FDA Changing Pain Meds

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This article is dated from July 2009. I saw this article and since so many of us with autoimmune diseases are treated with these types of pain meds, I thought it worthy of posting here. I understand the reasonings for lowering the amount of acetaminophen in these combination drugs and I hope it works out well. Enjoy the read! From Time Magazine’s webpage.

Wednesday, Jul. 01, 2009

FDA Advises Lower Dosage for Popular Painkiller

By Alice Park

A Food and Drug Administration advisory panel recommended on June 30 that the maximum over-the-counter dose of the popular pain reliever acetaminophen be lowered and that the current maximum single dose of the drug be available by prescription only.

Acetaminophen, more commonly known by the brand name Tylenol, is one of the most frequently used pain and fever relievers in the U.S. It has the advantage of not causing stomach bleeding or other gastrointestinal side effects that other popular pain medications, such as aspirin and ibuprofen, can cause. Acetaminophen is also found in several cold- and cough-remedy products as well as in prescription drugs such as Vicodin and Percocet. (Read “The Year in Medicine 2008: From A to Z.”)

But despite its widespread use, there have been growing concerns about the non-prescription drug‘s effects on the liver. The 13-member FDA committee convened specifically to address liver toxicities due to acetaminophen overdose. The group of doctors and patient representatives concluded that the daily maximum dose of acetaminophen should be reduced from the current allowable 4 g and that the maximum single over-the-counter level be set at 650 mg, down from the current 1,000 mg.

Experts stress that taken as recommended, the drug is safe. But because the agent is present in so many over-the-counter medications, there is the potential that users can unintentionally overdose. “People might be taking Tylenol and taking a combination cold product that also has Tylenol in it, and Vicodin, which also has Tylenol in it, and start combining medications and not realizing they are taking that much acetaminophen,” says Dr. Michelle Ruha, a medical toxicologist at Banner Good Samaritan Poison Control Center in Phoenix. (See the top 10 medical breakthroughs of 2008.)

Since 1998, acetaminophen-containing products have carried a warning label advising users to consult their physician when using the pain reliever in combination with alcohol. In 2002, the medication earned a warning advising users to avoid taking more than two acetaminophen-containing products at the same time. Nevertheless, in a study of adverse event reports submitted to the FDA since the 2002 label change, the number of liver problems has doubled, says Bill Soller, a professor of pharmacy at the University of California, San Francisco, who conducted the survey. “People don’t read labels, and physicians aren’t doing the communication in the office,” Soller says. “At some point, when you find the labels don’t work, then you’ve got to bump it up to the next level.”

That’s what the committee’s conclusions represent — a strong message that as safe as acetaminophen is, it can be made safer, to help people avoid accidental overdoses. McNeil Consumer Healthcare, Tylenol’s manufacturer, disagrees, citing 150 clinical studies on the drug’s safety if taken as recommended. In a statement, the company said, “McNeil Consumer Healthcare strongly disagrees with the committee’s recommendation. McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-the-counter products … in search of pain relief.” (See the most common hospital mishaps.)

There’s no guarantee that the FDA will actually follow the advisory committee’s advice and reduce the over-the-counter dose of acetaminophen. And even if the agency does, some experts aren’t convinced that the move will lead to fewer liver toxicities associated with the medication. “Honestly, I don’t think that is going to solve the problem,” says Ruha. “Most of the problem is with the prescription pain medications that contain acetaminophen.” Many people using drugs such as Vicodin or Percocet still don’t feel relief from their pain and either abuse their prescription or supplement with an over-the-counter medication. “The patients we see coming to our hospital from liver failure have either intentionally overdosed or taken too many prescription pain medications with acetaminophen in them,” she says.

Still, if the FDA does decides to follow the committee’s advice, it would represent an aggressive attempt to address the growing problem of liver problems associated with the non-prescription painkiller — one that goes beyond simply adding another warning label on a pill box.

Chemotherapy and Lupus

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Many of you who see this will think, what do these two have in common? The truth is, quite a lot. I personally have been on chemotherapy several times due to my lupus. Many of my lupie friends have as well. It is not well known to those outside of the lupus world though.

You see, lupus is an autoimmune disease, which means, that our bodies create antibodies against our own body and its cells. In effect, our body attacks itself. Antibodies are great when you are sick and need to fight an infection. When they go into hyper mode, you are now into the realm of autoimmune diseases.

