Product Liability Attorney Blog

The link between antidepressants taken during pregnancy and the development of birth defects in the fetus has been documented consistently. SSRIs and SNRIs like Paxil and Effexor are at the front of the list, leading to a range of disorders from Persistent Pulmonary Hypertension of the Newborn (PPHN) to cranial deformation and clubbed limbs. Now it seems that an even greater risk to the fetus is present when these medications are taken: the threat of miscarriage.

A study recently done on Paxil suggests that it and other drugs may increase the risk of a miscarriage to as much as 34 percent. The overall rate for miscarriages is approximately 20 percent. To put this in perspective, this is the same as going from one woman in every five pregnancies losing her unborn child to one woman in every three doing so.

A miscarriage, of course, is the body spontaneously terminating a pregnancy when it detects something is significantly wrong. Miscarriage is a terrible thing for any woman to go through; no matter how much she understands the possibility, nothing can prepare an expecting parent for the emotional intensity of the event.

The other numbers released by the study are just as sobering. Women taking Effexor had a 50 percent increased risk of having a miscarriage, while women taking Paxil had 75 percent risk increase. These are not small statistics or minor variances in data.

The study was not a statistically insignificant one either. Over 5100 women who miscarried were involved. Nearly 300 of the women who miscarried were on antidepressants. Of these, at least five percent had filled a prescription for their antidepressants while pregnant.

The study is careful to explain that there is no definitive information saying that the antidepressants cause miscarriages directly. There only is a demonstrable correlation between the two events. However, it is certainly enough evidence to warrant further investigation and to prompt any expectant mother prescribed one of these medications to speak honestly with her doctor.

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The death of Canadian university student Sara Carlin has brought attention back on the popular SSRI antidepressant Paxil. There have been a number of cases potentially linking the use of Paxil with increased risk of suicidal thoughts and fixations, particularly among young adults. Carlin was under the influence of Paxil, as well as alcohol and cocaine, when she hung herself in May 2007. While her doctor and Paxil's manufacturers stress that she had expressed depressive feelings leading up to the prescription of the medication, Carlin's family insist that she was normally a happy, healthy young lady and that the medication had drastically altered her personality.

A jury in the case has released a verdict, recommending strongly that doctors be retrained to properly inform patients of both the benefits and the risks of taking medicines such as Paxil. Emphasis would be on bringing up the rare but serious and dangerous side effects such as suicidal thoughts as in Sara Carlin's case.

Carlin's family said they were pleased with the verdict. They believe that had these warnings been available, Sara might have been able to make different decisions and could even still be alive.

This case comes at a curious time for Paxil's manufacturers. The company recently elected to settle nearly 200 pending and unresolved cases related to the drug and its role in the formation of birth defects. Usually a controversial medication is subject only to one type of litigation at a time, but Paxil is dealing with matters on two fronts: The formation of birth defects and the suicidal thoughts link.

Ultimately, this likely will not prove a watershed or landmark case in the ongoing struggle to bring the truth of these medications more completely into the open. However, it is a positive step that could very genuinely lead to better information — and prevent future tragedies.

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A great deal already has been said about the digestive medication Reglan and its links to the movement disorder Tardive Dyskinesia (TD). TD is deeply misunderstood by people who haven't experienced it; sadly, this group includes many doctors who may have prescribed Reglan to their patients. People who suffer from TD can't control the movements of their body, including nuances of facial expressions or spasming of their limbs. Interacting with delicate, sharp or fragile objects becomes hazardous — can you imagine handing a piece of glassware to someone whose hands jerk uncontrollably?

Yet in many cases TD patients are told to “live with it,” as if it were a minor matter that simply could be ignored and handled with the proper willpower and humility. This attitude makes this serious medical condition seem like little more than a minor inconvenience, and tells the patient he is rude to ask for help with it.

The language above is accurate by the way: TD is a serious medical condition. For example, consider the associated condition that certain TD patients have been known to develop — Neuroleptic Malignant Syndrome (NMS). While just 1 percent of TD patients develop this illness, 20 percent of that group dies due to NMS. NMS often results in high fever and varying blood pressure; in the worst cases this can lead to a coma and even death. While the numbers are indeed low, the fact that the initial condition (TD) was caused by a prescription medication should be considered worrisome, and should put to rest any kind of “live with it” commentary from those who really should know better.

TD is a frustrating, emotionally painful, physically disruptive illness that can have very serious and potentially fatal side effects. That it comes from a prescription medication is a terrible thought. So to those who have taken Reglan and are suffering from TD, don't feel that you have to live with it. Demand answers, and make sure you know your options.

