US FDA recalls for week ending 20OCT07

1
US FDA recalls for week ending 20-OCT-07
FDA Statement for the week ending October 20
Statement on Medtronic's Voluntary Market
Suspension of their Sprint Fidelis Defibrillator
Leads (October 15, 2007)
Statement by Daniel Schultz, M.D., director of
the Center for Devices and Radiological Health
Medtronic's decision to voluntarily remove its
Sprint Fidelis defibrillation leads from the
market is in the best interest of patient safety.
These electronic wires are prone to fracture in a
small number of patients which can cause the
defibrillator to deliver unnecessary shocks or
not operate at all.
(contined)
2
US FDA recalls for week ending 20-OCT-07
FDA Statement for the week ending October 20
Statement on Medtronic's Voluntary Market
Suspension of their Sprint Fidelis Defibrillator
Leads (October 15, 2007)
Based on our initial review of reported adverse
events, some deaths and major complications have
occurred after the leads have fractured.
Defibrillators are life-saving products for
patients with a heart rhythm abnormality.
We know it can be frightening for a patient to
learn that a product they rely on so much might
have a serious defect.
(more)
3
US FDA recalls for week ending 20-OCT-07
FDA Statement for the week ending October 20
Statement on Medtronic's Voluntary Market
Suspension of their Sprint Fidelis Defibrillator
Leads (October 15, 2007)
However, patients can be assured that the
likelihood of fracture is very low and FDA is
committed to ensuring that the risk to patients
is minimized.
FDA considers Medtronic's action to be a product
recall, as defined by FDA regulations, and we
will soon be issuing a recall classification for
this action.
We recognize that some patients and health care
professionals might inappropriately interpret the
word "recall" to mean that the devices must be
surgically removed and returned to the
manufacturer. (more)
4
US FDA recalls for week ending 20-OCT-07
FDA Statement for the week ending October 20
Statement on Medtronic's Voluntary Market
Suspension of their Sprint Fidelis Defibrillator
Leads (October 15, 2007)
Although the leads should no longer be implanted
in patients, we do not mean to imply that these
leads should be surgically removed.
Patients should recognize that a small number of
Sprint Fidelis leads are used with defibrillators
made by manufacturers other than Medtronic.
FDA will continue to monitor information on these
devices and will take whatever other actions may
be necessary.
5
US FDA recalls for week ending 20-OCT-07
Safety Alert for Medical Products for the week
ending Oct 20, 2007
Byetta (exenatide) (October 16, 2007)
FDA has reviewed 30 postmarketing reports of
acute pancreatitis in patients taking Byetta
(exenatide), a drug used to treat adults with
type 2 diabetes.
An association between Byetta and acute
pancreatitis is suspected in some of these cases.
Amylin Pharmaceuticals, Inc. has agreed to
include information about acute pancreatitis in
the PRECAUTIONS section of the product label.
(more)
6
US FDA recalls for week ending 20-OCT-07
Safety Alert for Medical Products for the week
ending Oct 20, 2007
Byetta (exenatide) (October 16, 2007)
Healthcare professionals should be alert to the
signs and symptoms of acute pancreatitis and
instruct patients taking Byetta to seek prompt
medical care if they experience unexplained,
persistent, severe abdominal pain which may or
may not be accompanied by vomiting.
If pancreatitis is suspected, Byetta should be
discontinued.
If pancreatitis is confirmed, Byetta should not
be restarted unless an alternative etiology is
identified.
