Drug Safety Information
Drugs to Avoid in the Elderly
Gateway Health Plan® has initiated a quality improvement activity to evaluate the medication profiles of our Medicare Assured® members who are at least 65 years old and are taking at least one of the most frequently used drugs that are deemed to be potentially harmful to an elderly patient according to the Beers List. The Beers criteria are based on expert consensus developed through an extensive literature review with a bibliography and questionnaire evaluated by nationally recognized experts in geriatric care, clinical pharmacology, and psychopharmacology.
Network physicians may receive a letter informing them that a Gateway Health Plan® patient under his or her care is receiving a potentially harmful medication based upon the above criteria. We ask that the physician evaluate this therapy to determine if there are safer alternatives considering the member's age and medical condition.
A copy of the Beers List can be obtained at http://www.dcri.duke.edu/ccge/curtis/beers.html Please take some time to review any opportunities to apply the Beers Criteria to applicable patients as this may decrease the possibility of potential drug related adverse reactions in the elderly.
The following list provides the rationale why specific medications are on the Beers List and alternative medications that can be prescribed.
Beers List Alternatives
| Frequently Used Medications On The Beers List |
Beers Rationale |
Alternative Medication Recommendations |
| Propoxyphene Containing Products |
Offers few analgesic advantages over Acetaminophen, yet exhibits adverse effects of other narcotic drugs, including fall risk |
Acetaminophen w/o Codeine, Morphine |
| Meperidine |
Not an effective oral analgesic in doses commonly used. May cause confusion and is highly recognized for possibility of seizures |
Morphine, Codeine and Fentanyl patches |
Indomethacin
Naproxen
Piroxicam
Ketorolac |
Of all the NSAID's available, these cause the most CNS adverse effects |
Ibuprofen, Diclofenac |
Amitriptyline
Doxepin
Fluoxetine |
Its strong anticholinergic and sedation properties make this a poor choice of antidepressants for the elderly |
Remeron, Celexa, Zoloft, or other TCA's such as Desipramine or Nortriptyline. |
Flurazepam*
Diazepam*
Clorazepate*
Chlordiazepoxide* |
These drugs have reduced clearance and therefore longer half lives. Sedation and increased risk of falls are problematic in the elderly. Shorter acting benzodiazepines are preferred |
Lorazepam*, Temazepam*, Clonazepam* |
| Fluoxetine |
Long half life of near 2 weeks produces excessive CNS stimulation, sleep disturbances and increased agitation |
Shorter acting SSRI's: Citalopram, Paroxetine, Sertraline |
| Clonidine |
Potential for orthostatic hypotension and CNS side effects |
Dependent on clinical scenario and comorbidities but may include: ACE-inhibitors, Ca++ channel blockers, Beta-blockers and ARB's |
| Short Acting Nifedipine |
Potential for hypotension and constipation |
Longer acting Nifedipine, Felodipine or Amlodipine |
Hydroxyzine
Diphenhydramine
Cyproheptadine
Dexchlorpheniramine
Promethazine |
Nonprescription and many prescription antihistamines have potent anticholinergic properties |
Fexofenadine, Loratadine |
| Digoxin |
Decreased renal clearance leads to toxic effects and narrow therapeutic window |
Periodic Digoxin Serum levels to ensure appropriateness of dose. Also specific renal testing as a monitoring tool. |
| Ticlopidine |
Has been shown to be no better then aspirin in preventing clotting and may be considerably more toxic |
ASA, Clopidogrel |
| Cimetidine |
CNS effects including confusion |
Ranitidine* |
| Desiccated Thyroid |
Concerns about cardiac effects |
Levothyroxine without T3 component |
| Meprobamate |
Highly addictive and sedating |
Buspirone |
| Thioridazine |
Greater potential for CNS and extrapyramidal side effects |
Abilify, Geodon, Zyprexa, Prolixin |
| Amphetamines |
Potential for dependence, angina, hypertension, and MI |
Strattera |
| All barbituates except Phenobarbital |
Highly addictive and causes more adverse effects than most sedatives or hypnotic drugs |
Phenobarbital* |
| Dicyclomine, Propantheline |
Highly anticholinergic, uncertain effectiveness |
No preferred agents |
| Atropine, Hyoscyamine, Scopolamine |
Strongly anticholinergic |
Paregoric |
| Soma, Flexeril, Skelaxin, Robaxin, Norflex |
Poorly tolerated in elderly, anticholinergic effects, sedation and weakness |
Baclofen, Dantrium |
| Oral estradiol, estrogen |
No cardioprotective effect. Risk of breast/endometrial cancer |
No preferred agents |
| Chlorpropamide |
Prolonged half life in elderly, prolonged hypoglycemia. |
Glyburide, Glipizide |
| Dipyridamole, Isoxsuprine, Cyclandelate |
May cause orthostatic hypotension |
Hydralazine, minoxidil |
| Nitrofurantoin |
May cause renal impairment |
Trimethoprim, Methenamine mandalate |
| Methyltestosterones |
Potential for prostatic hypertrophy and cardiac problems |
Danazol |
* Not Covered under Medicare Part D
References:
Fick DM et al. Updating the Beers criteria for potentially inappropriate use in older adults: Results of a consensus panel of experts. Archives of internal medicine. 2003 Dec 8-22;163(22):2716-24, American Medical Association.
