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Every drug available in medicine today carries a risk of side effects, including over the counter remedies.
Some drugs are much better tolerated than others, producing very few side effects in only a very small number of people.
Other, more powerful drugs, particularly those on the cutting edge of medicine, may carry the possibility of significant side effects.
The Purpose of this Section
The purpose of this section is to make you aware of the possibility of side effects of multiple sclerosis drugs.
Those who currently take a drug for the purposes of treating multiple sclerosis may be completely unaware of the possibility of the side effects of that drug, given the complexity of the information contained with the medication.
If you are about to begin a course of treatment for multiple sclerosis, or you are already on a course of treatment for multiple sclerosis, then you should already be aware that the drugs are designed to lessen the frequency and severity of exacerbations and therefore reduce overall disability.
Similarly with treatment for a specific symptom of multiple sclerosis; it is obvious why you are taking the drug - to help alleviate the symptom, for example, Baclofen for spasticity or muscle spasms.
What is not so obvious, are the possible side effects.
What is Avonex ® ?
Avonex ® is a drug used in the treatment of multiple sclerosis. It is from a class of drugs known as interferons.
Interferon beta-1a is a recombinant DNA produced synthetic of naturally occurring proteins.
Interferons are cytokines. Three major classes of interferon have been identified - interferon alpha, interferon beta and interferon gamma. Interferon alpha and beta form the Type I class of interferons and Interferon gamma is a Type II interferon.
Indicated and approved for use in Multiple Sclerosis (MS) are Interferon beta-1a and Interferon beta-1b.
Interferons are species specific. In other words, the effects and results of interferon therapy and animal experimentation is difficult to apply across the human-animal species barriers since the effects they have within any given species are different.
The specific interferon-induced proteins and mechanisms by which interferon beta-1a exerts its effects in multiple sclerosis (MS) have not been fully defined.
Avonex ® is administered by intramuscular injection (injection directly into the muscle) once weekly.
Avonex ® Side Effects
Anaphylaxis
Anaphylaxis (a life threatening allergic reaction) has been reported as a rare complication of Avonex ® use.
Other allergic reactions have included dyspnea (difficulty breathing), orolingual oedema (swollen tongue), skin rash and urticaria (hives).
Autoimmune Disorders
Autoimmune disorders of multiple target organs have been reported in patients using interferons, including Avonex ®.
These autoimmune disorders include arthritis, idiopathic thrombocytopenia (reduction in the number of platelets in the blood), hyperthyroidism and hypothyroidism, and rare cases of autoimmune hepatitis (inflammation of the liver caused by the body's immune system attacking it - liver damage) have also been reported.
Cardiomyopathy and Congestive Heart Failure
Patients with cardiac disease, such as angina, congestive heart failure, or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation and continued treatment with Avonex ®.
While Avonex ® does not have any known direct-acting cardiac toxicity, during the post-marketing period infrequent cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other known etiologies being established.
In rare cases, these events have been temporally related to the administration of Avonex ®.
In some of these instances recurrence upon rechallenge was observed.
Decreased Peripheral Blood Counts
Decreased peripheral blood counts in all cell lines (resulting in a reduced ability to fight infection), including rare pancytopenia (simultaneous decrease in the numbers of red and white blood cells) and thrombocytopenia (reduction in the number of platelets in the blood), have been reported in patients using Avonex ®.
Flu-like Symptoms
Most people who take Avonex ® have flu-like symptoms (fever, chills, sweating, muscle aches, and tiredness) early during the course of therapy.
Usually, these symptoms last for a day after the injection. For many people, these symptoms lessen or go away over time.
Hepatic Injury and Hepatitis
Hepatic injury (liver damage) including elevated serum hepatic enzyme levels and hepatitis, some of which have been severe, has been reported.
In some patients a recurrence of elevated serum (blood) levels of hepatic enzymes have occurred upon Avonex ® rechallenge.
In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury.
The potential of additive effects from multiple drugs or other hepatotoxic agents (liver damaging substance; e.g., alcohol) has not been determined.
Rare cases of autoimmune hepatitis (inflammation of the liver caused by the body's immune system attacking it) have also been reported in patients using interferons.
