Black box warnings

Longer-term studies evaluating the cardiovascular risks associated with the use of COX-2 inhibitors have found a higher incidence of cardiovascular mortality with the use of these agents compared to traditional NSAIDs.29,33,34 This prompted the withdrawal of both rofecoxib and valdecoxib from the market and the inclusion of a black box warning in... 

The most common adverse events reported with sirolimus are leukopenia (20%), thrombocytopenia (13% to 30%), and hyperlipidemia (38% to 57%).11,31 Other adverse effects include delayed wound healing, anemia, diarrhea, arthralgias, rash, and mouth ulcers. Sirolimus has an FDA black-box warning in newly transplanted liver and lung recipients.11 In liver transplant recipients, use of sirolimus immediately after transplant is associated with an increased risk of hepatic artery thrombosis, graft loss, and death. In lung transplant... 

The exact role of rituximab in RA is not clearly defined, but it is indicated for patients with moderate to severe RA with a history of inadequate response to DMARDs and other BRMs. Rituximab carries a black-box warning of fatal infusion reactions and severe mucocutaneous reactions even though these events did not occur during the RA clinical trials. The benefits of rituximab must be tempered against the safety concerns reported with use of rituximab in the oncology setting. 

Nausea heartburn Gl pain, irritation, perforation, ulceration, anchor bleeding transient flulike illness muscle pains black box warning for rare osteonecrosis of the jaw... 

Hot flushes, leg cramps, venous thromboembolism, peripheral edema, rare cataracts and gallbladder disease black box warning for fatal stroke... 

Rosiglitazone has been associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction in several studies. Although causality has not been conclusively established, the FDA has required that a black box warning be added to the labeling. A new longterm study to evaluate potential cardiovascular risks is planned. 

Warning No black box warning hyper- Black box warning ana- Black box warning ana-... 

The FDA has established a link between antidepressant use and suicidality (suicidal thinking and behaviors) in children, adolescents, and young adults 18 to 24 years old. All antidepressants carry a black box warning advising caution in the use of all antidepressants in this population, and the FDA also recommends specific monitoring parameters. The clinician... 

A black box warning for life-threatening liver failure was added to the prescribing information for nefazodone. Treatment with nefazodone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. 

Drug-induced hypersensitivity is a major clinical problem, and it also significantly increases the uncertainty of drug development. Between the years 1975 and 2000, over 10% of newly approved drugs either had to be withdrawn from the market or achieved Black Box warnings because of adverse reactions that were not predicted by preclini-cal testing and clinical trials [1],... 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

Graham, G.K. (2002) Postmarketing surveillance and black box warnings (To the Editor). The Journal of the American Medical Association, 288, 955-956. 

Intracranial hypertension Danazol has been associated with several cases of benign intracranial hypertension (also known as pseudotumor cerebri) (see Black Box Warning). 

Acute asthma These products are not bronchodilators and are not for rapid relief of bronchospasm. See Black Box Warning. 

Bronchospasm Bronchospasm may occur with an immediate increase in wheezing following dosing treat immediately with a fast-acting inhaled bronchodilator. See Black.Box.Warning. 

Of particular importance in tfie geriatric patient Weight gain, glucose intolerance, diabetes, increased risk of death (see FDA black box warning)... 

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