FDA Updates for Health Professionals

January 2, 2013

PRODUCT SAFETY Recall: P&J Trading Issues a Voluntary Recall of All Lots of the Dietary Supplements Slimdia Revolution P&J TRADING is conducting a voluntary recall after being notified by the US FDA that testing found the SLIMDIA REVOLUTION products, specific to the above lot numbers, contain Sibutramine. Sibutramine is an appetite suppressant that was FDA-approved for the treatment of obesity. More information Class I Recall: GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems – Failure to Achieve the Desired Inspiratory Pressure During Ventilation The disposable T-piece circuits do not achieve the maximum positive inspiratory pressure (PIP) levels of 45 +/- 5 cmH2O needed for intense resuscitation. This failure to achieve the desired inspiratory pressure during ventilation may result in inadequate therapy, and the need for additional medical intervention. More information Class I Recall: Zimmer Spine PEEK Ardis Inserter - Risk of Implant Breakage Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord (dural tear), cerebrospinal fluid leakage, significant blood loss and nerve injury.  More information Recall: Bunnell Incorporated Issues Nationwide Recall Notification of Life Pulse High-Frequency Ventilator Patient Circuits On December 12, 2012  Bunnell Incorporated initiated a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell’s website. More information Recall: Ventlab Adult and Pediatric Manual Resuscitators - Valve Leak Prevents Flow of Air/Oxygen to Patient The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of airflow to the patient may not be easily observable to the user because the bag still deflates when compressed. More information Recall: Medtronic Drug Infusion Pumps - Intermittent or Permanent Pump Motor Stall FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump’s performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. More information Recall: Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg - Potential for Oversized Tablets Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in unit dose (CD100) under the UDL Laboratories label. The lot numbers are Lots 3037841, 3040859 and 3042573. More information FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves FDA is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. More information For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch PRODUCT APPROVALS FDA approves first anti-diarrheal drug for HIV/AIDS patients FDA approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. More information FDA approves first drug to treat multi-resistant tuberculosis FDA approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. More information FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation FDA approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. More information FDA approves new orphan drug for rare cholesterol disorder FDA approved approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). More information FDA approves Varizig for reducing chickenpox symptoms FDA approved Varizig for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. More information FDA expands Tamiflu’s use to treat children younger than 1 year FDA expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days. More information FDA approves Gattex to treat short bowel syndrome FDA approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition). More information FDA permits marketing of device to seal lung punctures FDA allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed OPPORTUNITIES FOR COMMENT / GUIDANCES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. Fax written comments on the collection of information by January 25, 2013. More information Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide FDA is announcing the availability of two guidances for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” and “Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide.” These guidances are intended to help sponsors and investigators comply with the requirements for IND safety reporting and safety reporting for BA and BE studies. Submit either electronic or written comments on Agency guidances at any time. More information  Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments FDA will be holding a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products.Comments will be accepted until February 12, 2013. More information ANNOUNCEMENTS Consumer Update: Dangerous Supplement Now Sold as 'WOW' FDA is warning the public that a product distributed and sold under the name 'WOW' is really just another product in disguise, one that can cause serious harm. FDA laboratory analysis confirmed that WOW contains the same undeclared prescription drug ingredients that are in Reumofan Plus. More information Information on Medical Cribs Used in Homes and Child Care Settings On December 28, 2010, the Consumer Product Safety Commission (CPSC) issued a final rule identifying new safety standards for consumer cribs. The CPSC crib standards, which establish improved safety requirements, including a ban of drop-side rail designs for consumer cribs, took effect for consumer crib manufacturers and retailers on June 28, 2011 and child care centers, family child care homes, and places of public accommodation (such as hotels) on December 28, 2012. However, current FDA regulation allows pediatric medical cribs used in hospitals to keep the drop-side rail feature because it is critical for providing appropriate medical care to sick children. More information UPCOMING MEETINGS FDA advisory committe meetings are free and open to the public.  No prior registration is required to attend.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.  Click on "more information" for details about each meeting.  Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings. Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Jan 10) The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. More information Cellular, Tissue and Gene Therapies Advisory Committee Meeting (Jan 15) The committee will meet, by teleconference, in open session, to hear updates on the research programs in the Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More information Meeting of the Drug Safety and Risk Management Advisory Committee Meeting (Jan 24-25) On both days, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 29) The committee will discuss olodaterol metered dose inhaler (proposed trade name Striverdi Respimat) by Boehringer Ingelheim, for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 30) The committee will discuss mannitol inhalation powder (proposed trade name BRONCHITOL), by Pharmaxis, for the treatment of cystic fibrosis (CF) in patients aged 6 years and older. More information Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing (Feb 7-8) To obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain. More information Neurological Devices Panel of the Medical Devices Advisory Committee (Feb 22) The committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc.  The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information Public Workshop on Minimal Residual Disease (Feb 27) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). More information Public Workshop on Minimal Residual Disease (Mar 4) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7) The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information RESOURCES FDA Basics Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff. More information Medical Prouct Safety Network (Medsun) Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information