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Savella

"Oct. 28, 2013 -- A new blood test may predict fibromyalgia, a condition that can be hard to diagnose.

Research about the new test was presented Sunday at the annual meeting of the American College of Rheumatology in San Diego.

"...

Savella

Savella Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Savella (milnacipran HCl) is used to treat a chronic pain disorder called fibromyalgia. This medication is a selective norepinephrine and serotonin reuptake inhibitor. Common side effects include nausea, vomiting, dry mouth, constipation, loss of appetite, dizziness, increased sweating, headache, or hot flashes (flushing). Savella is similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.

The recommended dose of Savella is 100 mg/day (50 mg twice daily). Savella may interact with blood thinners, clonidine, diuretics (water pills), digoxin, epinephrine, lithium, tramadol, tryptophan, migraine headache medicine, or antidepressants. Tell your doctor all medications you are taking. During pregnancy, Savella should be used only when prescribed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor. It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding. Do not stop using Savella suddenly, or you could have withdrawal symptoms such as dizziness, anxiety, feeling irritable, confusion, headache, ringing in your ears, and sleep problems.

Our Savella (milnacipran HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Savella in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • pounding heartbeats or fluttering in your chest;
  • painful or difficult urination;
  • easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;
  • severe weakness, seizure (convulsions);
  • chills or goose bumps, memory problems, trouble concentrating,
  • agitation, hallucinations, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • very stiff (rigid) muscles, high fever, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or
  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • dizziness, drowsiness, tired feeling;
  • swelling in your hands or feet;
  • constipation, upset stomach, bloating;
  • dry mouth;
  • sleep problems (insomnia);
  • hot flashes, sweating;
  • weight changes; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Savella (Milnacipran HCl Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Savella Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, dry mouth, constipation, loss of appetite, dizziness, increased sweating, headache, or hot flashes (flushing) may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, changes in sexual ability, decreased interest in sex, painful/difficult urination, seizures, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Savella (Milnacipran HCl Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Savella FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Patient Exposure

Savella was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with Savella and 652 patients treated with placebo) for a treatment period up to 29 weeks.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Reactions Leading to Discontinuation

In placebo-controlled trials in patients with fibromyalgia, 23% of patients treated with Savella

100 mg/day, 26% of patients treated with Savella 200 mg/day discontinued prematurely due to adverse reactions, compared to 12% of patients treated with placebo. The adverse reactions that led to withdrawal in ≥ 1% of patients in the Savella treatment group and with an incidence rate greater than that in the placebo treatment group were nausea (milnacipran 6%, placebo 1%), palpitations (milnacipran 3%, placebo 1%), headache (milnacipran 2%, placebo 0%), constipation (milnacipran 1%, placebo 0%), heart rate increased (milnacipran 1%, placebo 0%), hyperhidrosis (milnacipran 1%, placebo 0%), vomiting (milnacipran 1%, placebo 0%), and dizziness (milnacipran 1% and placebo 0.5%). Discontinuation due to adverse reactions was generally more common among patients treated with Savella 200 mg/day compared to Savella 100 mg/day.

Most Common Adverse Reactions in Placebo Controlled Trials

In the placebo-controlled fibromyalgia patient trials, the most frequently occurring adverse reaction in clinical trials was nausea. The most common adverse reactions (incidence ≥ 5% and twice placebo) in patients treated with Savella were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

Table 4 lists all adverse reactions that occurred in at least 2% of patients treated with Savella at either 100 or 200 mg/day and at an incidence greater than that of placebo.

Table 4: Treatment-Emergent Adverse Reaction Incidence in Placebo Controlled Trials in Fibromyalgia Patients (Events Occurring in at Least 2% of All Savella-Treated Patients and Occurring More Frequently in Either Savella Treatment Group Than in the Placebo Treatment Group)

