A new group of lawsuits is claiming that the use of Paxil during pregnancy is responsible for children being born with significant birth defects. Studies have linked the prescription antidepressant with cardiovascular defects and congenital malformations in the brain, heart, lungs, and other vital organs. At this point, five personal-injury and product-liability actions have been taken against GlaxoSmithKline on behalf of Paxil patients who have given birth to infants with serious heart defects.

The most recent suit was filed in Pennsylvania–GSK’s offices are in Philadelphia–on behalf of Denver resident Lisa Boden, whose child was born with persistent pulmonary hypertension, a severe lung condition in which blood flow to the lungs is constricted. The suit was filed by Baum Hedlund, who also filed a suit in July on behalf of Texas residents Anthony and Matilda Vasquez, whose son Adrian was born with severe congenital heart defects.
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A new long-term government study has cautioned that young children using Ritalin are more susceptible to side effects than older children. While the study did find that Ritalin was moderately effective in treating preschoolers with ADHD, the researchers urged medical professionals to monitor them carefully. Side effects may include slowed growth, insomnia, weight loss, and irritability.

Currently, Ritalin has not been approved for use in children under 6, although thousands of preschoolers have been prescribed Ritalin “off label.” The study, to be published in the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry, was conducted in eight stages over the course of 70 weeks and funded by the National Institute of Mental Health (NIMH).
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It’s been an eventful week for DuPont with regard to their use of the chemical C8 and the potential environmental and health risks associated with it. On Wednesday, lawyers filed a suit in Wood County, West Virginia, alleging that DuPont sought to block C8 research by a court-ordered independent scientific panel. The suit comes on the heels of the release of an internal DuPont study, which claims to have found no health risks associated with the chemical.

Ammonium perfluorooctaonate, known as PFOA or C8, is used to make the non-stick coating Teflon in DuPont’s West Virginia-based Washington Works plant. The independent three-member panel was established as part of a class-action settlement in February of 2005. In that $100 million settlement, DuPont was forced to cooperate with the independent review panel after it was determined that local water supplies were being contaminated with C8. According to a 70,000-person screening, area residents appear to have 25 times more of the chemical in their blood than the regular population.
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Citing the ineffectiveness of Tamoxifen in certain patients, a panel told the Food and Drug Administration that the drug should carry a new label warning consumers of the risk of recurrence. The panel found that some patients with estrogen-related breast cancer are not as responsive to Tamoxifen. The panel has only offered its recommendations to the FDA, and any action to change the labels must be approved by the FDA at large.

Scientists believe the risk of recurrence relates to poor enzyme activity in certain women. Tamoxifen is used to block the production of estrogen–and therefore control the growth of tumors. However, a certain enzyme, CYP2D6, is required to metabolize the drug so that it can perform its intended goal of estrogen reduction. In women with deficiencies of that enzyme, Tamoxifen has been proven to be less effective in preventing a recurrence of the disease.
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Is there a cure for the cure? A review published in the October 18 issue of the Journal of the American Medical Association (JAMA) has estimated that more than 700,000 patients each year require emergency-room visits due to complications with their medicinal intake. The study was a joint project by the Centers for Disease Control and Prevention, the Food and Drug Administration, and the U.S. Consumer Product Safety Commission.

The study concludes, “Adverse drug events among outpatients that lead to emergency department visits are an important cause of morbidity in the United States.” The researchers based their results on active surveillance from January 1, 2004, through December 31, 2005, through the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project. The study also notes that “individuals aged 65 years or older were more likely than younger individuals to sustain adverse drug events and more likely to require hospitalization”–more than two times as likely.
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Oh, those wonderful omega-3 fatty acids. A new study published in the October 18 edition of the Journal of the American Medical Association (JAMA) has found that even modest consumption of fish can reduce the risk of coronary death by 36 percent and reduce total mortality by 17 percent. However, due to high levels of mercury, pregnant and nursing women and women of childbearing age should still closely monitor their fish intake.

“For major health outcomes among adults,” the authors contend, “the benefits of fish intake exceed the potential risks. For women of childbearing age, benefits of modest fish intake, excepting a few selected species, also outweigh risks.” The study was undertaken by the Harvard School of Public Health because they believed that, due to the presence of contaminants in fish, there’s been “confusion over the role of fish consumption in a healthy diet.”
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A new lawsuit was filed in federal court regarding the safety of the popular but controversial birth-control patch Ortho Evra. In the suit, Idaho’s Katy McKellips Braman, who was 17 when she was first prescribed the patch in 2004, claims that Johnson & Johnson and drug company Ortho McNeil failed to sufficiently test the patch before putting it on the market and that they knowingly misled consumers about the risks of the patch when compared to other birth-control alternatives. Braman’s suit is one of hundreds that have been filed throughout the United States.

Braman alleges that she developed deep vein thrombosis, a serious and potentially fatal blood-clot condition, in her left leg because of her use of Ortho Evra. She had been using the drug for little more than a month when she noticed pronounced swelling in the leg, which gradually worsened over the course of days. The condition required hospital treatment and has forced her to take anti-clotting medications on a daily basis. She is suing the companies for damages and all future medical costs related to the condition.
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Attempting to send a clear warning to would-be oil spillers and water polluters, the federal government has required ConocoPhillips to pay $2.233 million for cleanup costs and $80,000 in fines because of a 2004 oil spill near Tacoma, Washington. A day earlier, the state of Washington tagged the company with a $540,000 fine. Yet, the civil settlement means that the company will likely avoid criminal charges in the case, and furthermore, the company will not be forced to accept any legal responsibility for the accident.

In October of 2004, investigators say, the ConocoPhillips-owned oil tanker Polar Texas dumped more than 1,000 gallons of crude oil in the Dalco Passage of Puget Sound, contaminating 21 miles of beachfront. Federal, state, and tribal authorities are in the process of seeking further compensation for potential environmental damages. The $80,000 in fines was for violations of the federal Clean Water Act.
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Lester M. Crawford, the former head of the U.S. Food and Drug Administration, has been charged by the Justice Department for failing to disclose investments in corporations that were subject to his agency’s oversight. Crawford is expected to plead guilty in federal court on Tuesday to two misdemeanors: filing a false document and conflict of interest.

Crawford, 68, allegedly lied about his holdings in several companies by filing erroneous statements that claimed he had sold the investments in question. According to prosecutors, Crawford “knowingly made” false statements with regard to his ownership stake in several companies, including Kimberly-Clark, PepsiCo, and Sysco–each of which are considered “significantly regulated” companies by the FDA, therefore making them off-limits to FDA employees. Crawford also failed to disclose his exercise of stock options in the biotech company Embrex. Remarkably, Crawford had served in 2003 and 2004 as chairman of the FDA’s Obesity Working Group at the same time that he owned shares in soft-drink maker PepsiCo and snack distributor Sysco, two companies that would have been affected by that group’s findings.
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A new study of the antidepressant Prozac may have significant ramifications as to how the drug is prescribed to teenagers. In a study involving adolescent and adult hamsters, researchers discovered that pubescent hamsters who received low doses of the medication turned aggressive toward their cage mates. Adult hamsters did not display aggressive behavior under low or high dosage, and young hamsters given higher doses also seemed calmer. The findings may offer new insight into why some teenagers who take Prozac turn aggressive or even suicidal.

The difference in reactions may relate to the specific brain receptors affected. Prozac, or fluoxetine, seeks to regulate a patient’s mood by increasing the amount of serotonin that the individual produces. However, serotonin can bind with a range of different receptors in the brain. The study suggests that a person’s behavior is affected by which receptors are being used and that those variables may relate to the patient’s age. (more…)