Digestive Health Newsletter

Know Your Rights: Chronic Illness, IBD, and Employment

Jennifer C. Jaff, Esq, as updated by Eileen F. Swan, Esq

July 24, 2013

Introduction

More than 133 million Americans have at least 1 chronic illness. Of those, approximately 1.4 million Americans have inflammatory bowel disease (IBD). As is the case with many chronic illnesses, Crohn's disease and ulcerative colitis can occur in conjunction with other equally debilitating diseases. Most prevalent among these are the mental health disorders of depression and anxiety, which are more frequently diagnosed in patients with a recent diagnosis of IBD than they are in the general population. A primary focus of federal law, such as the Americans with Disabilities Act (ADA), has been on individuals with a single defining disability and the extent to which they qualify for protection and services. This article will focus on some of the employment-related questions you may have if you or a loved one has been diagnosed with both IBD and some form of depression or anxiety.

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Are IBD, depression, and anxiety disorders considered disabilities under the ADA?

The ADA defines "disability" as a physical or mental impairment that substantially limits one or more major life activities of an individual.

The ADA defines a major life activity as including, but not limited to, "caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working." The 2008 amendments to the ADA stipulate that major bodily functions, such as those related to the digestive and bowel systems, fit the definition. In addition, it has long been recognized that mental impairments, such as depression and anxiety, may substantially limit major life activities, such as eating, sleeping, concentrating, thinking, and working. Chronic, episodic conditions may be protected under the ADA if the condition is substantially limiting when active, or has a high likelihood of recurrence in a substantially limiting form. Thus, even if a disability isn't currently active, an employee who needs an accommodation to continue controlling symptoms may be protected by the ADA.

In the past, employers were able to argue that the episodic nature of many chronic illnesses, such as digestive disorders and mental impairments, didn't constitute substantial limitations on major life activities because they didn't limit activities on days when they were in remission. The 2008 amendments settled this issue by adding 2 critical sections stating that chronic illnesses that would be disabling when active are considered "disabilities" all the time, including when they're in remission. The amendments further state that the determination shall be made without regard to possible improvements in the condition due to medication or other measures. This is a very important section since medications may prompt remission for both mental impairments and digestive diseases, but they don't "cure" or negate the fact that the disabling condition is ever present. There's no doubt that mental illness such as depression and anxiety are disabilities that substantially impair major life functions, and the ADA now definitively includes IBD as a disability that's afforded the same protections from discrimination.

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Does the fact that I have multiple disabilities automatically mean I am entitled to protection under the ADA?

No. To be entitled to protection under the ADA, you have to be a "qualified individual" with a disability. Thus, you can be disabled, but not qualified. To be qualified, you have to be able to perform the essential functions of your job with or without accommodation. Essential functions are the fundamental duties of the position you hold (eg, typically those listed in your job description).

If attendance is an essential function of your job and your illness prevents you from getting to work every day, you may not be protected by the ADA, even with the 2008 amendments. For example, if you work in a call center or as a salesperson in a showroom, then your job requires your presence in the workplace. Even if you are disabled, you may not be entitled to ADA protections because, even with accommodation, you can't perform the essential function of being present in the workplace every day. On the other hand, if you have the sort of job that can be done from home, and allowing you to work from home does not constitute an undue burden on your employer, then you might be considered a qualified individual.

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Does the ADA protect me even if my depression, anxiety, or IBD is controlled by medication?

As of January 1, 2009, you're considered disabled even if your IBD is controlled by medication, surgery, or other measures. For example, an ostomy can't be considered a cure for your disease unless it means you'll no longer have flare-ups or other symptoms. Similarly, a treatment that leaves you with a new set of symptoms won't be found to eliminate your disability. This is important for mental impairments as well as IBD since medications used to treat anxiety or depression can cause side effects that can be as debilitating as the underlining illness.

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What are my rights when I apply for a job?

According to Title I of the ADA, the section that relates to employment, you can't be discriminated against during the recruitment or hiring process. For example, Title I restricts questions that a prospective employer can ask about your disability before making a job offer. Note, however, that Title I applies only to employers with 15 or more employees in 20 nonconsecutive workweeks of the current or preceding calendar year. Your state may have a law that applies similar protections to smaller employers.

A common question is whether a job applicant should disclose that he or she has a disability or multiple disabilities. In my view, there are only 2 reasons to disclose your disability: (1) if you're requesting accommodations under the ADA, or (2) if you're requesting leave under the Family & Medical Leave Act. Both of these will be discussed in more detail below.

