Drug News

July 1 2008 - difluprednate ophthalmic (Durezol by Sirion Therapeutics), has been approved by the FDA for the treatment of inflammation and pain associated with ocular surgery. Prescribing Information.

July 1 2008 - Methylphenidate (Concerta by Johnson & Johnson Pharmaceutical Research & Development), has been approved by the FDA for treatment of ADHD in adults ages 18 to 65. The doses approved for adults range from 18 to 72 mg daily. Prescribing Information

July 1 2008 - Rabeprazole (Aciphex by Eisai), has been approved by the FDA for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above. Prescribing Information

July 1 2008 - tipranavir (Aptivus by Boehringer Ingelheim), has been approved by the FDA in a new oral solution. The product labeling has been updated to include dosing recommendations for pediatric patients 2 to 18 years of age. Additionally, updated information regarding oral and parenterally administered midazolam is included in the Contraindications and Drug Interactions sections. Prescribing Information

June 30 2008 - Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept. Medwatch Information

June 25 2008 - Metformin-repaglinide (PrandiMet by Novo Nordisk Inc.), has been approved the FDA for the treatment of type 2 diabetes. Prescribing Information.

June 23 2008 - Duloxetine (Cymbalta by Eli Lilly and Co.) has been approved by the to treat fibromyalgia. Prescribing Information

June 23 2008 - Ropinirole (Requip XL by GlaxoSmithKline) has been approved by the FDA for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Prescribing Information

June 23 2008 - Dutasteride (Avodart by GlaxoSmithKline) has been approved by the FDA for use in combination with tamsulosin for the treatment of symptomatic enlarged prostate. Prescribing Information

June 23 2008 - Bortezomib (Velcade by Millennium Pharmaceuticals) has been approved by the FDA for patients with previously untreated multiple myeloma. Prescribing Information

June 16 2008 - FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section. Medwatch Information

June 6 2008 - The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Information

June 4 2008 - FDA issues an Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). Information

May 30 2008 - FDA has issued a public health advisory to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. FDA News | Public Health Advisory

May 28 2008 - FDA proposes a new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding. FDA News

May 21 2008 - Alvimopan (Entereg by GlaxoSmithKline) has been approved by the FDA to help patients regain gastrointestinal function earlier following bowel resection surgery. Alvimopan is a peripherally acting mu-opioid receptor (PAM-OR) antagonist. Prescribing Information.

May 16 2008 - FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy. Medwatch Information

May 15 2008 - Quetiapine (Seroquel by AstraZeneca), has been approved by the FDA for the maintenance treatment of patients with bipolar I disorder mania as monotherapy or as adjunct therapy to lithium or divalproex.

May 15 2008 - Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients. Medwatch Information

May 12 2008 - Aripiprazole (Abilify by Bristol-Myers Squibb), has been approved by the FDA for use in the maintenance treatment of bipolar disorder and schizophrenia. In addition, the FDA also approved a new recommended starting and target dose of 15 mg daily for monotherapy in the treatment of bipolar disorder in adults. Prescribing Information

May 7 2008 - Rilonacept (Arcalyst by Regeneron Pharmaceuticals, Inc.), has been approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. Prescribing Information

May 2 2008 - Risedronate (Actonel by Proctor and Gamble), has been approved by the FDA as a new once-a-month dose of 150 mg for the treatment and prevention of postmenopausal osteoporosis. Prescribing Information

May 1 2008 - Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued. Medwatch Information

April 30 2008 - Lubiprostone (Amitiza by Takeda Pharmaceutical Co), has been approved by the FDA as the first U.S. drug to treat irritable bowel syndrome with constipation (IBS-C) in women over 18 years old. Prescribing Information

April 24 2008 - Certolizumab (Cimzia by UCB Pharma), an anti-TNFa (Tumor Necrosis Factor alpha) antibody, has been approved by the FDA for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. Prescribing Information

April 23 2008 - Lisdexamfetamine (Vyvanase by Shire), has been approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. Prescribing Information

April 23 2008 - Olopatadine (Patanase by Alcon), nasal spray has been approved by the FDA for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. Prescribing Information

April 16 2008 - FDA issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg." Information

April 16 2008 - Naproxen-sumatriptan (Treximet by GlaxoSmithKline), has been approved by the FDA for the acute treatment of migraine attacks with or without aura in adults. Prescribing Information

April 10 2008 - FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Medwatch Information

April 10 2008 - Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease. The product is being recalled because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises. Medwatch Information

April 9 2008 - Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed. Medwatch Information

April 9 2008 - Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control. Medwatch Information

April 9 2008 - Abatacept (Orencia by Bristol-Myers Squibb), has been approved by the FDA for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Prescribing Information

April 3 2008 - Novartis, the manufacturer of Zelnorm, has notified the FDA that they will no longer provide Zelnorm (tegaserod maleate) under a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55. Novartis has agreed to continue to supply Zelnorm for use in emergency situations. Requests for Zelnorm for this purpose may be made to the FDA which in turn authorizes shipment of the drug by the manufacturer. Information

April 2 2008 - GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for zanamivir (Relenza) regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient. Medwatch Information