of Octagam 10% in 66 patients aged 17 to 88 years with chronic ITP. Eighty-two percent of patients with chronic ITP attained the primary efficacy endpoint of clinical response (platelet count?50 109/L within 7 days of dosing), which was significantly higher than the predicted responder rate of 70%. In this study, there were no unexpected tolerability issues even at the maximum infusion rate of 0.12 ml/kg/minute (720 mg/kg/hr). The researchers further reported that 78% of patients with chronic ITP, who had bleeding at baseline, reported no bleeding 7 days after treatment. The most common treatment-related adverse events during the clinical trial were headache, fever, and increased heart rate. The most serious adverse event was a moderate headache. The product is expected to be available in the United States in September page 17 / 27

18 New Drug Approvals Generic Name (Trade Name Company) Uses/Notes July 17, 2014 Recombinant C1-esterase inhibitor FDA approved the first recombinant C1-esterase inhibitor product for the treatment of acute attacks in (Ruconest Pharming Group NV/Salix adult and adolescent patients with hereditary Pharmaceuticals) angioedema (HAE). New product treats rare genetic disease HAE, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks of swelling can occur spontaneously or can be triggered by stress, surgery, or infection. Swelling of the airway is potentially fatal without immediate treatment. The new product is a human recombinant C1-esterase inhibitor purified from the milk of genetically modified (transgenic) rabbits. It is intended to restore the level of functional C1-esterase inhibitor in a patient s plasma, thereby treating the acute attack of swelling. Safety and efficacy were evaluated in a multicenter controlled clinical trial. Forty-four adult and adolescent patients with acute attacks were treated. The most common adverse reactions reported were headache, nausea, and diarrhea. The product received orphan-drug designation for acute attacks because it is intended for treatment of a rare disease or condition. page 18 / 27

19 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes July 21, 2014 Powdered pure caffeine FDA is warning about powdered pure caffeine being marketed directly to consumers and recommends (Multiple trade names Multiple avoiding these products. In particular, FDA is concerned manufacturers) about powdered pure caffeine sold in bulk bags over the Internet. It is nearly impossible to measure powdered FDA warns of dangers of powdered pure caffeine pure caffeine accurately with common kitchen measuring tools, and a lethal amount can easily be consumed, FDA warned. These products are essentially 100% caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people. FDA is aware of at least one death of a teenager who used these products. Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures, and death. Vomiting, diarrhea, stupor, and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea, or other caffeinated beverages. FDA advises that those who believe they are having an adverse event related to pure caffeine stop using it and seek immediate medical care or advice. Report adverse events associated with powdered pure caffeine and other highly caffeinated products by calling or at CAERS@cfsan.fda.gov. page 19 / 27

20 New Drug Approvals Generic Name (Trade Name Company) Uses/Notes July 23, 2014 Idelalisib FDA has approved idelalisib to treat patients with three types of blood cancers: relapsed chronic lymphocytic leukemia (CLL), used in combination with rituximabin in patients for whom rituximabin alone would be considered appropriate therapy due to other existing medical conditions; relapsed follicular B-cell non-hodgkin lymphoma (FL); and relapsed small lymphocytic lymphoma (SLL). Idelalisib is the fifth new drug with breakthrough therapy designation to be approved by FDA and the third drug with this designation approved to treat CLL. FDA granted idelalisib accelerated approval to treat patients with FL and SLL in patients who have received at least two prior systemic therapies. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Idelalisib's safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive idelalisib and rituximabin or placebo and rituximabin. The trial was stopped for efficacy following the first prespecified interim analysis point, which showed participants treated with idelalisib and rituximabin lived 10.7 months without their disease progressing (progression-free survival) compared with about 5.5 months for participants treated with placebo and rituximabin. Results from a second interim analysis continued to show a statistically significant improvement for idelalisib and rituximabin over placebo and rituximabin. The drug's safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing non-hodgkin lymphomas. All participants were treated with idelalisib and evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54% of participants with relapsed FL and 58% of participants with SLL experienced ORR. Idelalisib carries a Boxed Warning alerting patients and health professionals of fatal and serious toxicities page 20 / 27

21 (Zydelig Gilead Sciences) New drug treats three types of blood cancers including liver toxicity, diarrhea, and colon inflammation, lung inflammation, and intestinal perforation that can occur in idelalisib-treated patients. Idelalisib is also being approved with a Risk Evaluation and Mitigation Strategy (REMS). Common adverse effects include diarrhea, fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash. Common laboratory abnormalities include decreased levels of white blood cells, high levels of triglycerides, high glucose levels, and elevated levels of liver enzymes. page 21 / 27