http://prodruginfo.com/Formulary/MedicationSafety/beers%20list%203.pdf
Black Box Warnings
Drug Safety Warnings
| Date Released |
Drug (s) Involved |
Additional Information |
| November 12, 2008 |
Fosamax,
Fosamax Plus D (alendronate),
Didronel (etidronate),
Boniva (ibandronate),
Aredia (pamidronate),
Actonel,
Actonel w/ Calcium(risedronate),
Skelid (tiludronate),
and Reclast,
Zometa (zoledronic acid) |
www.fda.gov/cder/drug/early_comm/bisphosphonates_update_200811.htm |
| October 17, 2008 |
Raptiva (efalizumab) |
www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html |
| October 7, 2008 |
Spiriva Handihaler (tiotropium) |
www.fda.gov/cder/drug/early_comm/tiotropium.htm |
| September 26, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/cder/drug/early_comm/epoetin_alfa.htm |
| September 12, 2008 |
Tarceva (erlotinib) |
www.fda.gov/medwatch/safety/2008/tarceva_dhcp_letter.pdf |
| September 11, 2008 |
Rituxan (rituximab) |
www.fda.gov/medwatch/safety/2008/rituxan_DHCP_Final%209411700.pdf |
| September 4, 2008 |
Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) |
www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm |
| August 26, 2008 |
Tysabri (natalizumab) |
www.fda.gov/cder/drug/InfoSheets/HCP/natalizumab2008HCP.htm |
| August 21, 2008 |
Zocor (simvastatin), Vytorin (ezetimibe/simvastatin), Zetia (ezetimibe) |
www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm |
| August 18, 2008 |
Byetta (exenatide) |
www.fda.gov/cder/drug/InfoSheets/HCP/exenatide2008HCP.htm |
| August 12, 2008 |
Vivitrol (naltrexone) |
www.fda.gov/cder/drug/InfoSheets/HCP/naltrexoneHCP.htm |
| August 8, 2008 |
Zocor (simvastatin) or Vytorin (ezetimibe/simvastatin) used with Cordarone/Paceerone (amiodarone) |
www.fda.gov/cder/drug/InfoSheets/HCP/simvastatin_amiodaroneHCP.htm |
| August 7, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/medwatch/safety/2008/ESA_DHCP_Aug2008.pdf |
| July 29, 2008 |
Novantrone (mitoxantrone hydrochloride) |
www.fda.gov/cder/drug/InfoSheets/HCP/mitroxantroneHCP.htm |
| July 24, 2008 |
Ziagen (abacavir) |
www.fda.gov/cder/drug/InfoSheets/HCP/abacavirHCP.htm |
| July 11, 2008 |
Avastin (bevacizumab) in combination with sunitinib malate |
www.fda.gov/medwatch/safety/2008/MAHA_DHCP.pdf |
| July 8, 2008 |
Fluoroquinolone Antimicrobial Drugs |
www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm |
| July 30, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid) |
www.fda.gov/medwatch/safety/2008/Myfortic_DHCP_june2008.pdf |
| June 16, 2008 |
Conventional and Atypical Antipsychotic use in Elderly patients treated for dementia-related psychosis |
www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm |
| June 3, 2008 |
Tumor Necrosis Factor (TNF) Blockers (Remicade, Enbrel, Humira, Cimzia) |
www.fda.gov/cder/drug/early_comm/TNF_blockers.htm |
| May 16, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid)
|
www.fda.gov/cder/drug/InfoSheets/HCP/mycophelolateHCP.htm |
| April 10, 2008 |
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid) |
www.fda.gov/cder/drug/early_comm/mycophenolate.htm |
| April 9, 2008 |
Exubera (insulin human rDNA origin) Inhalation Powder |
www.fda.gov/medwatch/safety/2008/Exubera_DHCP.pdf |
| April 1, 2008 |
Relenza (zanamivir) |
www.fda.gov/medwatch/safety/2008/relenza_DHCP.pdf |
| March 27, 2008 |
Ziagen (abacavir) and Videx (Didanosine) |
www.fda.gov/cder/drug/early_comm/abacavir.htm |
| March 27, 2008 |
Regranex (becaplermin) Gel |
www.fda.gov/cder/drug/early_comm/becaplermin.htm |
| March 27, 2008 |
Singulair (montelukast) |
www.fda.gov/cder/drug/early_comm/montelukast.htm |
| March 18, 2008 |
Spiriva (tiotropium) |
www.fda.gov/cder/drug/early_comm/tiotropium.htm |
| March 12, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
www.fda.gov/medwatch/safety/2008/epo_DHCP_03102008.pdf |
| March 12, 2008 |
Prezista (darunavir) |
www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf |
| March 11, 2008 |
Tussionex Pennkinetic (Chlorpheniramine/ Hydrocodone Extended-Release Suspension) |
www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html |
| March 4, 2008 |
Tamiflu (oseltamivir phosphate) |
www.fda.gov/medwatch/safety/2008/Tamiflu_DHCP.pdf |
| February 29, 2008 |
Spiriva (tiotropium bromide inhalation powder)
Foradil (formoterol fumarate inhalation powder) |