In a job interview, employers are allowed to ask some health-related questions intended to determine if you can perform the essential functions of a job. For example, it's permissible to ask questions about your ability to meet the physical demands of a job (eg, are you able to lift 5 lbs), your ability to complete job tasks in a timely manner, your interpersonal skills, and your ability to arrive to work on time (you must arrive to work as scheduled, with or without an accommodation). However, an employer can't ask whether you have a chronic illness, whether you have a disability that would prevent you from performing the essential functions of the job even with accommodation, or whether you would need reasonable accommodations if you were hired.

An employer may make a job contingent upon the passing of a medical examination, but the company must first make you a legitimate job offer. Medical examinations or inquiries as to the need for accommodations prior to a legitimate job offer aren't permitted. Pre-employment medical examinations are permissible only if they're required of all candidates for a job. The physical exam can't exclude you from a job because you have a disability such as IBD, depression, or anxiety; it can exclude you only if it determines that your disabilities would make it impossible for you to perform the essential functions of your job with or without accommodation.

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What are my rights at work?

Title I of the ADA protects qualified individuals with disabilities from discrimination with respect to recruitment, hiring, promotion, training, pay, social activities, and other employment privileges. It requires employers to provide equal opportunities to qualified individuals with disabilities and protect them against discrimination or harassment due to disability.

In addition, if you have mental or physical limitations but are qualified for employment, the ADA requires your employer to make reasonable accommodations unless doing so results in an undue hardship for the employer.

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What are "reasonable accommodations"?

A reasonable accommodation is a modification or adjustment to a job or the work environment that will enable a qualified individual with a disability to perform the essential functions of the job. Accommodations may be as simple as relocating an employee's desk so that it is near a bathroom or as complex as restructuring a job, modifying work schedules, acquiring or modifying equipment, or reassigning an employee to a vacant position that is available and for which the employee is qualified. A reasonable accommodation might also include paid or unpaid leave for medical appointments, hospitalizations for surgery or to stabilize medication levels, or regular feedback regarding job performance. This doesn't mean that everybody who asks for a modified work schedule gets one. Accommodations are considered reasonable if they don't impose an undue hardship on the employer. An undue hardship is an accommodation that would be prohibitively costly; would require substantial changes to the physical environment, nature, or operation of the business; or would require significant difficulty or expense. Whether a particular accommodation constitutes an undue hardship depends on the context. For example, if you're 1 of 10 assistants answering phones and you need frequent restroom breaks, that might be reasonable because there are 9 other assistants and it wouldn't be an undue hardship to ask them to cover for you. On the other hand, if you're the only receptionist in a smaller office, having someone cover for you might be considered an undue hardship.

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How do I request a reasonable accommodation?

An employer is required to make a reasonable accommodation only when there is a known disability. Usually, the employee makes a request for an accommodation. In most cases, if the employee doesn't ask for an accommodation, the employer isn't required to provide one.

To request reasonable accommodation, you must do so in writing. Your employer may have forms for you to use, or you may be able to submit a note simply stating the nature of your disability and the accommodation you are requesting. You'll also need to submit sufficient medical documentation to show that the request is medically supported. The amount of information you need will depend, to some extent, on the employer. Some employers will accept a brief note while others will send an employee to an outside medical facility or company physician for examination. Any medical inquiry must focus on the precise need for, and nature of, the accommodation.

Keep in mind that all accommodations are the result of an interactive process between employer and employee. The law doesn't require an employer to give you the accommodation you want. It's a process of negotiation to accommodate you in a way that meets your medical needs with the least burden on the employer. There are no limits on what you and your employer can consider. Creativity can be a plus when an employer says no to one proposal, but is open to considering others. You should participate actively in this negotiation and be prepared for genuine give and take. This usually is the best opportunity you'll have to reach a satisfactory resolution while maintaining a good relationship with your employer.

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What can I do if I think my rights have been violated?

If you think you have been discriminated against, you should contact your local office of the Equal Employment Opportunity Commission (EEOC). You can find your local office at http://www.eeoc.gov/field/. Many state and local governments also have fair employment practice laws, and you can file a complaint with the state agencies that administer those laws. Whether you file a disability discrimination complaint with a state agency or the EEOC, you'll essentially be filing a "dual file" complaint, meaning that whichever agency is tasked with reviewing the complaint must do so in conjunction with applicable federal or state law. If you file with the state agency, the state agency will investigate the complaint; if you file with the EEOC, the EEOC will investigate. Either way, your complaint is evaluated under both state and federal law. Whether you decide to file with your state agency or with the EEOC, there's no cost involved.

