Apha drug info line

July 2013
Advising on this article: M. Lynn Crismon July 5, 2013
Should FDA backpedal on citalopram warning? New study shows
higher doses not associated with arrhythmia, death
Key Point
Citalopram (Celexa—Forest; various generics) doses greater than 40 mg daily were not associated with increased riskof ventricular arrhythmia or all-cause, cardiac, or noncardiac mortality as compared to lower doses in a large populationof individuals receiving treatment for depression within the Veterans Health Administration (VHA). Source URL:
http://www.aphadruginfoline.com/psychiatry/should-fda-backpedal-citalopram-warning-new-study-shows-higher-doses-not-associated July 8, 2013
Hormone replacement therapy guidelines help clarify role of
transdermal estrogen
Key Point
When determining optimal hormone therapy for menopausal symptoms, clinicians should weigh benefits and risks ineach individual patient. Possible thrombosis-sparing effects of transdermal estrogens as compared to oral dosageforms should be considered in this decision-making process, according to a recent guideline and expert positionstatement. Source URL:
http://www.aphadruginfoline.com/endocrinology/hormone-replacement-therapy-guidelines-help-clarify-role-transdermal-estrogen Advising on this article: Charles D. Ponte July 13, 2013
ADA hypoglycemia report provides helpful tools to assess, educate
patients with diabetes
Key Point
Hypoglycemia is a serious problem in patients with diabetes, especially in younger patients with type 1 diabetes andolder adults with type 2 diabetes, who may be at greater risk for adverse outcomes, according to a recently issuedreport from the American Diabetes Association (ADA) and the Endocrine Society (TES). Source URL:
http://www.aphadruginfoline.com/focus-diabetes-care/ada-hypoglycemia-report-provides-helpful-tools-assess-educate-patients-diabetes Advising on this article: Edward F. Foote July 13, 2013
Decreasing cardiovascular risk in chronic kidney disease: Cinacalcet
disappoints
Key Point
In patients with chronic kidney disease and moderate-to-severe hyperparathyroidism who were undergoinghemodialysis, use of cinacalcet (Sensipar—Amgen) for up to 5 years did not significantly reduce the risk of death ormajor cardiovascular events as compared to placebo. Source URL:
http://www.aphadruginfoline.com/nephrology/decreasing-cardiovascular-risk-chronic-kidney-disease-cinacalcet-disappoints July 19, 2013
Study, guidelines shed new light on lung cancer treatment
Key Point
Crizotinib (Xalkori—Pfizer) prolonged progression-free survival and increased response rates, as compared withstandard chemotherapy, in patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positivenon–small-cell lung cancer. Updated guidelines for the diagnosis and management of lung cancer were recentlyreleased from the American College of Chest Physicians. Source URL:
http://www.aphadruginfoline.com/oncology/study-guidelines-shed-new-light-lung-cancer-treatment July 19, 2013
When to hold aspirin, warfarin for medical procedures? New
guidelines provide answers
Key Point
Periprocedural management guidelines for patients with ischemic cerebrovascular disease have been updated toencourage clinicians to weigh bleeding risks of continuing anticoagulant or antiplatelet therapy against the risk ofthromboembolic events with their discontinuation. Source URL:
http://www.aphadruginfoline.com/focus-anticoagulation-care/when-hold-aspirin-warfarin-medical-procedures-new-guidelines-provide July 21, 2013
Dueling articles debate necessity of influenza vaccination
Key Point
The author of two commentaries argued that influenza is not a public health threat, vaccination is not effective andpossibly unsafe, and current immunization recommendations are inaccurate. In stark contrast, a cohort study added tothe evidence base for influenza vaccination, finding that vaccination averted nearly 6 million medically-attendedinfluenza cases and more than 100,000 influenza-related hospitalizations during a 6-year period. Source URL:
http://www.aphadruginfoline.com/focus-immunizations/dueling-articles-debate-necessity-influenza-vaccination Advising on this article: Charles D. Ponte July 25, 2013
Incretin mimetics: Experts, professional organizations call for
release of data, further investigation into adverse effects
Key Point
Glucagon-like peptide (GLP-1) agonists have been associated with reports of pancreatitis and signals for increased riskof pancreatic and thyroid cancers, but controversy persists regarding their safety. In three recent feature articles,experts draw widely differing conclusions about the implications of existing clinical data. Source URL:
http://www.aphadruginfoline.com/focus-diabetes-care/incretin-mimetics-experts-professional-organizations-call-release-data-further Advising on this article: Arthur A. Schuna July 29, 2013
Rheumatoid arthritis update: Tocilizumab superior to adalimumab as
monotherapy
Key Point
Monotherapy with the disease modifying antirheumatic drug (DMARD) tocilizumab (Actemra—Genentech) was superiorto monotherapy with adalimumab (Humira—AbbVie) for improving the signs and symptoms of rheumatoid arthritis (RA)in patients intolerant to the non-biological DMARD methotrexate. Source URL:
http://www.aphadruginfoline.com/rheumatology/rheumatoid-arthritis-update-tocilizumab-superior-adalimumab-monotherapy Generic Name (Trade Name—Company)
Uses/Notes
Treatment of hot flashes associated with
menopause
Paroxetine
FDA has approved paroxetine under the trade nameBrisdelle to treat moderate to severe hot flashesassociated with menopause. Brisdelle is currently theonly FDA-approved nonhormonal treatment for hotflashes. There are a variety of FDA-approved treatmentsfor hot flashes, but all contain either estrogen alone orestrogen plus a progestin.
