Selective serotonin reuptake inhibitors (SSRIs) are antidepressants that work by altering the levels of a mood-enhancing chemical called serotonin. But they are also linked to side effects like birth defects.
The first drug in the class known as selective serotonin reuptake inhibitors (SSRIs) hit the U.S. market in 1988 under the brand name Prozac. By 2005, antidepressants like Prozac had become the most prescribed drugs in the country. Today, about a dozen SSRIs are prescribed, including Paxil, Zoloft and Prozac.
SSRIs are considered third-generation antidepressants, and are known for having fewer side effects than older antidepressants. SSRIs are prescribed to treat depression, anxiety disorders, panic attacks and personality disorders. They have been shown to be more effective in severe cases of depression than in mild cases.
They work by increasing the levels of a brain chemical called serotonin, which plays a key role in mood. The body naturally produces serotonin and keeps it at a certain level, but SSRIs can increase that level by blocking (inhibiting) the re-absorption (reuptake) of serotonin.
People who take SSRIs for depression may be prescribed one or more of these prescription drugs, though not at the same time. If one SSRI medication is deemed ineffective, another is often tried. SSRIs can interact with other drugs or supplements in negative or positive ways.
SSRIs have a number of common side effects, including sexual side effects (a repressed libido, erectile dysfunction and difficult achieving orgasm, for men and women). Fatigue, weight loss, apathy, insomnia, headaches and pupil dilation are among the other most-reported side effects.
One serious side effect applies to women who are pregnant: If taken during pregnancy, SSRIs are shown to cause one or more birth defects. SSRIs can also cause suicidal thoughts and actions, especially in teenagers.
The overall side effects were serious enough to lead the FDA to issue multiple warnings about many of the drugs. In addition, some of the drugs are the target of product liability lawsuits.
Once considered a taboo in American culture, the taking of SSRIs is widely accepted, evidenced by both the growth in the market for the drugs and the number of available drugs. Prozac, Paxil and Zoloft are the most popular SSRIs.
Together, Prozac (fluoxetine) and its generic equivalents are the third-most-prescribed antidepressant in the United States. As a result, there are concerns that this SSRI is overprescribed, subjecting patients to a large number of side effects and complications. In addition to the birth defects cited, patients taking Prozac may experience nausea, insomnia, drowsiness, anorexia, anxiety, nervousness, weakness and tremors, and sexual dysfunction.
Paxil (paroxetine) was introduced to the U.S. market in 1992 by GlaxoSmithKline to treat depression, but this SSRI also is the first SSRI approved by the FDA to treat panic attacks. Paxil, however, is considered more dangerous to a fetus, and women are urged to avoid it during pregnancy. Paxil was reclassified as a grade D for safety during pregnancy.
Zoloft (sertraline hydrochloride) is a popular antidepressant that Pfizer began selling in 1991. This drug shares the higher rate of birth defects that most SSRIs are linked to, such as heart defects and persistent pulmonary hypertension of the newborn (PPHN). Studies show that mothers taking Zoloft in the first trimester were 2.8 times more likely to have the abdominal defects of gastroschisis and omphalocele, in which a hernia allows organs to float outside the body of the fetus.
SSRIs and FDA Warnings
Suicidal thoughts were well-documented in youths taking Prozac before the FDA stepped in and warned the public of this danger in October 2004. Two years later, the federal agency expanded the safety alert to include patients through age 24.
The FDA also issued official warnings in 2006 for an increased risk of PPHN and Serotonin Syndrome in pregnant patients taking SSRIs.
PPHN is the condition that often goes undetected during pregnancy and can lead to a baby being born with serious heart and lung difficulties. Serotonin Syndrome occurs when a patient accumulates too much serotonin in the brain — either from overdosing on an SSRI or taking a combination of medicines that boost the serotonin levels beyond what the brain can handle. With this condition, the onset can occur within minutes and be fatal if not treated immediately.
In 2007, the FDA began requiring antidepressant manufacturers to update their black-box warnings — the strongest alert before a drug is pulled from the market — to spell out the suicide risk children face during initial treatment.
Unfortunately, this may have resulted in more suicide attempts among youth who needed antidepressants but did not take them because of the warning. A study found that antidepressant use in adolescents dropped 31 percent after the FDA issued the black box warning, but suicide attempts among youth increased 22 percent. The FDA revised the warning, recommending physicians consider both the risk of prescribing and not prescribing the medication.
Have you taken an antidepressant?
If you took SSRIs while pregnant, you may have legal options.
