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1 June 2013 page 1 / 35

2 Focus on HIV Care Advising on this article: Betty J. Dong June 3, 2013 HIV infection linked to increased myocardial infarction risk Key Point Individuals with HIV had a 50% higher relative risk of acute myocardial infarction (AMI) than uninfected individuals. The observed increase in risk was beyond that explained by underlying cardiovascular risk, comorbidities, and substance use. page 2 / 35

3 Focus on Lipids Care Advising on this article: Amber Briggs June 3, 2013 Stick with statins: Adverse events, discontinuation common, but most patients successfully restart Key Point Over half of patients taking statins discontinued therapy at least once during an 8-year period. However, over 90% of patients who were rechallenged persisted on statins 1 year later. page 3 / 35

4 Psychiatry Advising on this article: M. Lynn Crismon June 6, 2013 Should SSRIs be stopped before surgery to lower bleeding risks? Key Point In a large population of adults who underwent major surgery, perioperative use of selective serotonin reuptake inhibitors (SSRIs) was associated with increased odds of bleeding, in-hospital mortality, and readmission at 30 days. page 4 / 35

5 Neurology Advising on this article: Jack J. Chen June 10, 2013 Valproate-autism link reinforces need for education in women of childbearing age Key Point Maternal use of valproate during pregnancy was associated with an increased risk of autism spectrum disorder (ASD) and childhood autism in offspring, according to a recent study. page 5 / 35

6 Respiratory Advising on this article: Devra K. Dang, Allana Sucher June 12, 2013 Novel avian influenza virus prompts new CDC infection control, treatment recommendations Key Point Clinical findings of Chinese patients infected with a novel avian-origin influenza A (H7N9) virus were summarized in a recent article. The majority of infected patients were older adults, male, and experienced severe illness. Complications included pneumonia and acute respiratory distress syndrome (ARDS); 27.0% of patients died. ecommendations page 6 / 35

7 Cardiology Advising on this article: Omar Badawi June 14, 2013 Are fish oil supplements dead in the water? Study shows no benefit in high-risk heart patients Key Point In patients with multiple cardiovascular risk factors but not myocardial infarction (MI), administration of 1 gram daily of n-3 polyunsaturated fatty acids over a 5-year period did not reduce cardiovascular morbidity or mortality as compared to placebo. rt-patients page 7 / 35

8 Focus on Asthma Care Advising on this article: Devra K. Dang June 14, 2013 Perimenstrual asthma linked to more severe symptoms, increased corticosteroid use Key Point Worsening asthma symptoms associated with or triggered by menses (perimenstrual asthma) was more common in women with severe asthma and was linked to increased use of inhaled or systemic corticosteroids and poorly controlled disease. orticosteroid-use page 8 / 35

9 Drug Interactions Corner Advising on this article: Daniel S. Streetman, Amber Briggs, Allana Sucher June 18, 2013 Use of macrolides with statins linked to increased risk of statin toxicity, death Key Point In older adults, coprescription of simvastatin, lovastatin, or atorvastatin with clarithromycin or erythromycin was associated with increased risk of hospitalization with rhabdomyolysis or acute kidney injury, and all-cause mortality. eath page 9 / 35

10 OTC Medicines Corner Advising on this article: Nicole M. Maisch June 22, 2013 Inappropriate use, dosing of cough/cold meds in children persist despite FDA warnings Key Point The majority of caregivers with children under age 6 presenting to an emergency department (ED) for treatment of cough/cold symptoms were unable to appropriately select and dose an OTC cough/cold product for their child in a recent study. Most caregivers were unaware of potential adverse effects, drug interactions, and recent warnings with these agents. pite-fda-warnings page 10 / 35

11 Gastroenterology Advising on this article: C. Wayne Weart June 27, 2013 PEG bowel prep before colonoscopy linked to acute renal failure Key Point Use of polyethylene glycol (PEG) for bowel preparation 1, 2, or 4 weeks prior to colonoscopy was associated with increased risk of acute renal failure (ARF) in older adults. page 11 / 35

12 Alternative Medicines Corner Advising on this article: Nicole M. Maisch June 28, 2013 L-carnitine supplementation may improve survival in acute myocardial infarction Key Point L-carnitine supplementation in the acute myocardial infarction (AMI) setting was associated with decreased all-cause mortality, ventricular arrhythmias, and angina, but not myocardial reinfarction or heart failure as compared to placebo or control, according to a recent meta-analysis. page 12 / 35

