Paxil was approved and marketed in 1992 by the British pharmaceuticals company SmithKline Beecham, which has now become GlaxoSmithKline, a huge multi-national conglomerate in the pharmaceutical industry. During its peak year of 2007, more than 18 million prescriptions were filled and it had become the fifth most popular antidepressant drug in the US.
Paxil (paroxetine) is a popular type of antidepressant which belongs to a group of antidepressants known as serotonin-specific reuptake inhibitors (SSRIs).
Paxil is prescribed to treat a mental disorders such as major depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety, and posttraumatic stress syndrome. It is also used for a number of related mental disorders and other disease states such as bipolar disorder, premenstrual dysphoric disorder (PMDD), Diabetic neuropathy, and headaches.
Paxil, like other SSRI drugs has a number side effects that range from simply irritating or bothersome, to severe side effects which may be life threatening.
In 2004, the FDA found that there was an increased risk of suicide in children and adolescents taking Paxil. The same year, the company was accused by the Attorney General of New York to be hiding information regarding suicide risks of the medication. In 2004, the FDA required the addition of a black box warning for its increased risk of suicide.
In 2005, another advisory was issued by the FDA regarding increased risks in women taking Paxil while pregnant. The advisory cited a number of debilitating and life-changing birth defects.
GSK has also had a number of lawsuits filed against it and settled several claims regarding accusations of packaging and mislabeling errors, sham litigation to block generic manufacturing of the medication, withholding safety information and the unlawful promotion of Paxil use in children.
What is Paxil?
Paxil is the brand name for the generic medication paroxetine. It is approved to treat a number of mental disorders such as major depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety, and posttraumatic stress syndrome. It has only been approved for use in adult patients.
It is also used as off-label treatment for bipolar disorder, premenstrual dysphoric disorder (PMDD) – Physical and psychological symptoms that start before the onset of a woman’s menstrual cycle), Diabetic neuropathy (tingling in the hands and feet), and headaches. Off-label use is allowed by a physician but the manufacturer is not allowed to promote or advertise off-label uses.
The SSRIs work by affecting the serotonin receptors in the mood centers of the brain. Serotonin is a neurotransmitter (a chemical messenger) in the brain that helps maintain mood states. Specifically, the SSRIs block the reuptake of serotonin that has been released so that it can send more “feel good” messages to the rest of the cells in the mood centers.
It is available in tablets of 10 mg, 20 mg, 30 mg, and 40 mg. It is also available in liquid, both for oral administration. In most cases, physicians advise that the medication will not begin to take full effect for two to three weeks after it is started.
Side Effects and Drug Interactions of Paxil
Paxil, like many other antidepressants has a number of side effects, related to its influence on the serotonin receptors in the brain. It also may have interactions with other medications. Most of these adverse effects are minor, but some are severe and may become life-threatening.
The most common side effects of Paxil include:
- Dry Mouth
- Sexual dysfunction in both males and females
Paxil can also have drug interactions with other medications including:
- Antianxiety agents such as lorazepam and alprazolam (increased sedation)
- Dextromethorphan (tyramine reaction: headaches, pain, increased heart rate)
- Diuretics such as furosemide and hydrochlorothiazide (low sodium levels)
- Antihistamines such as diphenhydramine or chlorpheniramine (increased sedation)
- Other antidepressants (increased side effects)
- Pain relievers such as hydrocodone (increased sedation)
- Appetite suppressants such as phentermine (nervousness, heartbeat irregularities and more severe effects)
- Radiopaque agents for x-rays (seizures, may need to withhold Paxil prior to X-ray)
- Caffeine and ergot combinations (serotonin syndrome – seizures, heart rate and blood pressure changes, fever and more severe effects)
Serious Adverse Events of Paxil
Some side effects of Paxil are more severe and warrant immediate emergency medical treatment:
- Balance or coordination disorders
- Racing heart or abnormal heart beats
- Allergic reaction
Paxil in Pregnancy
Paxil may cause complications for women who are pregnant and their fetus.
