Showing posts with label chron's disease. Show all posts
Showing posts with label chron's disease. Show all posts

Wednesday, June 1, 2011

Humira Causes Vision Problems - Abbot and Humira Face Lawsuit

Hmm, I took a lot of Humira for Crohn's Disease, and my eyes are much worse now than they were back in 2008. Maybe I should look into this!

Abbott Laboratories faces a product liability lawsuit over Humira, their blockbuster arthritis and Crohn’s Disease drug, which was filed by a woman who alleges that she has developed optic nerve damage and permanent vision problems from Humira.


The Humira lawsuit was filed by Jamie Bixby in the U.S. District Court for the Northern District of Illinois on May 20, 2011.

Bixby alleges that side effects of Humira caused her to develop optic neuritis, an inflammation of the optic nerve that has left her with permanent impairment to vision in her left eye and a future risk of other nerve problems, including multiple sclerosis or loss of vision in her other eye.
Humira (adalimumab) is a “biologic” drug, which is part of a class of medications known as TNF blockers or tumor necrosis factor blockers. The medication was launched by Abbott Laboratories in 2003 for treatment of rheumatoid arthritis, but was subsequently approved for other indications, including treatment of Crohn’s Disease.

According to allegations raised in the complaint, Abbott downplayed the potential risk of Humira vision problems, despite the fact that information was available to establish notice that the drug may increase the risk of optic neuritis and other nerve damage from central nervous system (CNS) demyelination.

Bixby began using Humira in April 2008 for treatment of Crohn’s Disease, after her doctor suggested that the medication may be a better option than the long-term use of the steroid prednisone, which had been managing her symptoms. No warnings were provided on the drug label or prescription information that Humira may cause permanent damage to her vision at the time she began taking the medication.

In May 2008, Bixby indicates that she began experiencing severe headaches and pain in her left eye, which led her to call the toll free number provided with her Humira packet to ask if the problems may be related to the use of Humira. According to allegations contained in the complaint, Abbott’s nurse told her that eye pain was not related to Humira and suggested she contact her physician.

When Bixby contacted her doctor, she was told by the doctor’s office that they were unaware that eye problems were a known issue with Humira and scheduled an appointment for the following week. However, the next day Bixby noticed that the vision in her left eye became blurry with blacked out areas, causing her to leave work and seek immediate medical attention at an eye clinic.

Bixby was diagnosed with optic neuritis from Humira in both eyes, though she only experienced vision problems in her left eye. Following her diagnosis, Bixby was admitted for inpatient treatment to receive 4 days of intravenous steroids.

“Unfortunately, because Abbott had not adequately warned Ms. Bixby or her physician about the risk of optic neuritis, the diagnosis and treatment came too late to prevent permanent vision impairment for Ms. Bixby,” the complaint states.

Bixby previously worked as a web designer, and claims that she continues to suffer from headaches and eye pain that impact her ability to look at a computer screen for significant periods of time. She also continues to suffer blurry vision and black holes in the vision from her left eye, and has extreme light sensitivity and changes to her depth perception that affect her ability to drive or ride a bike.

Plaintiff alleges that Abbott downplayed the risk of Humira side effects, including the risk of Central Nervous System (CNS) demyelination, which can cause optic neuritis, transverse myelitis, multiple sclerosis or other nerve problems.
http://www.aboutlawsuits.com/vision-problems-from-humira-lawsuit-18413/

Tuesday, July 28, 2009

Let's Talk About Poop - Unspoken pain of Crohn's disease

I enjoyed this article below, found in the Birmingham (UK) Post. It addresses several issues, but primarily focuses on the challenge of talking about Crohn's Disease. Crohn's is often an unspoken illness, but I say talk about it...throw it out there and you will be surprised.

Wendy Holt tells Diane Parkes why she is happy to challenge ignorance about an incurable bowel condition. Three weeks before walking down the aisle on her wedding day Wendy Holt was diagnosed with an incurable condition known as Crohn’s disease.

But the diagnosis was actually a relief as she had been suffering its symptoms for 18 months without knowing what the problem was.
Taking medication gave some immediate help which meant that by her wedding day in 1995 she was more than able to smile for the cameras.