Where does the chemotherapy come in, you ask? In an effort to slow down the autoimmune disease from being in hyper mode, we are given chemotherapy agents to shut it down, or at least attempt to take it down to a more normal level. Sometimes it works, sometimes it goes too far. It is a fine line on therapeutic effect and overkill.

I actually was on chemotherapy when I was “let go” from my last job. I had been told that my job would still be there while I was out on paid sick leave. The truth is, they fired me by email. They gathered my things up and federal expressed them to me too. How lovely. Ok, sorry, I am digressing into the land of the past and I need to let it go.

This information is from the Lupus Foundation of America website about chemotherapy:

“chemotherapy, is generally reserved for those individuals who have the most severe flares of lupus; or to enable the steroid dose to be reduced. A severe flare is one that affects an organ to the degree that the function is impaired. When this happens something has to be done to preserve the function of the organ and that’s when immunosuppressive or chemotherapy medications are prescribed. These actually suppress the over activity of the immune system brought on by the lupus, and help limit the damage and preserve the function of the involved organ. (Lupus is NOT a form of cancer).”

There are many types of chemotherapy agents used in treating lupus. I have looked them up and here are a few of them (from the Lupus Foundation of America website):

Imuran, Cytoxan And Related Drugs

Although immunosuppressive drugs can have serious side effects, they can be of great value in the treatment of systemic lupus erythematosus (SLE). They may help to:

  • prolong life
  • preserve kidney function
  • reduce disease symptoms
  • reduce damage to vital organs, such as the kidneys and lungs.
  • sometimes even serve to put the disease into remission.

Steroids used alone to treat major organ involvement in lupus must sometimes be given in high doses. This increases the risk of short-term and long-term side effects, which may sometimes be worse than the disease itself. Immunosuppressive drugs can be used either in addition to, or instead of, steroids to spare the patient some of the undesirable side effects of steroid therapy.

Thus, immunosuppressive and cytotoxic drugs are used in the treatment of lupus for two major reasons:

  1. They are potent drugs which help to control disease activity in major organs, including the kidney, brain, cardiovascular system, and lungs.
  2. They may reduce or eliminate the need for steroids (cortisone derivatives such as prednisone).

How Do They Work?

Cells in the body divide and grow at varying rates. Examples of rapidly dividing cells include:

Cytotoxic (cyto=cell, toxic=damage) drugs work by targeting these cells which grow at a rapid rate. In lupus, the immune system produces autoantibodies at a rapid rate of growth. Cytotoxic medicines can suppress the cells involved in the hyperactive immune response.

Possible Risks

There are risks associated with the use of cytotoxic drugs.

  • The immune system may be suppressed too much, which causes an increased susceptibility to infection, particularly shingles (a painful, blistering skin condition) and pneumonia.
  • The bone marrow can be suppressed as well, which results in reductions in red blood cells, white blood cells, or clot-forming platelets.
  • Suppression of hair cell growth may lead to overall loss of hair.
  • The cytotoxic effects on gonadal cells can lead to sterility.

Imuran (generic name: azathioprine)

Imuran is less potent and less effective than Cytoxan, but has fewer side effects. Imuran is well tolerated in most cases. Imuran is steroid-sparing and studies have shown that it clearly improves liver and kidney lupus.

Side effects can include:

  • nausea
  • decreases in white blood cell count, platelet count, or red blood cell count
  • increased risk of developing lymphoma (cancer involving the lymph glands, liver and spleen), with long-term Imuran use

Blood tests to determine the white blood cell, platelet, and red blood cell count should be done regularly in patients receiving this drug. Adjustments in dosage are made if the tests indicate a serious decrease in blood counts.

Cytoxan (generic name: cyclophosphamide)

Cytoxan is well tolerated by most patients. Like Imuran, it may cause an upset stomach, and its use may decrease the white blood cell count, platelet count, or red blood cell count

Side effects can include:

  • an increased risk of developing malignancies, including leukemia and bladder cancer, with long-term Cytoxan use
  • temporary or permanent sterility in both women and men, preventing them from having children
  • leading to damage of a developing fetus if a woman gets pregnant while being treated with the drug
  • bleeding from the bladder-this usually can be prevented by drinking large amounts of water
  • causing a predisposition to develop shingles
  • hair loss
  • like Imuran, causing a predisposition to develop unusual infections, particularly when given in combination with high doses of steroids

Blood tests to determine these blood counts should be done regularly for those receiving Cytoxan. If the blood count is seriously decreased, the dosage is adjusted and the blood counts will generally return toward normal.