13 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 3, 2013 No generic name FDA has announced that Nephron Pharmaceuticals Corporation is recalling the EZ Breathe Atomizer due to (EZ Breathe Atomizer Nephron a manufacturing defect that could result in the washer Pharmaceuticals Corporation) ("Plate A") becoming dislodged. If this occurs, users may accidentally swallow the washer or Washer could become dislodged from device choke on it. Devices were distributed between August 2012 and April The device was manufactured by Health & Life Co., LTD, and sold to Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit. The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100. Patients should stop using any EZ Breathe Atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually. page 13 / 35

14 Supplemental Approvals Generic Name (Trade Name Company) June 5, 2013 Uses/Notes Treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies Lenalidomide FDA has approved lenalidomide capsules for the treatment of patients with mantle cell lymphoma (MCL) (Revlimid Celgene Corporation) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Treatment for patients whose mantle cell lymphoma has relapsed or progressed The approval was based on a single-arm, multicenter clinical trial enrolling 134 patients with MCL who had relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All 134 patients received prior treatment with bortezomib, and 60% were documented to have disease refractory to bortezomib therapy. Patients had received a median of four prior therapies for MCL. The median age was 67 years; 81% of patients were male, 96% were Caucasian, and 61% had had MCL for at least 3 years. The most common (?15%) grades 1 4 adverse reactions included neutropenia, thrombocytopenia, fatigue, anemia, diarrhea, nausea, cough, pyrexia, rash, dyspnea, pruritis, constipation, peripheral edema, and leukopenia. The most common (?5%) grades 3 4 adverse reactions were neutropenia, thrombocytopenia, anemia, pneumonia, leukopenia, fatigue, febrile neutropenia, dyspnea, and diarrhea. The recommended dose and schedule for lenalidomide is 25 mg orally once daily on days 1 21 of repeated 28-day cycles. Lenalidomide should be taken at about the same time each day, either with or without food. This supplemental application also included the approval of a new 20-mg capsule strength. d-or-progressed page 14 / 35

15 Supplemental Approvals Generic Name (Trade Name Company) June 5, 2013 Uses/Notes Used in the operating room for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery Neostigmine methylsulfate Flamel Technologies announced FDA approval of neostigmine methylsulfate (Bloxiverz), a drug used (No trade name Flamel Technologies) intravenously in the operating room to reverse the effects of nondepolarizing neuromuscular blocking Reverses the effects of nondepolarizing agents after surgery. Flamel expects to launch the drug neuromuscular blocking agents after surgery in July 2013 in 0.5- and 1.0-mg/mL strengths. Bloxiverz is the first FDA-approved version of neostigmine, although other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug, and Cosmetic Act of Unapproved versions of neostigmine have been in short supply for nearly a year, according to Flamel Technologies. The most common adverse reactions include bradycardia, nausea, and vomiting. Atropine or glycopyrrolate should be administered prior to neostigmine to minimize the risk of bradycardia. Neostigmine should be used with caution in patients with arrhythmias, recent acute coronary syndrome, vagotonia, hyperthyroidism, myasthenia gravis, epilepsy, or peptic ulcer. Because of the possibility of hypersensitivity in an occasional patient, atropine and medications to treat anaphylaxis should always be readily available. Large doses of neostigmine administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. The dose of neostigmine should be reduced if recovery from neuromuscular blockade is nearly complete. ents-after-surgery page 15 / 35

16 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 6, 2013 Methylprednisolone acetate As part of the ongoing FDA investigation of Main Street Family Pharmacy in Newbern, TN, FDA has identified (No trade name Main Street Family bacterial and fungal growth in samples from two Pharmacy) unopened 80 mg/ml, 10-mL vials of preservative-free methylprednisolone acetate. The microbial growth was Bacterial and fungal growth found in samples from seen in samples from two separate lots (batches): two unopened vials #011413dan and #010913dan. Additional samples and lots are still under evaluation, as well as other sterile products produced by Main Street. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials and will share additional information as it becomes available. FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, FDA is not aware of any cases of meningitis associated with Main Street s preservative-free methylprednisolone acetate for injection. The sterility of all sterile products produced by Main Street is of significant concern and the products should not be used. On May 28, 2013, Main Street announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those products with a use by date on or before November 20, Clinics or patients with product on hand should contact Main Street Family Pharmacy at or from 8:30 am to 6:00 pm Central Standard Time Monday through Friday or by at msfpcc@bellsouth.net to obtain instructions on how to return products. FDA will continue to work closely with CDC and state authorities during the ongoing investigation. Suspected infections meeting CDC's case definition and the states reporting them will continue to be updated on CDC s website at ml. page 16 / 35

