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Case Study: Forest Laboratories Essay

Introduction and General Purpose Lexapro (Escitalopram) is an antidepressant that is classified under a group of drugs called Selective Serotonin Reuptake Inhibitors. It was approved by the Food and Drug Administration in the United States on August 2002 (Expert Reviews Ltd, 2003). Lexapro is used to treat adults and adolescents 12 to 17 years of age who have been diagnosed with Major Depressive Disorder. It has also been approved to treat adults suffering from Generalized Anxiety Disorder (Brown University Child & Adolescent Psychopharmacology Update, 2012).

It works by blocking the reuptake of the neurotransmitter of the brain called serotonin, which regulates mood, and restores the brain’s chemical balance by increasing its levels (Mayo Clinic, n. d. ). Off Label Uses In a study conducted by the Food and Drug Administration, Lexapro was reported as being used to treat other diagnosis than then approved Major Depressive Disorder and Generalized Anxiety. Out of the total 127 million cases reported, Lexapro was reported as being used in treating infantile Brain Injury in 1. 6%, Autism in 2. %, Obsessive Compulsive Disorder in 5. 4%, Attention Deficit Disorder in 11. 5% of the prescriptions dispensed for children ages 6 to 12. It is also been reported as used in treating Other Adjustment Reaction in 3. 8%, Obsessive Compulsive Disorder in 2. 8%, Phobic Disorders in 2. 1%, Alcohol Abuse in 1. 2%, Diabetes Mellitus in 0. 6%, and Down’s Syndrome in 0. 5% of children ages 13 to 17.

In adults ages 18 and up, Lexapro has been reported as used in treating Depression Psychosis, single and recurrent episodes in 18. 5% and Neurotic Depression in 5. % of reported cases (Mehta, 2010). No evidence of Lexapro being used for illicit purposes has been found. Selective Serotonin Reuptake Inhibitors have been deemed as non-addictive prescription drugs; however it is not recommended that an individual stop taking any Selective Serotonin Reuptake Inhibitors abruptly as it could cause withdrawals (National Institute on Mental Health, n. d. ). Public Response Prior to being approved by the Food and Drug Administration, a complaint was filed against Forest Laboratories, the creator of Lexapro.

The complaint accused Forest Laboratories of violating laws under the False Claims Act stating that personnel of Forest Laboratories improperly promoted Lexapro for off-label pediatric use. Forest Laboratories was accused of paying physicians to encourage them to prescribe Lexapro and other drugs created by them. Additionally, Forest Laboratories was accused of blocking negative publications of one of their trials and reports that individuals suffered from increased suicidal ideations. The lawsuit was eventually settled in 2010 for the sum of 149 million (Carandang, MacBride, 2011).

Prescribing Trends The Food and Drug Administration conducted a study of prescribing trends using the IMS Health, IMS National Sales Perspective data. From October 2005 to September 2010 approximately 127 million prescriptions of Lexapro were dispensed from retail pharmacies within the United States. About 3. 9 million prescriptions dispensed were for the pediatric populations, ages 0 to 17, which equates to 3% of the total reported prescriptions dispensed. Within the pediatric category, 24,000 prescriptions were dispensed for children of ages 0 to 5, 862,000 for ages 6 to 12 and 3 million for ages 13 to 17.

The most common diagnosis reported for use of Lexapro were “Anxiety Status” for children under 5, “Depressive Disorder Not Elsewhere Classified” for patients of ages 6 to 17 and adults over the age of 18. During this period, it was reported that family medicine practitioners and doctor of Osteopathy were the primary prescribers of Lexapro, prescribing approximately 32% of all prescribed medications. Psychiatry doctors were found to prescribe 21% and Pediatricians 1. 3% of the total prescriptions dispensed (Mehta, 2010).

Implications for Special Populations and Social Work Those who ingest alcohol should take into consideration that the consumption of Lexapro and alcohol will increase the feeling of drowsiness. Additionally, pregnant should notify their doctor prior to taking Lexapro as it could be of harm to an unborn baby and/or cause him/her to be born prematurely. Nursing women should also be cautious when taking Lexapro. Lexapro can also be of harm to their babies; it is possible for traces of Lexapro to expel on to the mom’s breast milk and cause the baby unwanted side effects.

Children may also be at risk when taking Lexapro. They can suffer the same adverse reactions as adults. It is important for parents to monitor their children for side effects, especially for increase in suicidal ideation. Older adults need to be alert when taking Lexapro, especially those with heart disease, liver, thyroid and a history of heart attacks. Older patients who take Lexapro have a greater risk of Hyponatremia, or low sodium levels of the blood. Patients who suffer from seizures should also be cautious when taking Lexapro; convulsions have been reported.

