Novo Nordisk Warns Customers About Stolen Insulin
2009年6月14日 - 2:09AM
PRニュース・ワイアー (英語)
PRINCETON, N.J., June 13 /PRNewswire-FirstCall/ -- Novo Nordisk
product previously reported as stolen in North Carolina has
resurfaced recently at a medical center in Houston. Three lots of
10 ml vials of insulin, marketed under the brand name Levemir(R)
(insulin detemir [rDNA origin] injection), were taken in the
original theft and identifiable by the following lot numbers:
XZF0036, XZF0037, XZF0038. A vial or vials of stolen insulin from
lot XZF0037 was discovered this week at a medical center in the
Houston area. Insulin from these lots did not circulate through the
normal Novo Nordisk distribution channel and therefore proper
storage conditions for the insulin may not have been followed.
Patients can locate the lot number on the side of the box of
insulin or the side of the vial. If a patient finds their insulin
is from one of the stolen lots, they should not use the insulin and
contact Novo Nordisk Customer Care Center at 1-800-727-6500 for
further information and instructions. The safety of our patients is
of paramount concern and we are working with our partners, the
pharmacy, the FDA and law enforcement authorities to investigate
the situation and take immediate steps to maintain the highest
standard of safety and quality for our products. About Levemir(R)
(insulin detemir [rDNA origin] injection) Levemir(R) is indicated
for once- or twice-daily subcutaneous administration for the
treatment of adult and pediatric patients with type 1 diabetes
mellitus or adult patients with type 2 diabetes mellitus who
require basal (long-acting) insulin for the control of
hyperglycemia. Important safety information Levemir(R) is
contraindicated in patients hypersensitive to insulin detemir or
one of its excipients. Hypoglycemia is the most common adverse
effect of all insulin therapies, including Levemir(R). As with
other insulins, the timing of hypoglycemic events may differ among
various insulin preparations. Glucose monitoring is recommended for
all patients with diabetes. Levemir(R) is not to be used in insulin
infusion pumps. Any change of insulin dose should be made
cautiously and only under medical supervision. Concomitant oral
antidiabetes treatment may require adjustment. Inadequate dosing or
discontinuation of treatment may lead to hyperglycemia and, in
patients with type 1 diabetes, diabetic ketoacidosis. Levemir(R)
should not be diluted or mixed with any other insulin preparations.
Insulin may cause sodium retention and edema, particularly if
previously poor metabolic control is improved by intensified
insulin therapy. Dose and timing of administration may need to be
adjusted to reduce the risk of hypoglycemia in patients being
switched to Levemir(R) from other intermediate or long-acting
insulin preparations. The dose of Levemir(R) may need to be
adjusted in patients with renal or hepatic impairment. Other
adverse events commonly associated with insulin therapy may include
injection site reactions (on average, 3% to 4% of patients in
clinical trials) such as lipodystrophy, redness, pain, itching,
hives, swelling, and inflammation. Less common, but more serious
are severe cases of generalized allergy, including anaphylactic
reaction, which may be life threatening. Levemir(R) is a registered
trademark of Novo Nordisk A/S. About Novo Nordisk Novo Nordisk is a
healthcare company with an 86-year history of innovation and
achievement in diabetes care. The company has the broadest diabetes
product portfolio in the industry, including the most advanced
products within the area of insulin delivery systems. In addition
to diabetes care, Novo Nordisk has a leading position within areas
such as hemostasis management, growth hormone therapy, and hormone
therapy for women. Novo Nordisk's business is driven by the Triple
Bottom Line: a commitment to social responsibility to employees and
customers, environmental soundness and economic success. With
headquarters in Denmark, Novo Nordisk employs more than 27,900
employees in 81 countries, and markets its products in 179
countries. Novo Nordisk's B shares are listed on the stock
exchanges in Copenhagen and London. Its ADRs are listed on the New
York Stock Exchange under the symbol 'NVO'. For global information,
visit novonordisk.com; for United States information, visit
novonordisk-us.com.
http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO
http://photoarchive.ap.org/ DATASOURCE: Novo Nordisk CONTACT:
Media: Sean Clements, +1-609-902-9164, or Ambre Morley,
+1-609-987-5898 Web Site: http://novonordisk-us.com/
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