June 5th
2007
3:02 PM
Drug Saf. 2007;30(6):515-25. LinkOut
Statins, neuromuscular degenerative disease and an amyotrophic lateral
sclerosis-like syndrome: an analysis of individual case safety reports
from vigibase.Edwards IR, Star K, Kiuru A.
The WHO Foundation Collaborating Centre for International Drug
Monitoring, the Uppsala Monitoring Centre (UMC), Uppsala, Sweden.
BACKGROUND: The WHO Foundation Collaborating Centre for International
Drug Monitoring (Uppsala Monitoring Centre ) has received many
individual case safety reports (ICSRs) associating HMG-CoA reductase
inhibitor drug (statin) use with the occurrence of muscle damage,
including rhabdomyolysis, and also peripheral neuropathy. A new signal
has now appeared of disproportionally high reporting of upper motor
neurone lesions.
AIM AND SCOPE: The aim of this paper is to present the upper motor
neurone lesion cases, with other evidence, as a signal of a
relationship between statins and an amyotrophic lateral sclerosis
(ALS)-like syndrome. The paper also presents some arguments for
considering that a spectrum of severe neuromuscular damage may be
associated with statin use, albeit rarely. The paper does not do more
than raise the signal for further work and analysis of what must be
regarded as a potentially very serious and perhaps avoidable or
reversible adverse reaction, though it also suggests action to be
taken if an ALS-like syndrome should occur in a patient using
statins.
METHODS: The 43 reports accounting for the disproportional reports in
Vigibase (the database of the WHO Programme for International Drug
Monitoring) are summarised and analysed for the diagnosis of an ALS-
like syndrome. The issues of data quality and potential reporting bias
are considered. RESULTS: 'Upper motor neurone lesion' is a rare
adverse event reported in relationship to drugs in Vigibase (a
database containing nearly 4 million ICSRs). Of the total of 172 ICSRs
on this reported term, 43 were related to statins, of which 40 were
considered further: all but one case was reported as ALS. In 34/40
reports a statin was the sole reported suspected drug. The diagnostic
criteria were variable, and seven of the statin cases also had
features of peripheral neuropathy. Of a total of 5534 ICSRs of
peripheral neuropathy related to any drug in Vigibase, 547 were on
statins. The disproportional reporting of statins and upper motor
neurone lesion persisted after age stratification, and such
disproportionality was not seen for statins and Parkinson's disease,
Alzheimer's disease, extrapyramidal disorders, or multiple sclerosis-
like syndromes. DISCUSSION: Because the cases were sometimes atypical
we propose the use of the term 'ALS-like syndrome' and speculate
whether this is part of a spectrum of rare neuromuscular damage. The
diagnosis of ALS is often problematic, and the insidiousness and
chronicity of the disease make causality with a drug difficult to
assess.
The disproportionally high reporting makes this an important signal
nevertheless, since ALS is serious clinically and statins are so
widely used. Wide use of the statins also makes a chance finding more
probable, but is unlikely to cause disproportional reporting when
there are no obvious biases identified.
CONCLUSION: We emphasise the rarity of this possible association, and
also the need for further study to establish whether a causal
relationship exists. We do advocate that trial discontinuation of a
statin should be considered in patients with serious neuromuscular
disease such as the ALS-like syndrome, given the poor prognosis and a
possibility that progression of the disease may be halted or even
reversed.
PMID: 17536877 [PubMed - in process
-- By olsen | Reply | Private Message me
August 7th
2006
1:02 PM
Hey Silke,
Congratulations.
My happiness for you is beyond measure. You truly show us that there's a light at the end of the tunnel, albeit a long and arduous tunnel.
I know I haven't posted in a while, but just to update you, my baby is due next month god willing. (which is a miracle in and of itself as I wasn't ovulating after getting off the pill.) I gained a lot of weight and I believe it's because of the yasmin. I hope that after the baby my body will start healing itself and I will go back to normal, but time will tell.
Good luck and many hugs to you. Your an inspiration to us all.
Regards,
Sherry
July 24th
2006
5:54 PM
RED YEAST RICE IS A STATIN--mevacolin K is the active anti cholesterol ingredient in red yeast rice--this is the SAME ingredient found in the very first statin manufactured--mevacor. so if your husband is taking red yeast rice, he is still taking a statin, albeit a much milder version of one.....
