December 19, 2012
U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want 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 issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
Serious Skin Reactions with Incivek (telaprevir) In Combination with Peginterferon Alfa and Ribavirin (Incivek combination treatment) (Dec 19)
FDA received reports of serious skin reactions, some fatal, in patients taking Incivek, a hepatic C virus NS3/4A protease inhibitor for the treatment of genotype 1 chronic hepatitis C. FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash.
Recall of Zicam Extreme Congestion Relief Nasal Gel by Matrixx Initiatives (Dec 19)
Burkholderia cepacia was found in a single sample of Zicam Extreme Congestion Relief nasal gel, a nasal decongestant, and could lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions.
Recall of Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, And Casanova by Performance Plus Marketing, Inc. (Dec 18)
Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova, dietary supplement sexual enhancers for men, contain undeclared Sulfoaildenafil and Thioaildenafil and may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Xyrem (sodium oxybate) - Warning Against Use With Alcohol or Drugs Causing Respiratory Depression (Dec 17)
Xyrem (sodium oxybate), to reduce attacks of muscle weakness (cataplexy) and daytime sleepiness, combined with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression).
Recall of Carboplatin Injection by Hospira (Dec 15)
Carboplatin Injection, for treatment of advanced ovarian carcinoma, previously recalled due to visible particulates have been identified as Carboplatin crystals.
Class I Recall of SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin by Ethicon, Inc. (Dec 14)
A cut within the packing process of the SURGIFLO Hemostatic Matrix, used in surgical procedures (other than ophthalmic) as an aide to stop the flow of bleeding, could potentially breach the double Tyvek pouch of the packaging.
Class I Recall of Verathon GlideScope Video Laryngoscope Reusable Blades (Dec 13)
The GlideScope Video Laryngoscopes, to obtain a clear, unobstructed view of the vocal cords for medical procedures, are at risk of developing stress cracks at the blade tip.
Chantix (Varenicline) - Updated Safety Review On The Risk of Cardiovascular Adverse Events (Dec 12)
A higher occurrence of major adverse cardiovascular events were observed in a large, combined analysis of Chantix, a prescription medicine used to help adults quit smoking, compared to placebo but was not statistically significant. It is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.
Class I Recall of Natus Medical Incorporated, Olympic Cool-Cap System (Dec 12)
The Olympic Cool Cap System (Cool-Cap), for treatment of hypoxic-ischemic encephalopathy (HIE) in full-term infants, may experience a frozen screen during treatment and is not providing cooling treatment to the infants.
November 2012 Safety Labeling Changes (Dec 11)
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.
Protandim by LifeVantage Corporation: Recall - Possible Metal Fragments in Product (Dec 7)
Protandim, the Nrf2 Synergizer dietary supplement, were distributed in the United States and Japan between July and November 2012.
Heparin: Container Labels to Clearly State the Total Drug Strength (Dec 6)
Manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP will be required to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL).
Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg by Qualitest (Dec 6)
It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen.
Please visit our MedWatch website for more information.
PRODUCT APPROVALS:
FDA Approves Signifor, a New Orphan Drug for Cushing’s Disease (Dec 14)
FDA approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery.
FDA Approves Raxibacumab to Treat Inhalational Anthrax (Dec 14)
FDA approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis.
FDA Approves Iclusig to Treat Two Rare Types of Leukemia (Dec 14)
FDA approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
FDA expands Zytiga’s use for late-stage prostate cancer (Dec 10)
FDA expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
Please visit Drugs@FDA for more information.
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee
All letters of interest and nominations should be submitted in writing by January 3, 2013.
Framework for Pharmacy Compounding: State and Federal Roles
FDA is also soliciting either electronic or written comments on the issues by January 18, 2013.
Request for Comments on Impact of Approved Drug Labeling on Chronic Opioid Therapy
Submit electronic or written requests to make oral presentations and comments by January 18, 2013. Electronic or written comments will be accepted after the hearing until April 8, 2013.
Guidance for Industry - FDA and Industry Actions on Premarket Notification 510(k) Submissions: Effect on FDA Review Clock and Goals
The Medical Device User Fee Amendments of 2012 authorizes FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s).
Request for Comments on Comprehensive Assessment of the Process for the Review of Device Submissions
Submit electronic or written comments by February 4, 2013.
Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket
Submit either electronic or written comments by February 12, 2013.
Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
Submit either electronic or written comments on the draft guidance by February 15, 2013.
Draft Guidance for Industry on Certification of Designated Medical Gases
Submit either electronic or written comments on the draft guidance by February 19, 2013.
Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public Workshop
FDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Comments for the open public hearing due by February 1, 2013. Written comments due by March 1, 2013.
Draft Guidance; Design Considerations for Devices Intended for Home Use
Submit either electronic or written comments on the draft guidance by March 13, 2013.
ANNOUNCEMENTS:
FDA Warns Against Improper Advertising, Promotion of Lasers Intended for LASIK Corrective Eye Surgery (Dec 18)
FDA warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK.
UPCOMING MEETINGS:
December
Framework for Pharmacy Compounding: State and Federal Roles (Dec 19)
At this public meeting, FDA and State representatives will share their perspectives. FDA is also soliciting either electronic or written comments on the issues discussed.
Arthritis Advisory Committee Meeting (Dec 20)
The Committee will discuss rintatolimod injection (proposed trade name AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of patients with chronic fatigue syndrome.
January
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Jan 10)
The Committee will discuss canagliflozin tablets (proposed trade name INVOKANA) by Janssen Research and Development, LLC. for adults with type 2 diabetes mellitus.
Drug Safety and Risk Management Advisory Committee Meeting (Jan 24-25)
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.
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.
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.
February
Impact of Approved Drug Labeling on Chronic Opioid Therapy Public Meeting (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.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 22)
The Committee will discuss the NeuroPace RNS System by NeuroPace, Inc., for 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.
March
Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7)
The committee will discuss fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), by GlaxoSmithKline, for chronic obstructive pulmonary disease.
Please visit FDA’s Advisory Committee for more information. Please visit Meetings, Conferences, & Workshops for additional information on other agency meetings.
CONSUMER UPDATES:
Helping Consumers Reduce Sodium Intake
Most Americans consume way too much sodium, with salt (sodium chloride) being the most common form.
Please visit Consumer Updates for more information.
RESOURCES:
2012 Health Professional Organizations Annual Conference - Meeting Summary
The summary captures highlights and presentations from the Second Annual Health Professional Organizations Conference on October 4, 2012.
FDA Basics Webinar: A Brief Overview of REMS
This presentation will discuss REMS and how they are used to help ensure that the benefits of certain medicines continue to outweigh their risks.
FDA Voice:
FDA Voice is the official blog from FDA's senior leadership and staff.
A New Law Advances Public Health: New Web Page Tracks Progress
Fighting Antibiotic Resistance
MedSun Medical Product Safety Network
The Medical Product Safety Network (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 Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.
Best regards,
Office of Special Health Issues
Food and Drug Administration
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