How Is Cytoxan Administered?

Cytoxan can be given as oral tablets, but more often is given through the vein (intravenously, or IV).

  • This procedure generally takes between 15 and 60 minutes.
  • Large amounts of intravenous fluids are also given to dilute the concentration of Cytoxan in the bladder.
  • Pre-medication for nausea is sometimes given, but treatment with Cytoxan is generally well tolerated.
  • IV Cytoxan seems to be associated with fewer malignancies and many fewer bladder problems, while being equally effective.
  • Controlled studies also show that it improves kidney and autoimmune lung disease.

 

Related Drugs

Leukeran (generic name: chlorambucil) and Mustargen (generic name: nitrogen mustard)

  • These two cytotoxic drugs are related to cyclophosphamide.
  • Both have similar side effects to Cytoxan.

Methotrexate

This drug is usually given orally on a weekly basis, although it may be given by injection.

  • The dosage is generally 7.5 to 25 milligrams per week.
  • Methotrexate is well tolerated by most patients.
  • Its use in lupus has not been thoroughly tested, but it is given commonly for rheumatoid arthritis and has been shown to produce improvement of joint pain and stiffness.
  • It is only modestly effective for organ-threatening lupus.
  • Liver disease and lung reactions can occasionally occur with the use of methotrexate.
  • Blood counts and blood liver enzyme tests should be monitored regularly in patients receiving this drug, and the dosage modified if side effects are detected.

CellCept (generic name: mycophenolate mofetil) and Neoral (generic name: cyclosporine)

  • These two medications modify the immune system, which, in lupus, appears to be both overactive and misdirected.
  • Both of these medications are used to prevent rejection of the donated organ in kidney, liver, heart and lung transplants.
  • CellCept can cause nausea and diarrhea.
  • Cyclosporin may elevate blood pressure and reduce kidney function.

Conclusion

All of these agents are steroid-sparing. While cytotoxic medications should not be used in cases of mild lupus, these medications can be very helpful and even life-saving when major organs are involved, or in cases where the lupus is quite active and symptomatic.

Sometimes a kidney biopsy or other tissue biopsy is necessary before deciding whether to use these drugs. Even in more serious cases of major organ involvement, cytotoxic drugs should not be used indefinitely without good reason.

It is important to weigh the beneficial effects as well as the risks involved in cytotoxic drug therapy. Doctors use the term “risk-benefit ratio” to describe the comparison of side effects to beneficial effects of medication. While these cytotoxic drugs are not FDA-approved for use in SLE, they are commonly used and accepted as standard practice. People with lupus should discuss the risk-benefit ratio of these medications with their physician.

It’s That Time Of The Year

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I bet you thought this would be about the holidays. Well, no, it is about winter.

This is that time of the year where the nights are longer, the air is colder, and we are indoors more. It is also that time of the year when many infectious viruses and bacteria are shared with others as we are indoors and have close contact with each other.

When I was in nursing school, my microbiology professor called this time of year, “a microbiotic soup of those infected and those susceptible”. In short, we are in closed spaces, and around more people and are more prone to the touching of places where some who are sick have touched, walking by someone who is sneezing or coughing and inhaling the germs, or being around a child who may have been exposed to germs at school. Hence the microbiotic soup analogy.

Those of us with lupus have to be more vigilant than most. You see, most of our medications are considered immunosuppressants and can leave us more vulnerable because of our immune systems being lowered. At this point, you may think, “Go get a flu shot”. I must state here that the jury is out in regards to lupus patients and flu shots. Many lupus patients are recommended by their doctors to get flu shots each year. They get them and all is good. Some others are advised by their doctors NOT to get the flu shots. My doctor is one of those who has told me not to get a flu shot.

Some have noticed that lupus patients seem to go into a flare when they get flu shots, others say the opposite. Like I said, the jury is out and since I am no doctor, I say talk to your doctor and follow their advice. It may be that your medications can play a role in whether you should get one or not. The type of lupus may be another reason. In the end, it is best to listen to those who are more qualified and know what the risks versus the benefits are.

Another thing about this time of the year is the colder air and the cold fronts which come through bringing the drop in barometric pressure and to some of us lupies, pain. For some reason, the cold weather makes our joints hurt. I know I experience this. I almost hibernate this time of the year because of it.

