ADHD DRUG WITHDRAWN
Risk of liver failure outweighs favorable effects.
Pemoline (Cylert and all generic formulations) was withdrawn from the market by the Food and Drug Administration after the agency received 13 reports of liver failure resulting in liver transplantation or death (the sum total of reports received since the drug was approved in 1975) occurring usually within four weeks of the onset of the signs and symptoms.
The labeling of pemoline, a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD), was revised in 1999 to include a boxed warning regarding the possibility of liver failure, and it was recommended that it serve only as a second-line therapy with the stipulation that a medication guide be dispensed with each prescription to warn patients of that risk. One additional report of liver failure has been filed since that time. Although pemo-line has been associated with a very slight total incidence of liver failure as an adverse effect, the rate of its occurrence among patients taking the drug was discovered to be 10 to 25 times greater than it is in the general population, and the manufacturer therefore halted the sales and marketing of the product in May 2005. Other drug therapies for ADHD currently in use have not been shown to carry a comparable risk. The drug will remain available at pharmacies and through wholesalers until the current supply is exhausted, and patients still taking it should take another drug.
U.S. Food and Drug Administration. Alert for healthcare professionals: pemoline tablets and chewable tablets (marketed as Cylert). 2005 Oct. http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm.
ADDITIONAL PRECAUTION CONCERNING ANTIDEPRESSANT
Further risk to liver function is noted.
The labeling of duloxetine (Cymbalta), a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) antidepressant, has been revised to include new precautions regarding hepatotoxicity, subsequent to post-marketing reports of liver injury, some of which indicate the heightened risk of it in patients who had liver disease before the initiation of drug therapy.
The types of liver injury reported include hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than 20 times the upper limit of the normal range, with or without jaundice, reflecting a mixed or hepatocellular pattern of injury. Cholestatic jaundice with minimal elevation of liver enzymes also has been reported. The duloxetine labeling always has borne the precaution that concurrent alcohol use can cause liver injury and that the drug should be used with caution if the patient is alcoholic. The revised label now indicates the types of recently reported liver injury and includes the statement that duloxetine can aggravate liver disease. Nurses should inform patients of the signs and symptoms of liver damage (pruritus, dark urine, jaundice, tenderness in the right upper quadrant, or unexplained flulike symptoms) and advise them to report them immediately to the health care provider and to receive prompt medical evaluation.
Eli Lilly and Company. [Label information:] Cymbalta (duloxetine hydrochloride) delayed-release tablets. 2005 Sep 22. http://www.fda.gov/medwatch/safety/2005/cymbalta-pi.pdf; Eli Lilly and Company. Dear healthcare professional [letter: Cymbalta (duloxetine hydrochloride)]. 2005 Oct 5. http://www.fda.gov/medwatch/safety/2005/Cymbalta_DearHCP05OCT2005.FINALSIGNED.pd.
NEW BOXED WARNING CONCERNING CANCER DRUG
Severe dermatologic reactions are possible.
Postmarketing reports of severe cutaneous and mucocutaneous reactions to ibritumomab tiuxetan (Zevalin Injection), a drug used with rituximab (Rituxan for Infusion) in a therapeutic regimen in the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin lymphoma, including those who have rituximab-refractory follicular non-Hodgkin lymphoma, have prompted a revised labeling.
Ibritumomab tiuxetan is a monoclonal antibody that interacts with the CD20 antigen found on the surface of normal and malignant B lymphocytes. The skin reactions reported are erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis, some cases of which were fatal. Nurses who administer the drug therapy should be aware of the possibility of severe cutaneous or mucocutaneous reactions and should both suspend the treatment if patients demonstrate any symptoms and order a prompt medical evaluation.
Biogen Idec. Dear healthcare professional [letter: Zevalin (ibritumomab tiuxetan)]. 2005 Oct. http://www.fda.gov/medwatch/safety/2005/Zevalin_dearhcp.pdf; Biogen Idec. [Label information:] ibritumomab tiuxetan: Zevalin. 2005 Sep. http://www.fda.gov/medwatch/safety/2005/ZevalinPI.pdf.
STOPPING FRAUDULENT WEIGHT-LOSS CLAIMS
The FDA and FTC join forces.
False claims made for products that facilitate the easy loss of body weight are fairly common, and during the last two years two federal government agencies have been working to decrease the incidence of them.
The Federal Trade Commission (FTC) brought 40 law-enforcement actions to stop the marketing and distribution of products that are claimed, in the absence of supportive data, to effect weight loss easily-actions that have resulted in more than $188 million in judgments against defendants. Additionally, the commission has launched a campaign, named Red Flag, to raise awareness in the media of the adverse consequences of advertisements of false weight-loss products and to enlist assistance in arresting their proliferation.
In addition to asserting that consumers can be harmed in using such products, the FTC program identifies the business liabilities incurred in making fraudulent claims, such as adversely affected profit margins, the compromising of credibility, and the tarnishing of reputation by association. The Red Flag Web site provides information to companies on how to determine whether a claim is likely to be false, examples of common false claims made for diet aids, and other downloadable educative information.
The FDA also has been pursuing companies that make false claims for weight-loss products. The agency has sent to 25 companies a warning concerning false claims made, and advisory letters to more than 1,000 manufacturers and distributors of "dietary supplements" (which is how most weight-loss products are marketed, usually over the counter) to remind them of the legal requirements for the claims made. Dietary supplements that have false or misleading statements regarding their effects are considered to be misrepresented and their manufacturers are subject to regulatory action.
The Canadian and Mexican governments have been working with the United States agencies to help curb the distribution and sale of fraudulent weight-loss products. The Mexican government has been working with the weight-loss industry, the distributors of weight-loss products, and the media on self-regulation activities, and an educational campaign directed toward consumers also has been undertaken. In Canada, the Internet is monitored for weight-loss fraud, and the government also has audited weight-loss products for compliance with the regulations concerning truthful labeling and issued compliance letters to companies violating them. In addition, Canadian officials have followed the FDA's example in providing educational information to consumers.
Obesity is a major factor in morbidity and mortality in the United States, and helping to select and implement effective weight-loss techniques is an important nursing intervention. But nurses should be aware that their patients may believe the claims of easy loss of weight that are made for dietary aids, and the necessity of being wary-particularly of those claims that describe loss of weight that does not entail diet modification or an increase in exercise-should be included in their education.
Federal Trade Commission. Red flag: bogus weight loss claims: a reference guide for media on bogus weight loss claim detection [brochure]. 2003. http://www.ftc.gov/bcp/conline/pubs/buspubs/redflag.pdf; U.S. Food and Drug Administration. Federal Trade Commission and Food and Drug Administration: fact sheet on weight loss fraud. http://www.fda.gov/bbs/topics/NEWS/2005/MUCHfactsheet.html.
UPDATE: PREGNANCY AND PAXIL
Not in the first trimester.
Last month's Drug Watch reported changes to the labeling of the antidepressant paroxetine (Paxil, Pexeva). As a result of preliminary information from a second study confirming a greater risk of congenital malformations, particularly cardiac defects, when paroxetine is used in the first trimester, additional labeling revisions have been made---the drug's pregnancy category has been changed to "D," indicating that studies of its use in pregnant women have demonstrated an associated risk to the fetus. Paroxetine still may be used if the prescribing clinician believes that benefits conferred to the patient outweigh the risks posed to the infant. Generally, paroxetine therapy should not be initiated in patients in the first trimester of pregnancy or in those who plan to become pregnant in the near future. Pregnant patients already taking paroxetine should consult their physicians to determine whether they should continue to do so. For further information please see http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm.