2010-04-12
In collaboration with the Food and Drug
Administration (FDA), and as a service to our members, ASH provides information
about newly approved therapies or other important information for patients.
This allows the agency to inform hematologists and professionals in
hematology-related fields of recent approvals in a timely manner. In providing
this information, ASH does not endorse any product or therapy and does not take
any position on the safety or efficacy of the product or therapy described. The
following is a message from the FDA’s Office of Oncology Drug Products.
Lundbeck
Inc., the sole worldwide manufacturer of Mustargen® (mechlorethamine
HCl for injection), has informed the FDA that there will be an extended supply
shortage of this drug.
A limited supply
of Mustargen is expected to be available starting in mid/late April, and will
be distributed by Lundbeck Inc. to meet current patient needs, with priority
given to sites with patients currently receiving Mustargen. Once this limited
supply is exhausted, a shortage is anticipated until early 2011. Pharmacies and
physicians’ offices will need to call their distributor/wholesaler to obtain
Mustargen on a drop ship basis only in order
to meet patient needs when the drug product is released in mid/late April. Given
the expected shortage, alternative treatment plans should be made for new
patients to avoid interruption to a treatment program that would normally
include Mustargen. The FDA has searched but is unaware of any other supplies of
mechlorethamine HCl available from any other sources at this time.
Attached
please find a letter from the manufacturer, Lundbeck Inc., concerning the
shortage: www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM207369.pdf
Questions
about the shortage can be directed to Drugshortages@fda.hhs.gov.
Health-care
professionals should report all serious adverse events suspected to be
associated with the use of any medicine and device to FDA’s MedWatch Reporting System
by completing a form online at www.fda.gov/medwatch/report.htm,
faxing (1-800-FDA-0178), mailing the postage-paid address form provided online,
or by telephone (1-800-FDA-1088).
back to top
