Critics contend steps don’t go far enough

By Gardiner Harris
NEW YORK TIMES NEWS SERVICE

January 31, 2007

The Food and Drug Administration announced changes yesterday that were intended to ensure marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way that it announces safety worries and a collaboration with the Veterans Health Administration to track how patients fare after taking drugs.

The FDA plan is the latest effort to fix the agency after a series of missteps. In September 2004, Merck withdrew its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attack. At about the same time, the FDA announced that antidepressants cause some teens to think more about suicide.

In both cases, the FDA took years to acknowledge risks to millions of patients that had been apparent to some researchers.

“We don’t see this as the only answer,” FDA Commissioner Dr. Andrew C. von Eschenbach said at a news conference announcing the initiatives. “It’s merely a step as we continue a process of improvement that will be ongoing.”

Sen. Christopher Dodd, D-Conn., said in a written statement that far greater changes are needed at the FDA. Dodd promised to introduce two bills today that would restructure the FDA and require drug makers to disclose the results of all clinical trials involving humans. The bills have been co-authored by Sen. Charles Grassley, R-Iowa, who has called the FDA far too “cozy” with drug makers.

In many cases, the date that the FDA will undertake the efforts it announced yesterday is uncertain. For instance, Dr. Steven Galson, director of the agency’s drug center, said at the news conference that the pilot program to systematically assess a drug’s safety 18 months after its introduction will probably take about a year to put into place, with the assessment due 18 months after that.

“We’re just organizing that process to get started,” Galson said.

In a scathing assessment released in September, the Institute of Medicine concluded that the FDA was rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations. The institute, the most important medical advisory organization in the country, suggested that the FDA undergo 25 major changes, many of which would require congressional authorization.

Alta Charo, a professor of law and bioethics at the University of Wisconsin and one of the authors of the Institute of Medicine’s report, described the FDA announcement as “a good set of first steps towards improving the safety of the drug supply in the United States.”

She said that she was “disappointed” that the agency had failed to adopt some of the institute’s bolder recommendations, including one suggesting that the agency give greater authority to officials who assess the safety of drugs after they go on the market.

“We viewed that as critical,” she said.

Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical and Research Manufacturers of America, praised the FDA’s announcement as a “very thoughtful and comprehensive response” to the Institute of Medicine’s report.

“The agency has made substantive and significant progress in improving and enhancing the drug safety system,” said Goldhammer, whose organization represents drug makers.

Still, the FDA plan does little to address a problem that nearly all agree underlies many of its woes: a chronic shortage of government money. As Von Eschenbach noted, the agency has regulatory authority over about a quarter of the U.S. economy. After the Sept. 11, 2001, terrorist attacks, the agency was asked to beef up its efforts to prevent bioterrorism. Despite having greater responsibilities, its budget has remained relatively flat for years.

There are now thousands of drugs in routine use. Figuring out which of these medicines may have undiscovered side effects will take a lot of money. The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the agency could use very little of this money to track the safety of already-approved drugs.

That deal between the FDA and drug makers expires this year, and drug makers have already agreed to allow more of their money to be used for these post-market safety assessments. Whether those fees are enough, whether there should be strings attached to them, and whether that money should be coming from drug makers has become the subject of fierce debate.

“Drug makers clearly get their money’s worth,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group. Wolfe and other consumer advocates say that the FDA’s dependence on drug industry fees has softened its oversight of drug makers.

Dr. Scott Gottlieb, who last week left his job as deputy commissioner of the FDA to return to the American Enterprise Institute, a free-market think tank, said that the real debate unfolding around FDA is between those who believe that the agency needs more money and tools to assess drug risks, and those who believe that the agency should begin regulating the practice of medicine.

“I think we need to give the agency the resources it needs to get information about drug risks quickly,” Gottlieb said. “But we don’t need the government telling doctors and patients what to do.”

The FDA plan promises to return the agency to its scientific roots. The FDA once had robust labs that undertook original studies to assess drug risks on its own. Those labs were largely eliminated over the past decade to plough more funds into the drug approval process and the support of a bare-bones computer program to track drug side effects.

But over the past two years, the agency has begun an aggressive effort to improve the science of drug safety, making itself a participant in scientific endeavors once left exclusively to drug makers and basic scientists.

