Lipitor and fda

Being a scientist, I am reluctant to say my symptoms are completely due to the statin (Crestor) that I've been on for 2.5 yrs. Started with a bulging/herniated disk in my lumbar region 4 months ago. Then increasing leg pain and major leg/foot cramping at night. Had my blood checked for electrolytes and CPK. Electrolytes were ok but elevated CPK (muscle breakdown enzyme). Doc took me off Crestor and now a month later, no cramping and much reduced leg pain. Am going in for a cholesterol check next week to see what the levels are. I wonder how much the Crestor played in my herniated disk. Certainly it has played a role in the leg pain and cramping as I no longer have it to the same degree. The FDA and surgeon general talk about putting everyone on statins. BIG MISTAKE!!!! Maybe CoQ helps, but I am done with statins.

I WORK WITH AN ARCHITECTURAL SOFTWARE DESIGN AND BILLING SOFTWARE. 1 MONTH AFTER I STARTED LIPITOR I STARTED TO FORGET THINGS LIKE CODES THAT I WORK WITH EVERY DAY AND BY THE SECOND MONTH I ALMOST LOST MY JOB WITH AN EVER INCREASING NUMBER OF MENTAL BLUNDERS AND VERY SERIOUS AND YET SILLY MISTAKES. ON MY WIFE'S (NOT MY DOCTOR WHO STILL DOESN'T ACKNOWLEDGE THE PROBLEM) ADVICE I QUIT TAKING IT. 6 MONTHS LATER I AM FINE AND THANKS TO THE PATIENCE OF MY BOSS I KEPT MY JOB. BUT I DEFINITELY HAD A MEMORY LOSS THAT WAS ALMOST DEBILITATING. IT IS ONLY AN OPINION, BUT I THINK BECAUSE THE MAJORITY OF USERS ARE OLDER THE MEMORY PROBLEMS ARE CHALKED UP TO OLD AGE AND NOT THE DRUG. IF I WERE NOT IN A DEMANDING MENTAL JOB I PROBABLY WOULDN'T HAVE NOTICED IT.

To send a report to the FDA about Lipitor and the side effects, go to ****** Hopefully, if enough people will complain about this dangerous drug, the FDA will ban it and it will be off the market.

Besides hair loss, vision problems, pain all the time, dry mouth, diarrhea, sleeplessness, pounding heart, I also had a problem with mucus filling my stomach and my food would get stuck. So I had to vomit to get the mucus up so I can continue eating. The first time I quite taking this poison pill, I got to feeling much better and my stomach got much better too. But never connected Lipitor with my problems. When I started taking this poison pill again, all my problems returned. But only worse, because I was in so much pain that it was hard for me to climb stairs and I had to hold on to everything just to go to the bathroom at night. Than I quit taking this poison pill again and haven't taken anymore since. All my problems disappeared again. I told my new doctor what this poison pill was doing and he told me to stop taking it, which I had already done.

So how many more people is this poison pill going to hurt and kill before Lipitor is taken off the market? I'm once again seeing Lipitor advertised on TV claiming this poison pill is FDA approved. Wasn't Baycol approved by the FDA as well and was taken off the market because it was too dangerous?Scary!

I'm 62

To complain about Lipitor , go to http://www.fda.gov/medwatch

Boy, after reading all the negative testimonials on Lipitor, I will throw mine in the garbage. That is what they are meant for. I have severe headache, and muscle pain, and foggy head, and I have only been on the crap for 2 months. I believe a lot of people's health is being ruined, and a lot of deaths are happening as well because of Lipitor and other statins. Mark my word, one day this drug will be withdrawn from the market, and the poor Pharmacutial companies will be in huge trouble.. They have the world convinced that we all need statins to bring cholesterol down.. The era when my parents lived , and lived long lives, and on farms, with butter, bacon, lots of fats, and never heard the word STATIN. I think every one that is writing to this forum and complaining about LIPITOR, should make a phone call to PYzier and tell them your side effects, that is the only way anything positive will come from this forum.. thank you for listening... I have called Pyzier and told them as well.

