Download Drug Information Updates News from the FDA SIUE School of Pharmacy

April/March 2010
Volume 2, Issue 3
Drug Information Updates
SIUE School of
Pharmacy
Special points of interest:
News from the FDA
Ongoing safety review of high-dose Zocor (simvastatin) and
increased risk of muscle injury
The U.S. Food and Drug Administration (FDA) is informing the public and
healthcare professionals about an increased risk of muscle injury in patients
taking the highest approved dose of simvastatin 80 mg, compared to patients
taking lower doses of simvastatin and possibly other drugs in the “statin” class.
Healthcare professionals should be aware of this risk, as well as the drug-drug
interactions with simvastatin, and determine if simvastatin is clinically
appropriate for a patient. The FDA conducted a review of prescription drug use
in 2010, and found that, despite dose limitations and drug-drug interaction
precautions included in the simvastatin drug label, patients are continuing to be
prescribed higher doses of simvastatin with other medications that are known to
increase the risk for rhabdomyolysis.
> News from the FDA
> Newly Approved Drugs
> Newly Approved
Devices
> New Formulations and
Indications
> New Generic Approvals
> Drug Information
Simvastatin Dose Limitations
Question of the Month
Do not use simvastatin with: Itraconazole, ketoconazole, erythromycin,
clarithromycin, telithromycin, HIV protease inhibitors, nefazodone
Do not use more than 10mg of simvastatin with: Gemfibrozil,
cyclosporine, Danazol
Do not use more than 20mg of simvastatin with: Amiodarone, verapamil
Do not use more than 40mg of simvastatin with: Diltiazem
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo
(entacapone/carbidopa/levodopa) and possible development of Prostate Cancer
The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that may suggest that patients taking
Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In the
Stalevo Reduction in Dyskinesia Evaluation – Parkinson's Disease (STRIDE-PD) trial, a greater number of patients
taking Stavelo were observed to have prostate cancer compared to those taking carbidopa/levodopa. Other
controlled clinical trials evaluating Stavelo did not find an increased risk of prostate cancer. The FDA is still reviewing
the available information and has not concluded that Stavelo increases the risk of developing prostate cancer.
Healthcare professionals should continue to monitor patients for the development of prostate cancer as
recommended by the current prostate cancer screening guidelines.
New Generic Approvals
GENERIC
BRAND
Indomethacin injection by Bedford
Indocin IV
Diltiazem extended release tablets by Watson
Cardizem LA
Timolol maleate ophthalmic gel forming solution by Aton Pharma
Timoptic XE
Losartan (several manufacturers)
Cozaar
Losartan/Hydrochlorothiazide (several manufacturers)
Hyzaar
Page 2
Drug Information Updates
Newly Approved Drugs
Carbaglu (carglumic acid) by Recordati
Class: Carbamoyl Phosphate Synthetase 1 (CPS 1) activator
Indication: Adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic
enzyme N-acetylglutamate synthase (NAGS) and maintenance therapy for the treatment of chronic
hyperammonemia due to the deficiency of the hepatic enzyme NAGS
MOA: Acts as a replacement for NAG in NAGS deficiency patients by activating CPS 1.
Interactions: No drug interaction studies have been performed
Doses Available: 200 mg tablets
Silenor (doxepin) by Somaxon
Class: Tricyclic antidepressant
Indication: Treatment of insomnia characterized by difficulties with sleep maintenance
MOA: Blocks histamine by binding to the histamine H1 receptor with high affinity
Interactions: MAOIs, cimetidine, alcohol, CNS depressants, sedating antihistamines, tolazamide
Doses Available: 3 mg, 6 mg tablets
*** Although doxepin is used at higher doses for depression, Silenor is a low dose formulation with a new
indication for insomnia.
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid by CSL Behring
Class: Immune Globulin
Indication: Treatment of Primary Immunodeficiency (PI)
MOA: Supplies a wide spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial
and viral agents
Interactions: Misinterpretation of the results of serological testing, interfere with the response to live virus vaccines
Doses Available: 0.2 g/mL (20%) protein solution for subcutaneous injection
Asclera (polidocanol) injection by Chemische Fabrik Kreussler & Co.