Under the law, there's a specified period of time in which to file. Generally, you have 180 days from the last act of discrimination to file. You'll be asked for any claim documentation, and then you'll be asked if you're interested in mediating your dispute. Mediation is not an opportunity to argue the merits of your case; its purpose is to see if you and your employer (or former employer) can reach a negotiated settlement. Whether to engage in mediation with your employer is up to you and should be decided after careful consideration.

Although you can file a complaint on your own, attorneys who are experienced in negotiations can be very helpful at the mediation stage, as well as beyond it. Some lawyers take employment discrimination cases on a contingent basis, which means they get paid only if they win, and they get roughly one-third of what you win. Note that most retainer agreements require you to pay litigation costs even if you lose, so a contingent fee isn't necessarily free.

Once you've filed a complaint, an agency will conduct an investigation and determine whether your employer engaged in discrimination based on your disability. At that point, you or your employer (or former employer) can request an administrative hearing, which is less formal than court. The evidence presented before the hearing officer here is the evidence obtained during the investigation.

Instead of requesting an administrative hearing, 90 days after you file a complaint you have the right to direct the investigation to end, and to take the case directly to court. This is called asking for a "right to sue" letter. Many employment attorneys do this because investigations take a long time and they may feel that they have more control over the proceedings once the case is out of the agency's hands. However, if you don't have an attorney, the court process can be technical and daunting. In that case, you may want to let the investigative process play itself out.

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Does having multiple disabilities mean I can get disability benefits if I was turned down before?

No. The ADA prohibits discrimination on the basis of disability and requires employers (and others) to provide reasonable accommodations, but it has no impact on the definition of "disability" used by the Social Security Administration and, therefore, has no influence on your ability to obtain Social Security disability benefits.

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What is the Family and Medical Leave Act?

The Family and Medical Leave Act (FMLA) provides eligible employees with up to 12 workweeks of leave during a 12-month period for one or more of the following reasons:

  • birth and care of the employee's newborn child
  • placement with the employee of a child for adoption or foster care
  • care for an immediate family member (spouse, child, or parent) with a serious health condition
  • medical leave when the employee is unable to work because of a serious health condition

Whether you're paid for your leave is up to your employer. Some employers cover portions of leave. For example, you may receive pay during the first 4 weeks of maternity leave but no pay for the remainder of the leave. Other employers may compensate you during your leave if you use accrued sick or vacation days. If you were receiving health insurance benefits prior to your leave, you're entitled to continue receiving those benefits during your leave. Finally, following your leave, you're entitled to return to your original job or a similar job with equivalent pay and benefits.

The FMLA applies to all public agencies (state, local, and federal), including schools and private-sector businesses that employ 50 or more employees in 20 or more nonconsecutive workweeks in the current or preceding calendar year.

The FMLA applies only to an employee who has been working for the same (or successive) employer for at least 12 months, for at least 1250 hours during the previous 12 months, at a location where at least 50 employees are employed by the employer within 75 miles. The 12 months of employment don't need to be consecutive, and the 1250 hours cannot include paid or unpaid leave; it includes only hours actually worked. Whether the employee has satisfied the 12 month/1250 hour requirement is determined as of the date the leave would commence. The 50 employee/75 mile requirement, however, must be met as of the date the employee gives notice of the need for leave.

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How do I request FMLA leave?

It's the employee’s responsibility to give notice of the need for leave. Notice may be given either in person or by telephone, telegraph, fax machine, or by other electronic means. In addition, someone other than an employee may give the notice. Notice includes advising the employer of the anticipated timing and duration of leave. Simply saying “I have lupus” is not enough. Note that many courts have said that an employer's knowledge of an employee’s medical condition and that the employee was seeing a doctor doesn’t mean the employer had notice of the employee’s need for leave.

Filing an FMLA complaint is similar to filing a discrimination-related complaint, except that you do so with the Wage and Hour Division of the U.S. Department of Labor (http://www.dol.gov/whd/).

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What if I need a day here and there, but not 12 consecutive weeks?

An employee can take the leave to receive “continuing treatment by a health care provider,” including physical therapy or intravenous therapy, such as Remicade or IVIg or chemotherapy, which takes a few hours. You don’t have to use all of your leave consecutively; you can use it intermittently.

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Conclusion

The FMLA is your best protection against being fired if your issue is absenteeism. However, the ADA will protect you if you require other types of accommodations. The ADA amendments of 2008, effective January 1, 2009, represent a huge advancement for patients with IBD and should make it far easier for IBD patients to obtain reasonable accommodations. Note that individual states have added certain restrictions on both the ADA and the FMLA, which may give you additional rights depending on where you live.

