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

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Again, similarly sounding drug names cause medication errors.

The Food and Drug Administration's MedWatch program has issued a safety alert concerning the use of two drugs, Reminyl (galantamine hydrobromide) and Amaryl (glimepiride), in response to reports of medication errors involving the two drugs, including the wrong drug named in a prescription, the misreading of a prescription, the incorrect labeling of a prescription, and the incorrect filling of a medication bottle (despite the correct interpretation of the prescription and correct labeling).


Reminyl is used to treat mild-to-moderate dementia of the Alzheimer type, and Amaryl is used in the treatment of type 2 diabetes. When Amaryl was incorrectly taken in place of Reminyl, various adverse effects occurred, including hypoglycemia and, in one instance, death. The drugs are both manufactured as tablets, have one dose denomination in common (4 mg), and may be stored near each other in a pharmacy because their generic names begin with the letter "g"-all factors that could contribute to the making of medication errors.


Although both drugs are issued in tablet form, they do not have similar appearances-Reminyl tablets are round and either white (4 mg), pink (8 mg), or orange-brown (12 mg), while Amaryl tablets are flat-faced oblongs, with notched sides at a double bisection, and are pink (1 mg) green (2 mg), or blue (4 mg). NPs who write orders for the drugs should be aware of the necessity of spelling the full drug name carefully and including the indications on the prescription form. Those administering either medication should be aware of the possibility of errors. Patient and family education on the drugs should include the particulars of the drugs' appearances and the instruction to question the pharmacist or physician about any dispensed prescription.


FDA MedWatch. 2004 Safety Alert: Reminyl (galantamine hydrobromide). 2004.



Infections, hypersensitivity reactions, and hematologic changes are possible.

New warnings have been added to the label of adalimumab (HUMIRA), a recombinant human immunoglobulin G1 monoclonal antibody that is specific for human tumor necrosis factor (TNF) and is used in the treatment of rheumatoid arthritis.


If the drug is administered concurrently with anakinra (Kineret), an interleukin-1 receptor antagonist that decreases the inflammatory and immune responses, serious infections can result, and the new warning states that the drugs should not be used together. Earlier studies of anakinra and etanercept (Enbrel), another TNF-blocking agent, showed that the combination of those therapies heightened the risk of serious infections without conferring any noted benefit, and both drugs already carry warnings on their labels stating that the two shouldn't be used concurrently. Because all TNF-blocking agents work similarly, they all would carry comparable risks of adverse effects when administered concurrently with anakinra, hence the revision of the adalimumab label.


A second revision to the label reflects rare postmarketing reports of anaphylaxis, stating that if an anaphylactic or other serious allergic reaction occurs, the drug should be stopped immediately and treatment for the reaction should be initiated. The third revision advises that hematologic events are possible, including medically significant cytopenia, and that there have been rare reports of pancytopenia and aplastic anemia. Patients taking adalimumab should be instructed to contact their prescribers or seek medical attention immediately if they develop signs and symptoms of blood dyscrasias or infection (persistent fever, bruising, bleeding, and pallor).


FDA MedWatch. Dear Healthcare Professional: Important Drug Warning. 2004.; FDA Medwatch. Revised label: Humira. 2004.



Long-term use of the contraceptive poses risk.

A black box warning has been added to the label of the injection contraceptive Depo-Provera (medroxyprogesterone acetate) because postmarketing studies have indicated that prolonged use of it may induce significant loss of bone density that may not be reversible after cessation, the extent of which is related to the length of time the drug is taken-the longer the period of use, the greater the loss that can occur.


The new warning advises that women should only use Depo-Provera for a long period of time (more than two years) if they cannot achieve adequate birth control through other methods. The manufacturer, Pfizer, has issued a "Dear Healthcare Professional" letter and a revised patient product information sheet containing the updated information. Although currently there are no specific Food and Drug Administration statements on the lifetime risk of decreased bone density secondary to Depo-Provera use, it is a reasonable hypothesis that women may experience the brunt of that adverse effect many years after they have stopped using birth control. Furthermore, some bone density loss normally occurs after menopause, and it would seem likely that that would be exacerbated if a woman had used Depo-Provera for a long time. Nurses should therefore inform patients of the risks associated with taking Depo-Provera.


FDA Talk Paper. Black box warning added concerning long-term use of Depo-Provera contraceptive injection. 2004.



Serious adverse effects of the drug have been reported.

Mifepristone (Mifeprex, also known as RU-486), a drug used to end pregnancies of 49 or fewer days, has carried a black box warning since it was approved by the Food and Drug Administration in 2000, one that will be revised to include new information on the risk of rare but serious adverse effects, including serious bacterial infections, sepsis, bleeding, and death, all of which can occur after the termination of a pregnancy by any means, including the use of the drug.


Serious bacterial infections and sepsis can occur even if the patient doesn't exhibit the typical signs of infection, such as fever and tenderness on examination, and prolonged, heavy bleeding may necessitate surgical intervention. The revised warning will also emphasize that mifepristone should not be used if the pregnancy is ectopic, a point of concern because such a pregnancy may not have been diagnosed because the condition may have gone undetected either by physical examination or on ultrasonography. An additional concern is that the symptoms of an ectopic pregnancy can be similar to those occurring during a medical termination of pregnancy.


Because of the serious risks associated with mifepristone and the need to have access to medical care from the time it is taken until the abortion is complete, a special medication guide is dispensed with the drug, one that also will be revised to include the updated information warning women that they should contact the health care provider right away in the event of fever, abdominal pain, and heavy bleeding, and advising them to take the guide with them if they go to an ED for care in order to prevent practitioners not familiar with the drug from overlooking its possibly serious adverse effects.


Nurses' education of patients who use the drug should emphasize to them the importance of reading the medication guide carefully and following the instructions concerning when to seek medical attention. Nurses who interact with patients receiving mifepristone should not offer assurance that heavy bleeding and severe abdominal pain are effects that are typical of the drug. Patients complaining of either or both of those symptoms must be assessed to confirm that they don't have an ectopic pregnancy (that may or may not have ruptured). Patients who report fever may have serious infections warranting a meticulous workup.


FDA Statement. FDA to announce important labeling changes for mifepristone. 2004.



Erlotinib is found to prolong survival.

Erlotinib (Tarceva), a new drug in tablet form, has been approved by the Food and Drug Administration via the "Fast Track" process as a single-agent treatment for locally advanced or metastatic non-small cell lung cancer that has continued to progress despite the use of other treatments, including at least one regimen of chemotherapy. The drug inhibits tyrosine kinase, an enzyme responsible for stimulating epidermal growth factor receptor (EGFR), and it's believed that growth stimulatory signals in cancer cells are thereby blocked. In a randomized trial, patients who had higher EGFR levels benefited more from erlotinib than did patients who had low levels of it, and the drug was shown to prolong survival, the median overall duration of which was 6.7 months among the patients taking it, compared with 4.7 months among those taking placebo. The most common reported adverse effects of erlotinib were diarrhea, rash, nausea, and vomiting, and the drug could cause fetal harm in pregnant women.


FDA News. FDA approves new drug for the most common type of lung cancer. 2004.