FDA Updates for Health Professionals -- May 23, 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 are 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: 

Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume (May 23)
FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc. The pre-filled cartridges containing the products listed in the Drug Alert may be overfilled by at least twice the expected amount, resulting in potential overdose.
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death (May 17)
FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17,2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug.
April Safety Labeling Changes (May 14)
Monthly Safety Labeling Changes includes 43 products with revisions to Prescribing Information.
Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose (May 14)
FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod).
Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume (May 14)
Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume.

For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch


PRODUCT APPROVALS:

FDA approves generic versions of blood thinner Plavix (May 17)
FDA approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
A new pancreatic enzyme product used to help aid food digestion (May 17)
A new pancreatic enzyme product used to help aid food digestion, Pertzye (pancrelipase), was approved by the FDA.
FDA expands use for FilmArray Respiratory Panel (May 15)
FDA expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.
                                                                                                                
  
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES: 
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket NotificationsThe Agency intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use and to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications. Submit either electronic or written comments on the draft guidance by September 7, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot StudyThis notice solicits comments on the survey entitled “Medical Device Decision Analysis: A Risk-Tolerance Pilot Study.”  Submit either electronic or written comments by June 18, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationThis notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a “small business” and pay certain medical device user fees at reduced rates.  Submit either electronic or written comments by June 18, 2012.
Proposed Collection; Comment Request; Financial Disclosure by Clinical InvestigatorsThis notice solicits comments on information collection on financial disclosure by clinical investigators. Submit either electronic or written comments by May 29, 2012.
Comment Request; Experimental Study of Graphic Cigarette Warning Labels
This notice solicits comments on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act.  Submit either electronic or written comments by May 29, 2012.
Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products This draft guidance provides the pharmaceutical industry with CDER's current thinking on the potential human health risks associated with exposure to DBP and DEHP. Submit either electronic or written comments on the draft guidance by May 31, 2012.

ANNOUNCEMENTS: 

May 25 Deadline: Commissioner’s Fellowship ProgramFDA invites outstanding healthcare professionals, scientists, and engineers to apply to its two-year Fellowship Program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific or regulatory issues under the mentorship of an FDA senior scientist.
FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions (May 22)
A team of researchers led by the FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
U.S. Marshals seize unapproved new drug from Crescendo Therapeutics LLC (May 22)
U.S. Marshals, acting at the request of FDA, have seized HybriSil (methylprednisolone acetate 1% percent in silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, LLC.
June 12 Webinar: Practical Advice for Preventing Surgical Fires--Safety Strategies from the Front LinesFDA experts will briefly discuss the ‘Preventing Surgical Fires’ Initiative. Invited hospital staff will share their experiences and protocols used to prevent surgical fires. Surgical Fire prevention recommendations will also be presented.
May 23 Webinar on Hearing Aids: The Basic Information You Need to KnowDo you have questions about hearing loss and hearing aids? Learn more Wednesday, May 23 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health will host a webinar to discuss basic information on hearing aids.
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis (May 10)
FDA is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency.
Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.) 

- Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple


UPCOMING MEETINGS: 
 
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (May 24)
Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 24)
Scientific Workshop on the Assessment of Analgesic Treatment of Chronic Pain (May 30-31)
Regulation of Pharmaceuticals: A Global Perspective (Jun 6-8)
Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge, Public Workshop (Jun 7)
Blood Products Advisory Committee Meeting (Jun 12)
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 13)
Oncologic Drugs Advisory Committee Meeting (Jun 20)
 
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 21)
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


RESOURCES: 
Continuing Education
Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and PharmacistsThe goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
Articles

Statins: The Story Behind the Label Changes
Videos 

A Short Tutorial on REMS: The FDA PerspectiveFeaturing Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
FDA Drug Safety Podcasts
Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
Availability of up-to-date electronic labels on DailyMed and FDA's new FDA Online Label Repository
Within one business day, drug companies may now update their electronic content of labeling on DailyMed and the FDA Online Label Repository.
Consumer Updates--Timely and easy-to-read articles covering all FDA activities and regulated products
- Database Is One-Stop Resource on Kids' Medications- Sun Safety: Save Your Skin! To remind everyone to protect their skin and health while enjoying the outdoors, the National Council on Skin Cancer Prevention has designated May 25, 2012 as “Don’t Fry Day.”

Best regards,

Health Professional Liaison Program, Office of Special Health Issues