Injection Site Necrosis
Injection site reactions, including injection site necrosis (destruction and death of the tissue surrounding the sites of injection), have been observed in patients using Avonex ®.
Menstruation and Abnormal Bleeding
Menorrhagia and metrorrhagia have been reported by some people using Avonex ®.
Menorrhagia (epimenorrhagia) - abnormally heavy bleeding at menstruation which may or may not be associated with abnormally long periods.
Metrorrhagia - bleeding from the womb when menstruation is not due.
Psychiatric Disorders
There have been post-marketing reports of depression, suicidal ideation and/or development of new or worsening of pre-existing other psychiatric disorders, including psychosis in patients using Avonex ®.
Some of these patients improved upon cessation of Avonex ® dosing.
Seizures
Some patients have had seizures while taking Avonex ®, including patients who have never had seizures before.
It is not known whether the seizures were related to the effects of their MS, to Avonex ®, or to a combination of both.
Thyroid
Some people taking Avonex ® develop changes in the function of their thyroid.
Symptoms of these changes include feeling cold or hot all the time, a change in weight (gain or loss) without a change in diet or amount of exercise, or feeling emotional.
Betaseron ®
What is Betaseron ®?
Betaseron ® is a drug used in the treatment of multiple sclerosis. It is from a class of drugs known as interferons. In Europe, Betaseron ® is called Betaferon ®.
Betaseron (interferon beta-1b) is a recombinant DNA produced synthetic of naturally occurring proteins. It is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon.
Interferons are cytokines. Three major classes of interferon have been identified - interferon alpha, interferon beta and interferon gamma.
Interferon alpha and beta form the Type I class of interferons and Interferon gamma is a Type II interferon.
Indicated and approved for use in multiple sclerosis are interferon types, Interferon beta-1a and Interferon beta-1b.
Interferons are species specific. In other words, the effects and results of interferon therapy and animal experimentation is difficult to apply across the human-animal species barriers since the effects they have within any given species are different.
The mechanisms by which Betaseron ® exerts its actions in multiple sclerosis (MS) are not clearly understood.
Betaseron ® is administered by subcutaneous injection (injection under the skin) every other day.
Betaseron ® Side Effects
Anaphylaxis and Allergic Reactions
Anaphylaxis has been reported as a rare complication of Betaseron ® use.
Other allergic reactions attributed to the use of Betaseron ® have included dyspnea (difficulty breathing), bronchospasm, tongue edema (swollen tongue), skin rash and urticaria (hives).
Some patients taking Betaseron have had severe allergic reactions leading to difficulty breathing and swallowing; these reactions can happen quickly.
Allergic reactions can happen after your first dose or may not happen until after you have taken Betaseron many times.
Less severe allergic reactions such as rash, itching, skin bumps or swelling of the mouth and tongue can also happen.
If you think you are having an allergic reaction, stop using Betaseron immediately and call your doctor.
Autoimmune Disorders
Autoimmune disorders of multiple target organs have been reported in patients using Interferons.
These include:
arthritis
idiopathic thrombocytopenia
hyper and hypothyroidism
rare cases of autoimmune hepatitis
Arthritis - painful (destructive) inflammation of the joints.
Idiopathic thrombocytopenia - reduction in the number of platelets in the blood.
Hyper and hypothyroidism - over and under-activity of the thyroid.
Autoimmune hepatitis - an abnormal condition where the immune system attacks the liver.
Cardiomyopathy and Congestive Heart Failure
Patients with cardiac disease, such as angina, congestive heart failure, or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation and continued treatment with Betaseron ®.
While Betaseron ® does not have any known direct-acting cardiac toxicity, during the post-marketing period infrequent cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other known etiologies being established.
Treatment with Betaseron is significantly associated with heart palpitation. It may also be associated with hypertension (high blood pressure), tachycardia (racing heart) and peripheral vascular disorder.
Decreased Peripheral Blood Counts
Decreased peripheral blood counts in all cell lines, including rare pancytopenia; a simultaneous decrease in the numbers of red and white blood cells; and thrombocytopenia (reduction in the number of platelets in the blood).
Treatment with Betaseron ® is not advised for those patients suffering from blood problems such as anemia.