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18 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 11, 2013 Vecuronium bromide for injection Sagent Pharmaceuticals has expanded its June 7, 2013, nationwide recall of vecuronium bromide for injection, 10 mg, based on the results of additional analyses. Sagent recalled the product due to an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The recall now includes all lots manufactured between July 2011 and May Vecuronium bromide for injection, which is supplied in a glass vial, is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.the drug is manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Sagent said it is not aware of any adverse patient events resulting from the use of this product and is continuing its investigation of the situation. Sagent's Distributor DDN is notifying Sagent's distributors and customers by fax, , and certified mail and is arranging for return of all recalled products. Customers should examine their inventory immediately and quarantine, discontinue distribution of, and return all recalled lots of the product. Customers who may have further distributed this product should notify their customers at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at Any questions about returning unused product should be directed to the customer call center at (866) , Monday through Friday, 8:00 am to 7:00 pm CST. Health care workers who have medical questions about the product may contact Sagent Medical Affairs ( , Option 3). Patients should contact their physician or health care page 18 / 35

19 (No trade name Sagent Pharmaceuticals) Elevated impurity results prompt nationwide recall provider if they have experienced any problems that may be related to using this product. page 19 / 35

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21 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 12, 2013 No generic name Bethel Nutritional Consulting has issued a voluntary recall of Bethel 30 Herb Supplement, marketed as a (Bethel 30 Herb Supplement Bethel natural herb for weight loss, because sample capsules Nutritional Consulting) tested positive for the undeclared drug ingredients sibutramine and phenolphthalein. Sibutramine is a Weight loss supplement recalled due to potentially controlled substance that was removed from the market life-threatening undeclared drug ingredients in October 2010 for safety reasons. Because FDA has not approved Bethel 30 as a drug, the safety and effectiveness of the product are unknown. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The product may also interact, in life-threatening ways, with other medications an individual may be taking. The supplement is packaged in plastic white bottles containing 30 capsules per bottle (lot #120514; expiration date 12/05/2014). Lot # is the only one subject to recall and was sold directly to individual customers in the company's New York, NY, sales office and online at The company has discontinued total distribution. No illnesses or injuries have been reported to the company to date in connection with this product. Individuals should return the product immediately to the place of purchase for a refund and contact their physician or health care provider if they have experienced any problems that may be related to using the supplement. declared-drug page 21 / 35

22 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 14, 2013 Warfarin Zydus Pharmaceuticals announced a voluntarily recall of one lot of warfarin 2 mg tablets (lot #MM5767; (Multiple trade names Zydus expiration date June 2014) to the retail level because Pharmaceuticals) four tablets in the lot were found to be oversized. Greater dose in oversized tablets could cause bleeding into a critical organ Ingestion of a greater than intended dose of warfarin could cause patients to develop bleeding as an adverse reaction, and in some patients, that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis. The product was distributed nationwide to wholesalers/distributors, retailers, and mail order providers from November 2012 to December 2012 and can be identified by its NDC # To date, Zydus has not received any reports of adverse events or any additional product complaint related to this lot. Anyone with an existing inventory of lot #MM5767 should stop use and distribution, quarantine the recalled lots immediately, and call between 7:00 am to 4:00 pm. CST, Monday through Friday, to arrange for their return. Patients who have tablets of this lot should check to see if they are of the same size and, if unsure, should consult their dispensing pharmacy. page 22 / 35

23 Supplemental Approvals Generic Name (Trade Name Company) June 14, 2013 Uses/Notes Treatment of giant cell tumor of the bone Denosumab FDA has expanded the approved use of denosumab to treat adults and some adolescents with giant cell tumor (Xgeva Amgen) of the bone (GCTB), a rare and usually noncancerous tumor. Approval expanded to treat giant cell tumor of the bone GCTB generally occurs in adults between the ages of 20 and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows, causing pain, limited range of motion, and bone fractures. Rarely, GCTB can transform into a cancerous tumor and spread to the lungs. Denosumab is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy bone. RANKL is also present in GCTB. Denosumab is intended for patients whose GCTB cannot be surgically removed or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be used in adolescents whose bones have matured. FDA reviewed denosumab under its priority review program, which provides for an expedited review of drugs. Denosumab was granted orphan product designation because it is intended to treat a rare disease or condition. In clinical studies, common adverse effects included joint pain (arthralgia), headache, nausea, fatigue, back pain, and extremity pain. The most common serious adverse effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive potential should use highly effective contraception while taking denosumab because of potential fetal harm. Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones. page 23 / 35

