New Indications & Dosage Forms for Existing Drugs
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
(rivaroxaban) Tablets
Date of Approval: July 1, 2011
Xarelto (rivaroxaban) is a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
New Indication Approved: November 4, 2011
Byetta (exenatide) Injection
Date of Approval: April 28, 2005
Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
New Dosage Regimen: October 19, 2011
Cialis (tadalafil) Tablets
Date of Approval: November 21, 2003
Cialis is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction, and to treat the signs and symptoms of benign prostatic hyperplasia.
New Indication Approved: October 7, 2011
Combivent (albuterol and ipratropium) Inhalation Aerosol
Date of Approval: October 24, 1996
Combivent (albuterol and ipratropium) is a beta2-adrenergic bronchodilator and anticholinergic bronchodilator combination for the treatment of chronic obstructive pulmonary disease (COPD).
New Formulation Approved: October 7, 2011
Soliris (eculizumab) Injection
Date of Approval: March 16, 2007
Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.
New Indication Approved: September 23, 2011
· Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Remicade (infliximab) Injection
Date of Approval: August 24, 1998
Remicade (infliximab) is a tumor necrosis factor (TNF) blocker indicated for use in the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
Patient Population Altered: September 23, 2011
Prolia (denosumab) Injection
Date of Approval: June 1, 2010
Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy.
New Indication Approved: September 16, 2011
Artiss (fibrin sealant (human)) Topical Solution
Date of Approval: March 19, 2008
Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients and for tissue adherence in facial rhytidectomy (face-lift) surgery.
New Indication Approved: August 31, 2011
Nucynta (tapentadol) Tablets
Date of Approval: November 20, 2008
Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.
New Dosage Form Approved: August 25, 2011
Botox (onabotulinumtoxinA) Injection
Date of Approval: December 9, 1991
Botox (onabotulinumtoxinA) is a neurotoxin complex indicated for the treatment of cervical dystonia, severe primary axillary hyperhidrosis (underam sweating), upper limb spasticity, prevention of chronic migraine and urinary incontinence in people with neurologic conditions.
New Indication Approved: August 24, 2011
Orencia (abatacept) Injection
Date of Approval: December 23, 2005
Orencia (abatacept) is a selective costimulation modulator indicated for the treatment of rheumatoid arthritis (RA).
New Formulation Approved: July 29, 2011
Gammagard Liquid (immune globulin infusion (human)) Solution
Date of Approval: May 2, 2005
Gammagard (immune globulin infusion (human)) is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
New Dosage Form Approved: July 22, 2011
Xeomin (incobotulinumtoxinA)
Date of Approval: July 30, 2010
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia, blepharospasm and glabellar lines.
New Indication Approved: July 20, 2011
Welchol (colesevelam) Tablets and Oral Suspension
Date of Approval: May 26, 2000
Welchol (colesevelam HCl) is a bile acid sequestrant indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia, and to improve glycemic control in adults with type 2 diabetes mellitus.
Labeling Revision Approved: July 18, 2011
Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.
New Dosage Regimen: July 15, 2011
Lialda (mesalamine) Delayed Release Tablets
Date of Approval: January 16, 2007
Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Labeling Revision Approved: July 14, 2011
Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))
Date of Approval: May 3, 2005
Boostrix is a combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.
Patient Population Altered: July 8, 2011
Lupron Depot (leuprolide acetate) Injection
Date of Approval: January 26, 1989
Lupron Depot is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostatic cancer.
New Dosage Regimen: June 17, 2011
Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
New Indication Approved: June 16, 2011
Creon (pancrelipase) Delayed-Release Capsules
Date of Approval: April 30, 2009
Creon (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.
New Dosage Form Approved: June 10, 2011
Sutent (sunitinib malate) Capsules
Date of Approval: January 26, 2006
Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of patients with gastrointestinal stromal tumors, advanced kidney cancer and pancreatic neuroendocrine tumors.
New Indication Approved: May 20, 2011
Humalog (insulin lispro) Injection
Date of Approval: June 14, 1996
Humalog (insulin lispro) is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Labeling Revision Approved: May 18, 2011
Fluzone (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection
Date of Approval: September 4, 2002
Fluzone is an inactivated influenza virus vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B.
New Formulation Approved: May 9, 2011
Afinitor (everolimus) Tablets
Date of Approval: March 30, 2009
Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced renal cell carcinoma, subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis and pancreatic neuroendocrine tumors.
New Indication Approved: May 6, 2011
AndroGel (testosterone) Transdermal Gel
Date of Approval: February 28, 2000
AndroGel (testosterone gel) is an androgen indicated for replacement therapy in males with hypogonadism.