Depression and Suicide
Betaseron ® should be used with caution in patients with depression or other mood disorders, conditions that are common with multiple sclerosis.
Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including Betaseron ®.
One suicide and four attempted suicides were reported during the study. There were no attempted suicides in patients on study who did not receive Betaseron ®.
Patients treated with Betaseron ® should be advised to report immediately any symptoms of depression and/or suicidal ideation to their prescribing physicians.
Flu-like Symptoms
Flu-like symptom complex was reported in 76% of the patients treated with 0.25 mg Betaseron ®.
A patient was defined as having a flu-like symptom complex if flu-like symptoms or at least two of the following symptoms were concurrently reported: fever, chills, myalgia (muscle pains), malaise, or sweating.
The incidence rate of these events decreased over time, with 60% of patients experiencing the event during the first 3 months of treatment compared to 10% after 24 months.
Hepatic Injury and Hepatitis
Hepatic injury including elevated serum hepatic enzyme levels and hepatitis, some of which have been severe, has been reported.
In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury.
The potential of additive effects from multiple drugs or other hepatotoxic agents (e.g., alcohol) has not been determined.
Injection Site Reactions
Injection site reaction is significantly associated with use of Betaseron ®.
86% adverse injection site reactions are reported.
Additionally, 5% of users in clinical trials developed injection site necrosis (death of cells / tissue at the injection site).
Necrotic lesions are typically 3cm diameter (larger and smaller areas also reported) and extend to the subcutaneous fat (fat beneath the skin) although rarely, this extends as far as the muscle tissue.
Infrequently, this has required skin grafting.
Other injection site reactions include:
inflammation (53%), pain (18%), hypersensitivity (3%), edema (3%) and mass formation (2%).
Menstruation and Abnormal Bleeding
28% of premenopausal females treated at 0.25 mg Betaseron ® reported menstrual disorders.
All of these reports were of mild to moderate severity and included: intermenstrual bleeding and spotting, early or delayed menses, decreased days of menstrual flow, and clotting and spotting during menstruation.
Psychiatric Disorders
Mental disorders have been observed in patients using Betaseron.
Symptoms included depression, anxiety, emotional lability (mood swings), depersonalization, suicide attempts, and confusion.
One suicide and four attempted suicides were also reported. There were no attempted suicides in patients on study who did not receive Betaseron ®.
It is not known whether these symptoms may be related to the underlying neurological basis of MS, to Betaseron ® treatment, or to a combination of both.
Some similar symptoms have been noted in patients receiving interferon alpha, a different interferon to that used to treat multiple sclerosis (interferon beta-1a) and both interferons are thought to act through the same receptor.
Patients who experience these symptoms should be closely monitored and cessation of therapy considered.
Seizures
Some patients have had seizures while taking Betaseron ®, including patients who have never had seizures before.
It is not known whether the seizures were related to the effects of their MS, to Betaseron ®, or to a combination of both.
Thyroid
Some people taking Betaseron ® develop changes in the function of their thyroid.
Symptoms of these changes include feeling cold or hot all the time, a change in your weight (gain or loss) without a change in your diet or amount of exercise you get, or feeling emotional.
Copaxone ®
What is Copaxone ®?
Copaxone: Glatiramer acetate (formerly known as copolymer-1)
Glatiramer acetate is the active ingredient of Copaxone ®. It is a synthetically produced facsimile of four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine.
It is indicated for use in the treatment of multiple sclerosis (MS).
The mechanism(s) by which Copaxone ® exerts its effects in patients with multiple sclerosis (MS) is (are) unknown.
Copaxone ® is administered by subcutaneous injection (injection under the skin)
Copaxone ® Side Effects
Anaphylaxis
Post marketing adverse event reporting which may or may not indicate a causal relationship with Copaxone ® has reported rare anaphylactoid reaction while using glatiramer acetate.
It should be noted however that during pre-marketing studies of Copaxone ®, approximately 10% of MS patients exposed to glatiramer acetate experienced immediate, post-injection, allergy-type reactions including: flushing, chest pain, palpitations, anxiety, dyspnea (difficulty breathing), constriction of the throat, and urticaria (hives).