Among these efforts announced yesterday was the creation of a database of genetic codes associated with bad drug outcomes; the development of a computer model to identify patients who are most likely to suffer liver injury; and the design of screening tests that would identify patients most at risk of general drug problems.

Source | Associated Press
By SHAYA TAYEFE MOHAJER

Search to Resume in Wreckage of W.Va. Convenience Store Where Blast Killed 4, Injured 5

GHENT, W.Va. Jan 31, 2007 (AP)— Twenty-five years as a police officer in New Jersey didn’t prepare Mike McDonough for the devastation from a convenience store explosion that killed four people in southern West Virginia and injured five others.

All that was left of the Flat Top Little General Store after Tuesday’s propane blast was a pile of splintered debris, twisted metal framework and a sign showing the price of gasoline. Candy and hot dog wrappers ended up in trees 200 to 300 yards from the store, said McDonough, who lives in nearby Flat Top.

“Strange things happen,” McDonough said.

Authorities had not determined whether any customers were in the store at the time or if there were more victims, state Fire Marshal Sterling Lewis said. A search of the debris was to resume Wednesday.

Seven nearby homes and an elementary school suffered minor damage. No injuries were reported at the school or the homes.

The explosion occurred about 10:50 a.m. as emergency workers were investigating a report of a propane leak, Lewis said. The victims included a building inspector and a volunteer firefighter.

Lewis said store employees were working on an above-ground tank capable of holding 500 pounds of propane. However, that tank and the store’s underground gasoline tanks did not explode, he said.

“It is our initial thought that the fumes entered into the building and had to have an ignition point,” Lewis said.

He said cold temperatures would have kept the gas close to the ground.

The U.S. Chemical Safety Board said it was sending a team to Ghent. The board makes safety recommendations to industry, labor groups and regulatory agencies.

Beckley-based Little General Inc. had no comment.

William Manning, a bartender at the nearby Bear’s Den, said he heard the explosion at his home 4 miles away in Cool Ridge. Manning drove to the store because his next-door neighbor works there. He said he helped carry her to an ambulance but would not give her name.

“I barely recognized her. I couldn’t believe it was her,” Manning said, crying.

Gov. Joe Manchin met privately with the victims’ relatives at the Ghent Volunteer Fire Department in the rural community about 70 miles southeast of Charleston.

“We seem to continue to go through many difficult times in West Virginia,” Manchin said at a news conference, referring to recent disasters including the deaths of nine people in a fire at a Huntington apartment complex and a string of coal mine accidents.

Four of those injured Tuesday were at Cabell Huntington Hospital on Wednesday and one was at Charleston Area Medical Center, said Celeste Hinzman, spokeswoman for the state Division of Homeland Security and Emergency Management. Hospital officials did not immediately return calls seeking comment.

Source | CNN

At least four people were killed and at least two critically injured Tuesday when an explosion leveled a gas station in this southern West Virginia city, officials said.

Among the dead are a firefighter and a paramedic, state fire marshal spokeswoman Celeste Hinzman said.

The volunteer fire department was at the gas station to evacuate people after a report of a leak in a 750- to 1,000-gallon propane tank, Raleigh County Sheriff Danny Moore said.

One ambulance that was on the scene to help with the evacuation “disintegrated,” he said.

Moore said as many as seven people may have been killed.

“The whole building is leveled,” Moore said. “We are digging through the debris now, trying to confirm how many were actually working, how many customers they had, how many were at the gas pump.”

Video from CNN affiliate WVVA showed what little was left of the structure and blackened, smoking rubble.

Hinzman said four people were injured, two critically, but a Raleigh General Hospital spokesman said five people had been brought in.

Blast heard for miles

A clerk with the Appalachian Inn three miles away said she heard the blast, which briefly knocked out power to the motel.

“I thought it was something in our building,” Shirley Cavendish said.

She said the news of the explosion traveled fast, and people are worried about their neighbors and friends in the area.

“Everybody’s upset about this around here,” Cavendish said.

Ghent is near the Winterplace Ski Resort, about 60 miles southeast of Charleston.

A massive explosion at a gas station near a ski resort in Gent West Virginia has left at least two people dead and five other injured, authorities said.

Officials say the blast was likely caused by a propane tank which exploded just before 11:00am Tuesday morning at the Flat Top Little Store.

Five people were taken to Raleigh General Hospital for treatment, a spokeswoman said.

Witness say the explosion was felt at least a mile away at The Ski Shop, reported CNN.

Source | BBC

Secret emails reveal that the UK’s biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers.
Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced ‘independent’ academics.

GSK told Panorama: “GSK utterly rejects any suggestion that it has improperly withheld drug trial information.”

GSK faces action in the US where bereaved families have joined together to sue the company.

As a result, GSK has been forced to open its confidential internal archive.

Karen Barth Menzies is a partner in one of the firms representing many of the families.

She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.

She said: “Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children.”

GSK’s biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.

She also found an email from a public relations executive working for GSK which said: “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.

“Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.”

But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world.

The editor in chief of the British Medical Journal, Fiona Godlee, said that what she calls the “blind-eye culture of medicine” should be exposed by professionals.

She has written in response to the Panorama film: “We shouldn’t have to rely on investigative journalists to ask the difficult questions.

“Reputations for sale are reputations at risk. We need to make that risk so high it’s not worth taking.”

The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet.

A spokesperson told Panorama that the investigation has been given substantial additional resources and remains a high priority.

Seroxat was banned for under 18s in 2003 after the MHRA, revealed that GSK’s own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.

Source | Associated Press

(West Virginia) An explosion leveled a gas station near a ski resort Tuesday morning, killing at least four people and seriously injuring at least nine others, authorities said.

A firefighter and a paramedic were among the injured at the Flat Top Little General Store on Route 19, said Kim O’Brien, spokeswoman for the state Fire Marshal’s office, who provided the casualty figures.

Authorities suspect that a propane tank exploded at about 10:45 a.m., just as a fire truck was pulling into the station in response to a report of a leak.

The cause of the explosion has not been determined. O’Brien said she’s not sure whether it was a propane tank or a liquid petroleum tank that exploded.

All that’s left of the building is a pile of debris, twisted metal framework and a sign showing the price of gasoline starting at $2.19 a gallon.

The explosion was felt at least a mile away at The Ski Shop.

“I thought we got struck by lightning. The whole building shook. The power went off,” said Ben Monast, the shop’s manager.

By Miranda Hitti

FDA and Drug’s Maker Warn Doctors of Possible Risk in Adults Aged 18-30

The antidepressant Paxil and its controlled-release version, Paxil CR, are getting a new warning about suicide risk in young adults.

The FDA and Paxil’s maker, drug company GlaxoSmithKline, are notifying doctors about the warning, which is being added to the drug’s package inserts.

Antidepressants already carry a warning about a possible increase in suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders who take antidepressants.

The new Paxil warning focuses on young adults aged 18-30. Paxil (paroxetine) is not approved for patients younger than 18.

“It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,” state an FDA news release and GlaxoSmithKline’s letter to doctors.

GlaxoSmithKline’s letter states that the company “continues to believe that the overall risk: benefit of paroxetine in the treatment of adult patients with MDD [major depressive disorder] and other non-depressive psychiatric disorders remains positive.”

About the Warning

GlaxoSmithKline’s letter to doctors is posted on the FDA’s web site.

The letter states that GlaxoSmithKline recently conducted a new analysis (in addition to numerous previous analyses) of suicidal behavior and suicidal thinking in adults participating in clinical trials of Paxil.

Participants in those clinical trials had psychiatric disorders including MDD, other depression, and nondepression disorders. Nearly 9,000 were taking Paxil and almost 6,000 others were taking a placebo.

The analysis showed a higher frequency of suicidal behavior in young adults (aged 18-24) with Paxil compared with placebo, but not in older adults. The age gap was not statistically significant, meaning it may have been due to chance.

Another analysis focused on adults of all ages with major depressive disorder. The frequency of suicidal behavior was higher among those taking Paxil than placebo, with 11 cases of suicidal behavior among 3,455 patients taking Paxil and one out of 1,978 taking placebo.

Overall, 0.32% of the Paxil patients of all ages with major depressive disorder showed suicidal behavior, compared with 0.05% of those taking placebo.

“All of the reported events of suicidal behavior in the adult patients with MDD were nonfatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30,” states GlaxoSmithKline’s letter.

Caution on the Data

The age differences in the frequency of suicidal behavior in adults of all ages with MDD were “statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution,” states GlaxoSmithKline.

Most patients who attempted suicide during the study “had an identified social stressor at the time of the event,” the letter notes.

The letter also says that “it is difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves.”

