Yourlawyer.com (Terbutaline News) http://www.yourlawyer.com/topics/overview/terbutaline Sat, 21 Nov 2009 06:13:44 -0800 pixel-app en Lawsuit Claims Drug Caused Brain Damage In Twins http://www.yourlawyer.com/articles/read/8832 Sun, 07 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8832
Doctors failed to tell John and Karen Ring there were risks to using the drug Terbutaline, the Rings claim. Mrs. Ring was given the drug between Feb. 25 and March 17, 2001, as treatment for pre-term labor.

The drug caused her heart rate to spike, gave her feelings of shakiness and caused her to hallucinate. When she questioned the dangers of using it she was told "'not to worry' and that 'you'll be fine,"' the Rings claim.

She delivered twin boys on March 20. The Food and Drug Administration warned doctors in 1997 that "'Terbutaline to treat pre-term labor is an unapproved use,"' according to the lawsuit.

Marti Harlan, a spokesman for the hospital, said she could not discuss the lawsuit or whether the hospital has a policy for the use of Terbutaline.]]> Regular Use of Asthma Drug Poses Dangers, CU And Stanford Studies Find http://www.yourlawyer.com/articles/read/8296 Thu, 29 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8296
One study compiles previously published clinical trials to conclude that patients could both develop a tolerance for beta-agonists and be at increased risk for asthma attacks, compared with those who do not use the drug at all. The second study shows that beta-agonist use increases cardiac risks, such as heart attacks, by more than two-fold, compared with the use of a placebo.

Furthermore, the researchers say that their analyses lead them to suspect a conflict of interest among scientists who are supported by pharmaceutical companies that make beta-agonists, among the world's most widely used drugs. This conflict, they say, could be putting 16 million U.S. asthma sufferers in harm's way. Their statement comes as the American Medical Association is voicing its concerns that drug industry sponsorship of clinical tests is affecting the quality of research.

The first study (a meta-analysis, meaning a study of other previously published studies) of more than a dozen research papers on the respiratory effects of beta-agonists is published in the journal, Annals of Internal Medicine (May 2004), by Shelley R. Salpeter, M.D., Thomas M. Ormiston, M.D., and Edwin E. Salpeter. The second meta-analysis pooled the results from 33 trials on the cardiac effects of beta-agonists, and is published in Chest (June 2004), the cardiopulmonary and critical-care journal.

Edwin Salpeter, the eminent astrophysicist who is professor of physics emeritus at Cornell, has turned his interest to medical issues in recent years. He assisted his daughter, Shelley, by performing statistical analyses for asthma drug studies. Shelley Salpeter is a clinical professor of medicine at Stanford University School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, Calif., where Ormiston also is a physician.

Adrenergic beta-agonists, such as albuterol and terbutaline, work on receptors located on smooth muscles and inflammatory cells in the lungs. These bronchodilator medicines can relax the muscles around the airways that constrict during an asthma attack. Short-term use of beta-agonists has been shown to be helpful in reducing symptoms associated with acute asthma attacks. But continuous use of beta-agonists is a riskier proposition, the authors suggest in their Internal Medicine article.

"Almost all the scientifically valid studies we examined associated continuous beta-agonist use by asthma patients with a decreased bronchodilator response to subsequent beta-agonist administration, and with increased airway inflammation compared to placebo use," said Shelley Salpeter. Continuous use of beta-agonist drugs cause asthma patients to develop a tolerance for the drugs, she adds, making beta-agonists less effective in true emergencies.

Edwin Salpeter questions why so many physicians ignore warning signs of beta-agonist overuse and why drug companies continue to promote the products for continuous use. "We think the studies warning of adverse respiratory effects are getting lost among the dozens of poor-quality studies that missed the point," he said.

Most studies of continuous use of the drugs that showed favorable results were eliminated from the Salpeter-Ormiston-Salpeter meta-analysis because Cornell and Stanford researchers considered them to be scientifically flawed in part because they allowed the as-needed use of beta-agonists in the placebo groups of clinical trials.

Most of these "poor-quality studies" that were eliminated from the meta-analysis, the three researchers say, also turned out to involve conflicts of interest because the studies were funded by pharmaceutical companies, because researchers had financial ties to the industry, or both.

"If you want to push continuous use of beta-agonists, you'll find plenty of published studies to back your point of view," Shelley Salpeter said. "However, because of their flawed study designs, none of these trials were truly placebo-controlled and therefore should not be used to make valid conclusions about the safety of beta-agonists. We worry that physicians who recommend regular use of beta-agonists may actually be putting their patients at risk."

To make matters worse, beta-agonist use in patients with asthma and chronic obstructive lung disease also increases the risk for adverse cardiac events (such as heart attacks) by over two-fold compared to placebos, the researchers warn. Beta-agonists work on receptors found in the heart, to increase the heart rate and decrease the level of the essential element potassium. These effects are the exact opposite of beta-blocker drugs, such as atenolol, that often are used in patients with heart disease to decrease their risk for heart attacks and congestive heart failure.

