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Children’s Motrin 14 articles

Heart risks added to safety label of Children’s Motrin

The labeling of over-the-counter Children’s Motrin has been updated to include a new warning regarding an increased risk of deadly heart attacks, heart failure and strokes, according to the Food and Drug Administration (FDA). Children’s Motrin, like Motrin for adults, contains ibuprofen, a painkiller from a family of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs. Other drugs in this class include Advil (ibuprofen) and Aleve (naproxen). NSAIDs are sold both over-the-counter and by prescription. The new warning states: “Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. ... Read More

High court upholds $140 million verdict involving Children’s Motrin injuries

The U.S. Supreme Court denied Johnson & Johnson’s petition to have a $140 million jury verdict reviewed in a failure-to-warn case involving a teenage girl who developed a serious skin reaction blamed on the company’s Children’s Motrin. Johnson & Johnson had argued that claims made by Samantha Reckis and her parents that the over-the-counter painkiller gave her a painful and blistering skin condition should have been preempted by the 2009 Supreme Court decision in Wyeth v. Levine, which found that drug makers cannot be held liable for not including a label that “clear evidence” indicates the FDA would not have ... Read More

McNeil denied appeal in $10 million Children’s Motrin verdict

The Pennsylvania Supreme Court refused to hear an appeal by Johnson & Johnson unit McNeil-PPC Inc., of a $10 million verdict levied against the company by the family of a girl who suffered a serious allergic reaction and blindness after taking Children’s Motrin as prescribed for fever. McNeil had petitioned the state high court to hear the case after its bid for appeal was rejected by the Pennsylvania Superior Court panel last September. The panel supported the lower court’s decision in July, which found the consumer health care company failed to warn that its over-the-counter medicine could cause the serious ... Read More

Woman suffers Stevens Johnson Syndrome, burning ‘from inside out’ after taking a friend’s medication

A young mother is fighting for her life after taking a friend’s prescription antibiotic and suffering an allergic reaction that doctors say is causing her to burn from the inside out. Yassmeen Castanada took the antibiotic on Thanksgiving to help ward off a sickness she felt coming on. But shortly afterward her eyes, nose and throat began to burn. She was rushed to the emergency room where her condition progressed. Within days, blisters covered her body and her skin began to peel off in sheets, causing excruciating pain and exposing her to life-threatening infection. The diagnosis – Stevens Johnson Syndrome ... Read More

McNeil loses appeal on $10 million Children’s Motrin judgment

Johnson & Johnson subsidiary McNeil-PPC failed to convince the Pennsylvania Superior Court to overturn a $10 million verdict alleging the company’s Children’s Motrin caused a girl to develop a life threatening condition that burned her skin and caused her to go blind. McNeil argued that there was no evidence to show that the company’s failure to warn consumers of the risk of the serious allergic reaction on the drug’s safety label led to the the girl’s injuries. Brianna Maya was 3 when her mother gave her Children’s Motrin over the course of four days to treat a fever and cough. ... Read More

Johnson and Johnson ordered to pay $63 million to girl who suffered severe reaction to Children’s Motrin

Consumer health product giant Johnson & Johnson has been ordered to pay $63 million plus interest to a Massachusetts teenager who suffered a serious skin reaction and lingering medical complications after taking the pain reliever Children’s Motrin. Samantha Reckis was given the ibuprofen when she was 7, an over-the-counter medicine she had taken previously without experiencing ill effects. But this time, Samantha suffered a severe reaction. Her throat, mouth, eyes, esophagus, intestinal tract, respiratory system and reproductive system became inflamed, and her doctors had to put Samantha into a coma to treat her. She was diagnosed with toxic epidermal necrolysis ... Read More

New warning added to Advil Cold and Sinus

Advil Cold & Sinus Liqui-Gels capsules are the latest over-the-counter medicine to receive a warning by the Food and Drug Administration (FDA). The drug now warns of the risk for stomach bleeding especially in people 60 years of age or older and in those who have had previous stomach ulcers or bleeding problems. Advil Cold & Sinus Liqui-Gels capsules contain 200 mg of ibuprofen and 30 mg of pseudoephedrine HCL. All varieties of over-the-counter nonsteroidal anti-inflammatory drugs, also known as NSAIDs, are now required to include a warning on their packaging for the risk of stomach bleeding. The FDA has ... Read More

Consent decree filed against McNeil for substandard OTC drugs

A consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements established by federal law. McNeil, a subsidiary of Johnson & Johnson, will not be allowed to manufacture or distribute drugs from its Fort Washington, Penn., facility until the Food and Drug Administration (FDA) deems its operations comply with the law. Millions of over-the-counter medicines made at the facility have been recalled over the past year because of problems that were traced back to substandard quality control measures at the plant. McNeil’s Consumer Healthcare Division ... Read More

FDA accuses Tylenol maker of not promptly fixing quality problems

A Johnson & Johnson manufacturing plant will begin shipping bottles of grape-flavored children’s Tylenol this week as the drug company’s chief executive faces a congressional committee to explain how the once-trusted company could have let its quality standards go so far downhill as to result in massive recalls of over-the-counter J&J medicines over the past year. Food and Drug Administration (FDA) investigators uncovered a recurring “failure to investigate and correct product problems in a prompt and thorough manner,” at the company’s McNeil Consumer Healthcare manufacturing plants, agency principal deputy Joshua Sharfstein told lawmakers at the hearing. The problems were of ... Read More

House committee to investigate children’s Tylenol recall

“This inspection report is pretty close to being the worst I’ve seen,” said David Lebo, a professor of pharmaceutical manufacturing at Temple University, about the Food and Drug Administration (FDA) inspection report of a Johnson & Johnson plant located in Fort Washington, Penn., that makes several popular over-the-counter drugs for children. “It suggests that basically the FDA found an issue with almost every system at the plant.” The FDA released the inspection report following a May 1st recall of 1,500 lots of children’s medicines such as Tylenol, Motrin and Benadryl. The drugs were recalled and production suspended at the plant after ... Read More