Although each of these SSRI manufacturers admit they do not know how their respective drugs work, each claim that they help to correct a “chemical imbalance of the brain.” The assumption for each of these drugs is that if a person is depressed (each and every depressed person), there is a reduced level of the neurotransmitter serotonin in their brains. As one well-known psychiatrist put it: “[SSRIs] are not correcting a biochemical imbalance, these drugs create severe imbalances in the brain. … The idea that human suffering, psychological suffering, is biochemical is strictly a promotional campaign, perhaps the most successful in the history of the world, created by the drug companies. We do not even have a technology, a scientific technology, for measuring what happens inside the brain … it is literally a fabrication.”
Antidepressants can cause a medical condition called akathisia or hyperkinesia. Both can best be described as severe agitation, sometimes accompanied by motor restlessness (inability to sit still, feeling the need to pace, etc.). This can be an extremely distressing experience and can lead directly to mental confusion and suicidality. If you experience this condition, it is very important to tell your doctor immediately. It can be relieved by stopping the drug or your doctor may prescribe a general sedative. (Do not stop taking any medication without first talking to your doctor.)On March 22, 2004, the FDA asked the makers of antidepressants to place in the “Warnings” section of their drug’s label a statement that both children and adults should be monitored closely at the beginning of drug therapy, or when a patient’s dosage is increased or decreased, for signs of “worsening depression,” or “emergent suicidality [that] is severe, abrupt in onset, or was not part of the presenting symptoms.” The FDA also stated that health care providers, patients and their families should be warned about the association between these specific antidepressant drugs and: “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (extreme restlessness), hypomania, and mania[.]”
PAXIL MAKER ISSUES WARNING REGARDING SUICIDALITY RISK IN ADULTS GlaxoSmithKline (GSK), the maker of the antidepressant Paxil, has amended its labeling for Paxil to include a warning that, like children and adolescents, adults are at a higher risk of suicidality when taking Paxil. GSK has also issued a letter to doctors in the
United States alerting them to the new label. The new warning comes following an analysis GSK conducted based in large part on data collected for the FDA’s currently-underway adult analysis of all antidepressants (in FDA’s attempt to determine if the suicidality risk found in children and adolescents extends to adults). GSK apparently decided to do its own analysis of the data rather than wait for the FDA’s conclusions.GSK’s analysis found a “higher frequency of suicidal behavior in young adults” ages 18-24 for all indications and for “adults with MDD [Major Depressive Disorder] (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. [ ] This difference was statistically significant.” Despite GSK’s admission of higher rates of suicidality and “statistical significance” (which generally means fairly conclusive proof of causation), in its letter and other briefing material, GSK attempts to downplay the risk and suggests that its awareness of the risk is “new.”Attorney Karen Barth Menzies of the Baum Hedlund law firm, a leader in antidepressant-induced suicidality cases for over 15 years stated:“GSK has finally done the right thing, unfortunately, it is over-shadowed by its delay. This analysis could and should have been done a long time ago. GSK has had this data in its possession for years. Unfortunately, it continues to spin the facts as if this is ‘new data.’ People need to realize that GSK limited this analysis to only certain of its clinical trials, which effectively excluded numerous suicide events. We know, for instance, that in GSK’s initial FDA submission in 1989, there were 7 suicides and 42 suicide attempts in Paxil patients, while there were zero suicides and 1 suicide attempt on placebo.“GSK should have warned from the beginning and the FDA should have done a better job at protecting American consumers. This warning, tragically, comes far too late for the families whose loved ones have fallen victim to this deadly side effect.”Ms. Menzies’ dedication and commitment to the cause of increased warnings about the risk of suicidality has brought her several prestigious lawyer awards. Along with some of her clients, Menzies testified in 2004 before FDA and then the California State Assembly and met with members of the House and Senate regarding the risk of antidepressant induced suicidality and preemption issues.The Baum Hedlund law firm has been fighting for increased warnings on all SSRIs since the early 1990s, starting with Prozac, and was the first law firm to take on the Paxil drug maker on a national scale in 2001. Baum Hedlund is still litigating dozens of suicide cases against GSK involving adults and children as young as 7-years-old.GSK has had an FDA ordered black-box warning (the most severe) on it’s Paxil label directed at children and adolescents concerning the increased risk of suicidality, as do all manufacturers of antidepressant-SSRIs, since 2004.
Side effects related to taking Paxil:
Body as a Whole: Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.
Cardiovascular System: Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.
Digestive System: Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, liver function tests abnormal, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.
Endocrine System: Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.
Hemic and Lymphatic Systems: Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia. 33
Metabolic and Nutritional: Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.
Musculoskeletal System: Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.
Nervous System: Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hallucinations, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.
Respiratory System: Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.
Skin and Appendages: Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.
Special Senses: Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.
Urogenital System: Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Discontinuation of Treatment With PAXIL: Recent clinical trials supporting the various approved indications for PAXIL employed a taper-phase regimen, rather than an abrupt discontinuation of treatment. The taper-phase regimen used in GAD and PTSD clinical trials involved an incremental decrease in the daily dose by 10 mg/day at weekly intervals. When a daily dose of 20 mg/day was reached, patients were continued on this dose for 1 week before treatment was stopped.
Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
