HEALTHLINE
September 2005
Palladone May be Fatal When Mixed With Alcohol
On July 13, 2005, the Food and Drug Administration (FDA) ordered a halt to sale of hydromorphone (Palladone) because of the way the capsule dissolves rapidly in the presence of alcohol. Palladone is designed as a slow release of hydromorphone over 24 hours. The FDA has stated that even one drink of alcohol could have fatal implications. The drug has been pulled from the market until further notice.
New Safety Warning for All Non-Steroidal Antiinflammatory Drugs (NSAIDs)
Since the recent reports of increased cardiovascular morbidity and mortality associated with nonselective (NSAID) and COX-2 selective (COX-2) non-steroidal anti-inflammatory drugs, the
Food and Drug Administration has issued letters to manufacturers requesting labeling changes for both prescription and non-prescription NSAIDs (such as ibuprofen) and COX-2s (such as
Celebrex). In addition, manufacturers of non-prescription NSAIDs are being asked to remind patients of the limited dose and duration of treatment of their products in accordance with the package instructions.
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
TRADENAME is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
New Safety Warning for all Atypical Antipsychotic Medications
Earlier this year, the Food and Drug Administration determined that the treatment of behavioral disorders in elderly persons with dementia with atypical antipsychotic medications is associated with increased mortality following evaluation of well-conducted, placebo-controlled trials. As a result, new language has been added to the package insert of all atypical antipsychotic medications.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients.
Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular
(e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature. TRADENAME is not approved for the treatment of patients with Dementia-Related Psychosis.
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HEALTHLINE
September 2005
Aging in the mental retardation/developmentally disabled (MR/DD) population was barely on the radar screen of scientists, clinicians, or policy analysts as recently as 20 years ago because
MR/DD was seen primarily as a pediatric diagnosis. For many years, an emphasis has been placed on its developmental course in these patients during the early childhood period. It is now well recognized that developmental disabilities last a lifetime and that the aging process is as relevant to this population as it is to society at large. A primary precept of patient care is that therapy must be tailored to the specific medical needs of the patient with the MR/DD population being no different.
Osteoporosis /Fracture Prevention
A significant portion of this population is non-ambulatory and is at risk for the under-recognition and under-treatment of osteoporosis. Additionally, because individuals with developmental disabilities commonly receive antiepileptic medication, which can induce bone loss, they are at increased risk for osteoporosis. Bone density screenings can be conducted to reveal bone loss in this suspected population. Several studies have shown a relationship between the prevalence of osteoporosis and individuals with Down syndrome and developmental disabilities.
Multiple studies have documented the presence of osteoporosis and osteopenia in the MR/DD population, the majority of which was undiagnosed prior to BMD screening. Many factors contribute to bone loss in this population. Recommended assessments include a bone mineral density assessment (DEXA). Prevention and treatment options include proper calcium and vitamin D intake or supplementation and a bisphosphonate such as Actonel.
1
Early Dementia/Alzheimer’s Disease
Down syndrome has captured a great deal of interest among researchers concerned about aging in individuals with MR/DD because of the increased risk and earlier onset of dementia in this population.
2 Investigators have sought to identify risk factors that explain why some older adults with Down syndrome develop clinical symptoms of dementia whereas others do not.
The management of dementia in Alzheimer's disease has dramatically changed since the development of anti-dementia drugs. However, the information available for treating the intellectually disabled population is limited to adults with Down syndrome. A review by Prasher highlights the important pharmacological and clinical aspects of donepezil, rivastigmine, galantamine and memantine and supports the view that such drugs play an important part in the management of dementia in adults with intellectual disability.
3
Prevalence rates for dementia among individuals with Down syndrome are higher when compared to those who do not have Down syndrome. Alzheimer-type dementia was the most frequent diagnosis. With the occurrence of dementia expected to rise proportionately with the increase of longevity among adults with intellectual disabilities, care systems will have to raise the
“index of suspicion” among staff and families, become “dementia capable,” and improve their diagnostic and technical resources, as well as their care management supports designed to prolong the “aging in place” of adults affected by dementia.
4
Response to donepezil in patients with Down syndrome and Alzheimer’s disease was reported in a study published by the Archives of Neurology in 2002. The authors concluded that acetylcholinesterase inhibitors might be helpful in reversing the symptoms of dementia during early and middle stages of cognitive decline in this patient type.