The safety and effectiveness of paroxetine for hotflashes were established in two randomized,double-blind, placebo-controlled studies in a total of1,175 postmenopausal women with moderate to severehot flashes (a minimum of seven to eight per day or 50to 60 per week). The treatment period lasted 12 weeksin one study and 24 weeks in the other study. Theresults showed that paroxetine reduced hot flashescompared to placebo. The mechanism by whichparoxetine reduces hot flashes is unknown.
The most common adverse effects were headache,fatigue, and nausea/vomiting.
Brisdelle contains 7.5 mg of paroxetine and is dosedonce daily at bedtime. Other medications, such as Paxiland Pexeva, contain higher doses of paroxetine and areapproved for treating conditions such as majordepressive disorder, obsessive–compulsive disorder,panic disorder, and generalized anxiety disorder. Allmedications that are approved for treating depression,including Paxil and Pexeva, have a Boxed Warningabout an increased risk of suicide in children and youngadults. Because Brisdelle contains the same activeingredient as Paxil and Pexeva, a Boxed Warning aboutsuicidality is included in the Brisdelle label.
Additional labeled warnings include a possible reductionin the effectiveness of tamoxifen if both medications areused together, an increased risk of bleeding, and a riskof developing serotonin syndrome (signs and symptomscan include confusion, rapid heart rate, and high blood pressure). Brisdelle will be dispensed with a Medication (Brisdelle—Noven Therapeutics)
Guide that informs patients of the most important First nonhormonal treatment for hot flashes receives information about the medication. The Medication Guide
FDA approval
will be distributed to patients each time the prescriptionis refilled.
Source URL:
http://www.aphadruginfoline.com/supplemental-approvals/first-nonhormonal-treatment-hot-flashes-receives-fda-approval Generic Name (Trade Name—Company)
Uses/Notes
Benztropine mesylate injection
Fresenius Kabi USA has recalled four lots ofbenztropine mesylate injection 2 mg/2 mL (1 mg/ mL) (No trade name—Fresenius Kabi USA)
due to the potential presence of glass particles in thevials.
Four lots recalled due to potential presence of glass
particles
Benztropine mesylate injection is indicated as adjuncttherapy in Parkinsonism and in drug-inducedextrapyramidal disorders, except tardive dsykinesia. Theaffected lot numbers are 030712, 071212, 090512, and111412 supplied in 2-mL single-dose vials. Shipmentdates range from 5/18/12 to 5/31/13. The product mayappear with “APP” or “Nexus Pharmaceuticals” labels.
If glass particulates in a parenteral drug areadministered to the patient, sequelae ofthromboembolism (e.g., pulmonary emboli) may occur.
Some literature suggests that possible phlebitis andmicrothrombi generation may occur. In addition,granulomas may form as a local inflammatory responseto the foreign material. Fresenius Kabi USA has discontinued distribution ofbenztropine mesylate injection during its investigation.
Anyone who received the recalled vials is being notifiedand should return any unused product to Fresenius KabiUSA.