Autoimmune Disorders
Post marketing adverse event reporting which may or may not indicate a causal relationship with Copaxone ® has reported rheumatoid arthritis while using glatiramer acetate
Chest Pains
Approximately 26% of controlled trial patients receiving glatiramer acetate experienced what was described as transient chest pain.
Some of these episodes occurred immediately post-injection (approx 10%), however many did not. The significance of this remains unexplored.
Post marketing event reporting has indicated hypertension as a frequently reported (at least 1/100) event for those on Copaxone ®.
Any causal relationship, if any, remains unknown.
Decreased / Increased Peripheral Blood Counts
Rare post-marketing reports of leukopenia (reduction in the number of white blood cells), anemia (reduction in haemoglobin, the oxygen carrying content of red blood cells), eosinophilia (an unusual increase in the number of eosinophils (white blood-cell type leukocyte) in the blood stream.
Generally considered an allergic reaction; pancytopenia (a simultaneous decrease in red, white and blood platelet cells) have been reported.
There is no indication as to whether these events are connected to Copaxone ® use.
Depression and Suicide
Post marketing reports of infrequent (< 1/1000) reports of psychotic depression which may or may not have causal relationship to the use of glatiramer acetate.
Suicide attempt was also listed as infrequent.
It is unknown whether these events are related to exposure to glatiramer acetate (Copaxone ®).
Hepatic Injury and Hepatitis
Post marketing, adverse event reporting of liver function abnormality; liver damage; hepatitis and cirrhosis of the liver.
There may or may not be a causal relationship with the use of glatiramer acetate.
Menstruation and Abnormal Bleeding
Post marketing adverse event reporting lists the following as frequent events (occurring in at least 1/100 patients exposed to glatiramer acetate):
Amenorrhoea (absence or stopping of period); menorrhagia (abnormally heavy bleeding).
Additionally, suspicious papanicolaou smears (pap smear) and vaginal haemorrhage were reported as frequent post marketing events.
It is unknown whether these events are related to exposure to glatiramer acetate (Copaxone ®).
Psychiatric Disorders
Post marketing adverse event reporting lists the following as frequent events (occurring in numbers greater than 1 in 100):
Abnormal dreams, emotional lability (mood swings) and stupor.
It is unknown whether these events are related to exposure to glatiramer acetate (Copaxone ®).
Renal and Urogenital Functioning
No data available for the use of Copaxone in patients with impaired renal functioning.
However it is worthy of note that animal studies suggest that immune complexes are deposited in the renal glomeruli (kidneys).
While the significance of this is undetermined, there is the possibility patients with impaired renal functioning may be adversely affected.
Additionally, post marketing adverse event reporting lists hematuria (presence of blood in the urine - indicative of renal disease/disorder) as frequent (reported in at least 1/100 patients exposed to glatiramer acetate) and in addition, urinary frequency.
It is unknown whether these events are related to exposure to glatiramer acetate (Copaxone ®).
Rebif ®
What is Rebif ®?
Rebif ® is a drug used in the treatment of multiple sclerosis. It is from a class of drugs known as interferons
Interferon beta-1a is a recombinant DNA produced synthetic of naturally occurring proteins.
Interferons are cytokines. Three major classes of interferon have been identified - interferon alpha, interferon beta and interferon gamma. Interferon alpha and beta form the Type I class of interferons and Interferon gamma is a Type II interferon.
Interferons are species specific. The effects and results of interferon therapy and animal experimentation is difficult to apply across the human-animal species barriers since the effects they have within any given species are different.
The specific interferon-induced proteins and mechanisms by which interferon beta-1a exerts its effects in multiple sclerosis (MS) have not been fully defined.
Rebif ® is administered by subcutaneous injection (injection under the skin) three times weekly.
Rebif ® Side Effects
Anaphylaxis
Anaphylaxis has been reported as a rare complication of Rebif ® use.
Other allergic reactions have included skin rash and urticaria (hives), and have ranged from mild to severe without a clear relationship to dose or duration of exposure.
Several allergic reactions, some severe, have occurred after prolonged use.
Some patients taking Rebif ® have had severe allergic reactions leading to difficulty breathing and loss of consciousness.
