Adverse Reactions

[Drug_Interaction_Data]

Recent medical studies show that that the brain levels of Prozac are 100 times greater than blood levels and it is believed that this is the case with the other serotonin reuptake inhibitors as well – evidence of toxic brain levels affecting behavior no matter what the blood levels demonstrate. As patients have continued to report, this accumulation is evidence that accumulation of drug residue will produce a delayed withdrawal and that it will continue to produce reactions, not only during the period of time the patient is using the drug, but for long periods of time after discontinuation of the drug use.

Brain wave patterns indicate patients are in a total anesthetic sleep state while appearing awake and functioning. Increasing serotonin – exactly what these drugs are designed to do – induces both nightmares and sleepwalk. Patients report over and over again that they have lived out their worst nightmare. And as with sleepwalk episodes, many have no recall or little recall of what they have done. Often someone must prove to them what they have done while they where under the influence of these drugs before they will believe it to be true. One patient stated that he could not detect during his two year use of Prozac what was real or what was a dream!

Seven to ten percent of patients do not have the liver function necessary to metabolize these drugs. Unfortunately even if they do have a functioning P450 IID6 liver system to metabolize the drugs, this group of drugs totally saturates that liver system so that the ability to metabolize the drug gradually becomes greatly impaired and the metabolism of other drugs becomes greatly impaired.

Stress or depression can be detected by elevated levels of cortisol, yet one single 30mg dose of Prozac clearly doubles the level of cortisol. This should in the long run double the patient’s stress and depression. But that is not the only detrimental effect of elevated cortisol levels. This can cause a multitude of serious physical and emotional adverse side effects.

Giving these drugs to children is absolutely unconscionable for many reasons. One of the most obvious is that increased cortisol impairs the development and regeneration of the liver, kidney and muscles, as well as impairing linear growth. Yet, learning that even one parent was given this information would be surprising. PROZAC: PANACEA OR PANDORA?–Ann Blake Tracy

Here is the complete list of adverse reactions attributable to SSRI medications:

1. Insomnia

2. Vivid and violent dreams

3. Inability to detect dreams from reality (The world takes on an other-worldly aspect)

4. No emotions

5. Inability to feel guilt or cry

6. Nausea

7. Loss of appetite

8. Rash; Breathing or lung problems

9. Heart fluttering

10. Shaking – jitteriness

11. Unusual energy surges at times producing super human strength (adrenalin rushes)

12. Memory impairment

13. Hair loss

14. Blurred vision or pressure behind the eyes

15. Inability to discontinue use of drug and increasing own dose

16. Cravings for alcohol, sweets, and other substances or drinking large sums of alcohol, coffee or other caffeinated drinks, diet pop with NutraSweet, etc.

17. Headaches

18. Swelling and/or pain in joints

19. Burning or tingling in extremities

20. Muscle twitching or contractions

21. Tongue numbness and slurred speech

22. Sweating

23. Dizziness

24. Confusion

25. Chills or cold sweats

26. Muscle weakness

27. Extreme fatigue

28. Diabetes or hypoglycemia

29. Lowered immune system

30. Seizures or convulsions

31. Weight gain or weight loss

32. Mood swings

33. Altered personality

34. Symptoms of mania, ie., inability to sit still or restlessness, racing thoughts, acting silly or giddy (like a teenager again)

35. Sexual promiscuity leading to unwanted pregnancy or divorce

36. Irresponsibility, wild spending sprees, gambling, criminal behavior, shoplifting, embezzling, stealing, hostility, etc.

37. Deceitfulness

38. Blank staring

39. Inability to see any alternatives in situations

40. Hyperactivity

41. Aggressive or violent behavior

42. Wanting to ram other cars or driving irrationally

43. Impulsive behavior with no concern about consequences

44. Numbness in various body parts – legs go numb and right out from under patient

45. Sexual organs go numb making orgasm impossible

46. Pulling away from loved ones and others (isolating oneself)

47. Divorce

48. No desire to be touched

49. Paranoia

50. Falsely accusing others of abuse – family members or acquaintances

51. Loss of spirituality

52. Feeling “possessed” or that something evil is inside

53. Self destructive behavior and suicidal ideation

54. Suicide attempts

55. Muscle tremors

56. Loss of co-ordination

57. Mania

58. Psychosis

[SOURCE: PROZAC: PANACEA OR PANDORA?, BY ANN BLAKE TRACY]

Prozac Label (September, 1988)

Here is the information as it written on the label insert for Prozac:

Body as a Whole—Frequent: chills; Infrequent: chills and fever, face edema, intentional overdose, malaise, pelvic pain, suicide attempt: Rare: abdominal syndrome acute, hypothermia: intentional injury, neuroleptic malignant syndrome, photosensitivity reaction.