24 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 14, 2013 Multiple generic names FDA has announced that 40 drug products have safety labeling changes to the following sections: Boxed (Multiple trade names Multiple Warnings, Contraindications, Warnings, Precautions, manufacturers) Adverse Reactions, and Patient Package Insert. A quick view table on FDA's website provides the drug FDA has announced safety labeling changes for 40 name and sections modified. The detailed view includes drug products sections and subsections modified, a description of new or modified safety information in the Boxed Warnings, Contraindications, and Warnings sections, and a link to the revised prescribing information. page 24 / 35

25 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 18, 2013 Olanzapine pamoate FDA is investigating two unexplained deaths in patients who received an intramuscular injection of the (Zyprexa Relprevv Eli Lilly) antipsychotic drug olanzapine pamoate. The patients died 3-4 days after receiving an appropriate dose of the Two deaths reported in patients who were treated drug, well after the 3-hour post-injection monitoring with antipsychotic period required under the olanzapine pamoate Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death. Under REMS, patients are required to receive the olanzapine pamoate injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. The olanzapine pamoate label contains warnings about the risk of post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium. FDA is continuing its investigation. If therapy with olanzapine pamoate is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns. page 25 / 35

26 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 20, 2013 Enteric coated aspirin tablets Advance Pharmaceutical announced a voluntary nationwide recall of enteric coated aspirin tablets, 81 (No trade name Advance mg, under the label Rugby Laboratories (lot #13A026; Pharmaceutical/Rugby Laboratories) expiration date 01/2015) because a patient reported that the bottle actually contained acetaminophen 500-mg Bottle labeled as aspirin tablets contained tablets. Rugby Laboratories (Major Pharmaceuticals) acetaminophen distributed the product nationwide to wholesalers and retailers. Patients may be inadvertently taking acetaminophen 500 mg instead of enteric coated aspirin 81 mg. This may cause severe liver damage to those who take other drugs containing acetaminophen, individuals who have three or more alcoholic drinks every day, or those who have liver disease. The labeled directions instruct patients to take 4 to 8 tablets every 4 hours but not more than 48 tablets in 24 hours. Patients who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of acetaminophen, which is about six times the maximum recommended daily dose of 4,000 mg. Advance Pharmaceutical notified Rugby Laboratories of the recall by and overnight mail and is arranging for return of all recalled bottles. Those who have the affected lot should immediately discontinue use and return it to the pharmacy or store where it was purchased. For questions about the recall, contact Advance Pharmaceutical Monday through Friday, 9:00 am to 5:00 pm EST. Patients should contact their physician or health care provider if they have experienced any problems that may be related to using this product. page 26 / 35

27 Supplemental Approvals Generic Name (Trade Name Company) June 21, 2013 Uses/Notes Emergency contraceptive following unprotected sexual intercourse or a known or suspected contraceptive failure Levonorgestrel FDA has approved the use of levonorgestrel (Plan B One-Step) as a nonprescription product for all women of child-bearing potential. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is effective in decreasing the chance of pregnancy and should be taken as soon as possible within 3 days after unprotected sex. On June 10, 2013, the agency notified a United States District Court judge in New York of its intent to comply with the court s April 5, 2013, order instructing the FDA to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions. To comply, the FDA asked Teva Women s Health, the manufacturer of Plan B One-Step, to submit a supplemental application seeking approval of the one-pill product to be made available without any restrictions. The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application. Plan B One-Step was first approved in July 2009 for use without a prescription for women age 17 and older and as a prescription-only option for women younger than age 17. In April 2013, the product was approved for nonprescription use for women as young as 15. With this approval, the product is now available without a prescription for use by all women of reproductive potential. The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to these contraceptive pills by stopping ovulation and therefore preventing pregnancy. Plan B One-Step will not stop a pregnancy when a page 27 / 35

28 (Plan B One-Step Teva Women's Health) Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus. Some women taking Plan B One-Step have reported experiencing the following adverse effects: nausea, vomiting, stomach pain, headache, dizziness, and breast tenderness. These are similar to the adverse effects of regular prescription-only birth control pills. ription-all-women page 28 / 35