5
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HEALTHLINE
September 2005
An overview of Alzheimer’s disease in Down syndrome can be found at the following web address: http://www.emedicine.com/neuro/topic552.htm#top
Hyperlipidemia and Stroke Prevention
While the literature is vague regarding lipid disorders and stroke prevention in the MR/DD population, many of these individuals may benefit from optimizing therapy for these disorders due to abnormalities of metabolic regulation that are seen in this patient population.
There is no reason to believe that the residents with MR/DD should not be assessed and treated according the NCEP/ATP III guidelines.
Adults with mental retardation have cardiovascular risk profiles similar to those of individuals without mental retardation.
6 Individuals with MR/DD may exhibit elevated cholesterol concentrations and should be treated according to ATP/NCEPIII guidelines. This holds especially true if the individual also has a diagnosis or risk factor for diabetes, stroke or cardiovascular disease. HMG CoA reductase inhibitors such as Lipitor are both safe and effective in optimizing cholesterol control.
Pain Management
The assessment of pain in a person with an intellectual disability (ID) is often a difficult undertaking complicated by idiosyncratic reactions or vague descriptions. The person with an ID may also be unable to communicate their discomfort. For the caregiver who knows the individual with an ID, knowing how they respond to painful stimuli assists in the detection of new instances of pain. Cues such as moaning during manipulations, crying during manipulation, not using affected body part, and moving the body in a specific way have been used appropriately to assess for pain.
7 The Wong-Baker FACES Pain Rating Scale may be a useful assessment tool for pain in certain individuals with MR/DD.
The initial treatment of pain should include agents such as acetaminophen, nonacetylated salicylates, celecoxib, or tramadol. If pain is not resolved, opioid analgesics should be considered. However, doses should be initiated at the lowest effective dose and gradually increased depending on response. Frequent monitoring for effect and adverse outcomes should also be performed. If a daily opioid is needed, routine assessment of bowel function and use of a bowel regimen is recommended to prevent constipation.
Persons with developmental disabilities are at risk of chronic health problems due to existing conditions, drug-induced abnormalities, age and immobility. Health quality can be improved by detection and correction of medication misuse, overuse and underuse.
1. Center J, Beange H, McElduff A.People with mental retardation have an increased prevalence of osteoporosis: a population study. Am J Ment Retard. 1998 Jul;103(1):19-28.
2. American Association of Clinical Endocrinologists Osteoporosis Task Force. American Association of Clinical
Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis:
2001 edition, with selected updates for 2003. Endocrine Prac 2003;9:544-64.
3. Janicki MP, Dalton AJ, Prevalence of dementia and impact on intellectual disability services. Ment Retard 2000
38(3):276-288.
4. Prasher VP.Review of donepezil, rivastigmine, galantamine and memantine for the treatment of dementia in
Alzheimer's disease in adults with Down syndrome: implications for the intellectual disability population. Int J Geriatr
Psychiatry. 2004 Jun;19(6):509-15.
5. Prasher VP, Huxley A, Haque MS. Down syndrome Aging Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Down syndrome and Alzheimer's disease--pilot study. Int J Geriatr Psychiatry. 2002
Mar;17(3):270-8.
6. Rimmer JH, Braddock D, Fujiura G. Cardiovascular risk factor levels in adults with mental retardation. Am J Ment
Retard. 1994 Jan;98(4):510-8.
7. Zwakhalen SM, van Dongen KA, Hamers JP, Abu-Saad HH. Pain assessment in intellectually disabled people: nonverbal indicators. J Adv Nurs. 2004 Feb;45(3):236-45
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HEALTHLINE
September 2005
Karen Burton, R. Ph., GCP, FASCP
Mark Coggins, Pharm. D., GCP, FASCP
Kelly Hollenack, Pharm. D. CGP
Philip King, Pharm. D., GCP, FASCP
Susan Kleim, B.S., Pharm., GCP, FASCP
Terry O’Shea, Pharm. D., GCP, FASCP
Elmer Schmidt, Pharm. D., GCP, FASCP
Barbara J. Zarowitz, Pharm. D., GCP, FASCP
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