Another advocate for organ donation – Steve Jobs – Apple Computer

Well if it had to happen I couldn’t think of a better spokesperson for the cause. First we had Larry Hagman, Mourning (Alonso) a well known basketball player, and know everybody’s bad-boy – Steve Jobs who I am glad to say is back in the saddle!

At today’s Apple event, CEO Steve Jobs took the stage to a very long standing ovation. His opening remarks were not about ipods or iphones or new releases – they were spent talking about the importance of organ donation. Jobs noted that he now had the liver of a person in their mid-20s who died in a car crash. Jobs urged everyone to think about organ donation, as it saved his life. Yes, he’s back.

When the Apple event started today, CEO Steve Jobs took the stage to a very long standing ovation. He used his opening remarks to talk about the importance of organ donation.
Jobs stated that he now had the liver of a person in their mid-20s who died in a car crash. Jobs urged everyone to think about organ donation, as it saved his life.

I’m so glad he took the time to acknowledge it and thank people like him and the good folks from 30-Rock for the great work they are doing with organ donor awareness.

What juices should you avoid when taking your transplant medications?

Wow – interesting new news on the fact that other juices can inhibit or decrease the effectiveness of your medications, including your transplant medications.   Bottom line:  Stay away from grapefruit juice and limit your Apple and Orange juice….

A leading Canadian researcher is warning people about taking their daily dose of prescription pills with orange or apple juice – nearly 20 years after his earlier caution about grapefruit juice prompted sticker warnings on drug vials.

David Bailey and colleagues announced to a startled – and skeptical – medical world in 1991 that grapefruit juice can boost the amount of certain drugs absorbed into the bloodstream two- to threefold, turning normal doses into potentially toxic overdoses. Today, nearly 50 drugs carry labels warning about the so-called Grapefruit Juice Effect.

Now, in another surprise discovery, Bailey is reporting that grapefruit juice – as well as orange and apple juice – also appears to do the opposite by substantially lowering the absorption of certain other drugs, including certain antibiotics and drugs used to treat high blood pressure and heart disease.

Chemicals in the fruit juices appear to turn off a pump that normally helps get drugs out of the gut and into the body. The concern is that drugs essential for treating serious medical conditions might lose their benefit.

“When we use drugs, you have to use it at the right dose. Too low a dose doesn’t give you the effect you want, too high a dose has the chance of producing too much of an effect or just basic toxicity,” says Bailey, a professor of clinical pharmacology at the University of Western Ontario in London.

“It’s a window you try and stay within. In the first case we were worried about getting too much in. Now, we’re worried about not getting enough in.”

“If you’re talking about substances that you have to have because of critical medical conditions, like cancer, or if you have had a kidney or some kind of transplant, or if you’ve had a previous heart attack, you have to get enough into the bloodstream to produce an effect.”

People often take medications with juice, but Bailey says drugs are almost always tested with water. “So if you want to get the most chance of having the most consistent, uniform effect, what you should really do is take your medication with a whole glass of water on an empty stomach.” He suggests not drinking fruit juices for at least two hours, the time it takes for most drugs to be absorbed.

In research presented Tuesday at the American Chemical Society’s national meeting in Philadelphia, Bailey and colleagues reported that when healthy volunteers took fexofenadine, the brand name for the antihistamine Allegra, with grapefruit juice, only half the drug was absorbed compared to when the drug was taken with water alone.

“We had expected that the (drug) levels were going to go up. In actual fact they went down. That was a bit of a surprise to us,” says Bailey.

The researchers say naringin, the major ingredient that gives grapefruit its distinctive smell and bitter taste, appears to block a drug transporter known as OATP1A2, which ferries drugs from the small intestine to the bloodstream.

But they were also startled to find orange juice – “common orange juice, which is probably drunk a lot more than grapefruit juice,” Bailey says – did the same thing. So did apple juice. Orange and apple juices appear to contain naringin-like substances, the researcher says.

So far, grapefruit, orange and apple juices have been found to lower the absorption of etoposide, an anti-cancer drug; the beta blockers atenolol, celiprolol and talinolol; cyclosporine, a drug used to prevent organ transplant rejection; and the antibiotics ciprofloxacin, levofloxacin and itraconazole.

“But I’m sure we’ll find many other drugs for which this happens,” Bailey says.

