Fibromyalgia Drug Milnacipran: Is it Worth the Dangerous Side Effects?

Fibromyalgia is a disorder that effects the lives of thousands of women. There is fatigue, pain, brain fog and these symptoms certainly compromise the quality of life for patients.

Milnacipran is a new drug to treat this disease available in the marketplace as of April, 2009. There is a petition sitting in the FDA office sent in by The Public Citizen Group to get this drug banned.. The drug's side effects in many cases are worse than the symptoms of the fibromyalgia. Many women are being placed on this drug without being informed of the serious, and dangerous side effects. From the research on this drug, it is not a healthy solution to the fibromyalgia problem.

Problem #1: Fibromyalgia is a chronic disease but the clinical trials only consisted of 3 months. So this means there is no long term data on its mental and physical effects on health.. You may feel good when you first take it, but that does not mean you will have long term improvement without damage to organs such as the liver. Just like diet pills, the damage to heart and other organs many not show up for months or years. Women loved the diet pills, but each one over time caused heart problems. Meridia just got banned in Europe in January of 2010. I am sure those women loved losing weight until the heart problems showed up.

Problem #2: These clinical trials showed that this dangerous drug only helped 7% to 9% of the patients. This means that 90% of the patients using this drug did not feel any better than the patients using the placebo. That is not a high rate of success. So you are taking a drug that in 90% of the patients did not work well but gives you serious and life threatening side effects. Somehow that doesn't make sense to me. Of course, patients are not being informed of its lack of success in the clinical trials.

According to the research by The Public Citizen, the drug's data was reconfigured with different criteria so that it could meet the FDA's 30% relief requirement. This fact is the main reason Europe denied its approval. Milnacipran is not backed up with enough clinical evidence to show it is an effective treatment for Fibromyalgia. If the evidence had been there, Europe would have approved the drug. It is approved in Europe for depression.

Problem #3: This drug has severe, life threatening side effects:

The drug is used in Europe and Japan as an antidepressant. Here it is not approved for depression but for Fibromyalgia. This drug has a potential for increasing the risk of suicide. If you are being treated for depression already, the use of this drug will increase your risk of suicide.

The trial of this drug was conducted only for three months and excluded patients with moderate to severe depression. That means they have no idea how this drug might impact those more severely depressed patients. They have no idea how this drug effects long term depression period.

This drug raises Serotonin levels and its use with other drugs that are Monamine oxidase inhibitors is a bad combination. This drug can cause hallucinations; coma; blood pressure and heart rate changes; nausea; vomiting; diarrhea; coordination problems; activation of mania and hypomania; and mood disorders;

GI Disorders: High doses of 400mg down to 100 mg cause nausea and vomiting in most patients. Even low dosages of 50 mg cause nausea in half the patients and vomiting in 10 to 13% of patients. These symptoms did reduce some over time but many of the patients dropped out over this and other side effects.

Blood Pressure: Many patients have developed high blood pressure taking the drug. Increasing blood pressure increases cardiovascular problems and risk of stroke and heart attacks.

Seizures: Increases risk of seizures.

Liver Toxicity: Milnacipran is very toxic for your liver function with reports of of liver damage, fulminant hepatitis, hepatic impairment, and elevations of liver enzymes. Most of the drugs manufactured have a negative impact on liver function. This can be a fatal problem. If you drink alcohol, this drug is especially toxic to the liver. Liver toxicity is one of the more common side effects with this drug.

Milnacipran causes physical dependence and the withdrawal symptoms can be severe. Do not stop the drug without the supervision of a doctor. This means it is addicting!

Internal Bleeding Problems: Drug increases bleeding so if you are taking aspirin, Warfarin, NAIDs, or other anti-coagulants you could see bleeding under the skin or even life threatening hemorrhages.

Low Blood Sodium: This side effect is especially dangerous in patients taking diuretics. This causes a sodium imbalance leading to headaches, memory impairment, confusion, weakness, respiratory arrest, coma or possible death.

Male Patients: prostatic hypertrophy, urinary tract obstruction, testicular and ejaculation problems, and erectile dysfunction.

Eye Problems: Can cause narrow-angle glaucoma.

Increased Fracture Risk: This drug has a negative effect on your bones, which could increase your fall risk and cause your bones to break more easily.

Toxic to Fetus and Newborn Babies: Toxic even at low dosage. This drug will carry over into the beast milk and your newborn baby. Do not use this drug if you are pregnant, thinking about being pregnant, or nursing.

Renal Impairment: Increases renal impairment.

Drugs You Should Not Take With Milnacipran: Phenelzine or Nardil; Sumatriptan or Imitrex for migraines; Citaopram or Celexa;antidepressants such as Clomopramine or Anafranil; herbs such as ginseng, St. John's Wort, and Tryptophan.

Fibromyalgia is very debilitating but are your symptoms worth destroying your liver for? Are your symptoms worth the other side effects that can result from this drug? This drug only had 3 month clinical trials, so you are basically a guinea pig using this drug. Is the relief worth the risk of the possible long term effects?

There is a petition to get this drug banned. I can sure understand why after researching this drug.
Have you investigated alternative medicine for Fibromyalgia such as acupuncture or massage therapy? I suggest you do so and only take this drug if other options don't work. Fibromyalgia does not kill you but liver failure does. Mental side effect symptoms can impact your life more permanently and severely than the symptoms of Fibromyalgia. Did your doctor really explain the toxic effects of this drug? If he did not or minimized the possible side effects, you need to change doctors. It is your responsibility to investigate these drugs yourself before taking them. Only then should you take any drug.

The Europe Medicine Agency in 2009 refused to approve both Lyrica (pregabalin) and Savella (Impulsor; milnacipran) for fibromyalgia. They refused it twice on the grounds there is not enough evidence that it is effective for Fibromyalgia and no data on long term safety. It seems that Europe is much more protective of its citizens than the FDA or the AMA is here. In Europe, pharmaceutical companies are not allowed to advertise directly to the consumer on television. Why do we allow them to do it here? It is a unethical practice. It misleads consumers and increases their profit margin by billions. It is time to make a stand.

References:

http://www.citizen.org/publications/release.cfm?ID=7723&secID=1676&catID=126

http://www.dancewithshadows.com/pillscribe/forest-fibromyalgia-drug-savella-milnacipran-can-increase-heart-disease-risk/

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a609016.html