-- By olsen | Reply | Private Message me
February 28th
2006
8:54 PM
I was on prednisone for 3 days. Took my first pill in the evening and another the next day. Took another that night. I was up all night discussing thing with my wife. I WAS WIRED. I crashed the next day, almost quit my job (I was heavily under stress at work). I went home, STILL WIRED, and shuttled my kids around all day. I started to think about my experiences as a kid. I was under severe stress. That night, I collapsed on my laundry room floor. I hallucinated all night. My wife and children were extremely frightened. They called the paramedics. I went to the emergency room. I litterly thought I had died. At the emergency room, I was disruptive and they admitted me. I spent 4 nights in a psychiatric ward, sedated with drugs but unable to differentiated my flashbacks from the past from the prednisone. It has taken nearly a week, to finally come to grips with the fact that I am not crazy. It was this drug and some stress (albeit, more than usual) that sent me into a life-changing experience. BE VERY CAREFUL if you are taking Prednisone, can't sleep, and are under stress. Your life may change forever. Mine did.
-- By knanke | Reply | (1) replies | Private Message me
October 22th
2005
9:11 AM
Insomnia, insomnia, insomnia --- this was the only notable (albeit frustrating) side effect of taking 40mg of Prednisone for 10 days.
-- By ggfire | Reply | Private Message me
April 21th
2005
10:16 PM
In response to the latest post:
I have been taking Singulair for the past week and have also broken out into hives. I have hives on my back, shoulders, chest, and sporadic bumps on other parts of my body. I thought it was just part of my seasonal allergies (albeit a very severe allergic reaction), but also suspected Singulair. I'm glad I Google searched the side effects and found this. I'm going to discontinue immediately.
-- By pyc211 | Reply | Private Message me
October 25th
2004
1:47 PM
after the first pill, I grew an extra arm. After the second pill, my head exploded but not to fear as shoving the 3 pill down my now exposed esophagus resulted in my growing another head albeit out of my left calf. I skipped the next four pills. Pill number eight increased my urine flow to 3.9 gallons/minute. Pill number nine made me thirsty (or was it pill eight?). I'm saving pills 10-16 for my ex-wife. Pills 17 and 18 were given to my Great Dane who is now a teacup Great Dane. I'll take 19, 20, and 21 tomorrow.
-- By jzehmisch | Reply | Private Message me
July 22th
2004
5:18 AM
How was this poison ever approved for long term? My body has all the side effects of a steroid after using it two years. Thank goodness for this site....I'm off advair and now am starting to feel like myself, albeit with joint pain.
-- By diana297 | Reply | Private Message me
May 27th
2004
2:35 AM
I was treated with prednisone for interstitial nephritis in Dec '03. Started at 60 mg for 2 days, then 40mg for 4 weeks. Doctor tapered drug too soon and too fast. Experienced painful swelling of joints of hands, elbows, shoulders, knees and ankles. Plus large, red, hot and very painful rashes and welts on neck, torso, arms, legs, particularly uncomfortable at pressure points like waistband and bra straps/bands (sides of stomach and breasts felt as if on fire). Was put back on prednisone in Feb '04 at 20mg daily and symptoms (which now I realize were side effects) subsided. Currently tapering again starting at 15mg for 3 wks and now on 2nd wk of 3 wks at 10mg...rashes/welts and aches have returned, but not as severe. I will be seeing my doctor in 2 wks for further tapering instructions (kidneys are fine and fully recovered). I had concerns about my "symptoms" being lupus since I got a positive ANA result, albeit a weak one, and my problems stemmed from the initial renal insufficiency. A dermatologist recommended I see and allergist because of the rashes. Although I'm not ruling out lupus or allergies just yet, after reading all the side effects on this website, I would have to think these aches, pains, rashes and swellings are prednisone related and I hope and pray they will go away once I'm off the prednisone. I will persue a more definitive diagnosis if the side effects continue and/or worsen after going off prednisone, but if anyone can offer a timeline as to how long the side effect took to wear off after being on prednisone for about 5-6 months (including tapering period), I would appreciate an e-mail.
-- By lisanyc76 | Reply | Private Message me
PredniSONE (3) Lipitor (2) Advair HFA (1) Yasmin (1) Methylpred DP (1) Aviane (1) Ambien (1) Singulair (1)
August 14th
2007
8:35 PM
I was taking Aviane for the past three months and hated it. I was on Alesse previously and had no problems. Since the first pill I felt like I had a yeast infection. The yeast infection continued the whole three months. No matter what I did, yogurt, monistat, it persisted. I also had a strange uncomfortable feeling in my vagina - it was horrible. My skin cleared up the first two months, the last month I got a cystic pimple. The last month I got my period and it was really heavy and painful.
-- By salliebeagle | Reply | (1) replies | Private Message me