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Microsoft powerpoint - fda 2012 latest news for diabetes & endocrinology. medscape 2012
The US Food and Drug Administration (FDA) has approved
labeling changes to the entire statin class
. These clarifications
include but are not limited to:
• Use may be associated with hyperglycemia and elevated A1c;
• Use may be associated with the potential for cognitive adverse
• Periodic monitoring of liver function tests is no longer required.
Lovastatin labeling was revised to include contraindications and
dose limitations for certain drug interactions which can increase
drug exposure and subsequent risk for rhabdomyolysis.
Lovastatin is contraindicated with strong cytochrome (CYP) 3A4
inhibitors, such as clarithromycin and ketoconazole. Daily doses
should not exceed 20 mg with diltiazem, verapamil, and danazol.
Daily doses should not exceed 40 mg with amiodarone.
Photo courtesy of Thinkstock/Getty
For more information, see FDA Adds Warnings to Statin Label.
(Korlym™, Corcept Therapeutics Incorporated,
Menlo Park, California) was approved to manage hyperglycemia
in patients with endogenous Cushing's syndrome and type 2
diabetes mellitus or glucose intolerance who are not candidates
for surgery or in whom surgical treatment has failed. This
cortisol receptor blocker has potent antiprogestational properties
and should never be used in pregnant women due to risk for
. Pregnancy must be excluded in women
of reproductive age prior to initiation of therapy or if treatment is
interrupted for more than 14 days. The manufacturer will
distribute Korlym through a central pharmacy; retail pharmacies
are unlikely to supply this drug adequately due to the rare nature
of the condition.
For more information, see Mifepristone Okayed for Adults With
The FDA has approved a once-weekly, extended-release
formulation of exenatide injection (Bydureon
Pharmaceuticals, Inc., San Diego, California). This
glucagon-like peptide-1 receptor agonist is indicated as
an adjunct to diet and exercise in adult patients with type
2 diabetes mellitus (DM) and is administered
subcutaneously once every 7 days. Bydureon is not
recommended as first-line therapy and should not be used
to treat type 1 DM or diabetic ketoacidosis. Use with
insulin and in patients with a history of pancreatitis is not
recommended. A Risk Evaluation and Mitigation
Strategy (REMS) is required with Bydureon to help
ensure that the benefits outweigh the risks for medullary
thyroid carcinoma and acute pancreatitis. Insulin de
For more information, see Once-Weekly Exenatide
Okayed by FDA for T2DM After Long Look.
The FDA changed the pregnancy category for insulin detemir
(rDNA origin) injection (Levemir®, NovoNordisk A/S,
Bagsvaerd, Denmark ) from C to B. No increased fetal risk
was found in a randomized controlled trial of pregnant women
with type 1 diabetes mellitus who were taking Levemir during
For more information, see Levemir Assigned More Reassuring
Pregnancy Risk Category.
The FDA approved a combination of the dipeptidyl
peptidase-4 (DPP-4) inhibitor linagliptin and
metformin hydrochloride (Jentadueto™,
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield,
Connecticut; and Eli Lilly and Company, Indianapolis,
Indiana) as an adjunct to diet and exercise in adult
patients with type 2 DM. Jentadueto should be given
twice daily with meals, using slow dose escalation to
decrease the adverse gastrointestinal effects associated
with metformin. Jentadueto should not be used for type
1 DM or diabetic ketoacidosis, and use has not been
evaluated in combination with insulin. Labeling
contains a black box warning about the risk for lactic
acidosis associated with metformin accumulation.
For more information, see Combination Type 2
Diabetes Pill Gets FDA Nod.
Once-daily Janumet® XR
(Merck & Co., Inc, Whitehouse
Station, New Jersey) was approved by the FDA for adjunct
management of type 2 DM in combination with diet and
exercise in adults. Janumet XR is the combination of the DPP-4
inhibitor sitagliptin and extended-release metformin. Janumet
XR is not indicated for type 1 DM or diabetic ketoacidosis and
has not been evaluated in patients with a history of pancreatitis.
To decrease the adverse gastrointestinal effects of metformin,
administration with the evening meal is preferred, and dosing
should be gradually escalated. Labeling contains a black box
warning regarding the risk for lactic acidosis associated with
metformin accumulation. Decrease of insulin or insulin
secretagogue (eg, sulfonylurea) dose requirements may be
needed with concomitant use of Janumet XR to minimize risk
For more information, see FDA Approves Once-A-Day Drug
for Type 2 Diabetes.
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