Product Liability Attorney Blog

The days of lengthy and expensive clinical trials may be coming to an end, as researchers now believe that virtual research which includes data mining can provide more detailed results in less time, even while spending less money.

Testing a new or existing drug’s efficacy and potential dangers is extremely important. This is particularly true in the case of drugs that are already approved for use because while they may be okay to use on their own, research may prove that the drugs are fatal when used in combination with other drugs. A good example of this is in the cases of the antidepressant drugs Paxil and Pravachol. While Paxil was first approved for use in 1992, and Pravachol was approved for use in 1996 for lowering cholesterol, it was proven that on their own, both drugs work and they were safe. However, researchers from Stanford University eventually discovered that when the drugs are taken together, patients suffered from increased sugar levels. This condition was particularly dangerous for diabetics.

Generally when researchers run clinical tests the process is a lengthy and arduous one. They have to gather the test patients and group them according to various factors including age, sex, weight and medical history. Once the testing is completed, the patients are split into different classes, such as those who reacted well to the drug, those that had a neutral reaction and those that had a bad reaction.

The information collected in the trials is then used to predict how new patients will respond to the drug by following patterns. This method takes up a great deal of time and money. Using data mining to collect data rather than clinical trials is a simpler way to get the information those researchers need when looking for the same patterns in patients. Russ Altman, director of Stanford's Biomedical Informatics Training Program, whose group published the Paxil/Pravachol result in the journal Clinical Pharmacology and Therapeutics, says "you're not constrained by the need to actually get patients lined up in a clinical trial that would be incredibly expensive. We had most of this paper done probably in a month."

Data mining is a research technique where researchers gather information from patient databases (based on the criteria of their research) and search for patterns to answer their questions. These databases are usually drawn from hospitals and medical records. So if a researcher wants to know how Paxil affects the elderly, they will use medical records and hospital files of senior patients using Paxil to gather up their information. Data mining is proving itself to be a significantly faster and cheaper route to clinical trials, and may wind up being the wave of the future when it comes to virtual research.

Jeff Lowe, a partner with the St. Louis law firm Carey, Danis & Lowe, was quoted in a recent Lawyers & Settlements article discussing the link between the antidepressant Paxil and birth defects.

In the April 27 article, Lowe urged mothers who took Paxil during the first trimester of their pregnancy and whose children were born with birth defects to consider contacting an attorney.

The primary birth defects linked to Paxil, made by GlaxoSmithKline, are persistent pulmonary hypertension of the newborn (PPHN) and cardiac defects.

Paxil is part of a class of drugs known as selective serotonin reuptake inhibitors. Lowe notes that initial studies did not find a connection between SSRIs and birth defects.

"Then some studies began finding a connection between Paxil and birth defects such as PPHN and cardiac defects. GlaxoSmithKline had a database they were keeping that was based on their own studies. In 2006, they published their online database, which demonstrated a higher risk in major malformations for infants exposed to Paxil in the first trimester. Additional independent peer reviewed studies confirmed the link.

"Paxil's warning was changed in 2005 [to include the risk of birth defects]. There was an FDA warning letter issued on December 8, 2005 and a Dear Doctor letter issued in September 2005."

Lowe noted that since the child is the one most impacted by the allegedly defective drug, in most states the time limits imposed on when suit may be filed often doesn’t begin to run until he or she reaches 18 or 21.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

As the number of lawsuits against GlaxoSmithKline mount over allegations that the antidepressant Paxil caused birth defects, evidence that the drug’s maker targeted pregnant women as a market has also surfaced, The Public Record reports.

The article “Number of Paxil-Related Birth Defect Cases Soar,” written by Evelyn Pringle extensively reviews the drug’s history. As we discussed in our previous blog entry, information has surfaced that suggests GlaxoSmithKline tried to bury evidence that the antidepressant was linked to birth defects when the drug was prescribed to pregnant women.

In addition, Pringle’s article discusses attempts by GSK to market the antidepressant to pregnant women and women of child bearing age even though the FDA had not approved it for use in pregnant women.

Dr. Lee Mangin, an expert witness in an upcoming case against GSK, reviewed the company’s promotional materials.

Pringle writes in her article that a report by Magin concluded:

“GlaxoSmithKline from 2000 mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age.”

An exhibit cited in the report from a “Paxil Tactical Marketing Plan in 2000,” states: “New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women.”

“ParentDish” blogger Monique El-Faizy wrote a post about The Public Record’s story and asked GSK to comment. Predictably, the antidepressant’s maker claims there is not enough evidence to link taking Paxil during pregnancy and birth defects.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

A Danish study that appears in the March issue of Pediatrics reveals that babies of women who took antidepressants such as Paxil experienced some developmental delays, Health Day reports.

The study, which looked at data from 81,000 births in Denmark, concluded that mothers who were prescribed antidepressants in the second or third trimester were more likely to have babies who sat 16 days later, walked one month later and were less able to occupy themselves for 15 minutes at 19 months of age than the children of mothers who did take the drugs. The delays were most pronounced in boys.