The finding is important, “because a lot of my patients – and I imagine other people’s patients – describe how they take their morning pills with a glass of orange juice. That’s how they remember to take it every day,” says Dr. Jim Wright, a professor in the department of anesthesiology, pharmacology and therapeutics at the University of B.C.

Hospital patients are normally given water to take with their pills, but often people get their pills at breakfast, “so they’d be having their juice in the morning with it,” Wright says.

But he and other drug experts urged caution. Wright says it’s possible the orange and apple juice effect is much smaller than what’s seen with grapefruit.

“People shouldn’t panic and change their consumption of fruit juices based on this information,” says Dr. David Juurlink, head of clinical pharmacology at Sunnybrook Health Sciences Centre in Toronto. It’s such a novel finding, “it’s not even fully clear yet which drugs it does it to, and to what an extent it does it.”

Doctors tend to worry more about drug toxicity, he says. That’s why the grapefruit juice interaction with the high blood pressure drug felodipine that Bailey first described in 1991 “was a real big deal, because you can kill somebody with too much felodipine.”

If a drug level isn’t high enough, “it’s not usually a scary clinical event,” Juurlink says. “There aren’t too many drugs where that is a real, real danger.” He said that two of the beta blockers tested – celiprolol and talinolol – aren’t really used.

“Until we know more, people taking certain medications should be perhaps talking to their doctor or pharmacist,” he says. Those drugs include methotrexate, an immune-suppressing drug used to treat certain cancers and arthritis, as well as thyroid supplements.

Bailey’s research was funded by grants from the Canadian Institutes of Health Research and the United States Public Health Service.

Cipro and Fluroquinolones may cause Tendon Ruptures

As a side note, we’ve known about this for a while, but this is especially important for renal transplant patients.   Often we are put on these medications because they don’t interact with Sirolimus or Cyclosporin – that said, consider yourself advised.  Please note the emboldened section below

FDA Warning: Cipro May Rupture Tendons

Agency Issues ‘Black Box’ Warning for Antibiotics Known as Fluroquinolones

By Todd Zwillich
WebMD Health News

Reviewed by Louise Chang, MD

July 8, 2008 — Federal regulators are ordering new warnings on Cipro and similar antibiotics because of increased risk of tendinitis and tendon rupture.

The new warnings apply to fluoroquinolones, a class of antibiotics that includes the popular drug Cipro. The FDA has told companies that the drugs must now carry “black box” warnings alerting doctors and patients that the drugs can increase risk of tendinitis and tendon rupture in some patients.

Fluoroquinolones have carried similar warnings for years, but officials say they continue to receive reports of safety problems. A “black box” warning is the FDA’s sternest warning.

“We have seen continuing reports of tendon rupture so we are trying to increase awareness,” says Edward Cox, MD, director of the FDA’s Office of Antimicrobial Products.

The warning applies to drugs of the fluoroquinolone class, including Cipro, Cipro XR, Proquin XR, Levaquin, Floxin, Noroxin, Avelox, Factive, and marketed generics.

Renata Albrecht, MD, who heads the FDA’s Division of Special Pathogen and Transplant Products, estimates that spontaneous ruptures occur in about one in 100,000 people. The agency says taking the drugs appears to triple or quadruple the risk.

Most of the tendinitis and tendon ruptures affect the Achilles tendon, behind the ankle. But the agency has also received reports of tendinitis and ruptures in the shoulder and hand. Tendons connect muscle to bone.

Officials also say they are adding new warnings cautioning that patients over 60, those taking corticosteroids, and those who’ve undergone heart, lung, or kidney transplants are also at increased risk of tendon rupture or tendinitis if they take fluoroquinolones.

Researchers don’t know exactly what fluoroquinolones do that promotes tendon rupturing. Theories suggest the drug may impede collagen formation or interrupt blood supply in joints, Albrecht says.

She says patients taking the drugs should tell their doctors immediately if they experience soreness or inflammation in muscles or tendons and that they should not exercise affected joints.

A consumer watchdog group sued the FDA in January asking for the new warnings. The agency has received more than 400 reports of tendon ruptures in fluoroquinolone patients since 1997, according to Public Citizen’s Health Research Group, which filed the suit.

FDA officials would not confirm the number of reports of ruptures it has received, citing the ongoing litigation.

“There are several hundred, I would say,” says Ann McMahon, MD, acting director of FDA’s Division of Adverse Event Analysis II.

