Author Archives: Alan Mader

Benzodiazepine drug use and adverse respiratory outcomes among older adults with COPD

A retrospective study conducted in the Canadian province of Ontario found an association between the use of benzodiazepines and increased risk of experiencing breathing problems in elderly patients with COPD.  In addition, this study found a 92 percent increased risk of going to the emergency room for treatment of pneumonia and COPD, and those patients were more likely to be hospitalized.


Benzodiazepine drug use and adverse respiratory outcomes among older adults with COPD, Nicholas T. Vozoris et al doi: 10.1183/09031936.00008014, ERJ April 17, 2014 erj00080-2014

Limitation of certain anti-infectives to ID service

You may already be aware of the growing menace of global antimicrobial resistance. Among the measures to control the selection pressure it was felt that certain anti-infectives should be limited to the order of ID service.

Up until this time, only two anti-infectives had such limitation, polymyxin E (COLISTIN) and fidaxomicin (DIFICID).  Several other agents will now be part of the restricted list. As you can see from the limitation list below, a number of these anti-infectives are currently non-formulary and in general are not commonly used and should therefore be reserved for specific cases.

Liposomal   AmphotericinAMBISOMEFORMULARY


We feel that this is an important and appropriate step in maintaining the current level of antimicrobial resistance that we are presently seeing at Centegra Hospitals.  We are asking for your full support in this effort.  If you have a patient that requires one or more of the drugs listed above, an ID consult will now be required.

Thank you for time and cooperation in this very important matter.

R. Damaraju, M.D. Co-Chair, Pharmacy & Therapeutics Committee
M. Hoffman, M.D. Co-Chair, Pharmacy & Therapeutics Committee

FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.


FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

Research Shows Probiotics Do Not Limit Antibiotic Associated Diarrhea or C. dif Diarrhea

Do probiotics prevent antibiotic associated diarrhea? A Welsh study published in The Lancet indicates that antibiotic-induced diarrhea is not prevented in the elderly by a daily dose of probiotics. Earlier research had shown potential, and prompted doctors to routinely prescribe antibiotics and probiotics together. The probiotic market had been estimated to reach $2.07 billion by 2015.

Approximately 10.8% of people in the probiotic group got antibiotic-associated diarrhea, compared to 10.4% of the control group. Researcher Stephen J. Allen concluded, “Our findings should discourage the use of microbial preparations for the prevention of AAD and C. difficile diarrhea.” He believes previous research showing promise was flawed because of microbial variation, small sample sizes, erroneous reporting, and poor trial designs.



Rapid tPA Treatment May Benefit Stroke Patients

Research by Saver et al published in the June 19th 2013 issue of the Journal of the American Medical Association shows that rapid treatment with a clot-dissolving drug reduces stroke patients’ risk of in-hospital death and increases their chances of being able to walk and return home when they leave the hospital. Data was reviewed from more than 58,000 patients who suffered an ischemic stroke and were treated with tissue plasminogen activator within four and a half hours of the onset of stroke symptoms. Researchers found that for every 15-minute faster start of tPA therapy, patients were less likely to die or have an intracranial hemorrhage, and were more likely to walk and be sent home when discharged from the hospital.


Saver JL, Fonarow GC, Smith EE, et al. Time to Treatment With Intravenous Tissue Plasminogen Activator and Outcome From Acute Ischemic StrokeJAMA.2013;309(23):2480-2488. doi:10.1001/jama.2013.6959.

Antibiotics That May Increase Risk Of Statin Toxicity

The Annals of Internal Medicine report of a study of more than 144,000 statin users over the age of 65 which evaluated patients who received clarithromycin or erythromycin and compared them with patients taking azithromycin. The researchers found that those patients who took erythromycin and clarithromycin with statins experienced a 26 percent increase in absolute risk for developing kidney damage compared with patients who took azithromycin with statins. The mechanism behind this interaction involves inhibition of the chytochrome P450 isoenzyme 3A4, which increases the level of statin medications in the body.


New Restricitions on Tolvaptan Use by FDA

The FDA announced new restricitions on the use of tolvaptan (SAMSCA) because of the risk of potentially fatal liver injury. The medication, which is indicated for clinically significant hypervolemic or euvolemic hyponatremia, should be used for no longer than 30 days. It should also not be used in patients with underlying liver disease, such as cirrhosis. Patients suspected of having liver injury should stop receiving tolvaptan immediately.
For more details see the FDA alert