The majority of the mothers who were prescribed antidepressants received serotonin reuptake inhibitors such as Prozac, Zoloft, Celexa and Paxil.

In addition to the latest news about development delays, Paxil has also been linked to birth defects.

Paxil, a GlaxoSmithKline drug, has been linked to persistent pulmonary hypertension in newborns, a rare, life-threatening condition that affects the baby’s heart and lungs.

Paxil was introduced to the U.S. market in 1992. The U.S. Food & Drug Administration gave the antidepressant a category B rating for pregnant women – meaning that animal testing failed to demonstrate a risk to the fetus. However, Glaxo never studied the safety of the drug in humans even though animal testing in 1980 raised the possibility that it could be linked to birth defects.

It wasn’t until 2005 that the FDA reclassified Paxil as a Category D drug meaning that studies in pregnant women demonstrated a fetal risk.

There are currently about 600 Paxil birth defect lawsuits nationwide pending against Paxil. In October 2009, a Philadelphia jury concluded that Glaxo negligently failed to warn a pregnant woman’s doctor about Paxil’s birth defect risks and concluded that Paxil caused her newborn’s heart defects and awarded the family $2.5 million.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.

The antidepressant Paxil was introduced in 1992 by GlaxoSmithKline. Over the past 18 years, the drugmaker has paid out nearly $1 billion to resolve lawsuits and $4 million of that amount involves claims that Paxil caused birth defects, the Health Sentinel reports.

And it is likely that number will climb as hundreds of Paxil birth defect cases ready for trial.

In October 2009, a Philadelphia jury concluded that Glaxo negligently failed to warn a pregnant woman’s doctor about Paxil’s birth defect risks and concluded that Paxil caused her newborn’s heart defects.

After the jury awarded the family $2.5 million, jurors indicated that they had taken particular note of the fact that Glaxo never studied the safety of their own drug, even though animal testing in 1980 raised the possibility.

When Paxil was originally introduced to the market, the U.S. Food & Drug Administration gave the antidepressant a category B rating for pregnant women – meaning that animal testing failed to demonstrate a risk to the fetus.

In 1995, after an FDA toxicologist raised a concern about Paxil, it was changed to a category C drug. It wasn’t until 2005 that the FDA reclassified Paxil as a Category D drug meaning that studies in pregnant women demonstrated a fetal risk.

There are currently about 600 Paxil birth defect lawsuits nationwide pending against Paxil.

Paxil has been linked to persistent pulmonary hypertension in newborns, a rare, life-threatening condition that affects the baby’s heart and lungs.The antidepressant belongs to a group of drugs known as selective serotonin reuptake inhibitors. Although the entire class of drugs has come under fire for undisclosed side effects, Paxil is believed to be the most harmful of the SSRIs.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

Worried that animal studies would link the antidepressant Paxil with birth defects, an executive with the drug’s maker, GlaxoSmithKline, suggested burying the evidence, Bloomberg News reports.

Written in 1997, the memo urged scientists to withhold information about the birth defect risks the drug posed to pregnant women. A company scientist had noted that rat studies of the Paxil compound in 1980 showed that young rats often died after receiving low doses of the drug. Those deaths could suggest birth defects.

A year after the memo was written, in 1998, a Glaxo internal review found an alarmingly high number of Paxil birth-defect reports. However, the information was not turned over to the U.S. Food and Drug Administration.

Three years later, a woman who was prescribed Paxil during her pregnancy wrote the company to inform them she aborted her fetus because of birth defects. An internal Glaxo report concluded that Paxil “almost certainly” cause the birth defects.

Incredibly, Glaxo still did not alert the FDA.

Paxil belongs to a group of antidepressants known as selective serotonin reuptake inhibitors. Although the entire class of drugs has come under fire for undisclosed side effects, Paxil is believed to be the most harmful of the SSRIs.

Paxil has been linked to persistent pulmonary hypertension in newborns, a rare, life-threatening condition that affects the baby’s heart and lungs.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.

Last month, a Philadelphia jury awarded $2.5 million to a woman whose son was born with severe heart defects after she had taken the antidepressant drug Paxil during pregnancy, the Associated Press reports.

Michelle David was prescribed Paxil, made by GlaxoSmithKline, during her pregnancy. Two months after her son was born, he was diagnosed with heart defects and required five months of hospitalization to repair two holes in his heart. David, who had no history of heart defects in her family, sued the drug maker for product liability.

Paxil is in a class of antidepressants known as selective serotonin reuptake inhibitors (SSRI). In September 2005, the U.S. Food and Drug Administration issued a warning that expectant mothers who took Paxil during their pregnancy increased the risk that their child could be born of birth defects.

In July 2006, the FDA updated the warning after studies showed that expectant mothers who took Paxil were six times more likely to give birth to an infant who suffered from a potentially fatal condition known as persistent pulmonary hypertension.

If you have experienced any of the side effects associated with Paxil, contact the attorneys of Carey & Danis. We can help. Carey & Danis is a national law firm that represents individuals injured by America’s largest corporations.