Birth Defect Lawyer Blog

There has been a lot of controversy about antidepressants, specifically whether the benefit outweighs some substantial risks. Antidepressants have been linked to internal bleeding, weight gain, and birth defects. Now, a new study reports another potential risk: irregular heartbeat.

Selective serotonin reuptake inhibitors (SSRIs) such as Celexa or Lexapro may lengthen the electrical activity in the heart, which is known as a QT interval. A long QT interval typically is a sign of cardiac risk. In men, a normal QT interval is less than 420 milliseconds, while in women, it is less than 440 milliseconds.

The Center for Experimental Drugs and Diagnostics at Massachusetts General Hospital decided to test how many users of SSRIs had long QTs compared to those who did not take antidepressants. Researchers collected information on more than 38,000 adults who had an ECG after using antidepressants between February 1990 and August 2011. What they found was that those who took Celexa, Lexapro, Elavil, and methadone had a small, yet significantly longer, QT interval. Furthermore, the higher the patient's dose, the longer the QT interval. Of those who took the antidepressants, nearly one in five had a longer QT interval. At the same time, researchers found that different antidepressants, such as Wellbutrin or Zyban (brand names for bupropion), actually experienced a shorter QT interval. Researchers have not yet determined whether a shorter QT interval is any healthier than a long one.

Researchers cautioned that just because a QT interval was long did not mean the patient had heart problems -- the QT interval would need to be longer than 500 milliseconds to be of concern. Also, the findings could be affected by any pre-existing heart conditions among those taking the antidepressants.

What the study shows is that the decision to take antidepressants can never be made lightly. Other studies have shown that depending upon your level of depression, antidepressants may be no more helpful than other forms of treatment, such as acupuncture. Taking antidepressants can lead to significant health problems, and your physician has a duty to inform you of all known dangers so that you can make an informed decision about whether to move forward. Failure to inform you of potential problems could make your physician liable for medical malpractice.

Continue reading "New Study Finds That Certain Antidepressants Are Linked to an Irregular Heartbeat" »

This blog has discussed the potential risks posed to pregnant women by certain antidepressant medication. Those who take antidepressants, especially during the first trimester of pregnancy, have a higher risk of having a baby with a birth defect. Pregnant women with depression would be wise to talk to their doctors about how to proceed. However, as a recent review demonstrates, finding the right approach is not always easy.

In a review of over 100 studies published in the journal Human Reproduction, researchers from Tufts University School of Medicine and Boston IVF found that there was no conclusive evidence that taking antidepressant medication led to better birth outcomes than not taking the medication. In fact, many women with mild depression tended to avoid selective serotonin reuptake inhibitors (SSRIs) such as Celexa, Paxil, and Prozac. At the same time, many doctors are reluctant to take any woman with depression off of antidepressants, believing that it is better for the fetus to be exposed to the effects of antidepressants than to higher stress hormones and other physiological problems the woman could have without the medication.

However, the researchers and many experts note that while there is no evidence connecting depression to problems with delivery or birth defects, there is evidence connecting antidepressants to these problems. For instance, for those who take the medication while pregnant, the rate of miscarriage increases from 8% to 12 to 16%. Moreover, women who take medication while pregnant double their risk of having their babies prematurely, which can lead to health and developmental problems. Finally, the effects of antidepressants could be found in many newborns' behavior. One third of newborns exposed to antidepressants in the womb developed "newborn behavioral system," which consisted of jitters, difficulties with feeding, and ceaseless crying. Researchers note that this condition is rare in babies who have not been exposed to antidepressants. While it clears up after a short time, it is unknown whether the condition leads to long-term effects, though animal studies suggest that it can change brain chemistry.

Researchers also note that it is mainly women with mild to moderate depression who do not show any major benefit from staying on antidepressants. It is not necessarily the case for women with severe depression.

It is a situation that deserves a lot of careful consideration. If you are pregnant and have concerns about whether to stay on your antidepressant medications, you should talk to your doctor and determine whether your depression is mild enough to permit a break from antidepressants if you so chose. In any event, your physician has a responsibility to discuss all possible risks and benefits so that you can make an informed decision. If he or she fails to do so, and you have a child with a birth defect as a result of your taking antidepressants while pregnant, you would have grounds to sue your physician for medical malpractice.

Continue reading "Researchers Find That For Women With Mild to Moderate Depression, Not Taking Antidepressants During Pregnancy May Provide the Best Outcome" »

In the past, this blog has often discussed new findings that show that pregnant women who take certain antidepressants are at greater risk of having children with birth defects. Now a new study has come out that provides more evidence of the dangers of antidepressant use.

The study, which was published in Human Research online, finds that those who take selective seretonin reuptake inhibitors (SSRIs) while pregnant are at a greater risk of miscarriage, preeclampsia, having children prematurely, or having children with autism. The class of SSRIs includes well-known brands such as Paxil, Prozac, Zoloft, and Celexa. At present, up to 13% of women are believed to take antidepressants, and use of the medication is most frequent among those between the ages of 18 and 44.

The study also found that Paxil use during pregnancy was linked to an increased risk of fetal heart defects. Paxil has been classified by the Food and Drug Administration as a Pregnancy Category D drug since 2005 -- meaning that studies have shown potential risks to the fetus, but that the risks may be outweighed by the benefits. Yet the study's senior author noted that while the results showed clear dangers to those who used Paxil and other SSRIs, it did not show that there was a benefit for women with mild to medium depression.

