As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.
July 2, 2014
PRODUCT SAFETY
Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here. Problem With a Medical Product? Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form |
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Drug Safety Communication: Lidocaine Viscous - Boxed Warning Required - Should Not Be Used to Treat Teething PainFDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. More information |
Recall: Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb - Particulate Matter
Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. More information
Drug Safety Communication: Over-the-Counter Topical Acne Products- Rare But Serious Hypersensitivity ReactionsFDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. The hypersensitivity reactions may occur within minutes to a day or longer after product use. More information |
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Drug Safety Communication: Olmesartan - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.More information
FDA/CDER Statement: Testosterone Products - Risk of Venous Blood Clots
FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). More information
Drug Safety Communication: Docetaxel - May Cause Symptoms of Alcohol Intoxication
FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk. More information
Recall: Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial - Visible ParticulatesHospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. More information |
Recall: Red Yeast Rice by Doctor’s Best- Undeclared Lovastatin
Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Doctor’s Best Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug. More information
FDA Safety Communication: Big Sky Diagnostic Imaging, LLC in Butte, Montana - Mammography Problems
The FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Montana. More information
Class I Recall: ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing
A Class I Recall was issued for all Flexi-Seal CONTROL Fecal Management System Kits. No 510k application was submitted to FDA. In addition, ConvaTec received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014. More information
Recall: HydroFinity Hydrophilic Guidewires by NDC/Covidien - Outer Jacket Damage
NDC issued a recall of all HydroFinity Hydrophilic Guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. More information
Immediate Public Notification: Weight Loss Products- Undeclared Drug Ingredients
FDA is advising consumers not to purchase or use these products, promoted and sold for weight loss on various websites and in some retail stores: Sport Burner (contains fluoxetine), Toxin Discharged Tea (contains fluoxetine), Sliming Diet (contains sibutramine). More information
Immediate Public Notification: Male Sexual Enhancement Products- Undeclared Drug Ingredients
The FDA is advising consumers not to purchase or use several products promoted and sold for sexual enhancement on various websites and in some retail stores. More information
Warning: Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label- Products Not FDA Approved
FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en españolDescargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA |
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch |
PRODUCT APPROVALS & CLEARANCES
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FDA approves Afrezza to treat diabetesFDA approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. More information |
FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk
FDA allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aide. More information
FDA approves Sivextro to treat skin infections
Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed |
OPPORTUNITIES FOR COMMENT / GUIDANCES
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FDA outlines expectations for human drug compounders, including registered outsourcing facilitiesFDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists. More information |
FDA issues guidance to support the responsible development of nanotechnology products
Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products. The draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by September 10, 2014. More information
ANNOUNCEMENTS
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Empowering Consumers through Accurate Genomic TestsFDA reviews genetic tests for medical conditions, whether they are intended to be ordered by a healthcare practitioner or directly by the consumer, to assure that consumers receive accurate test results. More information |
FDA Teams Up for Novel Campaign on Risks of Decorative Contact Lenses
Decorative contact lenses can cause serious eye damage if not fitted by an optometrist or ophthalmologist. That’s one of the messages of a joint campaign by the FDA, the American Optometric Association (AOA), and the Entertainment Industries Council (EIC). More information
UPCOMING MEETINGS
FDA advisory committee 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.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (July 10-11)
The committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. More information
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (July 30-31)
The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. More information
The Development of New Antibacterial Products: Charting a Course for the Future (July 30-31)
The National Institutes of Health (NIH) and FDA will host a two-day workshop to explore key issues and challenges related to antibacterial product development and discuss the development of streamlined regulatory pathways for bringing new antibacterial drugs to market. More information
Blood Products Advisory Committee Meeting Announcement (July 31)
The committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. The committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results. More information
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (August 1)
The committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. More information
Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (August 15)
The committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. More information
RESOURCES
MedWatchLearn - Practice Reporting to FDA!This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information |
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information
FDA BasicsEach 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 VoiceFDA voice is the official blog from FDA's senior leadership and staff.More information |
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