Posts Tagged 'black box warning'

FDA seeks less acetaminophen in prescription drugs

U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage. The move announced on on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a “black box” warning about potential liver failure.

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FDA orders cancer warning for Remicade, other drugs

The Food and Drug Administration is requiring the manufacturers of Remicade and four other drugs to issue a “black-box” warning that they could increase the risk of cancer in children. The agency spent more than a year examining 30 cases of lymphoma or other cancers in children who were prescribed these drugs to treat rheumatoid arthritis, inflammatory bowel disease or Crohn’s disease. Some of these cases were fatal.

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FDA: Arthritis drugs pose cancer risk to children

Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents. The agency studied several dozen reports of cancer in children taking the drugs, some of which were fatal. Half of the cases were lymphomas, a cancer that attacks the immune system.

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FDA: Chantix and Zyban anti-smoking drugs need warning

smoking-picU.S. health officials said on Wednesday they ordered Pfizer Inc and GlaxoSmithKline PLC to add strong “black box” warnings on smoking cessation drugs to highlight a risk of serious mental health problems including suicidal thoughts. The warnings must be added to Pfizer’s Chantix and Glaxo’s Zyban, the Food and Drug Administration said in a statement.

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FDA slaps warning on heartburn drug tied to spasms

Reglan metoclopramide side effectsFederal health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms. The Food and Drug Administration said the drug, widely known as Reglan, has been shown to cause spasms and tics when used for long periods of time or at high doses. The problems include uncontrollable movement of the limbs, face and tongue, and are usually irreversible, even after patients stop taking the drug, according to the FDA’s warning.

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FDA Puts Black-Box Warning on Bowel-Cleansing Drugs

FDA Puts Black-Box Warning on Bowel-Cleansing DrugsTwo prescription drugs used to cleanse the bowel before a colonoscopy may cause kidney damage, the U.S. Food and Drug Administration said Thursday. The FDA said it would now require a black-box warning on the oral sodium phosphate products Visicol and OsmoPrep, alerting consumers about the risk of acute phosphate nephropathy — a type of severe kidney injury.

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