Here's today's post on Savella. Brand new and fresh content, I promise.
You may have already heard that a Petition to Ban Fibromyalgia Drug Milnacipran (Savella) was filed with the FDA on January 20, 2010 by a group called Public Citizen. This petition was immediately picked up by the Associated Press. Word gets around (and around) when an article gets picked up by the AP. More on that later.
My first reaction was, who the hell is Public Citizen???
"Public Citizen is a non-partisan, politically left-of-center, non-profit public interest advocacy organization based in Washington, D.C., with a branch in Austin, Texas. Public Citizen was founded by Ralph Nader in 1971.http://en.wikipedia.org/wiki/Public_CitizenNormally this is a group that would be right up my alley. But in this case I think they have butted in where they have no business, and more to the point, where they do not have enough knowledge of the subject at hand to offer an opinion, much less to make a recommendation to the FDA.
Immediately, and I mean the same day that the Public Citizen petition became public, our old friend Matthew Perrone of the Associated Press (and author of the 2009 article Disease may not be real but the drug profits are, infamy) came out with an article titled Group urges recall of drug for fibromyalgia. You know that once an article hits the AP it travels all over the world in the most reputable and prestigious of publications. If not for the AP picking this up, I don't think we would have heard another peep about Public Citizen's petition.
A bit off topic, but Perrone ended his current article on Fibromyalgia on quite a different note than the article from last year: "The cause of fibromyalgia is not known, though some researchers point to abnormalities in how patients with the disorder process pain nerve signals." I'd call that a major victory for Fibromyalgia advocacy and awareness!
There ARE people who are helped by this drug; I happen to be one of them. I started on Savella in August of 2009. By the time I ramped up to the minimum recommended effective dose of 100 mg per day almost a month later, my pain levels had subsided to the point that I wasn't taking ANYTHING else for pain. My energy level went up. I started to think in terms of returning to work: I started physical therapy for my neck at TRMC Spine Therapy Center - in spite of the mandate of the spine specialist that I saw back in June of last year, that PT would not work for me because my pain had "gone on for too long." Luckily for me, my rheumatologist has a "never say never" policy and he referred me for PT. Anyway, I believe Savella should continue to be available because when it does help, it REALLY helps. Even if it's only helping one third of the people who take it (and I'm willing to bet that those numbers would go up if a few dosage changes were made during the clinical trials), it's totally worth it to keep Savella on the market.
Although I had to contend with nausea (the most common side effect) from the first day I started to take Savella, by happy accident and my inability to get the prescription medicine Zofran for nausea fast enough, I found that ginger capsules worked just as well for me. They kept the nausea in check.
Savella also caused me to have tachycardia, or rapid heart rate, so I am currently at one quarter of the minimum effective dose, hoping that my body will adjust to the medicine so I can eventually up the dosage, but I am also prepared to be one person that Savella is just not right for. (Tachycardia can be very bad news.)
The Fibromyalgia Network October 2009 newsletter article titled "What Are We Learning About Savella?" is the most helpful resource I've seen, aside from the actual Prescribing Information (this is the complete pdf in a font size that's actually legible). More on this in a future post, but here are the major points covered in the FM Network:
- How the drug works to target symptomsYou might also be interested in the FM Network article on Imaging the Effects of Savella.
- 503 fibromyalgia patients respond to a survey spurring discussion on Savella (milnacipran), the latest FDA-approved drug to treat fibromyalgia.
- Clinical trial results on which symptoms are likely to improve and the most common side effects that may occur
- 8 physicians and researchers offer advice on overcoming common side effects, drug interactions, and signs of trouble
It's always great fun to see what the Big Pharma Reps are saying about their drugs: From Cafe Pharma - Savella Questioned, Might Be Pulled and The End of Savella... Pulled Off Market. They almost all post anonymously and say some pretty aggressive, even combative things. For example, here are some responses to the second thread which was a partial quote from the AP article:
"While I absolutely hate working for CYP (Cypress BioScience,who manufactures Savella along with Forest Pharmaceuticals), I hate your posts as much. Your style is recognizable in every thread as a doomsday, "sky is falling" chicken-little attitude.Interesting, yes?
"For once- shut your mouth & do you home work before you post without all the facts. In this case, look up Dr. Wolfe's history and all of the drugs he's trashed & tried to get pulled off the market. Read his newsletter to see that he pretty much hates every new drug and trashes them straight from the PI and not from any clinical experience.
"This news is not new and is in the package insert. Guess what? Drugs are chemicals-when put in the human body they produce side-effects and affect individuals differently. Every now then there is an outlying patient that has an unpredictable reaction to a drug or class of drugs. Can you say Celebrex? It helped millions of people, yet causes high blood pressure in some people- like it's cousin Vioxx. And if it hadn't been for this crazy legal world we live in, Vioxx would still be on the market helping people.