For more information, call (800) 551-7176, or visit Fresenius-Kabi.com.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/four-lots-recalled-due-potential-presence-glass-particles Generic Name (Trade Name—Company)
Uses/Notes
No generic name
Dolphin Intertrade Corp. has voluntary recalled JaDeraand Xiyouji Qingzhi weight loss supplements. These (JaDera and Xiyouji Qingzhi Weight Loss
products have been found to contain undeclaredsibutramine, a previously approved controlled substance Supplements—Dolphin Intertrade Corp.)
for the treatment of obesity that was removed from the Weight loss supplements contain potentially
U.S. market in October 2010 for safety reasons, making dangerous drug removed from U.S. market
this product an unapproved new drug.
Sibutramine is known to substantially increase bloodpressure and/or pulse rate in some patients and maypresent a significant risk for patients with a history ofcoronary artery disease, congestive heart failure,arrhythmias, or stroke. These products may also interactin life-threatening ways with other medications aconsumer may be taking. The company has not receivedany reports of adverse events related to this recall.
JaDera and Xiyouji Qingzhi are marketed as dietarysupplements used as weight loss aids. JaDera ispackaged in bottles of 30 capsules. The affected JaDerasupplement includes lot #10.06.2011 with the expirationdate 9/6/2013. Xiyouji Qingzhi is packaged in bottles of30 capsules of 300 mg each. The affected XiyoujiQingzhi supplement includes all lots. The products weredistributed nationwide to consumers and distributorsfrom May 2011 to May 2013.
Dolphin Intertrade Corp. is notifying its distributors andcustomers by letter and is arranging for return of allrecalled products. Patients should contact theirphysician or health care provider if they haveexperienced any problems that may be related to usingthe supplements.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/weight-loss-supplements-contain-potentially-dangerous-drug-removed-us-market Generic Name (Trade Name—Company)
Uses/Notes
Olmesartan medoxomil
FDA has warned that the blood pressure drugolmesartan medoxomil (marketed as Benicar, Benicar (Multiple trade names—Multiple
HCT, Azor, Tribenzor, and generics) can cause intestinalproblems known as sprue-like enteropathy. Symptoms manufacturers)
of sprue-like enteropathy include severe, chronic Blood pressure drug may cause intestinal problems
diarrhea with substantial weight loss. FDA has approved known as sprue-like enteropathy
changes to the labels of these drugs to include thisconcern. Sprue-like enteropathy has not been detectedwith angiotensin II receptor blocker drugs other thanolmesartan. Olmesartan medoxomil is approved for the treatment ofhigh blood pressure, alone or with other antihypertensiveagents, and is one of eight marketed ARB drugs. Health professionals should tell patients to contact themif they develop severe, chronic diarrhea with substantialweight loss while taking an olmesartan-containingproduct, even if it takes months to years for symptoms todevelop. Patients should contact their health careprofessional right away if they take anolmesartan-containing product and experience severediarrhea, diarrhea that does not go away, or significantweight loss.
FDA will continue to evaluate the safety ofolmesartan-containing products and will communicateagain if additional information becomes available.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/blood-pressure-drug-may-cause-intestinal-problems-known-sprue-enteropathy Generic Name (Trade Name—Company)
Uses/Notes
Recombivax HB adult formulation
Merck Sharp & Dohme Corp. has initiated a voluntaryrecall of one lot (#J001183 ) of recombivax HB adult (No trade name—Merck Sharp & Dohme
formulation due to the potential for a limited number ofcracked vials to be present in the lot. If the vial was Corp.)
cracked, the integrity of the vial and the sterility of any One lot of vaccine recalled due to possibility of
product remaining in the vial can not be assured.
cracked vials
The lot was distributed solely within the United Statesbetween March 12, 2013 and May 2, 2013. Merckannounced there is adequate inventory to replacerecalled product at this time.
If product from this lot has been administered,revaccination is not necessary. Customers are asked toinventory and quarantine all products from the lot andfollow Merck’s instructions for return of product.
Report problems with vaccine products to the VaccineAdverse Event Reporting System (VAERS), the nationalvaccine safety surveillance program cosponsored by theCenters for Disease Control and Prevention and FDA.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/one-lot-vaccine-recalled-due-possibility-cracked-vials Generic Name (Trade Name—Company)
Uses/Notes
Norgestimate and ethinyl estradiol tablets
Sandoz has announced a voluntary nationwide recall tothe retailer level of one lot of norgestimate and ethinyl (Estarylla—Sandoz)
estradiol tablets, following a patient report of a placebotablet present in a row of active tablets in one pack. The One lot of oral contraceptives contains placebo
recalled lot is #LF01213A, expiration date 2/2014, NDC tablet among active tablets
The product is supplied in cartons containing 3 blistercards of 28 tablets each. This lot was distributed to theU.S. market only and was manufactured for Sandoz by athird-party manufacturer.