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It’s devastating to be harmed by a medicine that you're taking in order to get well. But the fact is that every medicine functions on a trading of effects, with the hope that the therapeutic benefits outweigh the risks. However, in some cases, these risks are quite out of proportion to the benefits, as can be argued about the antibiotic Levaquin. This drug consistently has been linked to severe tendon rupture injuries; now the FDA has ordered that Levaquin carry its strongest black-box label warning about such dangers. A tendon rupture is no small thing, and the effects it can have on someone’s life, especially in terms of the treatments involved, can be overwhelming.

The first part of any treatment is, of course, diagnosis. A trained physician should evaluate potential ruptures through hands-on testing such as blood pressure tests or observation of movement. Other tests include more technical examinations, such as x-rays, ultrasound or magnetic resonance imaging (MRI) tests. X-rays might be augmented by arthography tests, which use a special dye that shows up on x-ray images. Each of these tests costs money, especially MRI examinations which can cost several thousand dollars at some facilities.

Actual treatments do depend on the severity of the injury. All doctors recommend the standard RICE treatment procedure — rest, ice, compression and elevation. However, the exact nature of the injury will determine what needs to be done. Quadriceps ruptures can be treated with an immobilizing device such as a brace or a cast. While surgery isn't the first choice, some ruptures that result from trauma can require it. It all depends on the doctor’s discretion and the degree of damage done. In addition, Achilles tendon ruptures have a tendency to re-rupture one out of every three cases. This can mean more treatment, more time spent recovering and still more money poured into the hospital, all for a medicine prescribed for an entirely different ailment.

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If you have a story about how the progestins Yaz and Yasmin have caused you injuries such as a blood clot or stroke, the time has come to share it. One of the best defenses patients have in the case of injuries caused by prescription drugs such as Yaz and Yasmin is the consumer protection group. This concept exists as a fairly recent phenomenon from the last 100 years. Such groups monitor various elements that may affect consumer health, seeking to protect people from the harm that can be caused by a lack of information.

One such group, the U.S. Drug Watchdog, is asking women who have experienced negative health consequences from taking Yaz or Yasmin to share their stories.

"We are talking about blood clots, heart attacks, strokes and other potentially extremely serious medical side effects from the use of these drugs," officials from U.S. Drug Watchdog say.

The invitation calls for women with the aforementioned experiences to contact the Watchdog directly or to pass along the chance to speak out to other women who may have experienced these health consequences in whatever way they feel inclined.

Such measures as this are laudable, and they don't exist simply to help big class action suits. If you have a more private claim against the makers of these medicines, your story can help both you and others. By sharing it with as many people as you can, you expand the knowledge base about these medicines and improve the accuracy of the statistics involved. When there are many stories and testimonies available, the picture becomes much harder to ignore, and this can affect both the big sweeping cases and more personal, smaller efforts to gain recompense. Your story is never too small, and it should be shared if you feel you can share it.

Yaz and Yasmin have been linked to very serious complications. This is not something that can be ignored, but rather should be discussed openly, before other potentially dangerous effects occur.

The anti-depressant commonly known as Reglan has been consistently linked with the development of a movement disorder known as Tardive Dyskinesia (TD). TD is characterized by a belated development of involuntary physical tics that, in combination, can start to seriously impinge upon the patient’s life. The exact causes are unknown, and there are currently few treatments available for the disorder.

There are a number of symptoms of TD, some of which are very similar to those in Tourette Syndrome. In all cases, the movements are entirely involuntary, and can cause a sense of physical discomfort if the patient tries to ignore them.

Noted tics that come with TD are quite numerous: Arms, legs and the trunk will often move rapidly about, sometimes even violently. Some patients report continual, rapid blinking of the eyes. Others experience the need to suck on or “smack” their lips over and over. Some are described as trying to play an invisible guitar or piano as their fingers move rapidly back and forth. Still others report unexplained chewing motions, or facial grimaces that they did not intend to make. Movements of the tongue are also common.

In and of themselves, these may not seem like particularly bothersome afflictions. However, imagine trying to get a good night’s sleep when your body won’t stop moving. Consider the effect the same activity might have on a spouse or companion. Chapped lips frequently result from continual licking or sucking motions. Also, consider just how “harmless” an involuntary body motion would be when, for example, trying to drive a car or cut food for dinner.

TD is not necessarily as critical or life-threatening an ailment as some medical side effects. The point, however, is that it does not have to be immediately life-threatening in order to notably and negatively impact someone’s life. Given that there are few treatments beyond a small handful of promising medical trials and a “wait and see” approach, it would be quite unseemly to dismiss the impact of this disorder in those unlucky enough to be exposed to it.