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If you found this article interesting, you may also be interested in our previous Your Digestive Health newsletters:

About the author
Eileen F Swan, JD

Jennifer C. Jaff, Esq, as updated by Eileen F. Swan, Esq

Eileen F. Swan is an attorney and current Executive Director of Advocacy for Patients with Chronic Illness, Inc. She obtained her JD degree from the City University of New York School of Law where the motto “Law in the service of human needs” spoke to her desire to help people. After law school, Ms. Swan served as a Prosecutor for the Bronx District Attorney’s Office in the domestic violence and sex crimes unit advocating for the rights of victims. As a legal services professional with Legal Services of the Hudson Valley (LSHV), she continued her work with poor and indigent individuals. While at LSHV, Ms. Swan became the Deputy Director and program-wide Domestic Violence Coordinator. In 2007, Ms. Swan went to work at the New York State Office for the Prevention of Domestic Violence, an executive-level agency. There, she wrote policy and procedures for the legal community on how to handle domestic violence cases.

About the author
Eileen F Swan, JD

Jennifer C. Jaff, Esq, as updated by Eileen F. Swan, Esq

Eileen F. Swan is an attorney and current Executive Director of Advocacy for Patients with Chronic Illness, Inc. She obtained her JD degree from the City University of New York School of Law where the motto “Law in the service of human needs” spoke to her desire to help people. After law school, Ms. Swan served as a Prosecutor for the Bronx District Attorney’s Office in the domestic violence and sex crimes unit advocating for the rights of victims. As a legal services professional with Legal Services of the Hudson Valley (LSHV), she continued her work with poor and indigent individuals. While at LSHV, Ms. Swan became the Deputy Director and program-wide Domestic Violence Coordinator. In 2007, Ms. Swan went to work at the New York State Office for the Prevention of Domestic Violence, an executive-level agency. There, she wrote policy and procedures for the legal community on how to handle domestic violence cases.

About the author
Eileen F Swan, JD

Jennifer C. Jaff, Esq, as updated by Eileen F. Swan, Esq

Eileen F. Swan is an attorney and current Executive Director of Advocacy for Patients with Chronic Illness, Inc. She obtained her JD degree from the City University of New York School of Law where the motto “Law in the service of human needs” spoke to her desire to help people. After law school, Ms. Swan served as a Prosecutor for the Bronx District Attorney’s Office in the domestic violence and sex crimes unit advocating for the rights of victims. As a legal services professional with Legal Services of the Hudson Valley (LSHV), she continued her work with poor and indigent individuals. While at LSHV, Ms. Swan became the Deputy Director and program-wide Domestic Violence Coordinator. In 2007, Ms. Swan went to work at the New York State Office for the Prevention of Domestic Violence, an executive-level agency. There, she wrote policy and procedures for the legal community on how to handle domestic violence cases.

Important Safety Information about AZASAN

WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with AZASAN. See WARNINGS.

AZASANAZASAN® (azathioprine tablets) 75/100 mg is indicated as an adjunct for the prevention of rejection in renal homotransplantations, and also for the management of active rheumatoid arthritis to reduce signs and symptoms. Patients are at increased risk of developing lymphoma and other malignancies, particularly of the skin. Exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and a high SPF sunscreen. Patients should have complete blood count (CBC), including platelet counts periodically during treatment. TPMT testing should be conducted to identify with absent or reduced TPMT activity. The most commonly reported side effects associated with AZASAN therapy are leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea, fever, myalgias, skin rashes, and hepatotoxicity. AZASAN therapy should be given cautiously when used concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan, or others) may have a prohibitive risk of malignancy if treated with AZASAN. AZASAN is contraindicated in pregnant and lactating women and in patients who have shown hypersensitivity to this product.

Consult with your physician to see if this product is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for AZASAN, including BOXED WARNING.pdf

Indication for METOZOLV ODT

METOZOLV® ODT is indicated for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy (refractory GERD) and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.

Important Safety Information about METOZOLV ODT

WARNING: TARDIVE DYSKINESIA

See full prescribing information for complete boxed warning.

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Do not take METOZOLV ODT (metoclopramide hydrochloride) if you have stomach or intestine problems that could get worse with METOZOLV ODT, such as bleeding, blockage or a tear in your stomach or bowel wall; have an adrenal tumor called pheochromocytoma; are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medicines that can cause uncontrolled movements, such as medicines for mental illness; or have seizures. 

METOZOLV ODT can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements): these movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping METOZOLV ODT. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking METOZOLV ODT.

Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia): these muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults younger than 30.

Parkinsonism: symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you have Parkinson’s Disease, your symptoms may become worse while you are taking METOZOLV ODT.

Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen with METOZOLV ODT. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.

Depression, thoughts about suicide, and suicide: some people who take METOZOLV ODT may become depressed. You may have thoughts about hurting or killing yourself. Some people who have taken metoclopramide products have ended their own lives (suicide).

