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When caring for a loved one who suffers from Alzheimer's disease, the complications associated with mental and emotional health can be overwhelming for many families. From depression to extreme episodes of exhilaration and happiness, many Alzheimer's patients are simply unable to control their emotions as they once did.
A behavior that is quite common among Alzheimer's patients is commonly referred to as agitation outbursts. Symptomatically, agitation encompasses a complication wherein the Alzheimer's patient will scream, shout, pace back and forth, and curse for unknown reasons. Often, it is the agitation outburst episodes of the Alzheimer's patient that result in the most frustration for friends and loved ones.
While commonly believed to be associated to the side effect of medication administered to the Alzheimer's patient, agitation outbursts can result from any event that is deemed frightening or stressful to the Alzheimer's patient. Such agitating events might include moving to a new home, changing of caregivers or just a simple change to the dynamics and arrangement of the home in which the Alzheimer's patient lives.
When agitation in the Alzheimer's patient is related to an event or change in lifestyle, usually the episodes of outburst will dwindle with time. However, when the complication is persistent and related to a side effect of medication, it is important to speak with a health care professional to determine what, if any, treatment can be provided to alleviate the complication and frequency of agitation outbursts in the home.
When in the middle of an outburst, families and caregivers can learn simple techniques to alleviate agitation in the Alzheimer's patient. For example, re-directing their attention to another object, offering re-assurance, and using calming and positive reinforcement speech are all ways in which the agitation outbursts can be diminished.
While some medications can be used to manage agitation, your healthcare professional will need to take great care in prescribing additional medications so as to avoid other side effects or contraindications. Most commonly, however, the physician may want to use drugs such as Zyprexa, Seroquel or Risperdal to quell or subside the frequency of agitation outbursts in your loved one.
Creating a relaxing and stress free environment is the best way in which to reduce the agitation outbursts in the Alzheimer's patient. Avoiding the movement of furniture, loud sounds and changes in lighting are all measures you can take to create that environment that is so desperately needed by the Alzheimer's patient and, ultimately, create an environment where agitation and outbursts are less frequent.
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The Federal Drug Administration on Friday issued a warning to doctors that adolescents taking the drug olanzapine have an "increased potential" — in comparison with adults taking the new-generation antipsychotic drug — for weight gain and metabolic disturbances that could result in diabetes or elevated blood cholesterol levels.
"Clinicians should consider the potential long-term risks when prescribing to adolescents," the FDA said in a statement released Friday night. "In many cases, this may lead to prescribe other drugs first," the statement went on.
The agency has not approved the marketing of olanzapine — sold under the commercial name Zyprexa by the drug maker Eli Lilly — for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the "atypical antipsychotics," is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.
The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels — all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs — Seroquel and Risperdal — were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.
The FDA said that in cases where physicians opt to prescribe olanzapine, the drug should be part of a "comprehensive treatment program," which could include psychological, educational and social counseling as well as medication therapy.
–Melissa Healy
Johnson & Johnson (JNJ) shares are rebounding today, up nearly 1.5% to $65.51. The drugmaker is trying to recover from a rough week, when the Justice Department charged it with paying kickbacks to a pharmacy company to boost sales of its drugs to nursing-home patients, and the Food and Drug Administration accused it of being too slow with its product recall during a Tylenol scare.
Late last year, J&J, based in New Brunswick, N.J., expanded its recall of its top-selling Tylenol line, which sold at least $1 billion in the U.S. last year. The incident echoes an unsolved 1982 crime in which seven Chicago-area Tylenol consumers died after using tampered Tylenol laced with cyanide. Johnson & Johnson's quick, decisive response to the incident earned plaudits and sparked reforms in packaging over-the-counter drugs. The current recalls began in September, expanded in late December, and then expanded again last week to include more batches and other brands.
Voluntary Recall
The issue at hand is an unusual moldy, musty, or mildewy odor in the drugs caused by small amounts of a chemical associated with the treatment of wooden pallets. Users who reported the smell complained of nausea, stomach pain, vomiting, and diarrhea.
Despite a voluntary recall, J&J's McNeil Consumer Healthcare Products got a stern warning from the FDA for manufacturing-standards violations and for failing to report and investigate the problem quickly. Timothy Calkins, a marketing professor at Northwestern University's Kellogg School of Management, told The New York Times that the FDA's criticisms “were devastating, because they make the company seem to be complacent and sloppy.”
To make matters worse, the Justice Department has filed a civil False Claims Act complaint against Johnson & Johnson for paying millions of dollars in kickbacks to Omnicare, the nation's largest pharmacy to specialize in dispensing drugs to nursing homes.
The allegation isn't a huge surprise: In Novevember, Omnicare entered into a $98 million settlement for taking kickbacks from J&J. Omnicare's pharmacists, according to the complaint, reviewed charts of nursing-home patients with dementia and then recommended that the physicians add antipsychotic drug Risperdal if the patient showed signs of agitation or inappropriate behavior. Physicians, who were not involved in the scheme, agreed with the pharmacists' recommendations about 80% of the time, although Risperdal isn't approved to treat this form of psychosis.
“Kickbacks in the nursing home pharmacy context are particularly nefarious, because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving,” said U.S. Attorney Carmen Ortiz.
Risperdal sales brought J&J $1.73 billion in the first nine months of 2009: nearly 4% of the company's $45.3 billion in revenue.
Chemical Restraints
Risperdal doesn't reverse or relieve dementia, and in fact carries a “black box” warning of increased chances of death among elderly patients with dementia-related psychosis. Still, it has been widely prescribed in nursing homes, in a practice criticized as “chemical restraints”: altering patients' behavior for the convenience of the staff. The practice still continued by 2006, as a study published Monday in the Archives of Internal Medicine shows, although at a lower rate. Because most elderly patients are covered by Medicaid, the lawsuit suggests, J&J and Omnicare J&J and Omnicare had to have been creative in accounting for the kickbacks and listed them as education funding, grants, and data on the drug. J&J did not respond to inquiries.
J&J is on the hook not only with the FDA and the DOJ but with public opinion. The company's actions after the Tylenol scare of 1982 fully restored its corporate and brand images, but this recall and the FDA letter (not to mention the kickbacks allegations) has harmed its stature.
J&J reports financial results on Jan. 26. Whether the recall affects its business is unclear. The company doesn't expect the recall to be material, but the lasting effects on the company's image might be significant.
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