Sandoz is not aware of any reports to date of relatedadverse events. An internal medical assessmentconcluded that the probability of adverse health eventsis minimal, as the packaging flaw is easily visible and therisk of pregnancy occurring after nonadministration ofone placebo tablet is low.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/one-lot-oral-contraceptives-contains-placebo-tablet-among-active-tablets Generic Name (Trade Name—Company)
Uses/Notes
Maintenance treatment of opioid dependence
Buprenorphine and naloxone sublingual
FDA has approved buprenorphine/naloxone sublingual tablets for the maintenance treatment of opioiddependence. The drug is a once-daily, sublingual tabletwith higher bioavailability, a fast dissolve time, smaller (Zubsolv—Orexo)
tablet size, and a new menthol flavor. It should be used New sublingual tablet approved for maintenance
as part of a complete treatment plan that includes treatment of opioid dependence
counseling and psychosocial support to prevent relapse.
The sublingual tablets deliver more active ingredient tothe bloodstream, allowing patients to use a lowerstrength, thereby reducing the amount of available drugfor potential misuse and diversion. In addition, accordingto Orexo, the manufacturer, it is the only opioiddependence treatment option contained in the highestlevel of child-resistant unit dose F1 packaging, therebyreducing the chance of unintended pediatric exposure.
The naloxone component also reduces the potential forI.V. misuse and diversion.
Treatment should be initiated under the direction ofphysicians who are certified under the Drug AddictionTreatment Act of 2000 and who have been assigned aunique identification number (“X” number).
Adverse events commonly observed with the sublingualadministration of buprenorphine/naloxone sublingualtablets during clinical trials and postmarketingexperience are headache, nausea, vomiting,hyperhidrosis, constipation, signs and symptoms ofwithdrawal, insomnia, pain, and peripheral edema.
Source URL:
http://www.aphadruginfoline.com/supplemental-approvals/new-sublingual-tablet-approved-maintenance-treatment-opioid-dependence Generic Name (Trade Name—Company)
Uses/Notes
No generic name
FDA has taken action to remove from the market illegalproducts, including some labeled as dietarysupplements, that claim to mitigate, treat, cure, orprevent diabetes and related complications. FDA recently issued letters warning 15 companies thatthe sale of their illegally marketed diabetes productsviolates federal law. FDA has requested a writtenresponse from these companies within 15 business daysstating how the companies will correct the violations.
Failure to promptly correct the violations may result inlegal action, including product seizure, injunction, and/orcriminal prosecution.
FDA has targeted products sold as “natural” treatmentsfor diabetes that contain undeclared activepharmaceutical ingredients in unknown quantities thatcould cause harm or complicate medical conditions;dietary supplements and ayurvedic products that claimto treat, cure, and/or prevent diabetes; unapproveddrugs sold over the counter, including somehomeopathic products, intended to treat complicationsassociated with diabetes, which include relievingsymptoms caused by nerve damage in the arms andlegs (also called peripheral neuropathy); andprescription drugs for diabetes sold by onlinepharmacies without a prescription.
FDA has advised consumers not to use these or similarproducts because they may contain harmful ingredientsor may be otherwise unsafe. They may be improperlymarketed as over-the-counter products when theyshould be marketed as prescription products. Manyinclude claims such as “prevents and treats diabetes”and “can replace medicine in the treatment ofdiabetes.” Using these products could cause consumersto delay seeking proper medical treatment for theirdiabetes.
FDA-approved diabetes treatments, prescribed by alicensed health care professional and shown to be safeand effective, are readily available for people withdiabetes.
To date, the FDA is not aware of any reports of injury or (Multiple trade names—Multiple
manufacturers)
FDA cracks down on illegally marketed products
claiming to treat diabetes
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/fda-cracks-down-illegally-marketed-products-claiming-treat-diabetes Generic Name (Trade Name—Company)
Uses/Notes
For the prophylaxis of organ rejection in patients
receiving a kidney transplant
Tacrolimus extended-release capsules
Astellas Pharma US, Inc., announced FDA approval fortacrolimus extended-release capsules for the prevention (Astagraf XL—Astellas Pharma)
of organ rejection in patients receiving a kidneytransplant with mycophenolate mofetil (MMF) and First once-daily oral tacrolimus formulation
corticosteroids, with or without basiliximab induction. It is approved for patients receiving a kidney transplant
the first once-daily oral tacrolimus formulation to beapproved in the United States for patients receiving akidney transplant.