Autoimmune Disorders
Autoimmune disorders of multiple target organs have been reported in patients using Interferon products.
These include arthritis, idiopathic thrombocytopenia (reduction in the number of platelets in the blood), hyper and hypothyroidism.
There have also been rare cases of autoimmune hepatitis (liver damage) reported.
Cardiomyopathy and Congestive Heart Failure
Patients with cardiac disease, such as angina, congestive heart failure, or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation and continued treatment with Rebif ®.
While Interferons do not have any known direct-acting cardiac toxicity, during the post-marketing period, infrequent cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other known etiologies being established.
Peripheral Blood Counts
Decreased peripheral blood counts in all cell lines, including rare pancytopenia (simultaneous decrease in the numbers of red and white blood cells) and thrombocytopenia (reduction in the number of platelets in the blood) have been reported in patients using Interferons.
Depression and Suicide
Rebif ® (interferon beta-1a) should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis.
Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif ®.
The most common serious adverse event reported with Rebif ® were psychiatric disorders, including depression and suicide ideation or attempt.
The incidence of depression of any severity with Rebif ® treated groups (including placebo controls) was approximately 25%.
Patients should be advised to report immediately any symptoms of depression and/or suicidal ideation to the prescribing physician.
If a patient develops depression, cessation of treatment with Rebif ® should be considered.
Flu like Symptoms
Most patients have flu-like symptoms (fever, chills, sweating, muscle aches, tiredness, headaches, chest pain, back pain).
For many patients these symptoms will lessen or go away over time.
Hepatic Injury and Hepatitis
A case of fulminant hepatic failure requiring liver transplantation in a patient who initiated Rebif ® therapy while taking another potentially hepatotoxic (liver damaging substance) medication has been reported from a non-U.S. postmarketing source.
Severe liver dysfunction, leading to hepatic failure and liver transplantation, has been reported very rarely in patients taking Rebif ®.
Symptomatic hepatic dysfunction, primarily presenting as jaundice, has been reported as a rare complication of Rebif ® use.
Asymptomatic elevation of hepatic transaminases (particularly SGPT †) is common with interferon therapy.
Asymptomatic elevation of hepatic transaminases (particularly SGPT †) is common with interferon therapy.
Rebif ® should be initiated with caution in patients with active liver disease, alcohol abuse, increased serum SGPT † (>2.5 times ULN), or a history of significant liver disease.
Dose reduction should be considered if SGPT † rises above 5 times the upper limit of normal.
The dose may be gradually re-escalated when enzyme levels have normalized.
Treatment with Rebif ® should be stopped if jaundice or other clinical symptoms of liver dysfunction appear.
Injection Site Reactions
Rebif ® may cause redness, pain, or swelling at the place where an injection was given.
Injection site reactions are among the most commonly reported adverse reactions in patients taking Rebif.
A few patients have developed skin infections or areas of severe skin damage (necrosis).
Pregnancy
Rebif ® has been associated with significant increases in spontaneous abortion in animal studies given two times the equivalent human dose.
Although there are no adequate and well-controlled studies of Rebif ® in pregnant women, during initial pre-marketing studies of Rebif ®, 2 spontaneous abortions were observed and 5 fetuses carried to term among 7 women in the study groups.
Should a woman become pregnant or plan to become pregnant while taking Rebif ®, she should be informed or the potential risk to the fetus and discontinuation of Rebif ® therapy considered.
Psychiatric Disorders
Rebif ® (interferon beta-1a) should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis.
Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif ®.
Patients should be advised to report immediately any symptoms of depression and/or suicidal ideation to the prescribing physician.
If a patient develops depression, cessation of treatment with Rebif ® should be considered.
Seizures
Caution should be exercised when administering Rebif ® to patients with pre-existing seizure disorders.
Seizures have been associated with the use of beta interferons.
A relationship between occurrence of seizures and the use of Rebif ® has not been established.
Thyroid
Some people taking Rebif ® develop changes in the function of their thyroid.
Symptoms of these changes include feeling cold or hot all the time, a change in your weight (gain or loss) without a change in your diet or amount of exercise you get, or feeling emotional.