Crohn’s disease is one of the unspoken illnesses. Being an intestinal disorder whose symptoms can include diarrhoea and a sudden and urgent need to go to the toilet as well as exhaustion and sickness, it is not an illness people tend to feel comfortable talking about.
Indeed Wendy, who is 40 and works as a part-time school governors’ clerk, had never heard of it when she was told she had it.

“When I started getting the symptoms I thought it was just a series of stomach bugs and it would go away,” she recalls. “And many times it did. But then one day I came home and sat down on the stairs and literally just dropped.
“When Andy, now my husband, came back that night he said I was really poorly and needed to see a doctor.”

Initially the doctor treated the problem as a blockage to the bowel but a blood test led to an endoscopy and colonoscopy at Solihull Hospital where Crohn’s disease was first mentioned.
“The consultant said it could be Crohn’s disease or it might be tuberculosis,” says Wendy, of Solihull. “He gave me some steroids to take and said that if it was Crohn’s it would make it better but if it was TB I would be back in hospital the next day.

“And the steroids made it instantly better, it was great.”
This state of play lasted for two years when the symptoms returned with a vengeance.
“I was very poorly and the steroids weren’t working so I was taken to Solihull Hospital where they were feeding me with a tube but that didn’t work either so they operated.”
In the event, doctors removed part of the colon and Wendy spent a month in hospital recovering. All seemed well until 1999 when she had her first child Eleanor.

“They did warn me beforehand that I could have problems because of the pregnancy,” says Wendy. “When you are pregnant your body naturally creates steroids. If you are taking steroids as medication in a normal condition, you are weaned off them gradually. But when your body has been producing them naturally during pregnancy and you then have the baby they stop suddenly.”

More medication seemed to settle the problem until Wendy had her second child, Nicholas, now aged six. This time steroids were not enough and in December, 2007, Wendy underwent another operation to remove a narrowing of the small bowel.
This caused its own problems because Wendy had lost the part of the intestine which absorbs iron so she became anaemic and very poorly. Taken to Heartlands Hospital, her condition was stabilised again with tablets.

Wendy is the first to admit the entire experience has been a roller-coaster. Her condition is stable and she is under the care of the specialist inflammatory bowel diseases clinic at Heartlands where she can contact a nurse as a self-referral at any time.
Over the years Wendy and her 40-year-old husband Andy, an engineer with Land Rover, have learned to live with Crohn’s disease.

“When I am in remission and it is controlled by the steroids then the worst I get is tiredness,” she says. “But when it flares up it is a real pain as I always need to plan everything and know there are toilets nearby.”

Wendy is happy to talk about her condition in an attempt to battle the lack of knowledge about Crohn’s disease.

“When I was diagnosed I had never heard of it and most of the time when you tell people they don’t know what it is,” she says.

“The problem is that people don’t like to talk about it. It isn’t one of those conditions that everyone knows about.

“The point is that from the outside you cannot see there is anything the matter. Only once, when I was feeling really poorly, did a friend at work tell me I looked grey. Other than that, people don’t realise. When I was diagnosed I found out a lot of information from the National Association for Colitis and Crohn’s disease and became a member and still am. I don’t always read everything as you don’t always want to know but it can give you a lot of information.
“Crohn’s disease is not curable and they can’t say why someone develops it. And it can be difficult when people then don’t know what it is. I don’t want sympathy from people but it helps when people understand.”

Emmerdale actor Jeff Hordley is aiming to get the word out about Crohn’s disease after he was diagnosed with the condition 13 years ago.
This summer Jeff has joined forces with the National Association for Colitis and Crohn’s Disease (NACC) for their campaign – Rising to the Challenge.

Aiming to improve levels of understanding among the general public, Jeff, who plays Cain Dingle in the soap, has fronted the campaign. And he fully understands the implications of the disease. “Having lost my mum to Crohn’s when I was nine, I was devastated when I was diagnosed with Crohn’s and thought that it was a death sentence,” he recalls. “However my doctors were excellent and they explained that I would do well after a major operation to remove parts of the bowel.

“At the time of the operation I was a student actor and probably well-placed to talk openly about my condition. I personally find that people are more supportive and understanding if they know about my condition.”

And it is an uphill task. NACC, which provides support and information for families affected by Crohn’s disease and fellow inflammatory bowel disease colitis, says research shows only 64 per cent of the population are aware of the conditions.

