http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01261.html

T03-75
November 14, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


FDA Alerts U.S. Residents to Recall of Glaxo Smith Kline "Diskus" Asthma
Medicines Sold in Canada

As a precaution, the Food and Drug Administration (FDA) is alerting U.S.
residents to the recent recall of certain GlaxoSmithKline “Diskus”
medicines sold in Canada to treat asthma and chronic obstructive pulmonary
disease (COPD). The three asthma products – Ventolin Diskus, Flovent Diskus,
and Serevent Diskus -- were recalled in Canada November 12th, 2003, because the
products’ drug delivery system may not function properly and may deliver too
little of the drug – or none at all. Canadian patients are being advised to
return the affected product to the pharmacy or physician’s office where it
was obtained in order to get a replacement.

FDA emphasizes that FDA-approved Diskus products (Advair and Serevent) sold in
the U.S. through legitimate marketing channels are not subject to this recall.
But because some U.S. residents have obtained precription drugs from Canada and
elsewhere through on-line or storefront operations, they may have received
these potentially substandard and ineffective products.

The specific affected lots of the products recalled in Canada, and additional
information from the product manufacturer, are available on the Canadian
website of GlaxoSmithKline at
http://www.gsk.ca/en/media_room/news/public_advisory_en.pdf

U.S. patients who may have obtained these affected medications from Canada who
have questions or concerns about these products should discuss them with their
physician, pharmacist, or health care provider. Consumers and Healthcare
professionals have been asked to report any suspected adverse events associated
with the use of these products directly to GSK or Health Canada using the
following contact information:

GlaxoSmithKline Inc.
7333 Mississauga road N
Mississauga, Ontario
L5N 6L4
Telephone: 1-800-387-7374

Canadian Adverse Reacton Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201c2
Ottawa, Ontario K1A 1B9
Toll free phone: 1-866-234-2345
Toll free fax: 1-866-678-6789
cadrmp@hs-sc.gc.ca

FDA reminds patients that asthma, COPD and related diseases can be serious and
life-threatening. No one taking medications for these conditions should stop
taking them abruptly without first talking to their physicians. FDA also
emphasizes that all asthma drugs should be given as part of a comprehensive
treatment plan that takes into account the patient’s disease severity and
fully educates patients about the disease and its proper treatment.

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