Where did KITN GO??? – We’re back

Hi All

Sorry for the long hiatus – life got in the way.   Needless to say I’m back and will be posting some new and important updates for kidney transplant and dialysis patients alike.   The Need a Kidney Give a Kidney has really been heating up with a number of donors willing to give their kidney to someone who needs it and a number of people seeking kidneys.   Just so you know, I eventually want to revamp the site to be more interactive and less of a post and share site.   As a reminder I will NEVER allow people to offer kidney’s for sale and if I find out someone is posting under false pretenses, I will remove that account / message.

If you are interested in why I’ve been away, check out my ABOUT tab (later today), there will be more info there!

Cheers and stay well!

Cellcept and Myfortic may induce PML?

FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic

Communication About an Ongoing Safety Review of CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid)

This information reflects FDA’s current analysis of available data concerning these drugs.  Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue.  Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action.  FDA intends to update this document when additional information or analyses become available.

ROCKVILLE, Md., April 10, 2008–FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

PML is a rare disorder that affects the central nervous system.  When it occurs, it is usually in patients with immune systems suppressed by disease or medicines.  It happens when the polyomavirus, also known as the JC virus, is activated.  The JC virus is found in most adults but does not usually cause symptoms.  Scientists do not know exactly how the JC virus is activated.  Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells.  Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.  Many patients who develop PML die.  Patients who survive may have permanent disability due to irreversible nerve damage. More information on PML can be found at the National Institutes of Health website.

CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection.  Mycophenolate mofetil, the drug ingredient in CellCept, is metabolized by the body to mycophenolic acid, the drug ingredient in Myfortic.  Both CellCept and Myfortic are used with other drugs to suppress the immune system.

On November 8, 2007, Roche, the maker of CellCept, submitted an evaluation of its PML cases in patients who have received CellCept in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the CellCept prescribing information.  On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter it issued in Europe on February 18, 2008.

Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.

FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information.  FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.

FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for CellCept and Myfortic about PML.  As soon as FDA completes the review, FDA will communicate the conclusions and recommendations to the public.  Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.  Decreasing total immunosuppression may improve the outcome of patients who develop PML.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

FDA urges both healthcare professionals and patients to report side effects from the use of CellCept and Myfortic to the FDA’s MedWatch Adverse Event Reporting program

US probes Roche, Novartis drugs on rare central nervous system disorder PML

By Susan Heavey

WASHINGTON, April 10 (Reuters) – U.S. health regulators are investigating whether two transplant drugs made by Switzerland’s Roche Holding AG and Novartis AG could be linked to a rare central nervous system disorder, the U.S. Food and Drug Administration said on Thursday.

The FDA said it is reviewing whether the two drugs — Roche’s CellCept and Novartis’ Myfortic — trigger a potentially fatal disease called progressive multifocal leukoencephalopathy, or PML. Both drugs are used to prevent organ rejection.

The FDA has received 16 reports of PML in CellCept patients since 1995, including some deaths, FDA spokesman Christopher Kelly said, adding that the agency is checking its databases to see if there were additional cases.

Roche spokesman Christopher Vancheri said it had 10 confirmed PML cases, and six cases of possible PML.

According to the FDA, Roche received the reports from transplant patients as well as others with the autoimmune disorder lupus — although CellCept is not cleared for that condition. The company gave the data along with proposed new prescribing information for the drug to the FDA in November.

More than 500,000 patients worldwide have used CellCept, which brought in more than $2 billion Swiss francs ($1.99 billion U.S. dollars) in 2007, according to the company.

CellCept, also known as mycophenolate mofetil, is approved to help prevent heart, liver and kidney transplant rejection, while Myfortic, or mycophenolic acid, is cleared to prevent kidney transplant rejection.

“Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic,” the FDA said.

“Decreasing total immunosuppression may improve the outcome of patients who develop PML,” it added. FDA’s Kelly said the discontinuation of the drugs is not necessarily recommended.

It will take two months to complete its review, the FDA said.

The agency already appears to be on track to require the two Swiss drugmakers to provide information about possible PML on the drug labels for CellCept and Myfortic. It could also decide to take further action, such as calling for new warning information on the packages or holding a public meeting.