System Organ Class- Preferred Term Savella 100 mg/day
(n = 623) %
Savella 200 mg/day
(n = 934) %
All Savella
(n = 1557) %
Placebo
(n = 652) %
Cardiac Disorders
  Palpitations 8 7 7 2
  Tachycardia 3 2 2 1
Eye Disorders
  Vision blurred 1 2 2 1
Gastrointestinal Disorders
  Nausea 35 39 37 20
  Constipation 16 15 16 4
  Vomiting 6 7 7 2
  Dry mouth 5 5 5 2
  Abdominal pain 3 3 3 2
General Disorders
  Chest pain 3 2 2 2
  Chills 1 2 2 0
  Chest discomfort 2 1 1 1
Infections
  Upper respiratory tract infection 7 6 6 6
Investigations
  Heart rate increased 5 6 6 1
  Blood pressure increased 3 3 3 1
Metabolism and Nutrition Disorders
  Decreased appetite 1 2 2 0
Nervous System Disorders
  Headache 19 17 18 14
  Dizziness 11 10 10 6
  Migraine 6 4 5 3
  Paresthesia 2 3 2 2
  Tremor 2 2 2 1
  Hypoesthesia 1 2 1 1
  Tension headache 2 1 1 1
Psychiatric Disorders
  Insomnia 12 12 12 10
  Anxiety 5 3 4 4
Respiratory Disorders
  Dyspnea 2 2 2 1
Skin Disorders
  Hyperhidrosis 8 9 9 2
  Rash 3 4 3 2
  Pruritus 3 2 2 2
Vascular Disorders
  Hot flush 11 12 12 2
  Hypertension 7 4 5 2
  Flushing 2 3 3 1

Weight Changes

In placebo-controlled fibromyalgia clinical trials, patients treated with Savella for up to 3 months experienced a mean weight loss of approximately 0.8 kg in both the Savella 100 mg/day and the Savella 200 mg/day treatment groups, compared with a mean weight loss of approximately 0.2 kg in placebo-treated patients.

Genitourinary Adverse Reactions in Males

In the placebo-controlled fibromyalgia studies, the following treatment-emergent adverse reactions related to the genitourinary system were observed in at least 2% of male patients treated with Savella, and occurred at a rate greater than in placebo-treated male patients: dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, libido decreased, prostatitis, scrotal pain, testicular pain, testicular swelling, urinary hesitation, urinary retention, urethral pain, and urine flow decreased.

Other Adverse Reactions Observed During Clinical Trials of Savella in Fibromyalgia

Following is a list of frequent (those occurring on one or more occasions in at least 1/100 patients) treatment-emergent adverse reactions reported from 1824 fibromyalgia patients treated with Savella for periods up to 68 weeks. The listing does not include those events already listed in Table 4, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening.

Adverse reactions are categorized by body system and listed in order of decreasing frequency. Adverse reactions of major clinical importance are described in the WARNINGS AND PRECAUTIONS section (5).

Gastrointestinal Disorders - diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, abdominal distension

General Disorders - fatigue, peripheral edema, irritability, pyrexia

Infections - urinary tract infection, cystitis

Injury, Poisoning, and Procedural Complications - contusion, fall

Investigations - weight decreased or increased

Metabolism and Nutrition Disorders - hypercholesterolemia

Nervous System Disorders - somnolence, dysgeusia

Psychiatric Disorders - depression, stress

Skin Disorders - night sweats

Postmarketing Experience

The following additional adverse reactions have been identified from spontaneous reports of Savella received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella. However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:

Blood and Lymphatic System Disorders - leukopenia, neutropenia, thrombocytopenia

Cardiac Disorders - supraventricular tachycardia

Eye Disorders - accommodation disorder

Endocrine Disorders - hyperprolactinemia

Hepatobiliary Disorders - hepatitis

Metabolism and Nutrition Disorders - anorexia, hyponatremia

Musculoskeletal and Connective Tissue Disorders - rhabdomyolysis

Nervous System Disorders - convulsions (including grand mal), loss of consciousness, Parkinsonism

Psychiatric Disorders - aggression, anger, delirium, hallucination, homicidal ideation

Renal and Urinary Disorders - acute renal failure

Reproductive System and Breast Disorders - galactorrhea

Skin Disorders - erythema multiforme, Stevens Johnson syndrome

Vascular Disorders - hypertensive crisis

Read the entire FDA prescribing information for Savella (Milnacipran HCl Tablets) »

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Savella - User Reviews

Savella User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Savella sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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