Additionally, some patients did report mania or hypomania when taking Lexapro, so patients who have a history of mania are at higher risk (Brown University Geriatric Psychopharmacology Update, 2011). Social workers should know the implications for special populations to advocate for patients at all levels. At the micro level, social workers need to understand how these could potentially affect their client. Knowing the implications and precautions of this drug will be important in helping the patient understand and cope with their illness.

Potentially, it could also save the patient’s life. The social worker should be able to review the patient’s medications to ensure that the patient is not taking a medication that could potentially be lethal when taken with Lexapro. The social worker should also understand the implications of age and gender of the individual taking the medication. Children are more likely to be at risk for suicide since their struggles could overwhelm them easier and children under 12 should not be taking Lexapro.

Additionally, social workers should take into consideration who are of child bearing age, since it is mentioned that pregnant/nursing women are more likely to cause their baby harm while taking Lexapro. Social workers should also have these implications in mind for the elderly, specifically those suffering with the medical problems mentioned above. Social workers should take into consideration the patient’s drinking/drug usage. Mixing Lexapro with alcohol and/or drugs could potentially be lethal.

Last, it is important for social workers to take the patient’s driving routine as it could be dangerous for a patient that takes Lexapro. At the mezzo level, the social worker should take into consideration families and support that the patient has. A patient who lacks support may have less coping mechanisms in place and in turn may decide to use drugs/alcohol. Connecting patients with support groups within the community is very important to aid in coping. Additionally, a patient who may not have such a great social support may be more at risk for suicide. It is important to note this.

At the mezzo level it is important for social workers to advocate with prescribing clinicians and other disciplines. For example, treatment or care plan meeting concerning the patient. At the macro level, it is important for the social worker to take an active role in advocating for mental health and better medications for the patients. This is important to aid in creating medications that have fewer side effects for patients or improving existing ones. For example, the social worker should take an active role in advocating for Forest Laboratories to improve Lexapro.

Additionally, the social worker should take an active role in educating the community in regards to issues surrounding mental health, medications, side effects and lack of resources. Side Effects Lexapro was found to cause the following side effects: nausea, insomnia, increased sweating, fatigue, ejaculation disorder, and sleepiness or drowsiness (Formulary, 2002). In addition, an individual taking Lexapro may experience decreased libido, anorgasmia, increasing thoughts of suicide, Serotonin Syndrome, Hyponatremia, and abnormal bleeding (Brown University Geriatric Psychopharmacology Update, 2011).

Social workers need to be aware of the side effects this drug may cause to educate clients and families and aid them in making educated decisions. They also need to be aware of side effects to be able understand their patient’s daily struggles and assist them in coping. Additionally, social workers need to know these side effects to advocate for patients in the micro, mezzo and macro levels. This includes educating clients and families, advocating with prescribing clinicians and other healthcare specialties, and advocating for clients at the governmental level.

Interactions with other Medications Lexapro should not be used along with medications classifieds as Monoamine Oxidase Inhibitor or within 14 days of discontinuing any of these medications as it could be fatal. (Formulary, 2004). Monoamine Oxidase Inhibitors include: Isocarboxazid, Phenelzine, Selegiline, and Tranylcypromine. Lexapro should also not be used along Celexa and Lithium as it may increase the appearance of side effects or Aspirin as it may increase risk of bleeding (Brown University Geriatric Psychopharmacology Update, 2002).

Conclusion Lexapro is classified under the Selective Serotonin Reuptake Inhibitors. It is an antidepressant approved to treat Major Depressive Disorder and Generalized Anxiety Disorder in children ages individuals of age 12 and up. Lexapro is also used off label to treat conditions like Autism, Obsessive Compulsive Disorder, Infantile Brain Injury, Attention Deficit Disorder, Phobic Disorders, and Alcohol abuse to name a few. Fortunately, Lexapro is has not been found to be addictive so there is no evidence of it being used for illicit purposes.

In a study done from 2005 to 2010, it was reported that almost 127 million individuals were prescribed Lexapro. Of that number 3. 9 million were children. Lexapro can cause individuals serious side effects which include nausea, fatigue, insomnia, and increased thoughts of suicide to name a few. It is important for social workers to understand the implications for individuals, special populations and the roles social workers play in assisting patients. Social workers need to take active roles in psychoeducation and advocacy at all levels to help patients.

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