"So don't be so quick to ASSUME that Savella will be immediately pulled off the market. No one knows what the future brings for any drug...... so try to post with responsible info instead of being a sensationalist like a newspaper reporter."
"This post is a bunch of hogwash. If drug companies wouldnt hide clinical data, the mortality rates would drop significantly with marketed pharmaceuticals. In the case of Vioxx it was the "hiding" of data and poor promotion of the sales reps that was the cause. This poster is right on target to share with you something that your company and wimpy DM would not. Grow up. Your sky has been falling since the day you took this job. Savella BP profile and clinical findings are well known, it is all over the EU and all over the data accumulated from Europe for Depression. You should check yourself before you come on here bloating your mouth out like some slug marketing fool who sits in an office at HO all day!
FibroFocus is a new website provided by Forest Labs, Inc., for real medical professionals only. I tried to register. Not allowed. The faculty is rather impressive, especially Kim DuPree Jones, PhD, FNP. She has been affiliated with Dr. Bennett and the Fibromyalgia Info Foundation since WAY back. (9/2010 update: The FibroFocus website apparently no longer exists. No other explanation available.)
"FibroFocus is a web/teleconference series designed to provide healthcare professionals with information and strategies in the management of fibromyalgia. Led by a fibromyalgia expert, this interactive program will focus on enhancing your ability to diagnose this condition, while providing you with information regarding the safety and efficacy of Savella, the most recently approved agent for the management of fibromyalgia."
It's good that they are making the effort to train doctors. I say this because it was my PCP who originally started me on Savella but it was my rheumatologist who said basically 'Your heart rate is WAY up and you need to decrease your dosage of Savella immediately.' (Actually it was his nurse who said my heart rate was high, immediately upon taking it, at a regularly scheduled follow up visit) Would my PCP have just let me keep on taking Savella with a seriously elevated heart rate, which was very different from my usual low-normal rate? I wonder. I saw him one month after he started me on Savella; I had worked up to the minimum effective dose of 100 mg per day and I'm sure my heart rate was high. I could feel it beating crazy at odd times when I wasn't even doing anything. The next time I saw the PCP after I saw the rheumatologist, I gave him a copy of the FM Network article. So at least he knows better now.
So the rheumatologist cut my dose in half, to 50 mg per day. After a month at that dose my heart rate was better but it was still kind of crazy. And every day when I woke up I had a headache all along the top of my forehead. So I dropped the dose again, to 25 mg per day. The headache stopped immediately and my heart rate started to feel normal again.
Everyone who takes this drug should be under the care of a knowledgeable doctor that they see regularly.
For you folks who understand the scientific stuff:
Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is:
There is another study ongoing at the Indiana University. Their Fibromyalgia Clinical Research Center is evaluating communication as a therapeutic tool in treating FM: Fibromyalgia Study Involves Medication and Conversation.
"We are conducting this study to better understand how talk therapies, such as education and cognitive behavioral therapy (CBT), can improve the therapeutic benefits of medications for fibromyalgia. Savella ®, (milnacipran) is an FDA approved drug for fibromyalgia. The safety and efficacy of Savella has been established in two US-based clinical studies involving over 2,000 patients with fibromyalgia. Because Savella has already been shown to be effective when used in isolation to treat fibromyalgia, we are conducting the study to determine whether combination treatment (Savella + talk therapy) is more efficacious than just Savella or talk therapy alone. Participants are randomized to either Savella or placebo (sugar pill) and will receive either CBT or an educational phone series."Patient Assistance Program: This is where you can apply to receive Savella at no charge.
And last but not least (this only happened to one person; it won't happen to you), from the great folks at Crazy Meds! The Good, The Bad and the Funny of Neurological Medications:
"Unfortunately the PI sheet omits the best freaky rare side effect. EVER!Yeah, so I have a warped sense of humor. It runs in my family.
"Ejaculation After Defecation Without Orgasm Induced by Milnacipran
"You know what makes that the best ever? Even after reading the full text it's unclear as to exactly what happened.
"Did he require milnacipran to have an orgasm, otherwise he normally ejaculates after defecating without an orgasm?
"Did he not have his usual orgasm during defecation, and the milnacipran induced ejaculation after he wiped?
"Did the milnacipran induce an orgasm-free ejaculation after he defecated? Did he normally have orgasms during his post-defecation ejaculations?
"In the report it is noted, more than once, he observed "emission of sperm." He must have Gojira-sized swimmers. It also notes that "overpooling of sperm" (a.k.a. blue balls) can be responsible for spontaneous ejaculation. Yeah, right. I bet it hurts if they don't get a happy ending."