Prozac Advantages and Side Effects - Term Paper Example

Prozac Prozac belongs to a group of medications classed by chemists as selective serotonin reuptake inhibitors ( Ogbru, 2014) and is a trade name for fluoxetine , a commonly prescribed anti-depressant drug. It is available in several forms, as capsules, both short and in long acting delayed release from ; a tablet , and as a solution to be taken orally . Other trade names for fluoxetine include Rapiflux, Sarafem and Selfemra. Previous tricyclic antidepressants (TCAs) worked on three different neurotransmitters which are associated with human moods, these being dopamine, serotonin and noradrenaline. Prozac works on only one of these, serotonin. The recommended dosage daily is 10-80 mg in tablet form. Because its action is cumulative, it can take a number of weeks before positive effects are perceived. Prozac is used to treat a large number of mental health disorders such as serious depressive disorders, the eating disorder bulimia nervosa, anxiety conditions such as obsessive-compulsive disorder, panic disorders and premenstrual dysphoric disorder (Drugs.com, 2014). The same web sites states that there may be instances when Prozac is used to treat some other conditions. Prozac is also sometimes used together with olanzapine (Zyprexa) in order to treat the depression which occurs as part of bipolar disorder (manic depression). This combination can also be used to treat the symptoms of depression which has proved intractable to other medical interventions using at least two other medications which have not relieved the symptoms successfully. 2. The Development of Prozac. Prozac first became publically available in the United States of America in 1988, and quickly became a widely prescribed drug. It is the registered name of fluoxetine hydrochloride. It was thought to be a step forward in treatment, the first of a line of products in what became a major new class of ant-depressive drugs, the selective serotonin re-uptake inhibitors. The drug had first emerged in 1971 as LY110141 (Moore, 2007) in the laboratories of El Lilley. Up until the time of its release on the market those who went to their doctors with symptoms of anxiety would be given tranquilizers. At first it was being developed to lower blood pressure in cases of hypertension. This was a failure however, as it was found to only work in some animals and failed to make a difference in human beings. The next attempt was to help with obesity, but that was soon found to be a failure. This can sound almost like someone with a jigsaw puzzle piece trying to fit it into any available space. There was a trial of the drug on hospital patients with psychosis and the most severe depression, but again this resulted in failure, and in some cases symptoms actually worsened. Despite these failures the company persisted, and this time the drug was tried on a small group of people with milder depression. In every case there was improvement. It should be pointed out that any clinical trial for anti-depressive drugs needs to take into account the fact that feelings of depression are quite subjective and hard to measure and evaluate with any accuracy. The name Prozac was chosen by a branding company because it was thought to sound both professional and ‘zappy’, as well as positive and rapid. The company promoted the drug quite aggressively, producing leaflets detailing the dangers of depression. 8 million of these were sent out, together with a large number of advertising posters. Earlier anti-depressants were very toxic, and could be fatal if overdoses were taken. The new Prozac was however promoted as being completely safe to be taken by absolutely anyone , an instant wonder drug. The campaign was incredibly effective with patients going to their doctors and asking for it on the very first day it became available to the public. Despite its huge success the way in which this medication works is still not completely understood more than 40 years after it was first developed. Moore (2007) quotes Malcolm Lader professor of clinical psychopharmacology at the Institute of Psychiatry, who said The idea that it's been a major step forward for Prozac to select serotonin only is just hypothesis. There is no science behind it. It is felt, according to Moore’s article ( 2007), that the idea that Seratonin affects our moods in a positive way is too simplistic, as our moods, good or bad, in their turn can have an effect upon brain chemistry . Over time it has been found that Prozac works in a much less precise way than was once supposed, and there have been a number of trials which found it barely outperformed placebo pills made from sugar. Despite this, from 1995 onwards Prozac like drugs were beginning to be used in quite young children to overcome conditions such as selective mutism , that is a child who chooses not to speak. Moore describes how the drug has been used widely within the United Kingdom for children and young people, even though there were no licences for this, and the research which showed its poor performance as against the use of placebos. More recently the drug packaging has warned of possible suicidal effects in children ,and so prescriptions have decreased in number. 