New Formulation Approved: April 29, 2011
Fusilev (levoleucovorin) for Injection
Date of Approval: March 7, 2008
Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
New Indication Approved: April 29, 2011
Nexium (esomeprazole)
Date of Approval: February 20, 2001
Nexium (esomeprazole) is a proton pump inhibitor indicated for the healing and maintenance of healing of erosive esophagitis, treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for use in combination with amoxicillin and clarithromycin for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, prevention of NSAID-induced gastric ulcers and Zollinger-Ellison Syndrome.
Patient Population Altered: April 29, 2011
Lamictal XR (lamotrigine) Extended Release Tablets
Date of Approval: May 29, 2009
Lamictal XR (lamotrigine) is a once-daily antiepileptic drug indicated as adjunctive therapy for partial onset seizures with or without secondary generalization and primary generalized tonic-clonic seizures in patients 13 years of age or older. Lamictal XR is also indicated for conversion to monotherapy for the treatment of partial onset seizures.
Labeling Revision Approved: April 25, 2011
Menactra (meningococcal conjugate vaccine)
Date of Approval: January 14, 2005
Menactra (meningococcal conjugate vaccine) is a quadrivalent conjugate vaccine indicated for the prevention of meningococcal disease.
Patient Population Altered: April 22, 2011
Rituxan (rituximab) Injection for Intravenous Use
Date of Approval: November 26, 1997
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener's granulomatosus and microscopic polyangiitis.
New Indication Approved: April 19, 2011
Actemra (tocilizumab) Injection
Date of Approval: January 8, 2010
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults and for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
New Indication Approved: April 15, 2011
Invega (paliperidone)
Date of Approval: December 19, 2006
Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.
Patient Population Altered: April 6, 2011
Viramune (nevirapine)
Date of Approval: June 21, 1996
Viramune (nevirapine) is an NNRTI indicated for the combination antiretroviral treatment of HIV-1 infection.
New Formulation Approved: March 25, 2011
Zostavax (zoster vaccine live) Injection
Date of Approval: May 25, 2006
Zostavax (zoster vaccine live) is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.
Patient Population Altered: March 24, 2011
Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.
New Indication Approved: March 24, 2011
Banzel (rufinamide)
Date of Approval: November 14, 2008
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.
New Dosage Form Approved: March 3, 2011
Abilify (aripiprazole)
Date of Approval: November 15, 2002
Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder and treatment of irritability associated with autistic disorder.
Labeling Revision Approved: February 16, 2011
Reyataz (atazanavir sulfate) Capsules
Date of Approval: June 20, 2003
Reyataz is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Labeling Revision Approved: February 4, 2011
Menveo (meningococcal conjugate vaccine)
Date of Approval: February 19, 2010
Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.
Patient Population Altered: January 28, 2011
Rituxan (rituximab) Injection for Intravenous Use
Date of Approval: November 26, 1997
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener's granulomatosus and microscopic polyangiitis.
New Indication Approved: January 28, 2011
Actemra (tocilizumab) Injection
Date of Approval: January 8, 2010
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults and for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Labeling Revision Approved: January 4, 2011
Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Injection
Date of Approval: June 8, 2006
Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) in girls and women 9 through 26 years of age. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and men 9 through 26 years of age.
New Indication Approved: December 22, 2010
Intelence (etravirine) Tablets
Date of Approval: January 18, 2008
Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
New Formulation Approved: December 22, 2010
Prezista (darunavir) Tablets
Date of Approval: June 23, 2006
Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.
New Dosage Regimen: December 13, 2010
Cubicin (daptomycin ) Injection
Date of Approval: September 12, 2003
Cubicin (daptomycin) is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia).
New Dosage Regimen: November 30, 2010
Nexterone (amiodarone HCl) Injection
Date of Approval: December 24, 2008
Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
New Formulation Approved: November 16, 2010
Vyvanse (lisdexamfetamine dimesylate) Capsules
Date of Approval: February 23, 2007
Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.
Patient Population Altered: November 10, 2010
Cymbalta (duloxetine) Delayed-Release Capsules
Date of Approval: August 3, 2004
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder, fibromyalgia and chronic musculoskeletal pain.
New Indication Approved: November 4, 2010
Afinitor (everolimus) Tablets
Date of Approval: March 30, 2009
Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced renal cell carcinoma, subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis and pancreatic neuroendocrine tumors.
New Indication Approved: October 29, 2010
Sprycel (dasatinib) Tablets
Date of Approval: June 28, 2006
Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.
