FDA Approves Generic Duloxetine for Fibromyalgia-associated Pain and Depression

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Fibromyalgia may be due to injury, emotional distress, or viruses that change the way the brain perceives pain, but the exact cause is uncertain. People with rheumatoid arthritis, lupus, and spinal arthritis may be more likely to have the illness. Hallmarks of fibromyalgia include chronic musculoskeletal pain, extreme fatigue, and sleep and mood disturbances.

Patients can also experience psychological distress, including depression and anxiety. They often use antidepressants to help cope with these problems. People with fibromyalgia can have unusual levels of Substance P in their spinal fluid according to ACR. This chemical helps send out and intensify pain signals to and from the brain.

To find out the role of Substance P studies are being conducted and other neurotransmitters, and scientists are trying to find out that why people with fibromyalgia have increased sensitivity to pain and whether there is a gene or genes that make a person more liable to have it.

 Pain medicines, antidepressants, muscle relaxants, and sleep medicines are typically used to treat people with fibromyalgia. For particularly treating fibromyalgia in June 2007 Lyrica (pregabalin) became the first FDA-approved drug; a year later, Cymbalta (duloxetine hydrochloride) became the second a year later in June 2008; and in January 2009, Savella (milnacipran HCI) became the third. In some people with fibromyalgia Lyrica, Cymbalta and Savella decrease pain and improve function.

People suffering from fibromyalgia have been shown to experience pain in a different way from other people; the mechanism by which these drugs produce their effects is mysterious. There is information telling that these drugs influence the release of neurotransmitters in the brain.

Neurotransmitters are chemicals that transmit signals from one neuron to another. Treatment with Lyrica,  Cymbalta, and Savella may reduce the level of pain experienced by some people with fibromyalgia.

FDA approves generic Duloxetine for fibromyalgia

Major depressive disorder in adults is treated by Duloxetine. In adults and children who are at least 7 years old Duloxetine is also used to treat general anxiety disorder. In adults Duloxetine may be used to treat chronic muscle or joint pain (such as low back pain and osteoarthritis pain) or fibromyalgia (a chronic pain disorder).

“We are happy to receive this FDA consent, which adds to our growing line of central nervous system acting agents. Hai Wang, President of Solco Healthcare said in a press release that we continue to reinforce our presence within the US generic market by providing high quality medicines at reasonable prices. Scientists say Duloxetine works by increasing levels of the neurotransmitters serotonin and noradrenaline in the nervous system.


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Duloxetine’s benefits were compared in fibromyalgia patients with those of the depression treatment acetyl L-carnitine. Both of them reduced depression and pain, and improved patients’ physical quality of life. But only duloxetine improved patients’ psychological quality of life. In decreasing fibromyalgia patients’ pain and improving both their other symptoms and quality of life, Duloxetine did a considerably better job than a placebo. It was also safe, and patients tolerated it well.

Duloxetine may improve your mood, sleep, appetite, and energy level, and decrease nervousness. It can also reduce pain due to definite medical conditions. Duloxetine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). Balance of certain natural substances (serotonin and norepinephrine) in the brain is restored by this medication.

How to use?

As directed by your doctor, take this medication by mouth, usually 1 or 2 times a day with or with no food. If you have vomiting, it may aid to take this drug with food. Swallow the capsule whole. Do not crush or chew the capsule or mix the contents with food or liquid. This can lead to the release of whole drug at once, increasing the risk of side effects. The dosage is based on your age, medical condition and response to treatment.

Your doctor may direct you to start this medication at a low dose and slowly increase your dose in order to decrease your risk of side effects. Follow your doctor’s instructions carefully. Take this medication daily to get the most advantage from it. To help you remember, take it at the same time(s) each day. Even if you feel well it is significant to continue taking this medication as prescribed.

Without consulting your doctor do not stop taking this medication. When this drug is suddenly stopped it can worsen some conditions. Symptoms like confusion, giddiness, mood swings, headache, fatigue, diarrhea, sleep changes, and concise feelings similar to electric shock may also appear. To reduce side effects your dose may need to be slowly decreased. Report any new or worsening symptoms right away.

Side effects

Side effects include loss of hunger, increased sweating, vomiting, dry mouth, constipation, exhaustion, or drowsiness. If any of these effects persist or worsen, tell your doctor promptly. Especially when you first start or increase your dose of this drug faintness or lightheadedness may take place. To decrease the risk of faintness, lightheadedness, or falling, get up gradually when rising from a sitting or lying pose

Your physician has judged that the advantage of this medication to you is greater than the danger of side effects, that’s why your doctor prescribed this medication to you, Keep that in mind. A lot of people using this medication do not have severe side effects. This medication may raise your blood pressure.

Check your blood pressure regularly and tell your doctor if the results are high. If any of these serious side effects occur inform your doctor immediately: confusion, decreased interest in sex, easy bruising/bleeding,  changes in sexual ability, muscle cramps/weakness, shaking (tremor), signs of liver problems (such as stomach/abdominal pain, persistent nausea, vomiting, difficulty urinating ,yellowing eyes/skin, dark urine).

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Study Reference: Duloxetine for the treatment of fibromyalgia via NCBI

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