4. Off the label use and misuse. Any drug can be misused. Bellis ( 2014) describes Prozac as the most widely prescribed anti-depressant in the world. Smith ( 2012) points out however that it is financially better for psychiatrists to prescribe drugs than to offer any other forms of therapy, which could be more effective in the long term. Psychotherapy for instance, carries no risk of side effects , or drug interactions, and has been proved to be less likely to cause relapses. Smith (2012) states that:- Writing a prescription to treat a mental health disorder is easy, but it may not always be the safest or most effective route for patients. He describes how one in five Americans take some form of psychotropic drug, and describes inappropriate prescribing as dangerous, although he also states how valuable he feels these drugs to be in treating certain mental illnesses. He declares that the majority of prescriptions are given out by general practitioners. These are doctors who do not have specialist training in treating mental illnesses. He also describes a decrease in the use of psychotherapy. It is simply easier and less time consuming to offer medication. Within the United Kingdom cognitive behaviour therapy has been promoted as an alternative. Smith ( 2012) quotes Johnson :- Patients should be informed about the advantages, limitations and potential harm of all evidence-based treatments for their condition so they can make an informed choice. Too often, psychotropic medication is the only option that is offered. Pharmacokinetics. In man, after a single oral 40 mg dose, peak plasma concentrations of fluoxetine are produced at levels from 15 to 55 ng/mL after a period of 6 to 8 hours ( Rx.List, 2014). Taking food has no effect upon its take-up, although a full stomach may delay the effects by an hour or more. Van Harten (1993) reported peak levels of uptake after 4-6 hours. The drug is available with an enteric coating a type of delayed-release formulation, which causes a resistance to dissolution until the medication reaches a segment of the gastrointestinal tract with a pH level which exceeds 5.5. When blood concentration reach levels ranging from 200 to 1000 ng/mL, then roughly 94.5% of the fluoxetine becomes bound to human serum protein which include both α1-glycoprotein and .albumin. There are some members of the population , about 7% according to RxList, ( 2014) who are poor metabolizers of this and other similar drugs. Excretion is mainly through the hepatic system, although some, a minor amount, is excreted via the renal system, with larger amounts being broken down in the faeces, as well as in the breast milk of nursing mothers. Alta Laboratoires ( undated) describe how elimination of the drug can be quite slow and so the drug accumulates within the body over time. They give figures of 8.6 days as its half-life after just one dose. After taking multiple doses this increased to 9.3 days. Steady levels are eventually achieved after 4-5 weeks of regular dosage. This long half-life means that the drug remains at active levels within the body for a number of weeks after dosage ceases. This has implications for possible interactions with other medications as described elsewhere. Because the drug is mainly eliminated through the hepatic system, then those with liver disease such as cirrhosis have greatly extended periods where the drug remains in the body, a mean average of 7.9 days, as compared with only 2 or 3 days in those with fully active and healthy livers. Prescribers need therefore to ask questions about such things as alcohol intake, even if the person has not yet been diagnosed with a liver condition. Pharmacodynamics Alta Laborotoires ( undated) describe how using clinically relevant doses of Prozac used in humans have shown that the drug works by blocking the take-up of serotonin into human blood platelets. Animal studies also suggest that fluoxetine is a much more powerful uptake inhibitor of serotonin than of norepinephrine, also known as noradrenaline, a substance produced by the body’s nerve cells and whose effects include an increased heart rate and blood pressure, the dilation of the pupils and the narrow air passages in the lungs , while at the same time causing narrowing of blood vessels in some other organs, so enabling the body to perform at its optimum level in stressful situations ( Net Doctor 2013) . Prozac works by increasing levels of the neurotransmitter serotonin within the brain. This neurotransmitter is believed to influence such things as sleep, appetite for food, feelings of aggression and mood. Neurotransmitter chemicals transmit messages between the body’s nerve cells. They are secreted in one cell and then picked up by the receptor proteins found on the surface of a different cell. The receptor cell either destroys or absorbs the serotonin once the message has been received, a process referred to as re-uptake. When such re-uptake is subdued or inhibited, the effect of the available serotonin is increased. Despite a great deal of research it is not known exactly why increasing levels of neurotransmitters reduces the severity of a depressive illness. Bellis ( 2014) states that It may be that higher levels of serotonin cause, in their turn , alterations in the brain's number of neurotransmitter-binding receptors. It is possible that this then makes the person more capable of positive feelings. Desired effects vs. adverse effects The obviously desired effects are to relieve symptoms of the various conditions listed above, reducing anxiety, depression and lifting mood. There are a number of possible negative aspects to taking Prozac. Drugs .com (2014) state that, among young people in particular, taking