OVER-THE-COUNTER MEDICATIONS & VITAMINS



Thomas Shaw-Stiffel, MD,
Medical Director,
Living Donor Liver Transplantation
Univ of Pittsburgh Medical Center - Presbyterian Hospital Center for Liver Diseases
March 2003

Question
In light of the recent info about Tylenol and its effects, is it still the best pain reliever for those of us with PBC and arthritis? Has the maximum dose changed in light of this info? It seems to me that our livers are already compromised and Tylenol, which is not recommended for alcoholics or those drinking alcohol, would affect us adversely.

Answer
I still recommend mild-moderate doses of Tylenol (no more than 4 grams total a day, that's about 8 extra-strength since each tablet is 500 mg) since it's safe unless the patient is drinking a lot of alcohol or has advanced liver cirrhosis (awaiting liver transplant). Far safer than the ASA or NSAIDs which can affect platelet (the tiny blood cells that stop bleeding) or kidney function and could cause stomach ulcers or even contribute to causing bleeding from varices (large vessels due to cirrhosis in the esophagus and stomach).

Howard J. Worman, M. D.
Associate Professor of Medicine and Anatomy and Cell Biology
College of Physicians and Surgeons Columbia University
July 2003

Question
In light of the recent info about Tylenol and its effects, is it still the best pain reliever for those of us with PBC and arthritis? Has the maximum dose changed in light of this info?
It seems to me that our livers are already compromised and Tylenol, which is not recommended for alcoholics or those drinking alcohol, would affect us adversely. 

Answer
Aceptaminophen (Tylenol) is a very safe analgesic when used as directed.  It is safe for use by individuals with chronic liver disease when used as directed on the package label.  Of course, anyone with a chronic illness should discuss the use of medications, even over-the-counter ones, with her/his doctor.

David Bernstein, M.D.
Chief, Division of Gastroenterology
North Shore University Hospital
Manhasset, NY
July 2000

Question
 Do you recommend those with PBC take vitamins? Would it be easier on the liver to take children's vitamins?

Answer
People with PBC who develop advanced disease may develop deficiencies in the fat-soluble vitamins (vitamins A, D, E, and K). In these patients, I recommend specific vitamin replacement dependent on the needs.
In PBC patients who have not developed advanced liver disease, I recommend a multi-vitamin without iron and copper each day. I also recommend anti-oxidant use such as vitamin E in most patients. Children's vitamins can be as effective as adult vitamins. I believe that the important item to look for is the presence of copper or iron in the vitamin. If these are there, the vitamin should be avoided.

Kris V. Kowdley, MD
Associate Professor of Medicine
University of Washington School of Medicine
Division of Gastroenterology/Hepatology
Seattle WA
No answer date given

Question
I get 400 mg of Vit D in my daily multivitamin. I also take Calcium with Vit D so I get an additional 400 mg of Vit D daily with my calcium. If 400 mg is the recommended daily dosage, at what levels does Vit D start to become toxic? Is 800 mg per day too much?

Answer
There is no role for supplementation with vitamin D if you are not deficient. Most patients in fact are not deficient. I would suggest checking the serum level and adjusting the dose based on serum level.

Young-Mee Lee, M.D. &  Daniel Pratt, M.D.
New England Medical Center
Boston, Ma 02111
No answer date given

Question
 Would you encourage or discourage a patient of yours with stage 3 PBC from taking Milk Thistle? Please explain your answer.

Answer
There are no data of which I am aware about milk thistle in PBC. Hence I would not encourage anyone with PBC, no matter what stage, to take it. I am not aware of any side effects. Many patients take it on their own because it is sold over the counter. I would rather not have patients take milk thistle but do not feel strongly because it is seems to be safe in the doses taken.

Marshall Kaplan, M.D
Chief, Division of Gastroenterology
New England Medical Center
Boston, MA
September 9, 1999

Question
What are your thoughts on the vitamin preparation ADEK, which is manufactured by Axcan? Is this a good vitamin for PBCers or do you suggest another one or does the vitamin depend on the individual needs?

Answer
Vitamin replacement therapy has to be individualized. Vitamins are only useful if a patient is deficient in a certain vitamin. This can be easily measured. I have not used the preparation you mention so I can not really comment.

Marshall Kaplan, M.D
Chief, Division of Gastroenterology
New England Medical Center
Boston, MA
September 9, 1999

Question
There is a newly available supplement called S-adenosylmethionine. The insert says that it's been studied extensively and clinically found to promote and support liver health among other things. Physicians are encouraged to contact the company for scientific information.