Cardiovascular System —Frequent: hemorrhage, hypertension: Infrequent: angina pectoris, arrhythmia, congestive heart failure, hypotension, migraine, myocardial infarct, postural hypotension, syncope, tachycardia, vascular headache: Rare: atrial fibrillation, bradycardia, cerebral embolism, cerebral ischemia, cerebrovascular accident, extrasystoles, heart arrest, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation.

Digestive System—Frequent: increased appetite, nausea and vomiting: Infrequent: aphthous stomatitis, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage, hyperchlorhydia, increased salivation, liver function tests abnormal, melena, mouth ulceration, nausea/vomiting/diarrhea, stomach ulcer, stomatitis, thirst: Rare: biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal ulcer, fecal incontinence, gastrointestinal hemorrhage, hematemesis, hemorrhage of colon, hepatitis, intestinal obstruction, liver fatty deposit, pancreatitis, peptic ulcer, rectal hemorrhage, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema.

Endocrine System—Infrequent: hypothyroidism: Rare: diabetic acidosis, diabetes mellitus.

Hemic and Lymphatic system—Infrequent: anemia and ecchytmosis: Rare: blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, petechia, purpura, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional—Frequent: weight gain; Infrequent: dehydration, generalized edema, gout, hypercholesteremia, hyperlipemia, hypokalemia, peripheral edema; Rare: alcohol intolerance, alkaline phosphatase increased, BUN increased, creatine phosphokinase increased, hyperkaltemia, hyperuricemia, hypocalcemia, iron deficiency anemia, SGPT increased.

Musculoskeletal System—Infrequent: arthritis, bone pain, bursitis, leg cramps, tenosynovitis: Rare: arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, rheumatoid arthritis.

Nervous System—Frequent: agitation, amnesia, confusion, emotional lability, sleep disorder; Infrequent: abnormal gait; acute brain syndrome, akathisia, apathy, ataxia, buccoglossal syndrome, CNS depression, CNS stimulation, depersonalization, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, hypesthesia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, neurosis, paranoid reaction, personality disorder*, psychosis, vertigo; Rare: abnormal electroencephalogram, antisocial reaction, circumoral paresthesia, coma, delusion, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, reflexes decreased, reflexes increased, stupor.

Respiratory System—Infrequent: asthma, epistaxis, hiccup hyperventilation: Rare: apnea, atelectasis, cough decreased, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, pneumothorax, stridor.

Skin and Appendages—Infrequent: acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer, vesiculobullous rash; Rare: furunculosis, herpes zoster, hirsutism, petechial rash, psoriasis, purpuric rash, pustular rash, seborrhea.

Special Senses—Frequent: ear pain, taste perversion, tinnitus; Infrequent: conjunctivitis, dry eyes, hydriasis, photophobia; Rare: blepharitis, deafness, diplopia, exophthalmos, eye homorrhage, glaucoma, hyperacusis, iritis, parosmia, scleritis, strabismus, taste loss, visual field defect.

Urogenital System–Frequency: urinary frequency; Infrequent: abortion, albuminuria, amenorrhea, anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation, fibrocystic breast, hematuria, leukorrhea, menorrhagia, metorrhagia, nocturia, polyuria, urinary incontinence, urinary retention, urinaryurgency, vaginal hemmorrhagia, Rare: breast engorgement, glycosuria, hypomenorrhea, kidney pain, oliguria, priapism, uterine hemmorrhage, uterine fibroids enlarged.

*Personality disorder is the COSTART term for designating non-aggressive objectional behavior.