I have been on Zocor 40mg for many years and doing fine with it, until my doctor thought it was not working that well, hence, switched me to Lipitor 10mg. After a few months I developed severe chest pain along with neck pain. It felt like it might have been a heart attack, but it lasted more than 24 hours. I was admitted to ER for 1 night in the hospital and released the following day. They checked my heart and found it was fine. They ran my blood work, chest x-rays, cat scan and checked my lungs. All O.K.!!! The next morning they told me I had Slight Diabetes and an Under Active Thyroid and thought Esophagus Spasms were the cause of my pain. OH yeah, I also told them it hurt more with each breath of air I took in rather than out. It did not matter to them. They gave me Protonix 40mg because they thought it would reduce acid reflux to the esophagus, thus reducing my pain. Furthermore, they gave me Synthroid 25MCG for my Under Active Thyroid. After about 10 days of these medication plus LIPITOR, I had a recurrence of the same pain. I decided to research and came across this Website. I stopped the Lipitor and the next day my pain was subsiding. By this evening, my pain is almost completely gone. I am scheduled to have an Endoscopy in about a week from now and I am hesitant. Are the pharmaceuticals and physicians in cahoot with each other. I can't believe I was required to take all these tests and even more tests before the pain started (EKG, Heart Monitor, Nuclear Stress Test, Heart Scan and Angiography). Did I forget to mention I was diagnosed with High Blood Pressure and put on X-Forge a few months before all this started, but I was taken off it because of side effects (dizziness, lethargic, and so on). I did research on X-Forge and it said to NEVER use it as a first method of treatment for high blood pressure. I also was having pain under my right armpit. WHY DO WE HAVE TO SUFFER LIKE THIS BEFORE ACTION IS TAKEN TO PREVENT THIS FROM HAPPENING TO SOMEONE ELSE. Well, I guess it's just the price we have to pay before we decide to do things OUR WAY!! GOOD LUCK TO ALL OF YOU! THANKS FOR THE POST! PS. Can't wait to see what my Endocrinologist has to say about me next month $$$$$$$$$$$$$$$$$$$$.

Statin Drugs cause congestive heart failure, muscle wasting, memory loss, cancer, damage to the liver and kidneys and generally disrupt the quality of life of anyone who takes it. I know because my elderly mother was prescribed 20 mgs lipitor after her stroke in 2006. She suffers from everything I listed except for the cancer. The doctors did all the tests to rule out other causes but her problems are worsening to the point where she can barely walk. The doctors still don't want to stop the lipitor and won't even require that she take Coq10. How criminal is that? According to Therapeutics Initiative, statins provide only a 4% absolute benefit from having a major coronary event for people in the secondary prevention group like my mother but you have to take the statin for 5 years in order to get that lousy 4% benefit.
Add in the nasty side effects over the 5 years and I am sure that the side effects would cancel out all those benefits.
Lipitor is a scam drug that ruins the lives of the patients who take it.

Over 6 years ago, the following Petition was submitted to the FDA. I would encourage every patient being treated with statins to read it and bring it to the immediate attention of their physician:

CITIZEN PETITION TO CHANGE THE LABELING FOR
ALL STATIN DRUGS (MEVACOR, LESCOL, PRAVACHOL, ZOCOR, LIPITOR, AND ADVICOR) RECOMMENDING USE OF
100-200mg PER DAY OF SUPPLEMENTAL CO-ENZYME Q10 TO REDUCE THE RISK OF STATIN-INDUCED MYOPATHIES (INCLUDING
CARDIOMYOPATHY AND CONGESTIVE HEART FAILURE). http://www.fda.gov/OHRMS/DOCKETS/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf
May 24, 2002
Petitioner:
Dr. Julian M. Whitaker, M.D.

This Petition is based on the clinical findings of Dr Peter H. Langsjoen, MD, who also reported it to the FDA as follows:

Statins kill people - lots of people - and they wound many, many more. All patients taking statins become depleted in Coenzyme Q10 (CoQ10), eventually - those patients who start with a relatively low CoQ10 levels (the elderly and patients with heart failure) begin to manifest signs/symptoms of CoQ10 deficiency relatively rapidly - in 6 to 12 months. Younger, healthier people who's only "illness" is the non-illness "hypercholesterolemia" can tolerate statins for several years before getting into trouble with fatigue, muscle weakness and soreness (usually with normal muscle enzyme CPK tests) and most ominously - heart failure. In my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure secondary to statin usage, "statin cardiomyopathy". Over the past five years, statins have become more potent, are being prescribed in higher doses, and are being used with reckless abandon in the elderly and in patients with "normal" cholesterol levels. We are in the midst of a CHF epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes. We are now in a position to witness the unfolding of the greatest medical tragedy of all time - never before in history has the medical establishment knowingly (Merck & Co., Inc. has two 1990 patents combining CoQ10 with statins to prevent CoQ10 depletion and attendant side effects) created a life threatening nutrient deficiency in millions of otherwise healthy people, only to then sit back with arrogance and horrific irresponsibility and watch to see what happens - as I see two to three new statin cardiomyopathies per week in my practice, I cannot help but view my once great profession with a mixture of sorrow and contempt.