22 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes July 23, 2014 Ibuprofen tablets, oxcarbazepine tablets American Health Packaging (AHP) announced a voluntary recall of ibuprofen tablets, 600 mg (lot (No trade name American Health #142588, expiration date, 01/2016) in a hospital unit Packaging) dose presentation that may contain individual blistered doses labeled as oxcarbazepine tablets, 300 mg (lot Mislabeled packaging leads to recall #142544). In addition, AHP voluntarily recalled oxcarbazepine tablets, 300 mg (lot #142544, expiration date 02/2016) because a mislabeled inner unit dose blister packaging could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated. These hospital unit dose products were distributed nationwide beginning June 20, Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. Anyone who has received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at , 7:00 am to 5:00 pm, CST, for instructions on returning the recalled product. For medical information questions or product complaints related to oxcarbazepine tablets, 300 mg, or ibuprofen tablets, 600 mg, contact American Health Packaging customer service at from 8:00 am to 4:00 pm, EST. page 22 / 27

23 New Drug Approvals Generic Name (Trade Name Company) Uses/Notes July 23, 2014 Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets FDA has approved oxycodone hydrochloride and naloxone hydrochloride extended-release tablets, an extended-release/long-acting (ER/LA) opioid analgesic under the trade name Targiniq ER to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product s abuse-deterrent properties consistent with FDA s 2013 draft guidance for industry, Abuse-Deterrent Opioids Evaluation and Labeling. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved, and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally, which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident can cause an overdose that can result in death. Targiniq ER is not approved, and should not be used, for as-needed pain relief, FDA warned. Given Targiniq ER s risks for abuse, misuse, and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management. Safety and effectiveness of Targiniq ER were evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro and in vivo abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, page 23 / 27

24 (Targiniq ER Purdue Pharma) FDA approves new extended-release oxycodone with abuse-deterrent properties injecting). The most common adverse effects of Targiniq ER are nausea and vomiting. FDA is requiring postmarketing studies of Targiniq ER to assess the serious risks of misuse, abuse, increased sensitivity to pain,, addiction, overdose, and death associated with long-term use beyond 12 weeks. FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk of abuse of Targiniq ER. In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids. -properties page 24 / 27

25 Supplemental Approvals Generic Name (Trade Name Company) Uses/Notes July 28, 2014 Imbruvica FDA expanded the approved use of ibrutinib to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion) associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. FDA is also approving new labeling to reflect that ibrutinib s clinical benefit in treating CLL has been verified. In February 2014, ibrutinib received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug s clinical benefit. Approval for ibrutinib's expanded use was based on a clinical study of 391 previously treated participants, 127 of whom had CLL with 17p deletion. Participants were randomly assigned to receive ibrutinib or ofatumumab until disease progression or adverse effects became intolerable. The trial was stopped early for efficacy after a preplanned interim analysis showed ibrutinib-treated participants experienced a 78% reduction in risk of disease progression or death (progression-free survival). Results also showed a 57% reduction in risk of death (overall survival) in participants treated with ibrutinib. Of the 127 participants who had CLL with 17p deletion, those treated with ibrutinib experienced a 75% reduction in risk of disease progression or death. The most common adverse effects in the clinical study included thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, upper respiratory tract infection, rash, nausea, and pyrexia. Ibrutinib also received accelerated approval in November 2013 for the treatment of patients with mantle page 25 / 27

26 (Ibrutinib Pharmacyclics, Janssen Biotech) FDA expands approved use of ibrutinib for chronic lymphocytic leukemia cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe Imbruvica s clinical benefit in mantle cell lymphoma are ongoing. kemia page 26 / 27

27 Powered by TCPDF ( APhA DrugInfoLine is an official publication of, and is owned and copyrighted by the American Pharmacists Association, the national professional society of pharmacists. Materials in APhA DrugInfoLine do not neces- sarily represent the policy, recommendations, or endorsement of APhA. The publisher, authors, editors, reviewers, and contributors have taken care to ensure that information contained in APhA DrugInfoLine is accurate and current; however, they shall have no liability to any person or entity with regard to claims, losses, or damages caused or alleged to be caused, directly or indirectly, by use of any information contained in the publication. All decisions about drug therapy must be based on the independent judgment of the clinician. Copyright , American Pharmacists Association. All rights reserved. page 27 / 27