Sales of a multiple sclerosis drug, Biogen Idec Inc’s and Elan Corp Plc’s Tysabri, were suspended in 2005 amid three reports of PML.
The drug returned to the market in 2006 with limits, when the FDA decided patients were willing to accept the risk in light of the drug’s benefits.

The agency said it has also asked Novartis for related data and called on the drugmaker to update its prescribing information on Myfortic’s label. The drugmaker does not provide specific sales figures for Myfortic because it is not one of its top 20 products.
In a statement, Novartis said while it “is not aware of any instances of PML in patients using Myfortic, we will comply with the class label change requested by FDA.”

Shares of Novartis were off 3.9 percent, or $1.90, at $47.27 in afternoon trading on the New York Stock Exchange; earlier they closed down 2.8 percent in Switzerland. Shares of Roche closed down nearly 1 percent on the Swiss exchange. (Reporting by Susan Heavey; editing by Gerald E. McCormick and Dave Zimmerman)

What is Anemia?

Recently I’ve been discussing on our sister user group Yahoo - Kidney_transplants about anemia and what might bring it on / reverse it’s effects.    I thought addressing it hear on kidney in the news, might be a useful exercise.

Today starts a 4 part series on Anemia, what it is, what causes it and how to fix it!

For those of you who don’t know, Anemia is defined as: a deficiency in hemoglobin – a molecule in your Red Blood Cells (RBC’s) that carry Oxygen.  What’s happening is the RBC’s (Red Blood Cells) travel to the lungs where they pick up and store Oxygen in the molecule Hgb.  The RBC’s then delivery that to the other parts of you body.

Normally, the human body should have the following levels for men and women (For our international readers I’ve placed it in mmol/liter)

W 12.0-16.0 g/dl  -   7.4 – 9.9 mmol/l

M 13.0-18.0 g/dl –    8.1 – 11.2 mmol/l

When you fall below these levels you are considered Anemic – *However* just being slightly Anemic is not a bad thing (We’ll discuss this later).   The things you should be on the lookout for is continued long-term decreases or rapid decreases in your Hgb levels.

As we discussed, Hgb is a molecule inside the RBC – so having too little Hgb can bring on Anemia – so too can a decrease in size of the RBC or quantity of your RBC’s.  That’s why your doctor asks you to do a blood test and looks at your HGB and RBC counts.

Now back to the discussion of Anemia…

A shortness of hemoglobin means your body (Brain, muscles, organs etc) don’t get the normal amount of oxygen they need to do their job.

This shortness of hemoglobin can translate to the following:

• Shortness of breath
• Weakness when working out
• Malaise (being tired)
• Muscle weakness
• Lack of endurance

So often in the news we hear about athletes doping, or using medications to increase the amount of hemoglobin in their blood.  You see, not only can a decrease in Hgb(Hemoglobin) make you tired and slow, but an increase can impact your muscle strength, endurance, speed – in a lot of ways it can give you “Super Human Energy / Strength”.   A good way to think of it is like a car engine:

Car’s on normal gas (Hgb) run normally – but the higher octane gases run even more efficiently (Over 100 Octane is called racing fuel).  Lower Octane gas can make our cars sputter and stall – very similar to our bodies on Hgb!

So in summary, Oxygen helps our bodies (car) run efficiently.   RBC’s transport the Oxygen to our entire body (Brain, muscles and other organs).   The RBC’s have a special place they store the Oxygen on its trip to the body – that being Hgb.  One reason why we might become Anemic is becuase the RBC’s don’t have enough storage space (HGB).   Without this “storage space” or Oxygen, the RBC’s dont’ carry enough Oxygen to the body and the body starts to slow down.

So I’ve tossed a lot of stuff at you today – take some time to digest what we’ve discussed and next time we’ll look at how HGB and RBC’s are created and those triggers are.   From their we’ll move on to what might cause Anemia and how to reverse it.

PS – Want to receive this and other postings in email?  Sign up via feedburner or Google in the panel to the right  – Just click the Google or “Via Email” icon to the right.

Michael

images above from ADAM

World Kidney Day – Today March 13th

For those of you who are not aware, today is the day to be aware of your KIDNEYS!!!!

Today is World Kidney Day.

WKD is a joint initiative of the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF) and is held every second Thursday in March.

What can you do?

