NSAIDs Might Lower Breast Cancer Risk

From Everyday Health:

Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a reduced risk for breast cancer, a new review suggests.

But the findings aren't an invitation for all women to start popping the popular painkillers, the researchers added.

"We don't want that to happen here, for people to jump on the bandwagon and start taking aspirin or ibuprofen," said study senior author Mahyar Etminan, an assistant professor of medicine at the University of British Columbia. "A lot of people are taking these drugs for aches and pains, and aspirin to prevent cardiac events. Those people may actually get an added benefit, but, for someone relatively healthy, we don't recommend starting to [reduce breast cancer risk] as of yet."

"From a practitioner's standpoint, it's kind of reassuring to patients if they do take NSAIDs for whatever reason," added Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "I don't think women should be taking these medicines for prevention, but if they are taking them for other reasons like heart prevention or arthritis, this should be reassuring."

The study is in the Oct. 15 issue of the Journal of the National Cancer Institute.

Use of NSAIDs has been linked to a lower risk of cancer overall, particularly colon cancer, and even to a lower risk of breast cancer, although studies looking specifically at breast cancer have produced inconsistent results.

With colleagues at the University of Santiago de Compostela in Spain, Etminan reviewed mostly observational studies which, together, involved a total of almost 3 million women.

The analysis included the group of NSAIDs known as cox-2 inhibitors, only one of which, Celebrex (celecoxib), is still on the market.

NSAID use across all participants in all studies was associated with a 12 percent lower risk of developing breast cancer. Aspirin was associated with a 13 percent reduced risk, and ibuprofen with a 21 percent reduced risk.

Different doses did not yield different results.

The authors acknowledged that, given that almost all of the studies reviewed were observational, this analysis may be subject to the certain limitations, and all such analyses are only as good as the studies they review.

On the other hand, the review was a large one and has biological plausibility. The inhibition of the enzyme cyclooxygenase (COX) is thought to be one of the ways NSAIDs might reduce cancer risk. And, according to an accompanying editorial, cox-2 is over expressed by 40 percent in invasive breast cancer and 80 percent in colorectal cancer.

At the very least, the results should prompt further research.

"The question is, how can you apply these results? These drugs are widely used but not without side effects. You're not going to put someone on ibuprofen long-term, because it's not going to help the stomach, and there are kidney effects," said Dr. Debra Monticciolo, a professor of radiology at Texas A&M Health Science Center and vice chair of research in the radiology department and chief of breast imaging at Scott & White Hospital. "This is preliminary. You're looking at an observational meta-analysis. It's not the strength of a randomized, controlled trial. You want long-term efficacy and long-term safety data. We need more information."

A randomized trial looking at the protective effect of Celebrex on breast cancer is due to be completed in 2009, Etminan said.

Posted: 10/14/2008 1:57:00 PM

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Family Blames Girl's Blindness on Motrin

UPDATED 7/18/08 From the Associated Press:

Parents of blinded SoCal girl lose Motrin suit

A jury refused to award damages Thursday to a couple who sued drug maker Johnson & Johnson for $1 billion, claiming its Children's Motrin nearly killed their daughter and left her legally blind.

The Los Angeles County Superior Court jury voted 9-3 that the company and McNeil Consumer & Specialty Pharmaceuticals, a division of the drug maker's McNeil PPC Inc. subsidiary, were not liable for the problems of 11-year-old Sabrina Johnson.

Plaintiffs' attorney Browne Greene said he will appeal.

The lawsuit asked for $14 million in actual damages, $103 million for pain and suffering and $950 million in punitive damages.

During the trial, Sabrina testified that her eyes were so sensitive and painful that for several weeks she spent daylight hours inside a cardboard box.

The syndrome is potentially deadly and experts say it may be caused by infections and by reaction to certain drugs, including anti-inflammatory medications, anticonvulsants and some antibiotics.

The main ingredient in Children's Motrin is ibuprofen, a commonly used anti-inflammatory and pain reliever.

At trial, doctors testified that the chances of having a severe allergic reaction to ibuprofen was one in a million.

