FDA Changing Pain Meds


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.

It’s That Time Of The Year


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.



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


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!


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

Read Teri Robert’s SharePosts

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.”



  • 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.