Public citizen symptoms and conditions

I was on Yasmin for 5 years and have been off of it for 3. While on Yasmin I had a tearing sensation in my left thigh and it became a little red and swollen. Long story short I had a clot that increased in size quickly. I spent a week in the hospital and was told I was very lucky to have survived. After I was released I took the time to do the research and found out that Yasmin is a "Second Generation" birth control pill and that a letter was sent to the FDA by an organization called "Public Citizen" demanding that the FDA put additional warnings out that it doubled the chances of blood clots. This is all compared to "First Generation" birth control pills that have been around for quite some time and were found to be just as effective, but with a lower chance of blood clots. I wish I would have come across this information before I requested my doctor switch me to Yasmin in the first place. I chose Yasmin because of "the lesser side effects" that it advertises. Hope this helps any of you trying to make a decision about this drug.

I have been on Lipitor for five weeks. I can't believe how awful I feel. I ache all over. I my arms and elbows are sore; I have had pins and needles in my hands; charley horse like spasms in my calves (mostly at night); sharp knife like pains in my upper thighs; even my teeth hurt. I am a 46 year old female – I can’t believe this. I have made an appointment with my doctor as I have to get off this drug. I have experienced some blurred vision and hearing impairment too. If I hadn’t of found this website – I truly would have thought I was a bit crazy….
I have never had any symptoms like this before and never thought of myself as an old lady - but that is what I feel like. It is unbelievable.
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I go by the ID Miserable Knees. I posted last spring on medications.com about my adverse reaction to Levaquin. I was given a 10 day prescription for a respiratory infection. 3 days after I finished taking Levaquin, BOTH KNEES were swollen, painful and I could barely walk. I spent a month throwing myself backwards into chairs due to the inflammation in my knees. My knees were on fire, I was in pain every day. After seeing an orthopedic doctor an MRI showed cartilage damage. A year later, I'm living with permanently altered legs. I was an avid walker, loved to hike, would spend hours walking for recreation. Levaquin changed all of that. I had a career requiring me to be on my feet for 12 or more hours a day. Levaquin changed all of that. I decided, if this could happen to me, it could happen to anyone. Now, there is a documentary about the dangers of fluoroquinolne antibiotics. When I was harmed by Levaquin, I was flabbergasted that something like this could happen to me in the prime of my life. I made this 52 minute film for all of the people like me who trusted the system, (government, doctor, medicine) to guarantee my safety. "Certain Adverse Events" is the name of the documentary and it is now available online. You can reach the documentary site by going online to the .com of "Certain Adverse Events"

Miserable Knees Productions

My daughter was on Yasmin for a year, and almost immediately began experiencing a variety of symptoms including depression, mood swings, headaches, nausea, tingling and numbness in her legs, etc. Doctors checked her thyroid, gave her a cat scan, prescribed anti-depressants, anti-anxiety, anti-psychotic drugs ( she started hearing voices) and warned that she couldn't stop these drugs abruptly without causing their own serious side effects. After her second hospitalization for suicidal threats, the psychiatrist, at our insistence took her off Yasmin, the only prescription drug that she was taking when the problems began. She began to feel normal within a few months, and was able to wean herself off Prozac a short time later. We are convinced that this is a very dangerous drug.
In doing research, I found that there is a consumer watchdog group, called Public Citizen ( ******), which monitors FDA reports and has successfully lobbied to have a number of drugs removed from the market. They have Yasmin listed on their "do not use" list ( ******) because of the risk of increased potassium levels and blood clots. The British Medical Journal (******) also has articles suggesting a link between Yasmin and thromboembolisms.
I believe the first step for any of us who have had adverse experiences with this drug is to go to FDA.gov and "Report a Problem". My understanding is that the level of severity of the problem leads to a required response on the part of the agency.
I think the biggest problem is that this drug is very widely prescribed but that few doctors seem informed enough to make a connection when the serious side effects ( fully described on the label) begin to emerge.

All I can say is that when I heard that CIPRO and if I understand correctly LEVAQUIN will now have the "Black Box" warning, I thought THANK GOD. .I wonder how many people are "the box" from the drug and/or from committing suicide from this horrific drug?

THANK YOU, FDA, for listening to those who contacted you via letters and emails. Also, who knows? Maybe this board made a little bit of difference.

Either way, a warning is not a ban. I can't understand how Bextra could be pulled off the market and LEVAQUIN "lives all" to do more damage to some.

Pray for this drug to be further scrutinized and researched!!!!!!!!!!!!

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

******

FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

PLEASE READ:

I have posted my side effects here before. Was floxed at least twice but didn't put 2 and 2 together because the side effects came well after I had taken the medication. I caught it this time because I was on a higher dose. I was on Leva-Pac 750mg for 9 days. I have had 2 distal bicep tendon ruptures and surgery each time.

It's nuts that there is no treatment for the person who is floxed and how many doctors and hospitals are telling us this is all in our head. This needs some coverage. I had thought about Sonja Gupta on CNN but every other commercial is from a drug company.

Then I thought of Helmet Oz on Oprah. He is into alternative medicine and if he did a segment on Oprah I think it would raise awareness. I am writing and urging you to do the same. I am telling him my story and the lawsuit that Public Citizen with the Office of the Illinois Attorney General against the FDA to blackbox this medication.