Now on a personal note, and in an effort to be honest here, I have found myself not only flaring and in pain, but while out and about (I went to the grocery), I seem to have picked up a nasty cold bug. I am using my neti pot and keeping to comfort foods while resting up and fighting it. Sometimes, when it rains, it pours. Ah well, such is the life of a lupie patient.

The best news of the week is that the FDA committee approved sending Benlysta for final approval for lupie patients. The date it will go in front of the FDA is December 5th. It is imperative that this drug get approved. I am on the clinical trial of this and I inject a dose once every two weeks subcutaneously. The study I am in is different than what is hopefully being approved. The FDA is approving Benlysta for IV infusion for lupus patients. The study I am in is to see the effectiveness of injecting instead of infusing. So, we will hope that it gets approved so many of us can feel better instead of worse this time of the year.

I hope all of you have pain free days and restful nights this winter. Remember to watch out for the bugs which can infect us this time of the year.

UPDATE ON BENLYSTA

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I received this update on benlysta in my email from the lupus foundation of america. Important to read for all of us lupies!

Food and Drug Administration to Hold Hearing on BENLYSTA®

FDAOn November 16, 2010, the Food and Drug Administration (FDA) will hold a hearing to discuss the application to approve BENLYSTA® (belimumab) as a treatment to reduce disease activity in adults with active, autoantibody-positive lupus.

If approved, BENLYSTA® will be the first drug to be specifically developed for lupus and the first new treatment for lupus in more than 50 years.

While BENLYSTA® may not be appropriate for all people with lupus, having a new approved treatment for lupus would be a significant step forward and would provide a pathway for future approval of the arsenal of therapies required to manage a disease as diverse and complex as lupus.

Make your voice heard! It is important for the FDA Committee to have a clear understanding of the diversity of the disease and how it impacts people with lupus and their families. You can help by sharing your story about why new treatments are needed and the hope for new treatments in the future.

Email your short statement to Yvette Waples at the FDA, Yvette.waples@fda.hhs.gov by November 1, 2010.

Topamax for migraines

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This is yet another new medication my neurologist prescribed for me. I have found that researching medications is helpful to see how it affects me and why it is prescribed in the first place. This information I found on the website, www.healthcentral.com. Let me know if you have taken this and if it worked for you. Thanks!

Topamax

Learn more about the side effects, dosage, and details of Topamax, one of only four medications approved by the FDA for the prevention of Migraines.

Topamax (Topiramate)

by Teri Robert, MyMigraineConnection Lead Expert

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Topiramate is a neuronal stabilizing agent (aka anticonvulsant medication) that has proven effective as a Migraine preventive for some patients. It is one of only a few medications to have been approved by the FDA for Migraine prevention. As with other drugs in this category, patients should start at a low dosage and slowly taper up to therapeutic levels. The daily dose should be taken in two divides doses approximately 12 hours apart. If discontinuing this medication, it is essential to slowly taper off rather than discontinuing abruptly.

 

Type of medication: Rx, preventive, neuronal stabilizing agent (anticonvulsant )

 

Special Notes:

  • At the Migraine Trust’s 14th biennial International Research Symposium, noted Migraine specialist Dr. Stephen Silberstein noted:
    • The best results were achieved at a dosage of 100 or 200 milligrams of topiramate per day, a lower dosage than that used to treat epilepsy.
    • The most commonly experience side effects were nausea and tingling of the extremities.
    • “What was amazing in this trial was the effect on weight. The patients who got topiramate lost, on average, 3.8 percent of their body weight.”
  • In an interview with Teri Robert, Dr. Silberstein elaborated:
    • “The key to success with Topamax is a very slow titration up to the therapeutic dose. Patients should begin taking only 15 mg, once a day, and taper up slowly from there, being sure to take it in a split dose.”
    • “The effective dosages are lower than you might think. Many patients achieve good results at only 50 mg per day.”

 

Precautions:

  • Seek immediate medical attention if you experience blurred vision, changes in vision, or pain in or around the eyes during treatment with topiramate. These may be early signs of a serious side effect.
  • Do not stop taking topiramate without first talking to your doctor, even if your symptoms have improved. It is important to continue taking topiramate to prevent seizures from recurring.
  • Carry or wear a medical identification tag to let others know that you are taking topiramate in the case of an emergency.