7
US FDA recalls for week ending 20-OCT-07
Recall for the week ending October 20, 2007
Shain's of Maine Ice Cream issues Allergy Alert
on Undeclared Egg in Kahlua Brownie and Double
Fudge Brownie (October 17, 2007)
Shain's of Maine Ice Cream of Sanford, Maine is
recalling all quarts of Kahlua Brownie Ice cream,
all 3 gallon bulk tubs of Kahlua Brownie Ice
cream and all 3 gallon bulk tubs of Double Fudge
Brownie Ice cream, because it may contain
undeclared egg. (more)
8
US FDA recalls for week ending 20-OCT-07
Recall for the week ending October 20, 2007
Shain's of Maine Ice Cream issues Allergy Alert
on Undeclared Egg in Kahlua Brownie and Double
Fudge Brownie (October 17, 2007)
People who have an allergy of severe sensitivity
to egg run the risk of serious or life
threatening allergic reaction if they consume
these products.
Kahlua Brownie ice cream and Double Fudge Brownie
ice cream was distributed in Maine, New
Hampshire, and Massachusetts. (more)
9
US FDA recalls for week ending 20-OCT-07
Recall for the week ending October 20, 2007
Shain's of Maine Ice Cream issues Allergy Alert
on Undeclared Egg in Kahlua Brownie and Double
Fudge Brownie (October 17, 2007)
It has reached consumers through retail stores,
direct delivery and distributors.
Consumers who have purchased Shain's of Maine
Kahlua Brownie or Double Fudge Brownie Ice Cream
that are concerned of any egg allergens may
return the product to the place of purchase for a
full refund.
Contact Shain's at 1-800-324-0650.
10
US FDA recalls for week ending 20-OCT-07
FDA News for the week ending October 20, 2007
FDA announces Revisions to Labels for Cialis,
Levitra and Viagra ? Potential risk of sudden
hearing loss with ED drugs to be displayed more
prominently (October 18, 2007)
The U.S. Food and Drug Administration has
approved labeling changes for erectile
dysfunction (ED) drugs in the class that includes
Cialis, Levitra, and Viagra, to display more
prominently the potential risk of sudden hearing
loss, and to guide consumers on what to do if
they experience sudden problems with their
hearing. (more)
11
US FDA recalls for week ending 20-OCT-07
FDA News for the week ending October 20, 2007
FDA announces Revisions to Labels for Cialis,
Levitra and Viagra ? Potential risk of sudden
hearing loss with ED drugs to be displayed more
prominently (October 18, 2007)
In addition, the FDA plans to require the same
changes in labeling for the drug Revatio, also a
member of this drug class known as
phosphodiesterase type 5 (PDE5) inhibitors.
Revatio is used to treat pulmonary arterial
hypertension (PAH). (more)
12
US FDA recalls for week ending 20-OCT-07
FDA News for the week ending October 20, 2007
FDA announces Revisions to Labels for Cialis,
Levitra and Viagra ? Potential risk of sudden
hearing loss with ED drugs to be displayed more
prominently (October 18, 2007)
The FDA asked manufacturers of these drugs to
revise product labeling after a very small number
of patients taking the PDE5 inhibitors reported
sudden hearing loss, sometimes accompanied by
ringing in the ears and dizziness.
Patients taking Cialis, Levitra, or Viagra who
experience sudden hearing loss should immediately
stop taking the drug and seek prompt medical
attention. (more)
13
US FDA recalls for week ending 20-OCT-07
FDA News for the week ending October 20, 2007
FDA announces Revisions to Labels for Cialis,
Levitra and Viagra ? Potential risk of sudden
hearing loss with ED drugs to be displayed more
prominently (October 18, 2007)
Those using Revatio should continue taking their
medication but should contact their health care
provider for further evaluation.
Because Revatio is used to treat a potentially
life-threatening condition, the FDA does not
recommend patients abruptly stop taking this
medication but should consult their physician if
they experience sudden problems with their
hearing.
14
US FDA recalls for week ending 20-OCT-07
FDA Statement, Safety Alert, Recall, News for
week ending October 20, 2007
For complete details on these and other Recalls,
Market Withdrawals, and Safety Alerts including
FDA Statements and FDA News , go to
http//www.fda.gov/opacom/ 7alerts.html
For Consumer Inquiries by phone
Call 1-888-INFO-FDA