Chief executive Richard Driscoll says: “The major issue is that despite colitis and Crohn’s affecting one in 250 of the population, making them relatively common conditions, many young people with the symptoms of urgent diarrhoea, pain and severe fatigue have their lives made even tougher because two-thirds of the public have no understanding of their symptoms.”

Tuesday, April 28, 2009

Stem Cell And Crohn's - IBD Wound Healing CD24 Molecule

Hey guys, many of you (Scott Roy included) have been through stem cell treatments for Crohn's. Here is some new info I just found on Genetic Engineering and BioTechonolgy News:

Scientists at The University of Nottingham are investigating whether stem cell markers could have a role to play in speeding up wound healing in patients suffering from inflammatory bowel disease's (IBD) such as Crohn's Disease.

The study could eventually lead to the development of new drugs which use natural molecules to spark the recovery of patients suffering from ulcerative colitis and Chron's disease, reducing their risk of associated complications such as scarring, bowel obstructions and tumour growth.
Funded with a 118,500 grant from the National Association for Colitis and Crohn's Disease (NACC), the two-year project is being led by Professor Mohammad Ilyas in the University's Division of Pathology.

He said: "The study will focus on the molecule CD24 which is a stem cell marker and which plays a key role in cell proliferation and the migration of healthy cells to a damaged area to restore normal tissue.

"CD24 is a small molecule attached to the cell membrane which has been recently reported as a marker of stem cells in the colon. It occurred to us that CD24 might have a role to play in IBD and during further studies we found that it was indeed present in sections of diseased bowel."
IBD affects around one in 400 people in the UK. Common symptoms include inflammation and ulceration of the intestine and colon, pain, severe diarrhoea, tiredness and weight loss. The cause of the disease is yet to be definitively identified, although scientists believe it could be due to a combination of genetic predisposition and environmental factors. Currently, there is no cure and patients manage their condition with a mixture of lifestyle changes, anti-inflammatory drugs and, in severe cases, surgery.

Professor Ilyas added: "The power of the gut to heal the damage caused by acute episodes of inflammation is remarkable and frequently the gut lining reverts to normal. Anti-inflammatory drugs help this process along and allow the wound healing to begin earlier than it would naturally.

"In the future, it may be possible to use a variety of therapies (possibly including gene therapy) to manipulate the expression of the CD24 molecules on cells to promote even more rapid healing. This may mean less scarring, bowel obstruction and fistulation and less chance of developing tumours resulting from persistent inflammation. As a result of this, it may also reduce the chance of needing surgery further down the line."

In the early stages of the project, the pathologists will be using cell lines in the lab to study CD24 at a cellular and molecular level to discover the mechanisms by which it operates and encourages cell migration and other associated molecules that are co-expressed.

They will then examine diseased IBD tissue to establish whether what they have observed in the lab is occurring in reality.

It is hoped the findings will lead to further clinical work to look at the possible benefits of CD24 in allowing IBD patients to more effectively manage their disease.

The CEO of NACC, Richard Driscoll, explains, "Since 1984, NACC members have raised over 4.5 million and more than 100 research awards have been made to hospitals and universities throughout the United Kingdom. This year our Medical Research Committee selected three studies to receive NACC research awards which we hope will contribute to finding improved treatments and ultimately a cure for IBD. We welcome Professor Ilyas' work on CD24 in seeking a better understanding of the gut healing process and how it may be enhanced in inflammatory bowel disease."

Monday, November 10, 2008

CElgene Receives Approval to Start Human Testing Stem Cell Therapy for Crohn's

Hi guys, more great news on the stem cell front. Biotechnology giant Celgene Corp said it received approval from U.S. health regulators to start human testing of its experimental stem-cell therapy for the treatment of Crohn's disease. Celgene said clinical development of PDA001, its therapy utilizing human placenta-derived stem cells, would start by the end of the year.

ALSO:

Genzyme Corp said it would co-develop two adult stem-cell products of Osiris Therapeutics including Prochymal, which is being tested in late-stage trials for the treatment of Crohn's disease, among other indications.

Crohn's disease is a chronic and often debilitating inflammatory disease of the colon and large intestine that affects some 500,000 people in the United States and leads to frequent hospitalizations and surgery.