New Indication Approved: October 28, 2010
JAMA Study: Atypical Antipsychotics Have Variable Efficacy, Safety Risk in Off-Label Uses
First, as an important reminder, the atypical antipsychotic class already has a black box warning for increased mortality risk in off-label use in dementia-related psychosis. A review of previous studies published this week reports there may be variable benefit in some off-label uses, but there are also major side effects. The off-label (conditions without FDA approval) use of atypical antipsychotics, such as Risperdal, Zyprexa, and Abilify has skyrocketed. Common off-label uses for atypical antipsychotics include behavioral symptoms in dementia, anxiety, and obsessive compulsive disorder. Increased risks of serious adverse events were noted, including death, stroke, and movement disorders in the elderly.
Saphris (asenapine): Serious Allergic Reactions Prompt Label Revision
Allergic drug reactions can range from a mild rash to anaphylaxis that may disrupt breathing. Saphris (asenapine), an atypical antipsychotic medication used for schizophrenia and bipolar disorder in adults has been associated with 52 cases of Type I hypersensitivity as determined from the FDA's Adverse Event Reporting System (AERS). Some hypersensitivity cases have occurred after the first Saphris dose. Patients that are prescribed Saphris should ask their healthcare providers how to recognize the Saphris allergic reaction symptoms, which may include difficulty breathing, face, tongue or throat swelling, wheezing, lightheadedness, and itching. Patients should seek emergency treatment if they develop these reactions. Patients with a known allergy to Saphris should not use the medication.
Pertussis Vaccination Guidelines Updated to Include Older Adults
Infants may come into the world kicking and punching, but their immune systems are still catching up with the required vaccines. This week the Centers for Disease Control and Prevention (CDC) revised tetanus-diphtheria-acellular pertussis (Tdap) vaccine guidelines to now include healthcare workers and adults (including those over 65 years) with infant contact, as well as children 7 to 10 years old and adolescents, if not fully vaccinated. The Tdap recommendations still include adolescents and pregnant women. According to the CDC, there has been an increase in infant and teen cases of whooping cough since the 1980's. Infants are particularly susceptible to serious or fatal outcomes with whooping cough, and that is why it is so important for all contacts to be vaccinated.
Updated Boxed Warning for Tumor Necrosis Factor-alpha (TNFα) Inhibitors
The FDA has announced label changes to the boxed warnings for tumor necrosis factor-alpha (TNFα) inhibitors to include the added risk of Legionella and Listeria bacterial infections. TNFα blockers are a biologic class that suppress the immune system, and are used to treat diseases such as Crohn's disease, rheumatoid arthritis and psoriasis. Serious and sometimes fatal infections are a known risk with TNFα blocker use due to the decreased ability to fight an infection. Other warnings have been updated to reflect consistent information about serious infection risk and associated pathogens. Agents in this class include: Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).
Zofran Drug Safety Communication: Risk of QT Prolongation, Torsades de Pointes
Zofran (ondansetron), a 5-HT3 receptor antagonist approved over 2 decades ago and used for prevention of nausea and vomiting associated with chemotherapy, surgery, or radiation treatment has important new safety warnings. Updated labels will reflect an increased risk of QT prolongation, which may lead to fatal heart rhythms, including Torsades de Pointes. Patients with congenital long QT syndrome are at particular risk for these abnormal heart rhythms, and should avoid using ondansetron. Patients with low levels of potassium or magnesium, congestive heart failure, slow heart rhythms, or taking other drugs that may also lead to QT prolongation may need to have their electrocardiogram followed.
Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
BACKGROUND: These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected product.
RECOMMENDATION: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms
SSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.
BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which Zofran (ondansetron) may cause QT interval prolongation.
RECOMMENDATION: The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
· Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
· Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/15/2011 - Drug Safety Communication - FDA]
Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria
SSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.
Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.
BACKGROUND: The class of TNFα blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.
RECOMMENDATION: The risks and the benefits of TNFα blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. The revised label states that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.
The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.
BACKGROUND: Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.
These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label. Dose reductions for Zometa are provided for patients with renal impairment.
RECOMMENDATIONS: Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
ISSUE: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections have been revised to include information about type I hypersensitivity reactions which may include anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. In several cases, these reactions occurred after the first dose.
BACKGROUND: Saphris (asenapine maleate) is used to treat symptoms of schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
· Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
· Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.
BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.
RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
· Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
· Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
August 24, 2011
ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.
BACKGROUND: Celexa (citalopram hydrobromide) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Shamna
Sr lecturer
Alshifa college of pharmacy
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