MEDWATCH

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MEDWATCH
The FDA Safety Information and Adverse Event
Reporting Program, that serves both healthcare p
rofessionals and the medical product-using publi
c. They provide important and
timely clinical information about safety issues
involving medical products, including prescripti
on and over-the- counter drugs, biologics, medica
l and radiation-emitting devices, and special nu
tritional products (e.g., medical
foods, dietary supplements and infant formulas).
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USE OF SKIN PRODUCTS CONTAINING NUMBING
INGREDIENTS (TOPICAL ANESTHETIC DRUGS)FOR
COSMETIC PROCEDURE AND POTENTIAL LIFE-THREATENING
SIDE EFFECTS

• FDA informed consumers
  and healthcare professionals of the potential
  hazards of using skin numbing products containing
  topical anesthetic drugs such as lidocaine,
  tetracaine, benzocaine, and prilocaine in a
  cream, ointment, or gel. Numbing products are
  widely used to numb the skin for medical and
  cosmetic procedures, and to relieve pain, burning
  and itching due to a variety of medical
  conditions. FDA has approved many of these
  products uses. Some of these products must be
  prescribed by a doctor, others may be purchased
  without a prescription. FDA is aware that use of
  these products before a cosmetic procedure may
  not be supervised by trained health professional.
  With out this supervision, a patient may apply
  large amounts of the numbing products to their
  skin, which can cause life-threatening side
  effects and death. If a skin numbing product is
  prescribed or recommended for a procedure,
  consumers should do the following
• Use a topical anesthetic approved by FDA
• Use a topical anesthetic that contains the lowest
  amount of anesthetic drugs possible that will
  relieved pain.
  
• Ask for instructions from your doctor on how to
  safely use the topical anesthetic.
  
• Read the complete
  MedWatch 2007 Safety summary, including the link
  to the FDAs Public Health Advisory regarding
  this issue at
• 
  http//www.fda.gov/medwatch/safety/2007/safety07.h
  tmAnesthetics
  
• 
  Or
  
• Snapshot as on GMT
  Wed Feb 7 043620 2007

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NEW ONLINE TUTORIAL ON DRUG SAFETY AVAILABLE FOR
HEALTHCAREPROFESSIONALS AND THEIR PATIENTSa
letter from FDA Safety Information and Adverse
Event Reporting Program

• Dear FDA MedWatch listserve subscriber
• These FDA MedWatch safety alert
  notices are sent at your request to help you
  rapidly learn about updated safety information on
  the human healthcare products-drugs, both Rx and
  OTC, medical devices and diagnostics, biologics,
  and dietary supplements that FDA monitors for
  safety following their approval and that you and
  your patients may use, prescribe or dispense in
  day to day care.
• We intend that this information
  be concise, science-based, unbiased and
  clinically useful information that will help both
  provider and patient as they consider treatment
  choices. To assist both professionals and the
  healthcare consuming public to better understand
  the challenges of post-marketing drug and device
  surveillance and what FDA offers to address that
  challenge, I am pleased to announce of a
  web-based self-learning tutorial, FDA MedWatch
  and Patient Safety, http//www.connective.com
• This 30 minute video program
  will allow you, as either provider or patient, to
  have a better understanding of why voluntary
  reporting of serious adverse events, product
  quality problems and product use errors is
  essential to FDAs safety monitoring process, how
  FDA evaluates and takes action on your reports,
  and how MedWatch takes that new safety
  information and makes it available for your use.
• If you have comments about your
  FDA MedWatch safety alert process, this Patient
  Safety Tutorial or suggestions for how to share
  this FDA safety message more widely, please
  address your reply to CDERMedWatchTutorial_at_fda.h
  hs.gov
• Norman S. Marks, MD,MHA
• Medical Director, MedWatch
• FDA/CDER/Office of the Center
• Director
• Safety Policy and Communication Staff
• www.fda.gov/medwatch

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In September 2006, the Institute 0f Medicine
(IOM) issued a report, The Future of Drug Safety
Promoting and Protecting the Health of the
Public, that included substantive recommendations
on how the FDA can improve its drug safety
efforts. The FDA response, issued on January 30,
2007, details a comprehensive approach to the
IOMs suggestions. It includes 18 actions that
were initiated recently as a result of FDAs own
assessment of the drug safety system, eight items
that are part of the proposed recommendations for
the reauthorization of the Prescription Drug
Users Fee Act PDUFA and 15 new items. To learn
more about the FDA response, please
seeFDAs THE FUTURE OF DRUG SAFETY report
http//www.fda.gov/oc/reports/iom03007.htmlFD
As Commitment to Drug Safety Fact Sheet
http//www.fda.gov/oc/factsheets/drugsafety-.html