High blood pressure: METOZOLV ODT can cause your blood pressure to increase.

Too much body water: people who have certain liver problems or heart failure and take METOZOLV ODT may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet.

Symptoms from stopping (withdrawal) METOZOLV ODT: you may still have side effects after you stop METOZOLV ODT such as headaches, and feeling dizzy or nervous.

METOZOLV ODT comes as a tablet that melts in your mouth.  Take METOZOLV ODT exactly as prescribed by your doctor. Do not change your dose unless your doctor tells you to.  You should not take METOZOLV ODT for more than 12 weeks. Take METOZOLV ODT at least 30 minutes before eating and at bedtime. 

It is not known if METOZOLV ODT is safe or works in children.

The elderly may be at greater risk for sleepiness and movement disorders with METOZOLV ODT.

If you have kidney problems, speak with your healthcare provider before taking METOZOLV ODT.

The most common side effects of METOZOLV ODT are:  headache, nausea, vomiting, tiredness, and sleepiness. You may have more side effects the longer you take METOZOLV ODT and the more you take. Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of METOZOLV ODT.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for METOZOLV ODT, including BOXED WARNING.pdf

Indication for OSMOPREP

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about OSMOPREP

WARNINGS

There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).

It is important to use the dose and dosing regimen as recommended (PM/AM split dose).

Do not take OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) if you have had a kidney biopsy that shows you have kidney problems because of too much phosphate, a blockage of your intestines, had stomach surgery involving stapling or bypass, a hole or opening in your intestines, significant irritation of the bowels such as toxic megacolon or toxic colitis, or you are allergic to sodium phosphate salts or any of the ingredients in OSMOPREP.

Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OSMOPREP, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis. These problems occur within a few days, but may develop several months after taking OSMOPREP.

Conditions that can make you more at risk for having serious kidney problems with OSMOPREP include: the loss of too much body fluid (dehydration), slow moving bowels, bowels blocked with stool (constipation), severe stomach pain or bloating, any disease that causes bowel inflammation (colitis), kidney disease or kidney problems, heart failure, and the use of water pills or non‐steroidal anti‐inflammatory drugs (NSAIDS). Your age may also affect your risk for having kidney problems with OSMOPREP. Talk to your doctor before you start to take OSMOPREP.

If you have a history of seizures or are at risk for seizures due to certain medications (such as tricyclic antidepressants), are undergoing withdrawal from alcohol or benzodiazepines, or if you have hyponatremia, you should talk to your doctor before you take OSMOPREP.

If you have been told you are at high risk for developing an arrhythmias or irregular heartbeat, you should tell your doctor.

It is important to drink sufficient liquids before, during, and after use of OSMOPREP.

If you have had an inflammatory bowel disease diagnosis or a blockage/opening of your intestines, tell your doctor before taking OSMOPREP.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking OSMOPREP.

In clinical trials, the most common side effects occurring in at least 3% of adult patients taking OSMOPREP were bloating, abdominal (stomach) pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

Indication for OSMOPREP

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about OSMOPREP

WARNINGS

There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).

It is important to use the dose and dosing regimen as recommended (PM/AM split dose).

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are contraindicated in patients with a biopsy-proven acute phosphate nephropathy, gastrointestinal (GI) obstruction, gastric bypass or stapling surgery, bowel perforation, toxic colitis, toxic megacolon, and known allergy or hypersensitivity to sodium phosphate salts or any component of OSMOPREP.

Renal impairment may occur with OSMOPREP. Assess renal function before treatment and during therapy. Use OSMOPREP with caution in patients with impaired renal function (creatinine clearance less than 30mL/minute), patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities (such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia) should have their electrolytes corrected before treatment with OSMOPREP Tablets.

Seizures due to electrolyte abnormalities can occur. OSMOPREP should be used with caution in patients with a history of seizures or at higher risk of seizure [e.g. patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Use caution in patients with higher risk of arrhythmias (e.g., patients with a history of cardiomyopathy, prolonged QT, uncontrolled arrhythmias, or recent myocardial infarction).

Advise patients to hydrate adequately before, during, and after the use of OSMOPREP.

Use OSMOPREP with caution in patients with history of Inflammatory Bowel Disease. In patients with suspected GI obstruction or perforation, rule out the diagnosis before administration of OSMOPREP.

Animal reproduction studies have not been performed. OSMOPREP should only be given to a pregnant woman if clearly needed.

In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were abdominal bloating, abdominal pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

The information contained on this page is intended for US patients, healthcare professionals, and pharmacists only.


SWB 13/17