1. Aschenbrenner, Diane S. MS, RN, CS

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A continued review of a risk posed by antidepressant therapy.

The U.S. Food and Drug Administration (FDA) has issued a new public health advisory concerning antidepressant drug therapy, citing recent findings that suggest that it poses a greater risk of suicidality (suicidal ideation or behavior) in adult patients.


Much like earlier comparable research pertaining to pediatric patients, the present study findings indicate only a possibly greater risk of suicidality, not that antidepressants cause patients to become suicidal.


Currently, the agency is gathering data from the manufacturers of the antidepressants and will be examining the findings of all placebo-controlled trials conducted in adults taking the drugs, as it formerly had gathered and reviewed information concerning clinical trials of their use in pediatric patients. The present review will involve hundreds of trials and thousands of patients, and will take at least a year to complete, after which time further statements on the subject may be issued.


To date, the agency only has emphasized its previous warning issued to health care professionals that there may be a greater risk of suicidality in adult, as well as pediatric, patients taking antidepressants, especially during the first few months of treatment and at the time of a change in dosage (either higher or lower). Such patients should be monitored closely during that time, and any signs of clinical worsening, particularly in those being treated for depression, or of suicidality, or any unusual changes in behavior should be reported to the health care professional as soon as possible.


Information sheets concerning each of the antidepressants, addressed to both the health care professional and the patient, have been revised to emphasize the ongoing concern, in a warning formerly found only on the revised drug labels. Nurses should recognize that antidepressant therapy may pose some risk and that family members and caregivers should be taught how to monitor patients for behavioral changes that would indicate a possible concern. Close observation and follow-up visits to a mental health care provider are essential, and patients and their families should be made to understand that, for the fullest benefit of the medication to be derived, psychotherapy with a trained mental health professional should complement antidepressant drug therapy.


U.S. Food and Drug Administration. FDA public health advisory: suicidality in adults being treated with antidepressant medications. 2005.; U.S. Food and Drug Administration. Antidepressant drugs that have healthcare professional and patient information sheets. 2005.



Alcohol interactions too dangerous.

Although the sale of the remainder of the current supply is being permitted, Palladone (hydromorphone) extended-release capsules have been withdrawn from the market. The drug has been used to treat moderate-to-severe chronic pain in patients tolerant to opioids.


It has been found that taking the extended-release formula with alcohol rapidly increases the rate at which the opioid is released into the bloodstream, an effect termed "dose dumping." An eight-ounce drink of 40% alcohol taken with the lowest dose of Palladone (12 mg) increases the blood concentration of hydromorphone 5.5 times. Lower concentrations of alcohol (such as in a mixed drink that contains the equivalent of 20% alcohol or in a bottle of beer that is 4% alcohol) also raise the blood concentration of hydromorphone, though to a lesser degree (1.9 and 1.03 times, respectively).


Further, even the small amounts of alcohol contained in some over-the-counter drug preparations can increase the blood concentration of the drug. Such significant increases place the patient at risk for severe respiratory depression and other effects of opioid overdose (sedation, delirium, constipation). Nurses should instruct patients taking Palladone to not consume any alcohol concurrently.


U.S. Food and Drug Administration. FDA public health advisory: suspended marketing of Palladone (hydromorphone hydrochloride, extended release capsules). 2005.



Improper use dangerous.

A new safety warning concerning the Duragesic brand and generic brands of fentanyl transdermal patches has been issued, after accidental death and overdose occurred in some patients who used them improperly. Nurses assisting in the use of Duragesic or other fentanyl transdermal patches should be certain to emphasize several points that always have been included on the drug label. First, fentanyl is an opioid intended to be used daily for the treatment of moderate-to-severe chronic pain, and only in the presence of tolerance to opioids (for example, if the patient has been taking an opioid, such as 30 mg of oxycodone, daily for a week). It is not to be used occasionally, or only on an "as-needed" basis. Patients using fentanyl should be informed that the use of the product by members of their families would be dangerous. Second, the patch should be applied to clean, dry skin that does not have any soap, lotion, oil, alcohol, or other substance on it, thereby promoting adherence.


The plastic liner at the back of the patch should be peeled away and the patch applied immediately (touching the sticky side as little as possible), pressed with the palm of the hand for 30 seconds to help attain a good seal. Third, the patch should not be used if it has been cut or damaged, nor should it be applied to skin that is not intact because either would increase the rate of absorption of the drug. Fourth, the patch should be changed every three days, or as otherwise prescribed by the provider. It is imperative that patients be told that the old patch is to be removed when the new one is applied, and the application site rotated to prevent breakdown or irritation of the skin. The used patch should be folded in half (sticky side together) and flushed down a toilet to prevent children, pets, and adults from being exposed to it. Fifth, the patient should prevent the patch from being exposed to heat, such as that of heating pads and hot tubs, because such also would increase the rate of absorption of the drug. Sixth, if the gel in the patch leaks out onto the skin, the latter should be flushed copiously with only water to remove it; the use of soap, alcohol, or other solvents should be avoided because it may heighten the permeability of the skin-again, allowing more of the drug to be absorbed.


Further, patients should be made aware that the concurrent use of alcohol or other medications that affect brain function or the way in which fentanyl is metabolized, as well as increases in body temperature or exposure to heat, can result in a sudden and possibly dangerous increase in the blood concentration of the drug. The signs of overdose, for which medical attention should immediately be sought, include troubled or shallow breathing; tiredness; extreme sleepiness (difficulty in arousal from sleep) or sedation; difficulty in thinking, talking, or walking normally; and faintness, dizziness, or confusion.


U.S. Food and Drug Administration. FDA public health advisory: safety warnings regarding use of fentanyl transdermal (skin) patches. 2005.



Atypical presentation of infection may cause misapprehension.

The Food and Drug Administration (FDA) has issued a public health advisory after four cases of septic death in women in California who took mifepristone (Mifeprex) to induce medical abortion were reported. All of the deaths occurred after the use of an off-label dosing regimen in which oral mifepristone tablets are placed into the vagina--the regimen approved by the FDA is 600 mg of mifepristone taken orally as a single dose on the first day, and then 400 micrograms on the third.


The women presented more than 24 hours after vaginal administration of the drug with nausea, vomiting, or diarrhea, and weakness, with or without abdominal pain, symptoms atypical of infection (fever and other common signs were not present), and which may have been mistaken for the common effects of abortion. In two of the cases the causative agent of the sepsis has been identified as Clostridium sordellii, but prophylactic antibiotic therapy is not recommended in women who are to take mifepristone, because the instance of sepsis is rare with the prescribed regimen and adverse effects of such therapy are possible. It is not known why all of the reported cases occurred in California.


ED nurses should consider sepsis as the condition possibly afflicting all patients undergoing medical abortion with mifepristone who present with nausea, vomiting, diarrhea, weakness, or abdominal pain. A complete blood count is recommended in such cases to help identify an infection--significant leukocytosis with a marked shift to the left and hemoconcentration may be indicative of sepsis, and patients believed to have it should be immediately treated with an antibiotic that kills anaerobic bacteria such as C. sordellii.


U.S. Food and Drug Administration. FDA public health advisory: sepsis and medical abortion. 2005.; U.S. Food and Drug Administration. Alert for healthcare professionals mifepristone (marketed as Mifeprex). 2005.; U.S. Food and Drug Administration. Questions and answers on Mifeprex (mifepristone). 2005.; Danco Laboratories LLC. Dear health care provider letter: Mifeprex (mifepristone). 2005.