Lipitor an all Statins deplete the natural enzymes from your muscles.
Your Heart is a muscle. I haved been on Lipitor for a number of years
with many of the side effects posted here. I have had Heart Failure fo
a year now and the best doctors could not help me. My son recently
researched an found a possible solution the indicated Statins deplete
th heart muscled of COQ10 a natural enzyme in the Heart Muscle.
This depletion over time can caused Heart failure due to weak walls.
Since my doctors could offer no solution, I decided to try it for 90 days.
I am off Lipitor an taking 400mg of COQ10 per day.
I am now in day seven an have slept in my own bed with my wife for the first time in a year. I am less restless, an have ha no recurrence of Heart Failure. The drug companies know the problems but thy have
deep pockets an the best lobby to get laws passed and FDA approvals.

They have now received approval to get kids on Statins so they can
make even more money before the patient run out. Thy should be ashamed but they are not!!

Because of a “Global economy” - I suspect ingredients (even for Brand names) are coming from China or being manufactured in India with poor to non-existent quality control standards, and is the primary reason for the majority of Adverse Reactions to the Statins in general. Please take time to submit your complaint directly to the FDA, and hope they investigate and take action (see bottom of page for web sites to submit complaint).

My own recent experience with statins: After 3-weeks of being on generic Simvastatin 80mg for elevated LDL, I experienced significant fatigue, shortness of breath with tightness around my chest and a bout of Gout in my left foot. I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident. Also, if your physician is unresponsive to your negative experience with Statins (generic or Brand Name), inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if you’re a U.S. resident, so they know you're serious. Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality-controlled drug is available at Walmart Pharmacy for $10. I hope this helps, especially seniors on a fixed income.

U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html

CANADA
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf
Contact Name: Drug Compliance Verification and Investigation Unit Tel: (613) 952-9906 Fax: (613) 954-0941 E-Mail: DCVIU_UVCEM@hc-sc.gc.ca

I took Lipitor for 2 years with all the pain in my shoulder, hand and arm as well as fuzzy memory. I had a friend over for Lunch an have no memory of anything that happened including his arriving and leaving on his Harley and we all know how loud they are. I ended up in the hospital with all kins of tests including an MRI all of which I have no memory of to this date. My hospital bills are still coming in as well as all the Doctors that saw me. I just received my Divorce and then this happened , I was out of work for a week , the Doctors thought I had had a heart attack, stroke or aneurysm.I also had all the foot pain making it impossible to stand up , leg cramps, sleeplessness, sheer exhaustion, depression, headache and nausea. The Doctor at the Hospital took me off of the Lipitor and said to take a 325mg. aspirin daily . This happened on March 23, 2008 . I am felling better but I still pain in my shoulder , neck , stomach , and feet and legs but is nothing like it was. Here I am left with a few thousand dollars of Doctor and Hospital bills. Why can`t something be done about all of this we are all going thru? I called the FDA to report it and got no where. Did I really expect anything to happen ! I hope someone gets something done for us . I would be one of the first to sign up to take Lipitor off the market and get what is due us.

My husband has been taking Lipitor 20mg for 1 week. He immediately became fatigued (this is a 44 year old man who has NEVER used an alarm clock in his life and now, sleeps through the alarm clock for 45 minutes until I shake him to wake up), experienced joint pain in 1 of his knees and the sme side ankle. Needless to say, he will not be taking this medication anymore. I also reported this to the FDA because I read the following online:
U.S. patients can report side effects to the FDA themselves -- by logging onto the MedWatch Web site ( http://www.fda.gov/medwatch). But few know about this option.
The FDA needs to know how bad this drug is for people. I hope more people read everything that is written here to save themselves or loved ones from the pain and suffering caused by Lipitor.

