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Doi:10.1016/s1541-9800(07)70523-9

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R H E U M AT O L O G Y N E W S • S e p t e m b e r 2 0 0 7 Black Box Heart Warning Strengthened for TZDsThe labeling change extends to the TZD combination heart failure. After treatment with these products is initiated or after the dose is in- drugs Avandaryl, Avandamet, and Duetact. creased, patients should be carefully ob- the study, overnight hospitalizations for heart failure were reported in nearly 10% B Y E L I Z A B E T H M E C H C AT I E
data from meta-analyses of the rosiglita- risk for myocardial ischemia for the type are diagnosed with heart failure should re- verse event that was “more marked” in The labels of all thiazolidinediones 2 diabetes therapy. The agency is cur- ceive appropriate treatment for heart fail- patients taking insulin at baseline and in rently reviewing similar pooled data from tion of the TZD “should be considered.” FDA’s concerns that despite the warnings and information already listed in the drug that thiazolidinediones (TZDs) may “cause NYHA class I or II heart failure, who were or exacerbate congestive heart failure in some patients,” according to the FDA.
The FDA will continue to
ters requesting the labeling change in May.
monitor postmarketing
reports of heart failure, and
a review of rosiglitazone
“will consider further regulatory action and the possible increased
mation becomes available.” The agency’s (HF) in the warnings and precautions sec- risk of MI is ongoing.
review of rosiglitazone and the possible in- tions, but the labeling is being strength- warning advises health care professionals rosiglitazone’s cardiovascular safety.
to observe patients carefully for the signs www.fda.gov/medwatch/safety/2007/safety heart failure is “separate” from the con- excessive, rapid weight gain, shortness of and increases in heart failure medications 07.htm#rosi_pio. Adverse or serious events cerns over the increased MI risk associat- associated with TZDs should be reported to ed with rosiglitazone, which was the sub- the FDA’s MedWatch program at 800-332- tion of rosiglitazone or pioglitazone, or Brian Marson, assistant news editor for drugs, is contraindicated in patients with Elsevier’s “The Pink Sheet,” contributed to New York Heart Association class III or IV FDA Advisers Decide Rosiglitazone Should Stay, With Warnings B Y A L I C I A A U LT
dione on the market,” said Dr. Schade. If rosiglitazone move is not so clear. There is division within the FDA over Associa te Editor, Practice Trends was withdrawn, the panel might later regret having tak- whether the drug should stay on the market.
en away an option, he said, noting that the other thiazo- Dr. David Graham, an associate director for science G A I T H E R S B U R G , M D. — The oral diabetes agent lidinedione currently available—pioglitazone (Actos)— and medicine in the Office of Surveillance and Epi- rosiglitazone should remain on the market, albeit with also has some safety concerns, notably a signal of an demiology, said that rosiglitazone should be withdrawn.
some warnings about an increased cardiac ischemia risk, Dr. Graham, who sounded the alarm about Merck’s ro- said a majority of the members of a joint meeting of the In a statement, the American Association of Clinical fecoxib (Vioxx) in 2004, said that rosiglitazone may Food and Drug Administration’s Endocrinologic and Endocrinologists (AACE) said that it welcomed the FDA have been responsible for 66,000-200,000 excess cardio- Metabolic Drugs and Drug Safety and Risk Management panel’s recommendation that rosiglitazone stay on the vascular deaths, nonfatal heart attacks, and strokes from market, but that “at the same time, AACE recognizes the The combined panels voted 20-3 that rosiglitazone strong statement of the panel that the drug may increase The drug offers no unique short-term benefits for (Avandia) increases ischemic risk, and 22-1 that the drug, glycemic control and has not demonstrated long-term re- a thiazolidinedione, should stay on the U.S. market.
However, said AACE, “physicians can continue to treat ductions in micro- or macrovascular complications, said “The committee felt relatively uniformly that there was persons with diabetes who are well controlled with Avan- some risk associated with the use of rosiglitazone in cer- dia, knowing that it has been shown useful and effective His boss, Office of Surveillance and Epidemiology di- tain diabetic patients,” panel chairman Dr. Clifford Rosen rector Dr. Gerald Dal Pan, agreed that the “balance of the said in a postmeeting briefing with reporters. The expert advisers drew their conclusions primarily benefits and risks do not favor rosiglitazone.” Dr. Rosen said that panelists were most concerned from three meta-analyses of some 40 studies: one by But Dr. Robert Meyer, director of the Center for Drug about increased risk of ischemia, heart attack, and death Avandia manufacturer GlaxoSmithKline (GSK), another Evaluation and Research’s Office of Drug Evaluation II, in patients taking insulin along with rosiglitazone. Sev- by the FDA’s biostatisticians, and the third by Dr. Steven which oversees the approval of endocrinology drugs, said, eral committee members suggested a contraindication or Nissen, medical director of the Cleveland Clinic (N.
“there is a fundamental disagreement within CDER.” He added, however, “I do not have an opinion on what reg- A few others suggested a black box warning on in- Dr. Nissen was a nonvoting consultant, and his data ulatory action should be taken on Avandia.” creased potential for heart failure, for which there is al- were barely discussed, because the “FDA analysis of the The agency will “move this forward as quickly as we ready a warning. Several panelists also said that patients data, including patient level data [provided by GSK], is can,” Dr. Douglas Throckmorton, CDER deputy direc- with advanced cardiovascular disease or who regularly more robust than would be possible for an analysis uti- tor, told reporters after the meeting. “Obviously, this is a used nitrates should probably not take rosiglitazone.
lizing study-level data alone” according to the FDA’s “These are the people for whom clinicians are going to GSK said it would continue to provide the FDA with have to think twice before prescribing [rosiglitazone],” The trials in the meta-analyses included mostly short- information. “We welcome this decision as positive for said Dr. Rosen, a senior staff scientist at the Maine Cen- term data. GSK also provided the FDA with longer-term patients,” said Dr. Ronald Krall, GSK chief medical offi- ter for Osteoporosis, St. Joseph Hospital, Bangor.
data from three outcome studies and several epidemiol- cer, in a statement after the meeting.
An endocrinologist on the committee, Dr. David S.
Schade of the University of New Mexico, Albuquerque, Meta-Analyses
argued before the panel voted that Avandia should stay Dissension Within FDA
The FDA convened the joint panel primarily to assess the The FDA usually follows its advisory panels’ advice, Clinicians “absolutely . need to have a thiazolidine- though not always. With rosiglitazone, the agency’s next

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