FDA approval was based on two comparative Phase IIIstudies, which enrolled 1,093 patients in the UnitedStates, Europe, Canada, South America, Australia, andSouth Africa. The company received Europeanmarketing approval for tacrolimus extended-releasecapusules under the trade name Advagraf in 2007 andunder the trade name Graceptor in Japan in 2008. It hasbeen approved for use in 73 countries in total.
Tacrolimus extended-release capusules may causeserious adverse effects, including high blood sugar(diabetes), kidney problems, nervous system problems,high levels of potassium in the blood, high bloodpressure, or heart problems such as changes in theelectrical activity of the heart. Patients should call theirdoctor right away if they have any of these symptoms:frequent urination, increased thirst or hunger, blurredvision, confusion, drowsiness, loss of appetite, fruitysmell on their breath, nausea, vomiting or stomach pain,coma, muscle tremors, numbness and tingling,headache, seizures, or vision changes.
The most common adverse effects in people receivingkidney transplant are diarrhea, constipation, nausea,swelling of the hands, ankles or legs, tremors (shakingof the body), or low red blood cell count (anemia).
Source URL:
http://www.aphadruginfoline.com/supplemental-approvals/first-once-daily-oral-tacrolimus-formulation-approved-patients-receiving Generic Name (Trade Name—Company)
Uses/Notes
Heparin sodium injection, heparin lock
The National Alert Network (NAN) announced that flush solution
some older, problematic versions of the heparin labelremain in pharmacy stocks. On May 1, the U.S.
Pharmacopeial Convention (USP) updated labeling (Multiple trade names—Multiple
standards for heparin sodium injection and heparin lock manufacturers)
flush solution in an effort to reduce the risk of medication Older versions of the heparin label in pharmacy
stocks may lead to serious overdoses
The revisions stipulate that the label of new heparinproducts present clearly the strength of the entirecontainer of medication, followed by how muchmedication is in each milliliter. In the past, the labelemphasized the per-milliliter amount, with the containervolume appearing elsewhere. This led to errors in whichpractitioners misunderstood the per-milliliter amount asthe total amount in the vial, and on that basisadministered dangerous heparin overdoses.
Pharmacists should review their stock and take intoaccount all the locations where heparin is used in andout of the pharmacy (e.g., the emergency departmentand the ICU). NAN advised that during the transitionperiod, during which vials with both the old and newlabel will be available, it’s probably safer to remove andreplace vials with the new labeled product. If thedecision is made to use up the old product, the NANalert recommended storing it separately from the newand using all the old product before dispensing thenewer versions.
The NAN alert also advised keeping vial sizes of allhigh-alert drugs, including heparin, as small as possibleto reduce the chance of overdoses. Heparin is ahigh-alert drug that requires special precautions,including independent checks to ensure the correctdose.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/older-versions-heparin-label-pharmacy-stocks-may-lead-serious-overdoses Generic Name (Trade Name—Company)
Uses/Notes
Ketoconazole
FDA announced it is taking several actions related to ketoconazole tablets, including limiting the drug’s use, (Nizoral—Ortho-McNeil Pharmaceutical)
warning that it can cause severe liver injuries andadrenal gland problems, and advising that it can lead to Oral tablets for fungal infections may cause
harmful drug interactions with other medications. potentially fatal liver injury, risk of drug interactions,
adrenal gland problems
FDA has approved label changes and added a newMedication Guide to address these safety issues. As aresult, ketoconazole oral tablets should not be a first-linetreatment for any fungal infection.
FDA recommended that ketoconazole should be used totreat certain life-threatening mycoses, known asendemic mycoses, only when the potential benefitsoutweigh the risks and alternative therapeutic optionsare not available or tolerated.
Topical formulations have not been associated with liverdamage, adrenal problems, or drug interactions. Theseformulations include creams, shampoos, foams, andgels applied to the skin, unlike the ketoconazole tablets,which are taken by mouth.