There have been a number of legal cases and studies linking the antibacterial drug Levaquin with tendon injuries. These injuries range from relatively minor but uncomfortable tendonitis, which is frequently treatable with rest and anti-inflammatory medication, to the far more serious and potentially crippling tendon rupture. A rupture is a serious injury, frequently requiring surgical intervention to correct. Ruptures can be intensely painful, and if not treated promptly and properly can result in long-term crippling disability. For patients taking Levaquin, knowledge of the symptoms of a tendon rupture is therefore vital.

The first symptom a patient might notice is a sudden popping sensation. This can be similar to the sense of popping one's knuckles, and is felt, heard or both. Usually it is followed by severe pain, moderate swelling and the rapid spread of bruising in the affected area. The patient's ability to use the affected limb also usually will be markedly diminished. After all, a tendon is an important element in the ability to move muscles around.

Between the physical pain of the injury and the reduced range of motion, the patient is likely to feel a distinct sense of weakness in the affected limb. The reduction in range of motion can extend from difficulty using the affected limb to outright inability to move it at all. Further symptoms include the inability of the limb to bear even the slightest weight. The location of the rupture also can be the site of visible deformity, such as bulges or twisting contours.

Specific portions of the body also have their own unique reaction to a tendon rupture. If the Achilles tendon bursts, which is a common result of Levaquin damage, the patient is likely to find himself unable to stand on tiptoe. If the bicep has ruptured, a sure sign is being unable to extend the arm out to one side while holding the palm of the hand upward.

If a patient taking Levaquin experiences any of these symptoms, it is important to contact medical help immediately.

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There are hard decisions to make when choosing whether to continue taking an antidepressant while pregnant. Choosing to discontinue treatment means possibly exposing the child to unique difficulties in and of itself. These can include lower birth weight and decreased brain development. However, studies do increasingly show that exposure to SSRIs increases the risk of birth defects up to six times over not exposing the fetus. There are nonmedical methods of treating depression that might be considered instead of taking the risk, and doctors must be encouraged to give their patients all the information available.

One drug, Effexor, isn't technically identical to other SSRIs, because it doesn't exclusively affect serotonin intake. It also alters norepinephrine uptake to provide more overall coverage than a simple SSRI. In essence, though, it is the same broad type of medication as an SSRI in that it regulates the way the body processes chemicals related to mood and mental balance.

Effexor exposure has been shown to potentially result in the same type of defect that pops up among SSRIs and antidepressants in general — the heart defect. Studies performed in Denmark have shown a definitely increased risk for developmental problems in the heart when fetuses are exposed to Effexor and similar medications. These can include valve deformities, septal defects such as holes through the heart wall and the like.

Further, there are indications that such medicines also cause developmental disorders, a less immediately noticeable form of birth defect. Specific delays were noted in the ability to sit up without support, or beginning to walk. Children who had been exposed to SSRIs and SNRIs showed a marked delay in the development of these abilities, often only grasping them a month and a half behind children who were not exposed to the medicine. The studies showed that the effects existed in both permanent and reversible forms.

It's no secret that a number of antidepressants have been linked to the formation of birth defects, particularly SSRIs taken in the first trimester of pregnancy. In the last 10 years, numerous drugs of this type have been moved to a class D pregnancy rating, which is the FDA's signal that they are scientifically and consistently linked with the formation of these defects when taken by pregnant women. While Paxil is the most well-known of these medicines, there are other SSRIs that have been linked to the formation of these defects.

Zoloft

Also known as sertraline, Zoloft is an SSRI that gained popularity in the early 2000s with a series of advertisements based around morose little cartoon characters. It popularized the “chemical imbalance in the brain” argument to clinical depression treatments. Part of its popularity can be linked to the fact that it has markedly less pronounced side effects than older-generation antidepressants while still remaining potent.

It has been linked specifically with the birth defects Omphalocele, which is a condition in which the internal organs such as the intestines are found outside the body in a sac, instead of within the abdomen, limb reduction, and septal defects such as holes in the wall separating the chambers of the heart.

Prozac

Perhaps the most iconic of the SSRIs, Prozac is not only among the most commonly described medications for depression, it has become a shorthand word for antidepressants in general. It has such a widespread reputation that hearing others have been prescribed it doesn’t shock people; in fact, going onto the medication is almost seen as a “norm.”

Unfortunately. It has been empirically linked to the development of Persistent Pulmonary Hypertension of the Newborn (PPHN) when taken by the mother during pregnancy. PPHN can cause chest pain, dizziness, fainting and other weaknesses in a child. Often times victims of the malady require a lung transplant, a situation that is unthinkable and terrifying to many parents, and something no one should ever have to undergo if it can be prevented.