GlaxoSmithKline spokespeople were not immediately available for comment.

Source | Court House News

Johnson & Johnson subsidiary Ethicon fired its chief medical officer because of his insistence that unsafe medical products be recalled, Dr. Joel Lippman claims in Middlesex County Court. Lippman claims that during 15 years in high-ranking medical positions at Ethicon and Ortho McNeil, another J&J subsidiary, Johnson & Johnson repeatedly released or refused to recall dangerous products to which he objected, including the Ortho-Evra birth control patch and Intergel.

Both products have spurred numerous product liability lawsuits. Lippman says he objected to the release of the Panacryl suture, “whose use resulted in numerous adverse events,” but Ortho released it anyway and continued to receive reports of “adverse events.” He says he objected to the release of ProCeed, a “mesh product,” but Ortho released it anyway, until the FDA forced a recall. He says he told Ethicon it must inform surgeons that an endoscopic applicator leaks chromium during use, but Ethicon refused. He says he was fired less than a month after insisting that Ethicon recall a product called DFK24, used in heart bypass surgery, because its tip fell off and had to be fished out of the aorta.

Lippman has been an assistant professor of obstetrics and gynecology at Tufts, director of the clinical development division of medical affairs for Wyeth-Ayerst Laboratories, and worked for Ortho McNeil from 1990 to 2000, leaving that company as vice president of clinical trials.

He worked for Ethicon from July 2000 until May 15, 2006. He got his M.D. at New York Medical College and has a Master’s degree in public health from Harvard.

He claims that from 1998 to 2000, his last two years at Ortho, he “raised serious health concerns about two pharmaceutical products: Ortho-Prefest, a hormonal menopausal product, which did not have adequate safety data to prove that it protected against uterine cancer as did other therapies, and the Evra patch, which released dangerously high levels of estrogen into patients.”

Lippman claims, “The clinical research had revealed that the estrogen dose released by the Evra patch as a means of birth control may increase the risk of deep venous thrombosis and pulmonary embolisms.”

Ortho faces hundreds of lawsuits making precisely those claims – including 12 filed Tuesday in Newark Federal Court.

Lippman says he “advised Ortho that it should conduct further research to understand the impact of the hormones released by the patch and if necessary modify the package insert before introduction to the marketplace. (But) Ortho disregarded Dr. Lippman’s concerns and launched the product. J&J transferred Dr. Lippman to Ethicon in 2000, shortly after Dr. Lippman made his complaints about the menopausal product and the Evra patch.”

Soon after joining Ethicon in July 2000, Lippman says, he objected to the release of its “Corlink” device because data showed it “caused occluded arteries”. He says he also objected because of the “lack of adequate studies to justify the product’s release” and because a competing company had released a similar product, which had to be recalled and resulted in “numerous product liability suits.” Lippman says his boss told him that “if he continued to oppose the launch of Corlink, his action could affect his bonus and standing with the company.” His bonus could be as much as 50 percent of his annual salary, the suit states.

Lippman says that in 2002 he “insisted on the recall of a product known as Intergel” which “had caused serious injuries and was related to a number of deaths.”

Intergel also has been the basis of numerous product liability suits, which claim the product spreads infection during surgery, rather than prevent it.

Lippman says that he demanded for more than a year that Intergel be recalled, and that after “a decision to recall the product was made,” he was summoned to the officer of Michael Dormer, “Chairman of Medical Devices and Diagnostics for J&J in New York City,” where Dormer and four attorneys attacked him “for the decision to recall Intergel”.

Lippman claims he also objected to the release of Panacryl, “a suture whose use resulted in numerous adverse events,” and ProCeed, a “mesh product.” He says that despite his objections, Ethicon refused to recall Panacryl “and Ethicon continued to receive reports of adverse events.” And he says, “The FDA later required Ethicon to recall ProCeed.”

He says Ethicon ignored his advice, in late 2005, to warn physicians that a device called FS2 was not sterile because of two holes in it. In response, he says, “a member of Ethicon’s Quality Assurance Board stated that ‘surgeons are like five year olds. We need to control what is said to them.’”

He says he learned in April this year that an endoscopic applicator “was leaking chromium, a toxic heavy metal,” and that he “insisted that Ethicon notify physicians who had used the applicator during recent clinical usage that the applicator oozed chromium during use. (But) Ethicon ignored his objections.”