Postintroduction Reports: Voluntary reports of adverse events temporally associated with Prozac that have been received since market introduction and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation, cerebral vascular accident, cholestatic jaundice, confusion, dyskenesia (including, for example, a case of buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported to develop in a 77-year old female after 5 weeks of fluoxetine therapy and which completely resolved over the next few months following drug discontinuation),eosinophilie pneumonia, epidermal necrolysis, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest, hepatic failure/necrosis, hyperprolactinemia, immune-related hemolytic anemia, kidney failure, misuse/abuse, movement disorders developing in patients with risk factors including drugs associated with such events and worsening of preexisting movement disorders, neuroleptic malignant syndrome-like events, pancreastitis, pancytopenia, priapism, pulmonary embolism, QT prolongation, Steven-Johnson syndrome, sudden unexpected death, suicidal ideation, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after drug withdrawal and violent behaviors.

Hyperserotonemia

Hyperserotonemia (elevated serotonin levels) can produce very serious complications medically, as well as serious neurologic and psychiatric disorders. Carcinoid syndrome and the serotonin syndrome are two medical conditions in which elevated serotonin levels are present. Carcinoid syndrome is a set of symptoms caused by the secretion of serotonin by carcinoid tumors, prostaglandins, etc. Symptoms include attacks of severe cyanotic flushing of the skin lasting from minutes to days, diarrhea, bronchoconstrictive attacks, sudden drops in blood pressure, edema, and ascites, which is an abnormal accumulation of serous fluid in the abdominal cavity, also known as abdominal or peritoneal dropsy. [From PROZAC: PANACEA OR PANDORA?, Pg. 87.]

Serotonin Syndrome

The serotonin syndrome is a hyperserotonergic state which is a very dangerous and a potentially fatal side effect of serotonergic enhancing drugs which can have multiple psychiatric and non-psychiatric symptoms. It is a condition which has been on the rise since the 1960’s when we began using more and more drugs which directly affect serotonin. This is a toxic condition which requires heightened clinical awareness in order to prevent, recognize, and treat the condition promptly. Promptness is vital because, as we just mentioned, the serotonin syndrome can be fatal and death from this side effect can come very rapidly. This syndrome is a toxic hyperserotonergic state whose rate of incidence is unknown, but is on the rise. The suspected cause of that increase is the introduction of the new selective serotonergic enhancing agents in clinical practice – the SSRIs. This disorder, brought on by excessive levels of serotonin, is difficult to distinguish from the neuroleptic malignant syndrome because the symptoms are so similar. The neuroleptic malignant syndrome is a serious condition brought on by the use of the neuroleptic drugs.

The symptoms of the serotonin syndrome are (from The Serotonin Syndrome, AM J PSYCHIATRY, June 1991):

1. Euphoria

2. Drowsiness

3. Sustained rapid eye movement

4. Overreaction of the reflexes

5. Rapid muscle contraction and relaxation in the ankle causing abnormal movements of the foot

6. Clumsiness

7. Restlessness

8. Feeling drunk and dizzy

9. Muscle contraction and relaxation in the jaw

10. Sweating

11. Intoxication

12. Muscle twitching

13. Rigidity

14. High body temperature

15. Mental status changes were frequent (including confusion and hypomania – a “happy drunk” state)

16. Shivering

17. Diarrhea

18. Loss of consciousness and death.

The serotonin syndrome is generally caused by a combination of two or more drugs, one of which is often a selective serotonergic medication. The drugs which we know most frequently contribute to this condition are the combining of MAOIs with Prozac (this should also include the other SSRIs) or other drugs that have a powerful effect upon serotonin, ie., clomipramine (Anafranil), trazadone (Deseryl), etc. The combination of lithium with these selective serotonergic agents has been implicated in enhancing the serotonin syndrome. The tricyclic antidepressants, lithium, MAOIs, SSRIs, ECT (electric shock treatment), tryptophan, and the serotonin agonists (fenfluramine) all enhance serotonin neurotransmission and can contribute to this syndrome. Anything which will raise the level of serotonin can bring on this hyperserotonergic condition. The optimal treatment for the serotonin syndrome is discontinuation of the offending medication or medications, offer supportive measures, and wait for the symptoms to resolve. If the offending medication is discontinued, the condition will often resolve on its own within a 24 hour period. If the medication is not discontinued the condition can progress rapidly to a more serious state and become fatal. It should be apparent that the greater the enhancement of serotonin levels, the greater the chances of producing the serotonin syndrome. Therefore it is recommended that Zoloft, Prozac, Paxil, Luvox, Serzone, etc. not be used concurrently with each other or any other serotonergic drugs and that these serious adverse reactions should be expected with these combinations (Callahan, 1993). [PROZAC: PANACEA OR PANDORA?, p. 88.]