Thursday, August 28, 2008

Obby Khan - Candian Football League Star with Crohn's

Guys, came across this interesting story in the Montreal Gazette of Obby Khan, a CFL (Canadian Football League) Blue Bombers Player with Crohns. Looks like he is the northern version of the Jacksonville Jaguars David Garrard. Looks like this guy had exteme pain from Crohn's. Remember football season is coming up, so be sure to follow along the story of David Garrard.

WINNIPEG - Ibrahim (Obby) Khan, a grown man of 27 who has played professional football for five years, can't describe the sheer joy he experienced last winter, when he dug into his first cheese pizza. Or when he dove into a bowl of Doritos.

"It was simply awesome," the Winnipeg offensive-lineman said this week. "Now I eat them all the time - four or five days a week."

Ah, the staples of a healthy diet.

But Khan can be excused for his indulgences. There was a time last year when his diet consisted of boiled rice and salmon exclusively. He couldn't eat fried, fatty or spicy food, chocolate, sweets or anything with seasoning. He couldn't eat fruits or vegetables. He had to take 50 pills daily and had nearly as many trips to the bathroom. There was a time he received daily morphine injections, directly into his heart, to ease the stomach pain he felt 24/7. He saw his weight fluctuate nearly 100 pounds.


"It's tough to explain," he said. "Take the worst aches, cramps and gas. Magnify it by 10 and then amplify that 24/7."

Khan was diagnosed with Chron's disease five years ago. The autoimmune condition can affect any part of the gastrointestinal tract, from the mouth to anus. Its main symptoms are pain, diarrhea, constipation, vomiting and weight loss or gain.

Khan continued playing through it - he broke into the CFL with Ottawa in 2004 before joining the Blue Bombers two years later in a dispersal draft after the Renegades folded - for more than three years, taking medication that kept the disease in remission.

But things began to change last season, forcing the 6-foot-3 centre to miss 10 regular-season games, along with the Bombers' post-season run to the Grey Cup final. He took medicinal steroids, anti-inflammatory and anti-diarrhea pills. There was a pill to curb his nausea. He tried yoga, chiropractic treatments, even acupuncture. He underwent chemotherapy for six weeks after developing a virus he caught from taking all the medication. He was taking eight Percozets daily for back pain before advancing to morphine. This once healthy 300 pounder was now a shadow of himself, weighing about 205.

"I had serious cramping and bleeding,"he explained. "And the urges to go to the bathroom - there were two or three months I couldn't leave my apartment. There was a time I almost slept in the bathroom."


He has a 13- or 14-inch scar - it took 40 stitches to close the wound - he proudly displays, like a badge of honour, from the surgery he underwent to remove his large intestine, and another smaller incision from the removal of the colostomy bag. Khan said he endured three weeks of hell following the surgery.

"My whole body - I couldn't sit up. It was tough walking, coughing and breathing," he explained. "Even taking a deep breath hurt."

Jacksonville quarterback David Garrard had a foot removed from his large intestine. But Khan is the first pro athlete to have it entirely expunged and return to his career - ahead of schedule, we might add. He started practising in June and returned two weeks ago, against Calgary. It marked Khan's first game since the regular-season finale in 2007. He received a standing ovation from the crowd at Canad Inns Stadium when he was introduced, although he didn't start. He now weighs about 290 pounds.

"He's coming along, and his health's about 100 per cent," Winnipeg head coach Doug Berry said. "He's got to improve his game. We'll keep working him in, but he's not ready to play an entire game at centre. I just don't know if he'd last in this heat.

"He's a good athlete. He's tough and a motivational leader. We want him back."
Khan's diet must remain regulated, and there are still many things he can,t eat, including some fruits and vegetables. He hasn't enjoyed a salad in two years.

"I've learned I can get through anything," he said. "If you have heart, support, determination and desire, you can do anything. I've been through hell. Whatever else can happen, bring it on. I can take on anything."