Health professionals should assess patients' liver statusbefore starting oral ketoconazole and monitor serumalanine aminotransferase levels during treatment. Inpatients with adrenal insufficiency or with borderlineadrenal function and in patients under prolonged periodsof stress (major surgery, intensive care, etc.), theyshould monitor adrenal function. Review all concomitantmedications for the potential for drug interactionswith ketoconazole tablets.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/oral-tablets-fungal-infections-may-cause-potentially-fatal-liver-injury-risk-drug Generic Name (Trade Name—Company)
Uses/Notes
No generic name
FDA approved the Xpert MTB/RIF Assay, the firstFDA-reviewed test that can simultaneously detect (Xpert MTB/RIF Assay—Cepheid)
bacteria that cause tuberculosis (TB) and determine ifthe bacteria contain genetic markers that make them Faster, simpler test detects bacteria that cause TB
resistant to rifampin, an important antibiotic for the and are resistant to rifampin
The new test is less complex to perform than previousFDA-cleared tests for the detection of TB bacteria. Testresults, including the detection of TB bacteria andwhether the bacteria are drug resistant, are available inapproximately 2 hours. Traditional methods to detectdrug-resistant TB usually require 1 to 3 months.
FDA reviewed the Xpert MTB/RIF Assay through the denovo classification process, a regulatory pathway forsome low- to moderate-risk medical devices that are notsubstantially equivalent to an already legally marketeddevice.
Source URL:
http://www.aphadruginfoline.com/new-drug-approvals/faster-simpler-test-detects-bacteria-cause-tb-and-are-resistant-rifampin Generic Name (Trade Name—Company)
Uses/Notes
For the treatment of adult patients with major
depressive disorder
Levomilnacipran
Forest Laboratories, Inc. and Pierre Fabre Laboratorieshave announced FDA approval of levomilnacipran (Fetzima—Forest Laboratories, Inc., and
extended-release capsules, a once-daily serotonin andnorepinephrine reuptake inhibitor (SNRI), for the Pierre Fabre Laboratories)
treatment of major depressive disorder in adults.
New SNRI treats major depression in adults
In the placebo-controlled, pivotal Phase III studies ofadult patients with major depressive disorder,statistically significant and clinically meaningfulimprovement in depressive symptoms (primaryendpoint) was demonstrated across threelevomilnacipran dosage strengths of 40, 80, and 120 mgonce daily compared with placebo as measured by theMontgomery Åsberg Depression Rating Scale totalscore (primary endpoint). Levomilnacipran alsodemonstrated superiority over placebo as measured byimprovement in the Sheehan Disability Scale functionalimpairment total score (secondary endpoint).
The most common adverse reactions (incidence ?5%and at least twice the rate of placebo) in theplacebo-controlled trials were nausea, constipation,hyperhidrosis, increased heart rate, erectile dysfunction,tachycardia, vomiting, and palpitations. Rates of adverseevents were generally consistent across doses (40–120mg); the only dose-related adverse events (greater than2% overall incidence) were urinary hesitation anderectile dysfunction.
Forest Laboratories Inc. expects levomilnacipranextended-release capsules to be available towholesalers in the fourth quarter of 2013.
Source URL:
http://www.aphadruginfoline.com/new-drug-approvals/new-snri-treats-major-depression-adults Generic Name (Trade Name—Company)
Uses/Notes
Mefloquine hydrochloride
FDA announced that it has strengthened and updatedwarnings regarding neurologic and psychiatric adverse (Multiple trade names—Multiple
effects associated with the antimalarial drug mefloquinehydrochloride. A boxed warning, the most serious kind of manufacturers)
warning about these potential problems, has been Label changes for antimalarial drug warn of risk of
serious psychiatric and neurologic adverse effects
FDA has revised the patient Medication Guidedispensed with each prescription and wallet card toinclude this information and the possibility that theneurologic adverse effects may persist or becomepermanent.
Neurologic adverse effects can include dizziness, loss ofbalance, or ringing in the ears. The psychiatric adverseeffects can include feeling anxious, mistrustful,depressed, or having hallucinations.
Neurologic adverse effects can occur at any time duringdrug use and can last for months to years after the drugis stopped or can be permanent. Patients, caregivers,and health professionals should watch for these adverseeffects. When using the drug to prevent malaria, if apatient develops neurologic or psychiatric symptoms,mefloquine should be stopped, and an alternatemedicine should be used. The patient should not stoptaking mefloquine before discussing symptoms with thehealth professional.
FDA will continue to evaluate the safety of mefloquineand will communicate with the public again if additionalinformation becomes available.