And in the case that he claims led directly to his illegal firing, Lippman says that by April this year he had received three complaints that an Ethicon arterial cannula called DFK24, a life-sustaining device used in heart bypass surgery, lost its tip during surgery, and had to be retrieved from the patient’s aorta. He says he and the vice president of medical operations, a cardiac surgeon, decided in April that the DFK 24 must be recalled because “the risk of serious injury or intra-operative death was very high.” Ethicon’s Quality Assurance Board decided to recall it on April 14, but Ethicon refused, and still had not recalled it when it fired him on May 15, Lippman says.

Lippman seeks punitive damages.

By Miranda Hitti
 

The FDA and drug company GlaxoSmithKline have strengthened their warning about using the antidepressant drug Paxil during early pregnancy.

The warning is based on early results from two studies. The studies showed a higher rate of heart-related birth defects in babies born to women who took Paxil during early pregnancy than in babies of women in the general population or women who took other antidepressants.

The first of those studies prompted an FDA alert and an updated drug label by GlaxoSmithKline, which makes Paxil, in September.

Now, results of the second study have prompted an update. The update includes moving Paxil to a category “D” medication instead of a category “C” for use during pregnancy.

That change reflects a stronger warning about use during early pregnancy. Category “D” drugs have shown risks to fetuses in studies of pregnant women. However in this category, the benefits of the therapy may outweigh the risks.

GlaxoSmithKline, a WebMD sponsor, is sending a letter to doctors with the updated information.

More Heart-Related Birth Defects

In both studies, heart-related birth defects were rare but more common among women who took Paxil in early pregnancy.

“The expectation is that in the general population, the risk of cardiovascular defects is about one per 100 infants,” GlaxoSmithKline spokeswoman Gaile Renegar tells WebMD.

She says the studies show a risk of those heart-related birth defects is one per 50 babies born to women who used Paxil in early pregnancy.

Cause Not Clear

The studies didn’t assign anyone to take Paxil and don’t necessarily prove that Paxil caused those birth defects.

“It’s not clear whether there’s a true causal association,” Renegar says.

Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects).

“In general,” states the FDA, “these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.”

Studies’ Results

According to the FDA, early results from the two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.

In one study, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared with a 1 percent risk in the whole population.

In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared with 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Weighing Risks and Benefits

The FDA’s news release notes that “the benefits of therapy may outweigh the potential risks to the fetus.”

“In the labeling, I think there’s some important guidance for prescribers as well as patients to take note of,” Renegar says.

“The labeling now advises that patients who become pregnant while they’re taking [Paxil] should certainly be informed of the potential harm to the fetus,” she says.

“Consideration should be given to discontinuing [Paxil] or perhaps switching to another antidepressant, unless the benefit that the mother is experiencing justifies continuing treatment,” Renegar continues.

“For women who intend to become pregnant or are in their first trimester of pregnancy, other treatments and options should be considered first before initiating Paxil. So these are the recommendations that GSK and the FDA support to help put this information in a useful context for physicians as well as women to make well-informed treatment decisions,” she says.

Maker’s Comment

“These studies that are referenced in the new labeling are largely updated analyses from the data that was the justification for the change in September,” Renegar says.

“We have worked very closely with the FDA on the data interpretation, and what the labeling should say, and how to most quickly and effectively get this out into the public,” she says. “It was a collaborative effort.”

By Miranda Hitti, reviewed by Brunilda Nazario, MD

SOURCES: News release, FDA. WebMD Medical News: “Paxil’s Birth Defects Warning Strengthened.” Gaile Renegar, spokeswoman, GlaxoSmithKline. Letter, GlaxoSmithKline: “Dear Healthcare Professional.” Associated Press.

Do I Have a Paxil Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Paxil lawsuits. We are handling individual litigation nationwide and currently accepting new Paxil birth and heart defect cases in all 50 states.

Free Case Evaluation

Source | FDA

The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.  Paxil is approved for the treatment of depression and several other psychiatric disorders.  FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil. 

FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy.  Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.  In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus.  FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug’s labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

Additional information concerning today’s announcement is available on FDA’s Web site at:
Public Health Advisory: http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm and
CDER Information Sheets: http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm.

Do I have a Paxil Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Paxil lawsuits. We are handling individual litigation nationwide and currently accepting new Paxil birth defect cases in all 50 states.

Free Case Evaluation