Tuesday, July 8, 2008

Stress and Crohn's aka The Impact of Divorce on Crohn's

So I know this guy (cough, cough) that has Crohn's Disease and is going throughthe begininng stages of a divorce. Seems like every time he is stressed out his Crohn's Disease flares up. Nutrition is his main problem right now. He has loss 10 pounds mostly because he can't stomach food. Yesterday's nutrition consisted of a smoothie with protein powder, 4 Coors lights, and a half a peanut butter sandwich. Stress. Divorce stuff, financial obligations, AC broke and house is 92 degrees, dogs neglected and lashing out, work is crazy, he misses his daughter, etc. Oddly enough my...uh his health is actually pretty good. Started taking vitamins today to get some nutrients in my system. Workouts are suffering due to lack of fuel but still got in a fast 2 miles yesterday. Haven't had time for gym. Hopefully tonight. Anyhow, I am wondering if the inability to eat much is keeping the Crohn's at bay. Not taking ANY painkillers and am barely taking Pentasa. Missed an appointment for Stem Cell study at Dr. Shafrans....they are gonna be pissed...Anyways...he's gonna be allright in the long run. Everyone involved will be better off.

Thursday, May 15, 2008

Crohn's Disease Drugs Stolen - Procrit and Remicade

HORSHAM, Pa., May 15 /PRNewswire/ -- JOM Pharmaceutical Services, Inc. (JOM), a service coordinator that provides delivery services and customer support to Centocor, Inc. and Ortho Biotech, L.P., was notified May 6, 2008, that a transport trailer carrying DOXIL(R) (doxorubicin HCl liposome injection), PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was stolen while the driver was traveling from a distribution center in Kentucky to a specialty distributor. This incident has been reported to local and federal law enforcement offices, as well as the U.S. Food and Drug Administration; however, the transport trailer and product have not yet been recovered.

To ensure patient safety, Centocor and Ortho Biotech are voluntarily withdrawing products with lot numbers matching those of the stolen product from the market and communicating this action to all authorized distributors and all prescribing physicians, healthcare providers, and patients.

If the stolen product were to be reintroduced into distribution channels, the companies cannot guarantee that products were stored at appropriate temperatures, nor can the companies guarantee the products were not damaged. A voluntary withdrawal of products with lot numbers corresponding to that of the stolen product minimizes the possibility of inadvertent use of stolen product by physicians and, therefore, the overall risk to patients.

On May 7, 2008, JOM discontinued shipment of products with lot numbers matching those of the stolen product. Healthcare providers and patients that did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients that are concerned about products shipped after this date with the following NDC and lot numbers can return the product by contacting the companies at (888) 626-5660:NDC Description Lot Number Expiration
Date
59676-3100-1 Cartons containing six (6)D091534 07/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
10,000 U/mL
59676-3200-4 Cartons containing four (4) P113612 09/2010
multidose vials of
PROCRIT(R) (epoetin alfa)
20,000 U/mL
59676-3400-1 Cartons containing four (4) P106803 06/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
40,000 U/mL
17314-9600-1 Cartons containing 1 0717124 03/2009
DOXIL(R) (doxorubicin HCl
liposome injection) 20mg in
10mL (2 mg/mL) single use vial.
17314-9600-2 DOXIL(R) (doxorubicin HCl 0715423 02/2009
liposome injection) 50mg in
25mL (2mg/mL) single use vial
57894-0300-1 Cartons containing one (1)8AM26021P1 01/2011
vial of REMICADE(R)
(infliximab) 100mg
57894-0300-1 Cartons containing one (1)8BK35014P1 02/2011
vial of REMICADE(R)
(infliximab) 100mg

No other lot numbers of product are impacted by this incident. All three of these products have tamper-evident features that can be used to authenticate the package. Healthcare professionals and patients who have concerns about any product they possess may contact the number below for assistance with the identification of these features.

The amount of stolen and withdrawn product represents a very small proportion of the total product within the distribution channel; therefore the companies do not anticipate a disruption in product availability for patients.

JOM, Centocor, and Ortho Biotech will continue to work closely with healthcare providers and authorized distribution partners to identify and isolate product with lot numbers corresponding to those of the stolen product, and ask that anyone report any questionable activities to the appropriate authorities. Healthcare professionals, distributors or patients are asked to direct questions related to this voluntary withdrawal to the companies by calling (888) 626-5660.
Please see Important Safety Information for REMICADE(R) (infliximab), PROCRIT(R) (epoetin alfa), and DOXIL(R) (doxorubicin HCl liposome injection) at their respective websites.
About JOM Pharmaceutical Services, Inc.

JOM Pharmaceutical Services, Inc. is a service provider that is dedicated to providing safe and on-time delivery of pharmaceutical products for Ortho Biotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.

About Ortho Biotech, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.

About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

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