this medication, during the first weeks of taking it, suicidal feelings may develop. Medical staff, family and others therefore need to be aware of this and keep a close eye on such vulnerable young people in case such a situation develops. As well as emotional effects, allergic reactions such as skin rash or hives have been reported ( Ogbru, 2014) These problems may be accompanied by difficulty with respiration and swelling of the face, and the tissues of the tongue, lips, mouth , or throat. There are also some possible negative interactions with other medications. Drugs.com ( 2014) states that Prozac should not be used if the person is also taking pimozide, an anti-psychotic drug which slows up reactions; or thioridazine, one of the several medications used to treat symptoms of schizophrenia, and one which can have dramatic negative effects upon a person’s physiology (MedLinePlus, 2014). Another stated contra-indication is if methylene blue injections are being used as a diagnostic agent. Ogbur ( 2014) discusses the use of this medication in pregnancy, stating that it should not be used in the final weeks of pregnancy, the third trimester, as its use can result in negative effects upon the foetus. Nor should it be used by nursing mothers, as the drug will be excreted within the breast milk. Moore ( 2007) also mentions the possibility of sexual dysfunction, and points out that although it can take many years for a drug to be given a licence by organizations such as the FDA , actual trials may only take place over a few weeks and include only a very few users. This is perhaps why side effects may only develop when the drug is used by a much bigger consumer group over more extended periods lasting many months, especially in a drug with a long half-life. . Prozac is also contraindicated if a MAO inhibitor such as linezolid, isocarboxazid, phenelzine, selegiline, rasagiline or tranylcypromine, has been used in the past two weeks as an endangering drug interaction could take place . There must be at least a two week period between stopping taking Monomine, Oxydase inhibitors ( MAO inhibitors) and taking Prozac. MAO inhibitors are an older type of anti-depressant from the1950s, but produce withdrawal symptoms if stopped, and can also interact with over the counter remedies for such things as coughs ( Marshall 2013) . MAO inhibitors continue to be used today, but mainly in cases of atypical depression. This prohibition about mixing these drugs works the other way as well, even more so in that a break of at least five weeks is needed. Marshall ( 2013) states that if a newer type of MAO inhibitor , moclobemide, is used, then interaction problems are less likely or milder. These are not the only medications which cause problems. Drugs.com ( 2014) name 973 drugs which it is claimed can interact with Prozac, and also suggest that great care is needed if the patient is also taking olanzapine, a drug normally used to treat schizophrenic symptoms. Ogbru ( 2014) points out that some people may be allergic to Prozac, listing such symptoms as nausea ; anxiety, despite its use for anxiety conditions; headaches; drowsiness; insomnia,, and a decrease in appetite. It treatment is stopped however there are those who will experience such withdrawal symptoms as feelings of nausea; increased nervousness, and insomnia . Ogbru ( 2014) also lists a number of rarer, but more severe, problems with taking this drug, such as severe blistering and peeling of the skin ; muscular stiffness; pyrexia ; sweating ; increasingly overactive reflexes; vomiting; a lack of co-ordination. The rates of the heart rate may be altered or even irregular and breathing may become shallower or even stop altogether in the most extreme cases. The digestive system can be affected with diarrhea and vomiting.. The brain may be affected with headaches; difficulties in concentration and memory as well as confusion and the onset of hallucinations. There could also be fits or fainting turns, so many organs and body systems can be affected. To this can be added the complexity of its excretion , which Alta Laboratoires ( undated ) state can have negative consequences which could mean that the drug should not be used clinically. Ethnopsychopharmacological issues It is known that members of certain ethnic groups may react to particular drugs in ways different to the majority, because of small physical differences. This however can be hard to prove because of the small number s involved in any mixed population, although it is acknowledged as a possible problem (Oldham et al, page 573, 2007). Wagner et al tested this in patients taking Prozac in 1998. The individuals were however also HIV positive, so it must be asked how did the researchers separate out the results which were due just to the Prozac. This example of research just shows how difficult it can be to carry out ethnopsychopharmacological studies. Use of Prozac with children As already mentioned there may be particular problems with prescribing Prozac to younger patients, and the FDA has issued warnings about this (National Institute of Health, undated) . In more recent times however, because of the results of a wide ranging review of pediatric trials carried out between 1988 and 2006, it is suggested in a 2007 report ( Bridge et al, 2007), the benefits of using antidepressant medications for younger patients may outweigh possible risks to children and adolescents suffering the effects of major depressive and