29 Supplemental Approvals Generic Name (Trade Name Company) June 24, 2013 Uses/Notes Treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus when alternative treatments are not suitable Telavancin FDA has expanded the approved use of the antibiotic telavancin to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable. Telavancin is approved only to treat S. aureus, not other bacteria that cause pneumonia. HABP/VABP, also known as nosocomial pneumonia, is a particularly serious lung infection because patients in the hospital and especially those on ventilators are often already very sick and usually cannot fight the infection. Telavancin s safety and effectiveness to treat HABP/VABP were evaluated in 1,532 patients enrolled in two clinical trials. Patients were randomly assigned to receive telavancin or vancomycin, another antibiotic approved by the FDA. The trials measured the percentage of patients who died from any cause (all-cause mortality) 28 days after the initiation of treatment. Among patients presumed to test positive for S. aureus taken at baseline, mortality rates were comparable between the telavancin and vancomycin treatment arms, except for patients who had pre-existing kidney problems. During the clinical trials, more patients with pre-existing kidney problems treated with telavancin died compared to those treated with vancomycin. Telavancin can also cause new or worsening kidney problems. This information has been added to telavancin s Boxed Warning. Diarrhea was the most common adverse effect identified in the clinical trials. page 29 / 35

30 (Vibativ Theravance) Expanded approved use treats hospital-acquired and ventilator-associated bacterial pneumonia Telavancin was approved in 2009 to treat complicated skin and skin structure infections. tor-associated page 30 / 35

31 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 25, 2013 Hydroxyethyl starch FDA has analyzed recent data that indicate an increased risk of mortality and renal injury requiring renal (Multiple trade names Multiple replacement therapy in critically ill adult patients, manufacturers) including patients with sepsis and those admitted to the ICU; and an increased risk of excessive bleeding, New Boxed Warning cites increased mortality, particularly in patients undergoing open heart surgery in severe renal injury, risk of bleeding association with cardiopulmonary bypass. FDA has concluded that hydroxyethyl starch (HES) solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and has issued a Boxed Warning to include the risk of mortality and severe renal injury. In addition, FDA has reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and has determined that an additional warning about excessive bleeding is needed in the Warnings and Precautions section of the package insert. HES solutions are used for the treatment of hypovolemia when plasma volume expansion is desired. Recent data have associated the use of these products with an increased risk of severe adverse events when used in certain patient populations. Patients should be aware of the risks associated with the use of HES solutions and discuss these risks with their health care provider. Recommendations for health professionals include the following: Do not use HES solutions in critically ill adult patients, including those with sepsis and those admitted to the ICU, and avoid use in patients with pre-existing renal dysfunction. Discontinue use of HES at the first sign of renal injury. If the need for renal replacement therapy has been reported up to 90 days after HES administration, continue to monitor renal function for at least 90 days in all patients. Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding. Discontinue use of HES at the first sign of coagulopathy. page 31 / 35

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33 Alerts and Recalls Generic Name (Trade Name Company) Uses/Notes June 27, 2013 No generic name Medtronic s SynchroMed infusion pumps have been linked to four flaws that have led to 14 patient deaths (SynchroMed Implantable Infusion since 1996, spurring FDA to place its most serious level System Medtronic) of recall on the implantable system. Infusion pump linked to 14 deaths under Class 1 recall In a statement Wednesday, Medtronic announced that earlier this month, it sent notifications to customers about the flaws that may interfere with the safe and reliable delivery of medications using the system. Medtronic spokesperson Donna Marquard said that 11 of the 14 deaths were related to the inadvertent injection of a drug into the patient s subcutaneous tissue, rather than into the pump, two deaths were attributed to a blockage, and one, to an electrical shortage. Medtronic's intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose. Patients with questions should contact their physicians. page 33 / 35

34 Alerts and Recalls Generic Name (Trade Name Company) June 28, 2013 Uses/Notes Treatment of excessive bleeding associated with hemophilia Recombinant coagulation factor IX (Rixubis Baxter International) New hemophilia B drug prevents, controls excessive bleeding Baxter International announced that FDA has approved recombinant coagulation factor IX for routine prophylactic treatment, control of bleeding episodes, and perioperative management in patients 16 years and older with hemophilia B. A purified protein made with recombinant DNA technology, the drug is the first new recombinant factor IX (rfix) approved for hemophilia B in more than 15 years. The drug's efficacy was assessed in a late-stage trial that included 73 male patients between the ages of 12 to 65 years. Patients who received recombinant coagulation factor IX for routine prophylaxis experienced a significant reduction in annual bleeding: 75% lower compared with those who received other treatment options. Common and less severe adverse effects include dysgeusia (distorted taste), atypical blood results, and pain in an extremity. Serious and uncommon adverse effects of the drug include life-threatening allergic reactions. page 34 / 35

35 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 35 / 35