Michelle

Mother in law...70 years old. On Statins for quite a few years...Slowly noticed memory loss. Can't find the right words or sometimes even what something is...like, you know the "thing" they put the mail in (mailbox).
In assisted living now since June. Can't even cook, too dangerous.
She'll be penniliess in April '08.
Thanks statins and imcompetent Drs!.
I love how the Drs. continue to deny that these drugs have any role in memory loss, or other dangerous side effects at all!
She doesn't remember eating so has gained 12 pounds since May. BUT that isn't a hazard....oh the statins are the lesser of the 2 evils according to the Dr.
Maybe the Dr. would like to take her home for the holidays and watch her sit, quiet as she can't contribute to conversations, remember what we talked about 15 minutes earlier, etc.
WHY ISN'T there a class action on these damaging, dangerous drugs yet?
We will be strapped with her care for many years as she is otherwise healthy.
We need to take back the FDA from the special interest (BIG PHARMA) lobbyists and make medicines about curing people again...not about bottom lines and big profits...
HOW DO WE DO THIS??
I guess we all need to bombard our elected officials with letters and petitions..
Good luck to all here...I feel for you and pray your side effects don't get as bad as hers did.

GET LIPITOR AND ALL THE OTHER STATINS OFF THE MARKET. WRITE TO THE FDA AND COMPLAIN !!!!

My husband was diagnosed with MS 2 1/2 years ago. He has been on Lipitor for about 1 year. Within the past 4 months, his walking has gotten worse. Where it used to be just his right leg, now it is his left as well. Severe leg cramps, fatigue -which could be the MS - trouble keeping balance - also could be MS - lower back aches, slurred speach and memory loss. I know alot of these are associated with MS but after reading all the other letters, I am beginning to wonder if his walking has gotten worse due to the Lipitor. He used to have trouble walking but with a cane, could go for miles. Now he can't even walk 15 minutes without almost falling. A friend of ours stopped taking the Lipitor and felt better within 1 week. I am hoping the same happens to my husband. Thanks to everyone for sharing their stories.

57 years old male. I took Lipitor for 5 years. I didn't notice that 3 months ago I was getting very weak - attributed it to being out of shape. I went to the Dr when I started having trouble swallowing, and shortly after that I lost most of my strength and have difficulty walking, getting out of chairs, rolling over in bed, etc. If I walk more than 200 yards, I need to be supported by friends on both sides, and my legs and arms start shaking. I have been off Lipitor for 3 months with no improvements.

I would recommend to anyone on this drug to get off it if any sign of these side effects shows up, no matter how mild...

My husband, former commercial airline pilot, began taking Lipitor January 27, 1998. He was misdiagnosed with alzheimers and treated for it till Smart Money magazine article: Nov 2003. He quit the statin, but his brain was too damaged. Recently he received an Allen Cognitive Level test at a nearby Memory Disorder Clinic. Six is normal, his score is 2.2 Withing 5 1/2 months of when he began Lipitor, he had bladder, prostate, sinus, muscle pain in arm, pectoris pain and a 8 months when he first mentions that he has had problems with his memory. His Dr. wrote, "alzheimers". There are no miracles on the horizon. The doctors and pharmacists are not told. The FDA is totally broken. There is no independenet agency tracking drug side effects. This is all about greed. Everyone thinks the situation is fine. The pharmacutical companies, insurance companies, doctors, pharmacists, and nursing homes are quite pleased. Once someone is diagnosed or mis-diagnosed, you are on your own. Care-givers are told to "get on with their lives". (liquidate your assest and put your loved one in a nursing home-you are not capable of caring for them) All forms of media are also receiving huge profits from drug commercials.
Tell your doctor to take Lipitor and let you know how it works!
Both political parties get huge amounts of money from the drug companies and they won't touch this issue. A doctor told me that 80% of drugs that are given are to mask the side effect of a previous drug. Studies show that Lipitor shuts down the production of Co Q10 which results in cell death.
Bk

40 yr old male taking Lipitor 10MG for 4 yrs. Not able to express the anger and at the same time relief that I am not crazy and that others feel like I do. Its crazy how many people have written that their head feels heavy. I remember how I felt when I mentioned that to my Dr. He ignored me so I tried cutting down to 5 mg on my own for last 1.5 yrs. I have experienced significant muscle deterioration, mood swings, fast heartbeat, and many of the same things as other contributors. I took my last dose this morning and thats it. Plenty of useful natural alternatives for me to try from here. Who was calling the shots at the FDA when these statins were approved and protected from litigation? Its criminal.

