Another reason may be that doctors, confronted with a bold-print, boxed warning, do heed its advice.
See below for Important Safety Information about JUXTAPID, including the Boxed Warning, Contraindications and Warnings and Precautions.
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In another vote, the panel had voted to advise the FDA to put a boxed warning on the prescription combination drugs.
Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death.
The FDA's approval of the drug comes with the requirement that the prescribing information comes with a boxed warning alerting patients about the possibility of these side effects.
The panel had not been asked to consider a second safety issue, called Stevens-Johnson Syndrome, a rare and potentially deadly skin reaction for which Bextra already has a boxed warning.
Additionally, the drug was approved with a Boxed Warning to alert patients and health care professionals that the drug should not be used in patients 16 years of age and younger.
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Clopidogrel has a boxed warning to alert health care professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug.
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Its two-and-a-half-minute new advertisement points out that all common arthritis drugs, including ibuprofen, naproxen and Celebrex, carry the same boxed warning advising consumers and doctors that they can cause both heart and stomach problems.
Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use.
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On Feb. 10, a panel of drug safety experts unexpectedly recommended that the U.S. Food and Drug Administration put a visible, boxed warning on stimulant medicines like Adderall, Ritalin and Concerta, which are used to treat the disorder in both children and adults.
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