Drug labeling
changes
Product: Colesevelam HCL
(Welchol for Oral Suspension)
Manufacturer: Daiichi-Sankyo
(877) 437-7763
http://dsi.com
Reason for label change: Welchol is
prescribed for blood glucose control in people with Type 2 diabetes
and to lower LDL (low-density
lipoprotein, or “bad”) cholesterol.
The FDA has recently expanded
dosing options for Welchol Oral
Suspension to allow people taking
the drug to dissolve their doses—
one 3.75-gram packet once daily or
one 1.375-gram packet twice daily—
in 4 to 8 ounces of diet soda or fruit
juice. The original guidelines stated
the drug could only be taken with
water.
Product: Humalog (insulin lispro
injection [rDNA origin])
Manufacturer: Lilly
(317) 276-2000
www.lilly.com
Reason for label change: The FDA
has issued several labeling changes
to the Humalog label: People using
Humalog in a pump can now use
the insulin in the pump’s reservoir
for up to seven days and should
change infusion sets and insertion
sites every three days. Before the
label change, both the insulin in
the reservoir and the insertion sites
needed to be replaced every two
days.
Product: Humulin R (insulin
regular) U-500
Manufacturer: Lilly
(317) 276-2000
www.lilly.com
Reason for label change: Lilly, the
manufacturer of Humulin R U-500,
changed that drug’s label to prevent confusion with Humulin R U-
100. U-500 insulin is five times as
concentrated as U-100 insulin, the
type used by most people in the
United States. U-500 vials are now
marked with a band of diagonal
brown stripes, while the U-100 vials
have no stripes. “U-500” is now also
highlighted in red on the label.
Product: Pioglitazone (Actos,
ActoPlus Met, ActoPlusMet XR,
Duetact)
Manufacturer: various
Reason for label change: The FDA
has decided that the labels for the
Type 2 diabetes drug pioglitazone
(and combination drugs that
include pioglitazone) should carry
a warning that use of the drug for
more than a year may increase a
person’s risk of developing bladder
cancer. The FDA’s 5-year interim
review of a 10-year study on the
relationship between the pioglitazone and bladder cancer found
that people taking the drug were
1. 4 times as likely to develop bladder cancer than people taking a
placebo. The new label warns of
that risk, and recommends that
people who have or have a history
of bladder cancer avoid the drug. It
also urges people taking pioglitazone to watch for symptoms of
bladder problems, such as blood in
the urine or painful urination.
Product: Rosiglitazone (Avandia,
Avandamet, Avandaryl)
Manufacturer: GlaxoSmithKline
(888) 825-5249
www.gsk.com
Reason for label change: In late
2010, the FDA announced severe
restrictions on the prescribing of
the Type 2 diabetes drug rosiglita-
zone, due to the higher risk of heart
attack associated with the drug.
These restrictions, which state that
doctors can only prescribe rosiglita-
zone if all other diabetes drugs have
failed to achieve blood glucose con-
trol, have this year been added to
the drug’s label and Medication
Guide (the paper handout that
comes with a prescription drug
when, among other reasons, the
FDA determines it carries a health
risk or side effect that people taking
it need to know about). The Med-
ication Guide also now includes
detailed information about the car-
diovascular risks involved with tak-
ing rosiglitazone.
Product: Saxagliptin (Onglyza)
Manufacturer: Bristol-Myers Squibb
(800) 332-2056
www.bms.com
AstraZeneca
(800) 236-9933
www.astrazeneca.com
Reason for label change: The FDA
approved a labeling update to
Onglyza that reflects the results of
further research on the suitability
of the drug for people with Type 2
diabetes who also have severe kidney damage or end-stage kidney
disease. Drug information for
Onglyza now includes a recommended dose that people with serious kidney problems can take
safely, but states that these people
should have their kidney function
tested before starting Onglyza and
periodically while taking the drug.
Discontinuations
Product: FreeStyle Navigator
Manufacturer: Abbott Laboratories
(800) 221-7700
www.abbottdiabetescare.com
Reason for discontinuation: Abbott
Laboratories has discontinued its
FreeStyle Navigator continuous glucose monitor in the United States
due not to safety issues with the
product, but to problems fulfilling
demand for the product and providing replacement parts under
warranty. The FreeStyle Navigator
will remain in production outside
the United States. For its US customers, the company is providing
help transitioning to other glucose
monitoring options until March
2012. Abbott recommends that
people currently using the product
call the customer support number
(above) for specific information
about available options. ■
This product update was prepared by
Alwa A. Cooper, an Assistant Editor at
Diabetes Self-Management.