In the spirit of full disclosure, the meta-analysis authors say they have no ties to the pharmaceutical industry.]]> Lawsuit Contends Drug Caused Brain Damage In Twins http://www.yourlawyer.com/articles/read/8077 Fri, 21 May 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8077
It involves terbutaline a drug commonly prescribed to treat preterm labor and one a local mother claims caused her twin's brain damage. WBAL-TV 11 News health reporter Donna Hamilton reported this may become a huge controversy for pregnant women and their doctors.

Travis and Tyler Ring are fraternal twins who appear to be healthy normal 3-year-olds.

"Neither one of them speaks," said their mother, Karen Ring. "They're not able to spoon feed themselves yet."

Both boys suffer from brain damage. Their mother said she first knew something was wrong when Travis and Tyler were around 1. Doctors did all kinds of tests.

"Genetic metabolism, organic, MRI, CT scans," said Karen Ring. "All tests coming back normal."

That's when she started looking into terbutaline also known as Brethine the drug was used to stop her labor when she was pregnant with the twins. Her research led her to a Duke study on lab rats. It suggests the drug enters the fetal brain, and could potentially cause problems.

"Why did this lawsuit attract so much attention?" said Hamilton. "Because for decades, terbutaline has been routinely prescribed for millions of pregnant women to stop preterm labor."

And terbutaline's drug insert says it should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Weltchek says a pregnant woman has a right to know.

Terbutaline is approved by the Food and Drug Administration for asthma. For pregnant women, it helps stop contractions of the uterus, but in pregnancy the drug is used "off label," which means it's never been FDA approved for that use.

That's the heart of this lawsuit. Karen Ring claims she was not told by her doctors that terbutaline was being used off label.

"Basically, every drug is being used off label and we as physicians don't tell patients," said Dr. John Elliott. "That's not meaningful to them. Look, we're giving you prenatal vitamins. They're being used off label. That's not a meaningful conversation."

Elliott is the director of maternal fetal medicine at Banner-Good Samaritan Medical Center in Phoenix and he's been published for his research on multiple pregnancies.

"I believe that with all the information we have, doing research in humans and looking at lab data in animals, there's nothing to indicate terbutaline causes any harmful side effect in humans," said Elliott.

Hamilton said terbutaline is used in two ways. It is used as a first-line intravenous therapy to stop labor in the hospital, but some doctors also use it for what's called maintenance when a woman goes home. Hamilton said it is taken in pill form at a much lower dose in the second case.

But some studies say it's not effective used as a maintenance dose. So why expose the fetus to it?

Elliott says the point of oral terbutaline is to reduce the number of contractions, and while he says it won't stop a true episode of preterm labor, it may reduce unnecessary visits to the hospital and anxiety.

What Karen Ring knows is the prognosis of her two sons is uncertain.

"I know I did all the right things," she said. "I took extra care of myself. I knew I was carrying twins. I was extra, extra careful." Elliott says this case could have far-reaching consequences for doctors and patients.

"Without any scientific basis, we could end up with a medication that would not be used for something we know is harmful preterm delivery," said Elliott.]]> Terbutaline Preterm Labor Brain Injury Lawsuit http://www.yourlawyer.com/topics/overview/terbutaline Fri, 21 May 2004 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/terbutaline DOWNLOAD OUR TERBUTALINE INFORMATION PACKAGE

Injured by Terbutaline?

Terbutaline is an asthma medication that is commonly used to treat preterm labor. Terbutaline is sold under the brand names Brethine and Bricanyl. Recent studies have shown a link between the use of Terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits in the baby. A recent study conducted at Duke University illustrated the risk of Terbutaline to infants.

The study showed that the use of Terbutaline might leave the brains of children susceptible to other chemicals ubiquitously present in the environment. The study suggests that certain early drug or chemical exposures can predispose people to particular ailments. Recently, the National Asthma Education and Prevention Program has recommended that Terbutaline no longer be given to women with mild intermittent asthma while they are pregnant.

 As early as 1997 the FDA issued its first warning about the use of Terbutaline Sulfate for the treatment and prevention of preterm labor.  Terbutaline sulfate, in various dosage forms, has been approved by FDA for the treatment of asthma but it has be given to pregnant women subcutaneously, to stop early labor. The use of Terbutaline sulfate to treat preterm labor is an unapproved or "off-label" use. Premature labor occurs in approximately 20 percent of all pregnancies in the United States.

Of those, an estimated 1 million women annually are treated with Terbutaline or related drugs to halt the early contractions. The drugs administered to pregnant women also penetrate to the unborn baby where they affect brain development.

If you or a loved one took Terbutaline and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>