Health Highlights: Dec. 20, 2012
Incivek Hepatitis C Drug Gets Black Box Warning About Dangerous Rash Amgen Illegally Marketed Anemia Drug, Will Pay $762M: Report European Union Proposes Tougher Anti-Smoking Action
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Incivek Hepatitis C Drug Gets Black Box Warning About Dangerous Rash
A black box warning -- the most serious type of safety warning -- is being added to the label of the hepatitis C drug Incivek to alert doctors and patients about a potentially fatal rash, the U.S. Food and Drug Administration says.
Patients taking the pill can develop a rash that covers more than half the body. The FDA said patients taking the drug in combination with two other treatments should stop taking Incivek immediately if they develop a rash that grows worse or is accompanied by symptoms such as fever, mouth sores or diarrhea, the Associated Press reported.
Incivek is taken with the pill ribavirin and interferon, which is given by injection.
Vertex Pharmaceuticals Inc. said Incivek's labeling had already warned patients to stop taking the drug if they developed a serious skin reaction. The new black box warning is much more prominent on the label, the AP reported.
Amgen Illegally Marketed Anemia Drug, Will Pay $762M: Report
Biotechnology company Amgen pleaded guilty to charges of illegally marketing the anemia drug Aranesp and agreed to pay $762 million in criminal penalties and civil lawsuit settlements, according to U.S. government officials.
Federal prosecutors said Amgen marketed the drug for unapproved uses even after the Food and Drug Administration ruled out such uses, The New York Times reported.
In court on Tuesday, prosecutors said Amgen promoted the use of Aranesp to treat anemia in cancer patients who were not receiving chemotherapy, even though the FDA's approval of the drug was only for patients undergoing chemotherapy.
The company was "pursuing profits at the risk of patient safety," Marshall L. Miller, acting United States attorney in Brooklyn, said in a telephone news briefing, The Times reported.
At a hearing scheduled for Wednesday, presiding judge Sterling Johnson Jr. will announce whether he will accept the settlement.
European Union Proposes Tougher Anti-Smoking Action
European Union health officials want bigger warnings on cigarette packs and a ban on certain flavorings -- such as strawberry, vanilla and menthol -- that can lure young people to smoking.
Under the proposal, health warnings would increase to 75 percent of the front and back of a pack, and 50 percent of the sides. The warnings would include messages such as "Smoking kills -- quit now," and have pictures of cancer-damaged lungs, the Associated Press reported.
The proposals are meant to reduce the 700,000 smoking-related deaths that occur each year in the 27-nation EU.
EU Health Commissioner Tonio Borg noted that "a city the size of Frankfurt or Palermo is wiped off our map every single year" due to smoking-related deaths, the AP reported.
The proposals will be sent to EU member nations and parliament and could be adopted by 2014.