Please follow my suit and submit a letter and also spread the word to other floxed web sites. The link to Oprah is
http://www.oprah.com/email/reach/email_showideas.jhtml

Crapshot, thanks for the info on your thoughts. But in my case as well as others I do not believe this is at all related to Candidiasis. If you scroll down and read my post you will see that I have snapped two biceps from Levaquin. This in not the first time I was Floxed But the other times I was on lower doses and the symptoms didn't appear until well after I had finished my prescriptions. Not only did I have to have 2 surgeries but I was also having heart palpations and severe joint pain that went away after months of my body cleansing itself. This time I figured it out because they put me on a higher dose for a longer period. This time around the symptoms started before I finished my course. I quit taking the Leva-pak and googled the side effects. And they were spot on. Not only do I take probiotics and vitamins daily but I work out and do cardio 4 to 5 times a week, and eat a healthy diet. At the ripe ol age of 41 the doctors were amazed that I have torn each bicep tendon from the bone in a 2 year time period. I AM blaming the pill. Also Public Citizen along with the Attorney General from Illinois is suing the FDA to get this Black Boxed. They are also suing the FDA because they haven't been updating the newer cases of tendon ruptures. It's easy to blame the consumer, but do you think I would have taken this after my history with this medication. If they had the proper warnings and black boxed the tendon rupture I wouldn't have even allowed this drug to be in my house. I'm glad you didn't come away with the serious side effects but please don't blame the patients.

For all of you suffering on this board I strongly suggest you log unto www.fqresearch.org where you will find over 4000 medical journal entries, case reports, etc., that detail the horrendous damage these drugs are capable of. You will also find a link there for a support forum hosted by yahoo that everyone here is invited to join.

We have been fighting with the FDA since 1999 to get "Black Box" warnings as well as "Dear Doctor" letters sent. Had this been done I doubt that most of you would be suffering like this. This class is a drug of LAST RESORT, and it is not approved as a first line agent for ANY disease state.

It is both shocking and appalling that we see people coming on this site promoting the use of these drugs and chasing you for suffering a reaction. I can assure you this is not "in your head" by any means. These severe adverse reactions have been documented since 1982 within ALL of the leading medical journals. They are THE most toxic and dangerous antibiotic in clinical use today.

But the FDA refuses to provide adequate warnings within the package inserts and Public Citizen has had to SUE them in Federal Court to even have them review their petitions seeking, once again, "Black Box Warnings and Dear Doctor Letters."

Recently Bayer issued a "Dear Doctor" letter in Europe regarding the severe adrs to Avelox. But we find no such letters being written here in the United States.

Anyhow, just a brief note to let you know that you are not alone, your name is "Legions", and we have been fighting on your behalf since 1999.

Regards,

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org

For all of you suffering on this board I strongly suggest you log unto www.fqresearch.org where you will find over 4000 medical journal entries, case reports, etc., that detail the horrendous damage these drugs are capable of. You will also find a link there for a support forum hosted by yahoo that everyone here is invited to join.

We have been fighting with the FDA since 1999 to get "Black Box" warnings as well as "Dear Doctor" letters sent. Had this been done I doubt that most of you would be suffering like this. This class is a drug of LAST RESORT, and it is not approved as a first line agent for ANY disease state.

It is both shocking and appalling that we see people coming on this site promoting the use of these drugs and chasing you for suffering a reaction. I can assure you this is not "in your head" by any means. These severe adverse reactions have been documented since 1982 within ALL of the leading medical journals. They are THE most toxic and dangerous antibiotic in clinical use today.

But the FDA refuses to provide adequate warnings within the package inserts and Public Citizen has had to SUE them in Federal Court to even have them review their petitions seeking, once again, "Black Box Warnings and Dear Doctor Letters."

Recently Bayer issued a "Dear Doctor" letter in Europe regarding the severe adrs to Avelox. But we find no such letters being written here in the United States.

Anyhow, just a brief note to let you know that you are no alone, your name is "Legions", and we have been fighting on your behalf since 1999.

Regards,

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org

For all of you suffering on this board I strongly suggest you log unto www.fqresearch.org where you will find over 4000 medical journal entries, case reports, etc., that detail the horrendous damage these drugs are capable of. You will also find a link there for a support forum hosted by yahoo that everyone here is invited to join.

We have been fighting with the FDA since 1999 to get "Black Box" warnings as well as "Dear Doctor" letters sent. Had this been done I doubt that most of you would be suffering like this. This class is a drug of LAST RESORT, and it is not approved as a first line agent for ANY disease state.

It is both shocking and appalling that we see people coming on this site promoting the use of these drugs and chasing you for suffering a reaction. I can assure you this is not "in your head" by any means. These severe adverse reactions have been documented since 1982 within ALL of the leading medical journals. They are THE most toxic and dangerous antibiotic in clinical use today.

But the FDA refuses to provide adequate warnings within the package inserts and Public Citizen has had to SUE them in Federal Court to even have them review their petitions seeking, once again, "Black Box Warnings and Dear Doctor Letters."

Recently Bayer issued a "Dear Doctor" letter in Europe regarding the severe adrs to Avelox. But we find no such letters being written here in the United States.

Anyhow, just a brief note to let you know that you are no alone, your name is "Legions", and we have been fighting on your behalf since 1999.

Regards,

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org

It has been one year since my reaction. My life very gradually gets better but is has been horrible. After recovering for 6 months and starting to feel better, my bicep spontaneously ruptured. I KNOW this was due to the drug. Before taking this poison I led a very active and healthy life. I participate in many sports and do a great deal of physical labor.... or at least I used to.

To see a posting about the benefits of this drug just rubs salt in the wound. I'm sure it has helped some people. I'm also sure the drug companies are not above posting a "planted" message on the benefits. It still doesn't help those of us who have been harmed or the potential persons who may be harmed in the future.

In the paper today I noted that a suit has finally been filed on all of our behalf. It's about time. There is also information about this on:

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that states:

PUBLIC CITIZEN
FINALLY SUES THE
FDA OVER THE
ADVERSE DRUG
REACTIONS OF THE
FLUOROQUINOLONES

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.