When Paxil is taken by pregnant women it may cause:
- Premature Birth
- Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS)
- Other septal heart defects
- Persistent Pulmonary Hypertension in Newborn (PPHN – blood vessels to lungs are under high pressure and cannot supply oxygen to the rest of the body)
- Cranial defects
- Spina Bifida
- Cleft Palate or Cleft Lip
- Ophalocele (abdominal organs on the outside of the body)
- Club Feet or other malformation of limbs
- Delayed development
- Autism spectrum disorder
- Pulmonary stenosis and atresia
Medical groups such as the American College of Obstetrics and Gynecology (ACOG) recommends that women who are or intend to become pregnant should not use paroxetine because of an increased risk of birth defects and miscarriage or premature birth.
Paxil and Suicide
The FDA voted in 2004 to require all manufacturers of antidepressant medications to add a black-box warning to the product labels. A black-box warning is a notification that is placed at the top of all prescribing information so that it will be the first thing seen by a physician or health care provider. The black-box notification is the most serious warning that any medication can get.
The black-box warning on Paxil and other SSRI antidepressants identifies an increased risk of suicidal thinking and behavior in children, adolescents, and young adults following short-term use for a major depressive disorder. The warning also advises that patients who take the medication for depression should be closely monitored for signs of suicidal type behavior and other changes.
Risperdal Events, Criminal Charges, Recalls and Lawsuits
Manufacture Criminal Indictment
In 2012 GLAXOSMITHKLINE settled the largest Health Care fraud case in U.S. history the manufacturer pled guilty to a criminal indictment and pay $3 billion in penalties and fines for the illegal promotion of Paxil and Wellbutrin, both manufactured by GSK, for the use of the medications in the treatment of children and adolescents. Neither medication had been approved for these age groups but was reportedly being marketed for off-label use. The indictment also included a failure to report safety data about another medication, Avandia, also manufactured by ideas GSK for the treatment of diabetes.
The manufacture was also found guilty of giving kickbacks to doctors including the provision of high-priced entertainment such as Hawaiian vacations, millions of dollars in payments for speaking tours, and tickets to Madonna concerts.
Specifically regarding Paxil, it was alleged that GSK published a medical journal article misrepresenting data from a clinical study and exaggerating data regarding Paxil’s ability to reduce depression in adolescents.
As part of a settlement, the manufacturer, did not admit any wrongdoing in the civil settlement but agreed to be monitored for five years. Penalties were the largest ever awarded but critics have argued that they were not enough to deter pharmaceutical companies from the illegal activities.
During an approximately 10 year period, GSK’s revenue was over $28 billion for the three medications: Avandia, Paxil and Wellbutrin. The settlement of $3 billion was less than 15 percent of sales for the three drugs.
Recalls for Paxil
In 2005, several lots of Paxil CR were recalled due to manufacturing problems at the Knoxville, TN and Cidra, Puerto Rico facilities. However, the FDA seized additional remnants of the recalled lots because of determination that tablets could split causing the controlled release system to fail, resulting in some patients receiving too much active ingredient and others receiving little to none.
Despite the recall, GSK continued production and distribution from both plants, for several months after the recall.
Lawsuits for Paxil
Approximately 5000 lawsuits have been filed in the United States against GSK since Paxil was approved. A portion of these claims have been class action suits and the company has paid $billions for resolution.
The first birth defect case went to trial in October of 2009. It was found during discovery that animal studies dating back to 1980 had shown the risk of birth defects in rats. In addition, an internal memo dating back to 1997 showed that the company would “bury” any negative results if forced to perform additional animal studies were required.
Lawyers for the plaintiff argued that GSK had been negligent in its failure to warn a doctor about the use of Paxil in pregnant women and that the medication was the cause of her infant son’s heart defects and subsequent death. A Philadelphia jury awarded the family $2.5 million in damages which was twice the amount asked for by the family.
By July 2010, the manufacturer had paid over $1.14 billion to settle over 800 lawsuits regarding birth defects. The average lawsuit recovery regarding injuries to children has been shown to be $1.25 million by the University of Richmond Law School.
GSK also faced over 3,000 lawsuits regarding Paxil’s link to drug addiction. The plaintiffs claimed that sufficient warning was not given about withdrawal effects occurring after the drug was discontinued and that Paxil had specifically been marketed as “non-habit forming”. Each case was settled for an average of $5,000. The company also has paid over $390 million for cases related to suicide or attempted suicide that had been linked to the drug.
GlaxoSmithKline has set aside $3 billion to help settle court cases but hundreds of cases of Paxil lawsuits are still emerging.