anxiety disorders Prozac and older patients According to MedLine Plus ( 2012) suicidal risks described among young people who take Prozac may also apply to older users. Also Melnick ( 2011) reported that among a cohort aged 65 taking Prozac and similar medications, the group were more likely to suffer adverse effects than other people of their own age during a five year follow-up. These negative effects were severe, as users were more likely to die, or to have a stroke, fall, suffer fracture and have seizures. These results were more likely than if older types of anti-depressants were prescribed, although it was found that even using these resulted in more negative effects than if no medication was used. Melnick (2011) does point that when older anti-depressants were prescribed dosages tended to be rather lower, which may explain any differences. It should also be pointed out that older people are more likely than younger ones to suffer from a number of different medical conditions at the same time. This therefore increases the number of possible drug interactions, some of which could produce negative effects. Conclusion This drug has been used for over 25 years, having been on the market since 1988, and first developed more than forty years ago. . After being licenced Prozac took only two years to reach a ‘most prescribed’ status according to Bellis, (2014). It can therefore be said to have proved its efficacy as an anti-depressant, despite reports which claim its relative ineffectiveness, the claim being that results are skewed by placebo effects. There are however a number of possible side effects and drug interaction problems for some patients, as well as problems with elimination. This means that practitioners, other health care staff, including pharmacists , as well as patients and their families and carers, need to be aware of possible problems which could arise, however rare these are , as well as how these can be dealt with. Such matters should be discussed before medication begins. If reactions do occur however, because the drug has a particular slow elimination rate , it can be quite a while before any difficulties which arise are overcome. This is therefore a drug which can be beneficial, although even that is in doubt apart from a seeming placebo effect, but it is also something which should only be used with caution, and with a full awareness of various issues such as other medication being taken, even for common illnesses such as coughs and colds, on the part of all those involved. References Alta Laboratoires,( undated) Clinical Pharmcology, 6th Match 2014, www.altacare.com/products_select.asp?pSection=16‎ Bellis, M.,(2014) Prozac, About.com, Inventors, 6th Match 2014, retrieved from http://inventors.about.com/library/weekly/aa980225.htm Bridge J., Iyengar S, Salary C., Barbe, R., Birmaher, B, Pincus, H., Ren, L., Brent, D., MD. (2007) Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment: A Meta-analysis of Randomized Controlled Trials. The Journal of the American Medical Association ,297 pages 1683-1696, Drugs.com,(2014) Prozac, 6th Match 2014 , retrieved from http://www.drugs.com/prozac.html Marshall, H., (2013) Monamine oxydase inhibitors, Net Doctor, 6th March 2014, retrieved from http://www.netdoctor.co.uk/diseases/depression/monoamineoxidaseinhibitors_000101.htm MedLine Plus,(2012) Fluoxetine, 6th March 2014, retrieved from http://www.nlm.nih.gov/medlineplus/druginfo/meds/a689006.html MedLinePlus, (2014) Thioridazine, , 6th March 2014, retrieved from http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682119.html#why Melnick, M.,(8th August 2011) Newer Antidepressants May Not Be as Safe for Seniors, Time 6th March 2014, retrieved from http://healthland.time.com/2011/08/08/newer-antidepressants-may-not-be-as-safe-for-seniors/#ixzz2vCj8hSaT http://healthland.time.com/2011/08/08/newer-antidepressants-may-not-be-as-safe-for-seniors/#ixzz2vCiQiGc6 National Institute of Health, (undated) Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers, 6th March 2014, retrieved from http://www.nimh.nih.gov/health/topics/child-and-adolescent-mental-health/antidepressant-medications-for-children-and-adolescents-information-for-parents-and-caregivers.shtml NetDoctor,( 2013), Noradrenaline, 6th March 2014, retrieved from http://www.netdoctor.co.uk/heart-and-blood/medicines/noradrenaline.html#ixzz2vC0EMhze Moore, A., (13th May 2007), Eternal Sunshine, Observer, retrieved from http://www.theguardian.com/society/2007/may/13/socialcare.medicineandhealth Ogbru, O.,(2014) Prozac Side Effects Center, RXList,, 6th March 2014, retrieved from http://www.rxlist.com/prozac-side-effects-drug-center.htm Oldham, J., Skoldol, A.,Bender D., (2005) The American Psychiatric Publishing Textbook of Personality Disorders, Arlington, American Psychiatric Publishing, Rx.List, (2014) Prozac,, 6th March 2014, retrieved from http://www.rxlist.com/prozac-drug/clinical-pharmacology.htm Smith, B. ,( June 2012) Inappropriate prescribing, American Psychological Association, Volume 43, number 6, , 6th March 2014, retrieved from https://www.apa.org/monitor/2012/06/prescribing.aspx Van Harten, J.,(1993) Clinical pharmokinetics of selective serotonin reuptake inhibitors Clinical Pharmacokinetics, inhibitors, March 24( 3)pages 203-220, Wagner,G., Manguen,S., Rabkin, J., (1998) Ethnic difference in response to fluoxetine in a controlled trial with depressed HIV positive patients, Psychiatric Services, 49,pages 239, 40, Read More