I had the Zocor death story... I cannot report to the FDA since I live in Europe, I did reported it to our national equivalent but havent heard any follow-up. Dont forget this is all about money. This is a legal maffia, they are not even willing to issue a worldwide warning... not to mention withdrawing...

Guest from sept 1: please go to your doctor ASAP, thats the exact symptoms my mother had, she died in 10 days. Ive recently spoken to a professor who told me that serious rhabdomyolisys is irreversible after 2-3 days. Hopefully we will hear about you!!!

I am 45 and started taking Lipitor in December 2004. Iy lowered dramtically the cholesterol count from 225 to 130. After my first 3 month supply ended (with no side effects), I got another order but since I am an avid golfer, came up with horrible tendonitis near my left elbow (i.e. tennis elbow) while diligently practicing for a tournament in June 2005. The pain was so bad, I could not wash my hair after the golf round. I have never had an ache like this in my entire life. It then went into my right elbow. I halved my dose from 20 mg to 10 mg by taking every other day. After reading the posts here, I will now go cold turkey and see if the pain goes away. I have another golf tournament in 2 weeks which I will start practicing for again. It will be very interesting to see if this flares up again. I still have mild pain in both elbows right now. How can we get this information to the FDA? It is too important.

In response to ahcb87 #8069: You state that for every statin user with side effects there are 1,000 without. I would bet that many of the 1,000 are experiencing side effects that they are attributing to age, not putting two and two together. If you are having good results with statin, I am thrilled for you, but I know from experience how dangerous it can be. As for your statement "During clincal trials they stopped giving placebo to the control group, as the benefit of the statin was so great they felt it was wrong to deny it to them...." Isn't it a frightening thing to know the testing was not even allowed to conclude. Perhaps if they had given the trials the time they deserved, the side effects would have been observed. Shame on the FDA, which has been renamed the Fraud and Drug Administration, deservingly so.

the following concerns another statin drug, crestor. since almost all statins work by blocking the pathway to make cholesterol....
By Lisa Richwine

WASHINGTON (Reuters) - Twenty-nine patients who took AstraZeneca Plc's cholesterol drug Crestor have developed kidney damage, a U.S. consumer group said on Friday as it called again for a ban on the medicine.

The rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same cl-------- combined, consumer group Public Citizen said. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled.

"It becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market," Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, wrote in a letter to the Food and Drug Administration (news - web sites).

AstraZeneca insists Crestor, known generically as rosuvastatin, is as safe as other drugs in the family known as statins. The FDA (news - web sites) has agreed but promised to closely monitor reports of safety problems.

"Our data shows, with regard to that particular adverse event, it remains in line with other statins," company spokeswoman Emily Denney said. She added that AstraZeneca updates Crestor's reported health problems every week on its Web site www.rosuvastatininformation.com.

According to the site, "serious" kidney problems are "very rare" and occur at a rate of less than 1 in 10,000. Of all statin-related kidney problems reported to the FDA, 3.5 percent were related to Crestor as of early October, the site said.

Writing in this week's edition of The Lancet medical journal, AstraZeneca said Crestor's "safety profile is similar to those of the marketed statins. This view of the benefit-risk profile ... is shared by regulatory authorities in the 64 countries where rosuvastatin is approved."

The company's letter was written in response to earlier criticism from Wolfe.

Public Citizen said its latest analysis was based on reports to the FDA since Crestor's approval in September 2003 through Aug. 26, 2004. The reports of "adverse events" from doctors, patients, manufacturers and others do not prove if a drug caused a particular problem, but the FDA uses them to look for signals of possible drug-induced hazards.

Millions of people worldwide take statins, such as Pfizer Inc.'s Lipitor (news - web sites) and Merck & Co Inc.'s Zocor, to lower their cholesterol. High cholesterol is a major risk factor for heart disease.

Bayer AG's statin Baycol was pulled from the market in 2001 after it was linked to more than 100 deaths, many of them from a severe muscle-damaging condition called rhabdomyolysis.

The FDA has received 65 reports of rhabdomyolysis in Crestor patients, which is similar to the rate --------ociated with Baycol, Public Citizen said. AstraZeneca says the problem, also linked to other statins, is rare with Crestor.