Archive for October, 2008

NuvaRing Lawsuit

Wednesday, October 8th, 2008

The NuvaRing is a contraceptive vaginal ring that can be prescribed by a doctor. To prevent contraception, the ring releases a dose of progestin and estrogen over a period of three weeks. After three weeks is over, the ring is removed and the woman has a normal menstrual period.

NuvaRing is manufactured by Organon and was first used in The Netherlands in February 2001. It was approved by the Food and Drug Administration (FDA) for use by consumers in the United States on October 2, 2001 and hit the market the next summer. NuvaRing is currently used by about 1.5 million women throughout the world.

The known side effects of NuvaRing are vaginitis, headache, upper respiratory tract infection, leucorrhea, sinusitis, nausea, and weight gain. It is believed that chances of cardiovascular problems such as stroke or heart attack are higher in women who smoke, have had recent surgery, a history of cardiovascular disease, or are of an older age.
Rarer side effects from use of NuvaRing may include difficulty breathing, chest pain, coughing up blood, severe headaches, severe abdominal pains, lumps in the breast, constant fatigue, vomiting, rashes, and depression.

Other than the expected side effects, it is believed that NuvaRing causes an increased risk of blood clots because it contains etonogesterel. Some studies have shown that third generation contraceptives such as NuvaRing that contain etonogesterel (an active metabolite of the progestin desogestrel) can increase the risk of blood clots by as much as 1.5 to 2.4 times that of second generation oral contraceptives. These blood clots can cause tissue and organ damage, leading to amputation or even death. In addition to blood clots, it is believed that NuvaRing may cause stoke or myocardial infarction (heart attack) in patients using it.

Last year, Public Citizen, a consumer advocacy group, requested that the FDA ban oral contraceptives that release desogestral due to the link to strokes and blood clots. While the packaging says a low dose of etonogestral is released, some believe that the dose, administered per day, is actually high.

This past March, a lawsuit was filed against Organon as well as the distributors and marketers of NuvaRing. The suit was filed by Robert Bozicev in Essex County, New Jersey. He is the late husband of Kelly Bozicev, whom he claims was killed due to the use of NuvaRing. In December 2007, she had a seizure and died while being transported to the hospital. Doctors determined that she died due to a massive pulmonary thromboemboli. The lawsuit states that the Organon USA, Inc., Organon Pharmaceuticals USA, Inc., Organon International, Inc., Akzo Nobel NV, Organon Biosciences, N.V., and Schering-Plough Corporation knew about the increased risk of blood clots, but failed to disclose it to consumers.

Since then, more than 50 other lawsuits against the manufacturers of NuvaRing have been filed. If you are using NuvaRing, you may want to consult your physician about the risks.

Lexapro Lawsuits

Wednesday, October 1st, 2008

Lexapro is one of the brand names for the drug escitalopram. It is used to treat both depression and anxiety. It was developed by Lundbeck and Forest Laboratories in 1997 and approved by the Food and Drug Administration (FDA) in spring 2001. Some of the known side effects of lexapro are nausea, constipation, drowsiness, impotence in males, fatigue, indigestion, runny nose, and sinusitis.

Thoughts of suicide may also be an adverse side effect of taking lexapro. After the FDA did an evaluation of 372 studies that involved over 100,000 patients (all of whom were taking at least one of eleven different antidepressants including lexapro), it found that there was an elevated risk of suicidal thoughts in patients between the ages of 18 and 25.

However, it may not just be those between 18 and 25 that are at risk. In March 2007, a widow of a 50 year old man filed a lawsuit against Forest Laboratories among others, saying that her husband committed suicide due to lexapro use. The multi-million dollar suit said that antidepressants were prescribed after a car crash and the victim got progressively worse until he jumped off a bridge in February 2005. Mark and Lucy Bibbee also filed a lawsuit against Forest Laboratories. They believe that taking lexapro caused both their sons to commit suicide within a 17 month of each other. By the end of 2006, there were believed to be at least 25 lawsuits filed against Forest Laboratories by the loved ones of patients who committed suicide while taking antidepressants such as lexapro.

A new study conducted by Duke University shows that antidepressants such as lexapro may also increase the chances of death in patients who suffer from heart disease. The study found that 21.4% of heart disease patients who were taking antidepressants died within a three year time frame of the follow-up as opposed to 12.5% of those that were not taking antidepressants. After making certain adjustments for demographics and cardiac risk factors, this still was an increased risk factor of 62%.

In addition, patients who take lexapro during pregnancy may be at risk for birth defects. The FDA warned doctors to advise patients taking lexapro during pregnancy that their baby may be at increased risk for congenial heart defects such as atrial septal defects and ventricular septal defects.

A study appeared in the New England Journal of Medicine that showed that taking antidepressants such as lexapro could increase the chance of a patient’s baby being born with persistent pulmonary hypertension in newborns (PPHN). After this study was published in the journal, the FDA released a Public Health Advisory with the warning about PPHN. PPHN can cause heart failure, brain hemorrhage, seizures, and organ damage in newborns. Between 10 and 20% of newborns that suffer from PPHN die.

In addition to heart defects, it is believed that lexapro can also cause omphalocele, an abdominal wall defect, and craniosynostosis, which causes sutures on the head to close earlier than expected, resulting in an abnormally shaped head.