We've spent a good amount of time exploring the link between SSRIs and birth defects. Paxil remains the most notorious drug for causing this heartbreak, but there are birth defects linked to many popular SSRIs, and patients prescribed these medications should be informed. While no decisions should be made without consulting a doctor, information is vitally necessary in order to make the best, safest choice for mother and child alike.

Symbyax is an interesting case among SSRI treatments in that it is not a single medication. It is a combination of the SSRI Prozac with an antipsychotic medication. It's used to treat depression patients with atypical and serious depression symptoms. In particular, the FDA has approved it for use in managing depression related to bipolar disorder, popularly known as manic depressive disorder, which is characterized by severe mood swings between hyperactivity and severe depression.

It also has been linked consistently to the formation of heart defects in infants when taken by a mother during pregnancy. Predominant among these are septal defects, which consist of holes in varying size through the walls separating the heart chambers. Atrial defects, or ASDs, are holes through the wall in the upper chamber, while ventricular defects, or VSDs, are present in the lower chamber wall. Either condition can result in stunted physical development and a limitation on activities, and some ASDs require surgical intervention.

In addition, Symbyax has been connected to the development of craniosynostosis. In short terms, this is a condition in which parts of the child's brain fuse together and seal up too early. These parts, called sutures, grow together at an abnormal rate when the child is exposed to Symbyax, and the result is an abnormally-shaped cranium. This can create any number of problems ranging from simple but tragic deformity of appearance to actual danger to the child's developing brain.

More information is always good, particularly when you're trying to sort out a difficult issue. It's never easy being sick, and it can be heartbreaking to realize that the medicine you took for your illness hurt someone special to you. SSRIs such as Paxil have been linked to a number of birth defects when taken by women in the first trimester, so having a bit of information about what types of defects the medicine has been known to cause can help you sort through the confusion and consider what your next step should be.

Some of the defects caused by Paxil are visible, external matters. They can affect appearance and overall health equally. For example, some children exposed to SSRIs in the womb develop a clubbed foot. This is a malformation of the foot that can make it difficult and painful to walk, and can lead to strain on the joints of the leg and lower back. In other cases, some children developed an abnormally-shaped skull when exposed to the medicine. Beyond the difficulties this causes for appearance, an abnormal skull can be more fragile than a properly-developed one.

Other defects aren't as visible, but are no less serious for that. In some children exposed to SSRIs, the anus doesn't develop properly, and forms partially-closed or even entirely closed. The danger this creates is frighteningly obvious. Other defects include spine and brain deformities that can severely hinder their development. Still more involve the heart growing improperly with defective valves. In some cases, children are born with a terrible condition known as PPHN (persistent pulmonary hypertension). In the simplest terms, this horrifying ailment means they cannot breathe properly in the outside world. Many of these internal conditions require surgical intervention, which can be both costly and dangerous for the child.

In short, there are many defects that can be linked to in-pregnancy exposure to SSRIs like Paxil. If you have any suspicion that this might be the case in your family, there is no shame at all in looking into the matter.

One of the most difficult matters in deciding pharmaceutical cases is determining where fault lies in the production of generic medications. Plaintiffs injured by generics often feel they have a right to pursue the originators of the formula in question. After all, the original manufacturer and developer came up with the medicine, testified it was safe for common use to the FDA and got FDA approval, all long before secondary manufacturers began producing the generic equivalent in bulk. Thus, regardless of whether it was the original formula or a generic copy, the theory argues that a certain amount of blame can be placed on the original producers.

For the time being, however, the Federal courts do not seem to agree. In a recent decision, Federal judge Marcia Crone ruled that because plaintiff Judith Finnicum only took a generic formulation of the drug Reglan, produced wholly by Actavis-Elizabeth, then she could not sue the manufacturers of the original medication. Finnicum's suit against Actavis-Elizabeth may proceed as planned, but the drug's original development/manufacturing companies, Wyeth and Schwarz Pharma, are excluded.

People like Judith Finnicum who have been prescribed the medication have developed a movement disorder known as Tardive Dyskenesia. This disorder is characterized by uncontrollable muscle tics and movements that can be distracting and exhausting, and in some cases painful to live with.

This decision is one of the latest that presents a major setback for plaintiffs complaining of the disorder after taking Reglan. In 2009, a suit sought to consolidate all the ongoing Reglan cases into one major case. The judgment in that case went against the plaintiffs, however, so each Reglan case must proceed on its own merits and be resolved individually.

The risks from Reglan are not new, and have in fact been well-documented. It is one of a select few drugs with a black box warning from the FDA, which is the agency's strongest possible warning criteria.