Not everyone agreed with the study's conclusions. Dr. Currier at the University of Miami argues that there is no specific evidence linking antidepressant use to miscarriage or a higher rate of preeclampsia, although there is some evidence of a connection to low birth weight. The study's authors cautioned that this study was not intended to discourage women with severe depression from taking antidepressants.

The study's results illustrate why it is important for women with depression who are thinking about becoming pregnant to have a serious discussion with their physicians. A physician has duty to each patient to inform him or her of all of the risks of a potential medication, so that the patient can make a responsible decision as to whether to take the medication. If you were prescribed Paxil or another SSRI while pregnant and had a child with a birth defect, you may be able to successfully sue your physician for medical malpractice. You would need to prove that your physician failed to warn you about the dangers of taking that medication, even though the information was within reasonable access. Therefore, your physician breached his or her duty to you, and as a result, you were injured and the damage was your child's birth defect.

Continue reading "New Study Provides More Evidence That Certain Antidepressants Increase the Risk of Miscarriage and Birth Defects" »

To add fuel to the fire about whether antidepressants are appropriate for pregnant woman to take, a new study has alarming information: certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), increase the risk of a brain bleed. SSRIs are commonly prescribed, and include familiar brands such as Prozac, Zoloft, Celexa, and Paxil.

After past studies offered conflicting evidence of whether SSRI users had a higher risk of brain bleeding and stroke, researchers from Western University in Canada decided to put the findings from 16 past studies together. The studies involved over 500,000 people who were SSRI users. What the researchers found was that SSRI users were 40 to 50% more likely to suffer from a brain bleed. While that number might sound alarming, it is actually an "extremely low" risk, representing one incidence of brain bleed for every 10,000 people who took SSRIs over the course of a year.

Researchers also cautioned that evidence did not show that SSRIs were directly responsible for brain bleeds. The cause might be the users' lifestyles, such as if they had a tendency to smoke or drink. At the same time, studies show that the danger of a brain bleed is greatest within the first six months of SSRI use, possibly because SSRIs make it harder for blood platelets to come together and clot. A person's platelet function may drop significantly during the first few weeks of SSRI use.

While the likelihood of brain bleeds may be small, it is still a concern, especially if the SSRI user is pregnant or thinking of becoming pregnant. As this blog has noted, there is already concern about the other potentially harmful effects of SSRIs and other antidepressants. Studies have shown that use of certain antidepressants during the first trimester of pregnancy can increase the risk of birth defects. At the same time, as noted recently, leaving depression untreated could also cause problems for the child developmentally, such as delayed speech.

What these studies underscore is how important it is for you to have a thorough discussion with your physician before agreeing to take antidepressants. Physicians have what is known as a "duty to inform," meaning that they are expected to inform patients of all possible risks associated with a specific course of treatment, so that the patient can then make an informed decision about whether or not to move forward. If you were prescribed a certain antidepressant, then later had a child with a birth defect, you could sue your physician for medical malpractice if he or she never informed you of the risks. Much would depend upon when you were first prescribed the medication and at what point you took it during your pregnancy.

Continue reading "New Study Finds That Certain Antidepressants Increase the Risk of a Brain Bleed" »

There is already evidence that women who take certain selective serotonin re-uptake inhibitors (SSRIs) during their first trimester of pregnancy are more likely to have babies with birth defects. Now the FDA has issued a warning to women who take the antidepressant Celexa based on a new study. Not only could Celexa potentially cause birth defects, but women who take the maximum 60 milligrams per day could also experience abnormal changes in the electrical activity of the heart. These changes could result in potentially fatal abnormal heart rhythms. As a result of the study's findings, the FDA has lowered the approved maximum dosage to 40 milligrams per day.

SSRIs are frequently prescribed to treat depression, anxiety disorders, eating disorders, chronic pain, and post-traumatic stress disorder. Their use has been linked to several serious birth defects, including persistent pulmonary hypertension of the newborn (PPHN), heart defects, and higher rates of autism. The FDA cautions that those on Celexa with congestive heart failure, or a genetic predisposition to low potassium or magnesium, are especially susceptible to health problems and should be careful when taking the medication.

If your child was born with a birth defect that you believe may be traced to your usage of Celexa, you have the option of filing a products liability lawsuit against Forest Laboratories, Inc., the maker of Celexa, and/or a medical malpractice suit against your physician. In both cases, it is important that you have strong evidence linking the birth defect to Celexa. That is because certain birth defects could come from many different sources, including environmental pollutants, genetics, and personal health habits. If you are certain that no other factor is the predominant cause of your child's birth defect, you would likely argue that the manufacturer was strictly liable and your physician negligent.

With the manufacturer, you would argue that whether or not negligence was involved, it was strictly liable because Celexa had a design defect that caused health problems, when it could have been made safer, without losing its effectiveness, for roughly the same cost. The design defect caused you injury, and you suffered damage in the form of your child's birth defect. With your physician, you would argue that he or she had a duty to warn you about the health effects of Celexa, but failed to do so, even though your physician knew or should have known about the risks. As a result, you took the 60 milligram dosage and suffered injury, with damage in the form of your child's birth defect (and your health problems as well). In both cases, the most common form of relief is damages, or a money award, for medical bills, pain and suffering, and more.

Continue reading "FDA Warns Users of Celexa That Maximum Dosage Could Lead to Health Problems " »