Group Calls for Ibuprofen Warnings
Petition Sent to FDA Says Drugs Can Cause Dangerous Skin Reactions
Group Calls for Ibuprofen Warnings
Feb. 15, 2005 -- A group of doctors and families called on federal
regulators Tuesday to warn the public that Advil and similar drugs can cause
rare but potentially fatal skin reactions.
The group filed a petition with the FDA asking it to order on-label warnings
on products containing ibuprofen, the drug found in popular brands including
Advil and Motrin.
The drug can cause a rash and skin-blistering reaction known as Stevens
Johnson Syndrome (SJS) in about five in 1 million users. Patients who continue
to take the drug despite the rash can develop toxic epidermal necrolysis, or
TEN, which resembles severe burn injuries all over the body and is fatal in up
to one-third of cases.
"We're merely asking the FDA to look at this and tighten up the
warnings," says Roger E. Salisbury, MD, chief of plastic surgery at
Westchester Medical Center in Valhalla, N.Y., who signed the petition along
with three other doctors and three families of children who were allegedly
injured or who died after taking ibuprofen.
The petition calls for warnings on all ibuprofen products highlighting the
risk of the disorders and urging consumers to stop the drug immediately if a
rash appears. It also asks the FDA to launch an investigation to see if
ibuprofen manufacturers withheld critical safety data about over-the-counter
forms of the drug.
"All we're asking for is a few sentences on the box. We're not asking
that the drug be 'withdrawn' from the market," says Michael Nicar, PhD, a
toxicologist from Baylor University Medical Center in Dallas, who also signed
Nicar and the other doctors petitioning the FDA have all served as expert
witnesses in ibuprofen lawsuits, a spokesperson representing the group says.
The three families on the petition have all filed lawsuits against drug makers
alleging wrongful death or negligence because the companies did not warn them
about the risk of SJS or TEN.
The Makers of Motrin and Advil Respond
McNeil Consumer & Specialty Products, which makes several forms of adult
and children's Motrin, issued a statement stressing that Stevens Johnson
Syndrome is rare and has many potential causes besides ibuprofen.
"Children's Motrin when used as directed is safe and efficacious,"
says company spokeswoman Kathy Fallon.
"If my doctor and my husband and I had known about these risks of SJS
and TEN we would have never given her Children's Advil," says Darlene Kiss,
who sued Advil maker Wyeth Consumer Healthcare last month alleging that the
drug caused the death of her 3-year-old daughter Heather in March 2003.
Wyeth spokesman Doug Petkus declined to comment on any litigation facing the
company. But he did say that Advil and Children's Advil already refer to the
potential for severe allergic reactions and that the labels are
"They're safe when taken as directed," he said.
Drug reactions cause about one-third of the estimated 5,000 hospitalizations
required to treat SJS, TEN, and similar disorders each year in the U.S.,
according to a study published in January.
Several drugs, including seizure medications and antibiotics, as well as a
variety of viruses, can cause the reactions.
But petitioners say that few U.S. doctors, and almost no consumers, know of
the risk or that ibuprofen should be stopped immediately if a rash appears
following its use. Advil labels carry a warning in Europe but not in the