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/label-changes-antimalarial-drug-warn-risk-serious-psychiatric-and-neurologic Generic Name (Trade Name—Company)
Uses/Notes
Ferric carboxymaltose injection
American Regent Inc., a subsidiary of LuitpoldPharmaceuticals Inc., announced FDA approval of ferric (Injectafer—American Regent)
carboxymaltose injection, a parenteral iron replacementproduct used for the treatment of iron deficiency anemia Parenteral iron replacement product treats iron
(IDA) in adult patients who have intolerance to oral iron deficiency anemia
or have had an unsatisfactory response to oral iron. Theproduct is also indicated for iron deficiency anemia inadult patients with non–dialysis-dependent chronickidney disease.
A single dose of up to 750 mg of ferric carboxymaltosecan be administered undiluted as an I.V. push injectionat a rate of 100 mg/minute or as an I.V. infusion in up to250 mL 0.9% sodium chloride injection, USP, over atleast 15 minutes.
Safety and efficacy were evaluated in two clinical trialsin which ferric carboxymaltose injection wasadministered at a dose of 15 mg/kg body weight up to amaximum single dose of 750 mg of iron on twooccasions separated by at least 7 days up to amaximum cumulative dose of 1500 mg of iron. Theinclusion/exclusion criteria for both studies allowedpatients with various comorbidities, characteristic of thisbroad patient population. Additionally, patients with ahistory of drug allergies were included in the trials,providing robust safety data in this difficult-to-treatsubset of patients.
Source URL:
http://www.aphadruginfoline.com/new-drug-approvals/parenteral-iron-replacement-product-treats-iron-deficiency-anemia Generic Name (Trade Name—Company)
Uses/Notes
Vitamin B dietary supplement
FDA has warned that consumers should not use orpurchase Healthy Life Chemistry By Purity First B-50,marketed as a vitamin B dietary supplement. Apreliminary FDA laboratory analysis indicated that theproduct contains two potentially harmful anabolicsteroids: methasterone, a controlled substance, anddimethazine. These ingredients are not listed in the labeland should not be in a dietary supplement.
FDA has received reports of 29 adverse incidentsassociated with the use of the supplement. Thesereports include fatigue, muscle cramping, and myalgia(muscle pain), as well as abnormal laboratory findingsfor liver and thyroid function and cholesterol levels.
Females who used this product reported unusual hairgrowth and missed menstruation, and males who usedthe product reported impotence and findings of lowtestosterone. Individuals who have used the product andhave had any of these symptoms should consult ahealth professional and report their experience to FDA.
Using anabolic steroid-containing products may causeacute liver injury. Some of the cases reported haveresulted in hospitalization, but there were no reports ofdeath or acute liver failure.
In addition, anabolic steroids may cause other seriouslong-term consequences in women, men, and children.
These include adverse effects on blood lipid levels,increased risk of heart attack and stroke, masculinizationof women, shrinkage of the testicles, breastenlargement, infertility in males, and short stature inchildren.
Healthy Life Chemistry By Purity First B-50 ismanufactured by Mira Health Products Ltd. inFarmingdale, NY, and is sold on various websites and inretail stores. The company, Purity First Health Products,has declined to voluntarily recall the product or to warnconsumers about the potential for injury.
Health professionals are advised to ask their patientsabout any dietary supplements they may be using, particularly in patients exhibiting warning signs that may (Healthy Life Chemistry By Purity First
be associated with the use of steroids or steroid-like B-50—Mira Health Products)
substances. These warning signs include liver injury, Product contains two potentially harmful anabolic
kidney failure and stroke. They also include steroids
hormone-associated adverse effects such as bloodclots, including pulmonary embolism and deep veinthrombosis (a blood clot that forms in a vein deep in thebody, often in the lower leg or thigh).
Source URL:
http://www.aphadruginfoline.com/alerts-and-recalls/product-contains-two-potentially-harmful-anabolic-steroids APhA DrugInfoLine is an official publication of, and is owned and copyrighted by the American Pharmacists Association, thenational 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 toensure that information contained in APhA DrugInfoLine is accurate and current; however, they shall have no liability to anyperson or entity with regard to claims, losses, or damages caused or alleged to be caused, directly or indirectly, by use of anyinformation contained in the publication. All decisions about drug therapy must be based on the independent judgment of theclinician. Copyright 2000–2011, American Pharmacists Association. All rights reserved.

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