February 2013
IMPORTANT DRUG INFORMATION
Subject: Affymax and
Takeda are instituting a voluntary product recall of OMONTYS following serious
hypersensitivity reactions, including life threatening and fatal events,
reported in patients receiving OMONTYS
Dear
Healthcare Provider:
The
purpose of this letter is to inform you to cease use of OMONTYS products in all
patients at this time. All OMONTYS
in your control should be quarantined until you receive further instructions on
product returns. Any patients who have been given OMONTYS for home use should
be immediately contacted and instructed to stop use of the product and to
return the product to your facility.
This
recall has been initiated due to postmarketing reports of serious
hypersensitivity reactions in patients who received OMONTYS. Use of OMONTYS may result in serious
hypersensitivity reactions including anaphylaxis, which may be life-threatening
or fatal.
To
date, fatal reactions have been reported in approximately 0.02% of patients
following the first dose of intravenous administration. The reported serious
hypersensitivity reactions have occurred within 30 minutes after such
administration of OMONTYS. There have been no reports of such reactions
following subsequent dosing, or in patients who have completed their dialysis
session. Since launch, more than
25,000 patients have received OMONTYS in the postmarketing setting. The rate of overall hypersensitivity
reactions reported is approximately 0.2% with approximately a third of these
being serious in nature including anaphylaxis requiring prompt medical intervention
and in some cases hospitalization.
No
new or existing patients should receive OMONTYS. Patients returning to the clinic for
future dosing should not receive OMONTYS and be converted to an alternative
therapy as per your local clinical practice guidelines.
Should
any patient that has already been dosed with OMONTYS present with
hypersensitivity reactions, symptoms may respond to intravenous fluids,
corticosteroids, epinephrine, and/or antihistamines.
Reporting
Adverse Events
To
report all adverse events suspected with the use of OMONTYS contact:
- Affymax at 1-855-466-6689 [9:00 am to
5:00 pm Eastern Standard Time, Monday through Friday].
Adverse
reactions or quality problems experienced with the use of this product may also
be reported to the FDA's MedWatch Adverse Event Reporting program either
online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid,
pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on
the pre-addressed form.
- Fax: 1-800-FDA-0178
This
voluntary recall is being conducted with the knowledge of the Food and Drug
Administration.
Further
instructions on product returns will be provided in a further communication.
Sincerely,
Anne-Marie Duliege, M.D.,
M.S.
Chief Medical Officer
Affymax, Inc.