www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm |
| February 27, 2008 |
Tysabri (natalizumab) |
www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf |
| February 26, 2008 |
Avandia (rosiglitazone maleate) Medication Guide |
www.fda.gov/cder/Offices/ODS/MG/Avandia_MG.pdf |
| February 8, 2008 |
Botox (botulinum toxin type A)
Myobloc (botulinum toxin type B) |
www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm |
| February 1, 2008 |
Chantix (varenicline) |
www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm |
| January 31, 2008 |
Antiepileptic Medications |
http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm |
| January 25, 2008 |
Zetia (ezetimibe)
Vytorin (ezetimibe/ simvastatin) |
http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm |
| January 18, 2008 |
Ortho Evra Transdermal Patch (ethinyl estradiol /norelgestromin) |
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html |
| January 17, 2008 |
Nonprescription Cough and Cold Medicine Use in Children |
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm |
| January 16, 2008 |
Endrate (edetate disodium) |
http://www.fda.gov/cder/drug/advisory/edetate_disodium.htm |
| January 7, 2008 |
Actonel (risedronate)
Fosamax (alendronate)
Boniva (ibandronate) |
http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm |
| January 3, 2008 |
Aranesp (darbepoetin alfa)
Epogen (epoetin alfa)
Procrit (epoetin alfa) |
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01769.html |
| December 21, 2007 |
Duragesic (fentanyl transdermal system) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.htm |
| December 12, 2007 |
Tegretol, Carbatrol (carbamazepine) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm |
| December 4, 2007 |
DDAVP (Desmopressin Acetate) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm |
| November 27, 2007 |
Myfortic (mycophenolic acid) |
http://www.fda.gov/medwatch/safety/2007/Myfortic_DHCP_Letter.pdf |
| November 20, 2007 |
Chantix (varenicline) |
http://www.fda.gov/cder/drug/early_comm/varenicline.htm |
| November 14, 2007 |
Revatio (sildenafil) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/ED_HCP.htm |
| October 24, 2007 |
Provigil (modafinil) |
http://www.fda.gov/medwatch/safety/2007/Provigil_dhcpletter091207_final.pdf |
| October 18, 2007 |
Revatio (sildenafil) |
http://www.fda.gov/cder/consumerinfo/viagra/default.htm |
| October 16, 2007 |
Byetta (exenatide) |
http://www.fda.gov/cder/drug/infopage/exenatide/default.htm |
| October 1, 2007 |
Bisphosphonates |
http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm |
| September 28, 2007 |
Unapproved Hydrocodone Products |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html |
| September 26, 2007 |
Fentora (fentanyl buccal tablets) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_buccal.htm |
| September 17, 2007 |
Haldol (haloperidol) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm |
| September 10, 2007 |
Viracept (nelfinavir) |
http://www.fda.gov/medwatch/safety/2007/VIRACEPT_HCPLetter_9_10_07.pdf |
| August 17, 2007 |
Codeine Products Used by Nursing Mothers |
http://www.fda.gov/cder/drug/infopage/codeine/default.htm |
| August 16, 2007 |
Coumadin (warfarin) |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html |
| August 15, 2007 |
Nonprescription Cough and Cold Medicine Use in Children |
http://www.fda.gov/cder/drug/advisory/cough_cold.htm |
| August 6, 2007 |
Kaletra (lopinavir/ritonavir) Oral Solution |
http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf |
| July 5, 2007 |
Rocephin (ceftriaxone) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/ceftriaxone.htm |
| May 14, 2007 |
Exjade (deferasirox) |
http://www.fda.gov/medwatch/safety/2007/Exjade_DHCPL_May2007.pdf |
| March 16, 2007 |
Zyvox (linezolid) |
http://www.fda.gov/cder/drug/infopage/linezolid/default.htm |
| March 14, 2007 |
Sedative/Hypnotic Medications |
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html |
| March 9, 2007 |
Actimmune (interferon gamma 1b) |
http://www.fda.gov/cder/drug/InfoSheets/HCP/interferon_gamma1bHCP.pdf |
| January 24, 2007 |
Lucentis (ranibizumab) |
http://www.fda.gov/medwatch/safety/2007/Lucentis_DHCP_01-24-2007.pdf |
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Medicare Assured® 2008 |
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