"While we are sympathetic to the pain and hardships suffered by Sabrina Johnson, Children's Motrin has been proven safe and effective for treatment of minor aches and pains and fever when used as directed and the medicine is labeled appropriately," McNeil PPC Inc. said in a statement after the verdict.

The jury found in its verdict that Children's Motrin did carry "substantial and dangerous" potential risks to consumers and that the companies failed to properly provide warnings.

But the panel answered "No" to the question: "Was a lack of sufficient instructions or warnings a substantial factor in causing harm to Sabrina Johnson?"

One juror, Robin Nickel, said the girl's mother failed to follow directions on the label by giving Samantha Children's Motrin after the girl woke up with puffy eyes.

"It said on the label, any new symptoms call the doctor, and she didn't do that," Nickel said.


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From WebMD:

Children's Motrin caused the severe Stevens-Johnson syndrome that blinded a California girl, a lawsuit claims.

The lawsuit -- and at least nine others scheduled this year and next in cities across the U.S. -- seeks stronger label warnings and punitive damages against drugmakers.

The girl, Sabrina Johnson, was 6 years old in September 2003 when she was sent home from school with a fever. Her parents gave her Children's Motrin drops that afternoon and again that night.

The next morning, the lawsuit says, Sabrina woke with a high fever. Her eyes were pink and her mouth was swollen and covered with sores. Her pediatrician had her hospitalized at Cedars Sinai Pediatric Intensive Care Unit. By the next day, she was blind in both eyes. Doctors diagnosed Stevens-Johnson syndrome.

"This is a very important consumer case involving the really potent tragedy of a little girl blinded by Children's Motrin, an over-the-counter, seemingly benign medication," Browne Greene, the attorney representing the Johnson family, tells WebMD.

Greene claims that McNeil PPC, a subsidiary of Johnson & Johnson, has long known of a link between ibuprofen, the active ingredient in Motrin, and Stevens-Johnson syndrome. While the prescription version of the drug has stronger warnings, Greene says, the over-the-counter version mentions nothing about this risk.

In a statement provided to WebMD by a McNeil spokesman, the company says it is aware of reports alleging an association between Children's Motrin and Stevens-Johnson syndrome. The statement notes that Stevens-Johnson syndrome has been linked with a wide variety of medications and even viral infections.

We are deeply concerned about all matters related to our products and have reviewed case reports, reviewed the scientific literature, reviewed the latest studies and consulted with the top experts in the field," the statement says. "Based upon our investigation we firmly believe that it is unlikely ibuprofen can cause SJS and that Children's Motrin is safe and effective when used as directed, and is labeled appropriately."

Stevens-Johnson syndrome is a rare, often fatal adverse reaction triggered by many different kinds of drugs, particularly certain antibiotics and some painkillers. A recent New York study linked ibuprofen to nearly half of the 32 children referred to a local burn unit over an eight-year period.

Burn units generally treat patients because Stevens-Johnson syndrome attacks the skin and mucous membranes. It can cause the top layer of the skin to separate from the lower layer of the skin in affected areas. When large areas of skin are involved, the disease is known as toxic epidermal necrolysis, although there is overlap between the two diagnoses.

Often the eyes are involved, leading to blindness. Sabrina was not only blinded, but also left highly sensitive to light. When she goes out, she wears a large hat pulled down over her face.

Stevens-Johnson syndrome is fatal in about 5% of cases; toxic epidermal necrolysis kills about 30% of patients.

While ibuprofen has been linked to Stevens-Johnson syndrome, so have many other drugs. There is no definitive proof that ibuprofen causes Stevens-Johnson syndrome. Ibuprofen is in dozens of products and is used by millions of adults and children who do not suffer serious side effects.

Greene says he will file two more lawsuits against McNeil, each linking Children's Motrin to the death of a child.

Greene says that before Sabrina fell ill, there were 15 known cases of Stevens-Johnson syndrome in children who took ibuprofen. Since then, he says, there have been 12 more cases in which children were "blinded, burned, or killed."

Posted: 6/18/2008 11:41:00 AM

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