SSRI Side Effects
The unpleasant reality of choosing to take an SSRI is that the patient must be willing to live with certain side effects. Although each SSRI drug works slightly differently on each person because of its chemical makeup and the person’s overall health, the class of medications has many side effects in common.
|Patients are likely to experience some or all of the following:|
|Rash||Weight loss or weight gain|
|Agitation||Decreased sexual desire|
|Difficulty reaching orgasm||Erectile dysfunction|
SSRIs and Severe Side Effects
Because antidepressant medications are such big business for drug manufacturers, the pharmaceutical industry reacts slowly to research that links these prescription medications to dangerous side effects. Among the two most frightening are birth defects and suicide in children and young adults.
Prozac is the only SSRI approved by the U.S. Food and Drug Administration (FDA) for use by children ages 8 and older. As the number of children being treated for depression with Prozac increased, doctors observed an alarming number of reports of their thoughts about suicide and even actions taken to hurt themselves.
These young patients are especially vulnerable during the first two months of treatment when their bodies are adjusting to the medicine. Parents and caregivers should watch for worsening of irritability, nervousness, agitation, mood instability or sleeplessness. Unfortunately, the legal options are limited for family members of someone who committed suicide while taking an SSRI.
Another serious concern for SSRI patients is whether they will suffer withdrawal symptoms when they stop taking the antidepressants. SSRIs technically are not considered addictive, because they do not cause cravings in the body when the patient stops taking the drugs. However, doctors do say that these antidepressants make users dependent on them, and they can suffer withdrawal symptoms. Drug dependency is the state where a person needs steady or increasing doses of the drug to maintain normal functioning. Because of this, patients are warned not to stop taking SSRIs suddenly, or they can expect to experience nausea, headaches, dizziness and lethargy.
In severe cases, patients will have a collection of symptoms called SSRI Discontinuation Syndrome, which can last up to several weeks. According to a panel studying this condition, “Physical symptoms include problems with balance, gastrointestinal and flu-like symptoms, and sensory and sleep disturbances. Psychological symptoms include anxiety and/or agitation, crying spells, irritability and aggressiveness.”
|Other severe side effects of SSRIs include:|
|Risk of bleeding: Patients taking SSRIs have a reduced capacity for their blood to clot. A lower concentration of serotonin in platelets increases the risk for stomach or uterine bleeding, which means an increased need for a blood transfusion during or after surgery.|
|Hyponatremia: This condition is a drop in a person’s sodium levels, which can lead to the accumulation of fluid in cells and is dangerous. Elderly people especially should be monitored for this condition from the beginning of treatment.|
SSRIs and Birth Defects
Doctors caution women about the use of SSRI antidepressants during pregnancy. One way they convey this warning is with the letter grades that are assigned to prescription medications to denote their safety ratings. Most SSRIs are grade C, and this category of drugs has been known to harm laboratory animals when they ingested the drugs in large quantities. For ethical reasons, SSRIs cannot be tested on unborn humans.
|However, many serious birth defects have been reported in babies whose mothers took SSRIs during pregnancy.|
|Heart defects: The most common heart conditions in babies are septal defects — atrial septal defects (ASD) and ventricular septal defects (VSD) — which are holes in the heart that compromise blood flow.|
|Persistent Pulmonary Hypertension of the Newborn (PPHN): This condition, which damages the hearts and lungs, occurs in utero but is rarely detected until the baby is born.|
|Anencephaly: This is a devastating birth defect that leaves a baby without a large part of the functioning brain, skull and scalp and is always fatal.|
|Cleft lip and palate: Clefts are the gaps left when the facial structures are forming and typically occur on the top lip and roof of the mouth. These deformities usually require multiple surgeries to correct and can hamper feeding, breathing and speech development.|
|Respiratory distress: Respiratory Distress Syndrome is a kind of breathing difficulty occurs in premature babies and is attributed to the baby’s underdeveloped lungs. Respiratory distress also is a symptom of Neonatal Adaptation Syndrome, which researchers have linked to the use of SSRIs in the third trimester.|
Many medical and legal professionals believe antidepressant manufacturers need to be held accountable for not fully informing patients about what could happen to them and their babies if they take these prescription medicines.
One manufacturer already paid millions of dollars in verdicts and settlements to those who suffered birth defects after taking its antidepressant medication:
In 2009, a Pennsylvania jury awarded $2.5 million to the Kilker family after Lyam Kilker was born with heart defects attributed to his mother’s use of Paxil while pregnant. The jury found GSK failed to warn users of the drug’s risks.
In 2010, GSK settled more than 800 cases involving Paxil birth defects for more than $1 billion, averaging more than $1.2 million per case.
Hundreds of lawsuits against other manufacturers remain in court. Victims of SSRIs deserve to be compensated for mounting medical bills, loss of wages, and the pain they have experienced as a result of taking the drugs. To find out about your rights, contact an experienced prescription drug lawyer.