• Participate in one of these great events in your own country: Link Here 

• Learn more at one of these great sites:

World Kidney Day Website 

National Kidney Foundation – World Kidney Day Co-Sponsor 

• Teach someone about how important your kidney’s really are – share some kidney facts

Kidney Facts Page

Don’t be evil…

PS – If you’re interested in being a contributor / editor for Kidney In the News (Volunteer of course), please reach out to me – looking for some good people!

Watch Video’s About Kidney Related Issues

Came across an interesting beta site today – “ICYOU.COM“. Which stands for “Intensive Content for Your Health” – It’s actually a video hosting site for medical /health related content. While it’s not dedicated to just kidney’s or transplantation – it is a good place to find some kidney related health video’s – our friends over at “Donate Life Illinois – I Am Are You” regularly have video’s posted about successful kidney transplants.

It looks like it’s shaping up to be a great health related resource – I’ll add them to the blog role on the right and keep you posted on any video’s I think are worth while. A few of them already online are posted below.

JAMA VIDEO – Nighttime home dialysis might be a better option

JAMA VIDEO – Why Folic acid and Vit B might save your Heart

Kidney transplant without medications (Drugless Transplants)

So you want a new kidney but not all the adverse effects that come with the medications. Or you think the cost of the medications make it prohibitive? There might be some good news on the VERY close horizon. A number of hospitals are participating in clinical trials to investigate the potential of using bone marrow from the donor to “trick” the recipients body into accepting the new organ. The process requires bone marrow from the donor to be injected into the recipients body.

Here’s is a REALLY quick drawing of how it works – you’ll notice radiation is included – at least in the model I read about, as is short term immunsuppression – both are not needed after the initial induction period.

Hospitals actively running pilots like this include: Mass General Hospital in Boston,MA and Northwestern Hospital in Chicago (First time transplants ONLY for both sites).

ISA247 – a new less toxic calcineurin inhbitor(cyclosporin is one)

EDMONTON – Transplant drug company Isotechnika said Thursday the first
commercial application of its lead product ISA247 will likely be as a
treatment for uveitis, an inflammation of the middle eye layer.

The drug is in late-stage trials as an anti-rejection drug for kidney
transplants, but CEO Robert Foster said the uveitis program, a
partnership with Lux Biosciences, has been fast-tracked by the U.S. Food
and Drug Administration and could get its New Drug Application (NDA)
approval next year.

Foster told an analyst’s conference the main focus is still kidney
transplants and trials have shown ISA247 is an effective and safer
alternative to the two current drugs in a $3-billion-a year market.

He said transplant trial partner Roche will write Isotechnika a cheque
for $75 million if it decides to go ahead with commercialization, plus
the Edmonton firm will get royalty payments.

Foster also said they are hoping Roche will come back into ISA247’s
psoriasis treatment program. The Swiss giant pulled out in 2004, but
Foster said positive clinical trials since then may persuade them it is
worth pursuing.

“The value seems to be there for Roche or anybody else.

“I would say we’re working very well with Roche and our relationship has
never been better.”

From their website :

ISA247

Indications

Some of the potential indications for ISA247 may include:

Autoimmune Indications

• psoriasis
• rheumatoid arthritis
• type 1 diabetes
• Crohn’s disease
• Uveitis

Transplantation:

• kidney
• liver
• heart
• lung

Phase 2b Kidney Trial

The Company announced enrolment of its first patient in the Phase 2b Kidney transplant trial on January 5, 2006.  The trial is currently being performed at forty-two centers across North America, including thirty-eight centers in the United States and four centers in Canada.  Patient enrolment was completed on June 26, 2007.

A total of 334 de novo (newly transplanted) kidney transplant patients were enrolled in this trial.  Patients were placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm.  Patients in all four treatment groups had their doses adjusted in order to achieve pre-defined blood levels of either ISA247 or tacrolimus.  All patients received oral treatment of the drug (ISA247 or tacrolimus) over a six month period, along with other standard immunosuppressive therapies used following transplantation.

On January 3, 2008, the Company announced that the last patient enrolled completed the six month trial.  On June 7, 2007, and August 2, 2007, the Company announced that it had received permission from Health Canada and the Food and Drug Administration (USA), respectively, to allow patients to remain on ISA247 until the drug is commercially available.

The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared to the tacrolimus control.  Additionally, kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.  The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of rejection) with minimal side effects.  The use of the other two calcineurin inhibitors, cyclosporin and tacrolimus, are often associated with significant safety concerns.