Class: Sclerosing agent
Indication: Treatment of small varicose veins
MOA: Damages the cell lining of the blood vessels causing them to close and eventually be replaced by other types
of tissue
Interactions: N/A
Doses Available: N/A
Newly Approved Devices
MiniMed Paradigm REAL-Time Revel System by Medtronic
Combination insulin pump and continuous blood glucose monitoring system
Page 3
Volume 2, Issue 3
New Formulations and Indications
Xifaxan (rifaximin) by Salix
New Formulation: 550 mg tablets
Indication: Reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older
Dacogen (decitabine) injection by Eisai
New dosing regimen: 5-day dosing regimen for treatment of patients with myelodysplastic syndromes (MDS)
Trelstar (triptorelin)
New dosage form: Twice yearly 22.5 mg formulation for the treatment of advanced prostate cancer
Botox (onabotulinumtoxin A) by Allergan
Expanded indication: To treat spasicity in the flexor muscles of the elbow, wrist, and fingers in adults.
Differin (adapalene) by Galderma
New Formulation: 0.1% lotion
Zyclara (imiquimod) by Graceway Pharmaceuticals
New Formulation: 3.75% Cream
Indication: Actinic keratosis of the face and/or scalp
Recent Guideline Updates
Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of
America (IDSA)
Practice Guidelines for Clostridium difficile Infection in Adults
Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH. Clinical practice
guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of
America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31
(5):431-55.
♦
The new guidelines include more detailed recommendations and dosing than the previous guidelines from 1995.
American Cancer Society
Guideline for the Early Detection of Prostate Cancer: Update 2010
Wolf AM, Wender RC, Etzioni RB, Thompson IM, D'Amico AV, Volk RJ, et al. American Cancer Society guideline for
the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010 Mar-Apr;60(2):70-98.
♦
The guideline recommends that men have an opportunity to make an informed decision with their health care
provider about screening for prostate cancer after learning about the risks and benefits associated with prostate
cancer screening. A list of some decision aids for prostate cancer screening can be found in the guideline, and
these aids are available online through the supporting organizations.
♦
The new guideline also makes the digital rectal exam (DRE) optional and offers the option of extending the time
between screening for men with low prostate-specific antigen (PSA) levels.
SIUE School of Pharmacy
Drug Information Question of the Month
What are the Federal and Missouri state laws regarding insulin use in commercial truck
drivers?
Background: A 45 year-old truck driver has Type 2 Diabetes and his current therapy consists of Metformin,
Glyburide, and Januvia which are all at max dosages. His most recent HbA1c was 12.4%, and in order to
achieve a goal of < 7%, insulin therapy needs to be started.
A search of the Missouri Department of Transportation (MODOT) and the Federal Motor Carrier Safety
Administration (FMCSA) provided the following information.
There are many physical and emotional demands on a commercial truck driver, so each driver must be
medically cleared before they are allowed to drive. A driver is considered physically qualified if they do not have
any loss of limb, foot, or hand and do not have any impairment that would interfere with the normal operating
duties associated with being a commercial truck driver. If a driver has a clinical diagnosis, such as,
hypertension, hyperlipidemia, diabetes mellitus, or any other diagnosis that may interfere with the safe handling
of a commercial vehicle, then it is the driver’s responsibility to show that their disease status is controlled, and
they are still physically able to perform their duties. All drivers must be physically cleared by a medical
professional before they are allowed to drive. If a driver has any vision impairments, limb impairments, or insulin
treated diabetes mellitus (ITDM) then they must go through a special application process to become medically
cleared.
Intrastate commercial drivers who operate only in Missouri can apply for a Skill Performance Evaluation (SPE)
Certificate if the patient has ITDM. In order to be granted a SPE Certificate, the driver must go through an
application process through MODOT. This process consists of, but is not limited to; an exam by an
endocrinologist, optometrist, and the patient must demonstrate safe use of insulin for either 30 days (Type 2
Diabetes) or 60 days (Type 1 Diabetes) prior to the application being submitted. Also, MODOT has a maximum
of 180 days to review the application before granting a decision of approval.
Interstate commercial drivers who operate out of Missouri and pass over state lines can apply for a medical
exemption through the FMCSA. The application and requirements are similar to that of MODOT. If granted a
medical exemption, MODOT will most likely except the medical exemption and allow the driver to operate in
Missouri.
The SPE Certificate or medical exemption is generally valid for 2 years determined upon the driver meeting
certain monitoring parameters. The driver must have quarterly written confirmation from an endocrinologist
specifying the driver’s daily glucose measurements and current HbA1c, annual examination from an
endocrinologist and optometrist, and report any accident involvement or episodes relating to diabetes. The
application is renewable every 2 years.
For more information about medical exemptions or SPE Certificates pertaining to diabetes or other programs;
such as, vision impairment, limb impairment or amputation please contact either MODOT or FMCSA.
Missouri Department of Transportation
www.modot.org
1-866-831-6277
Federal Motor Carrier Safety Administration
www.fmcsa.dot.gov
(703) 448-3094
(Diabetes and Vision Program)