Answer
Yes. I know a lot about it and used to use it in biochemical research 35 years ago. It is one of many products that has no established role in the treatment of liver disease, certainly no role in the treatment of PBC. I can only assume that some entrepreneur or company hopes to make money by promoting its sale. In contrast to "ethical drugs" e.g., URSO and Actigall, our government does not regulate this industry, one which many of us feel should be more carefully monitored.

Marshall Kaplan, M.D
Chief, Division of Gastroenterology
New England Medical Center
Boston, MA
September 9, 1999

Question
 Any thoughts on BETA-CAROTENE? (1 A DAY EQUIVALENT TO 25,000 I.U. VITAMIN A)

Answer
Most PBC patients do not need it. If there is doubt, blood levels can be measured and it can be taken by those who are lacking it.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
May 2000

Question
 In your opinion is it safe to take adult vitamins when diagnosed with PBC or any other autoimmune liver disease? Instead of taking adult vitamins would it better for PBCers to take children's vitamins?

Answer
I usually recommend that patients with autoimmune liver disease and biliary disorders take regular multivitamins with the recommended dosage of any brand. Patients with biliary disease and those taking oral corticosteroid treatments are prone to bone disease. Therefore, patients should ensure that the multivitamin tablet has vitamin D in it and take additional calcium supplements such as Tums or Oscal 1 to 1.5g per day.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
May 2000

Question
 Do you know of any alternative methods used to help improve the liver and PBC such as Milk Thistle?

Answer
I usually tell patients that there are no good studies to indicate prescription of alternative medicines. Milk Thistle appears to be well tolerated but of unknown benefit. I am not aware of any other good alternative treatments but I always recommend a daily multivitamin with vitamin D as well as calcium supplements.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
May 2000

Question
What causes the decrease of vitamin D in a person with PBC? Shouldn't this be easily corrected by taking vitamin D orally?

Answer
Vitamin D is a fat soluble vitamin that can be inadequately absorbed in patients with biliary disease. This can be easily corrected by taking 400 IU vitamin D, which is the usual dose in a standard multivitamin tablet.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
August 2000

Question
Are there any suggestions on lifestyle, diet, etc. that can delay the passing of one stage of PBC to the next one?

Answer
There are only a few general suggestions for lifestyle and diet for PBC patients. I advise all patients to exercise, watch their weight and take multivitamins with Vit. D as well as additional calcium (2 extra strength Tums for example) to avoid bone disease. However, there are no specific recommendations to delay disease progression.

Some patients with stage I PBC without symptoms can have a very benign course of disease. Once symptoms have developed, untreated patients are thought to have a variable course with a need for transplantation within 5 to 12 years. In untreated patients with worsening symptoms, the histologic progression can be as short as one stage every 1.5 years. However with treatment, the need for transplantation in symptomatic PBC patients varies from 7 to 15 years depending the progression of disease.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
August 2000

Question
I read somewhere that instead of Calcium Carbonate a PBCer should take Calcium Nitrate tablets. Do you know anything about this?

Answer
I am not sure why calcium nitrate would be any better than calcium carbonate. I usually advise patients to take 1.5 grams of calcium per day, such as 3 extra strength Tums.

Melissa Palmr, M.D.
Specialty: Gastroenterology and Hepatology
Medical advisory board of the ALF New York Chapter
ALF National Chapter Nutrition Education Subcommittee
April 2000

Question
With the recent on-line discussions about taking "carnitor" to boost energy, can we get a doctor's opinion on it's potential effectiveness and safety for pbcers?

Answer
I am unfamiliar with "carnitor". However, any over-the-counter supplements that claim to boost energy is unlikely to do so. Furthermore, these supplements are not regulated by the FDA and thus have been found to sometimes contain substances such as ephedrine which may boost energy and may also be dangerous to your health. I recommend avoiding any supplements that make such claims until they are tested in regulated trial studies proving their claims.

Melissa Palmer, M.D.
Specialty: Gastroenterology and Hepatology
Medical advisory board of the ALF New York Chapter
ALF National Chapter Nutrition Education Subcommittee
April 2000

Question
Can PBCers use plant derived products such as aloe vera to improve their condition?  Dermic gel containing aloe vera is good for skin problems and is a efficient mean to drive moisture inside. It strengthens the immune system  which can be valuable for cancer for instance but what could be the impact on autoimmune diseases? Do you know anything about this product?

Answer
There are no studies on aloe vera and PBC. However if used topically, aloe vera is unlikely to cause problems for individuals with PBC. However, it is also unlikely to have a significant impact on the long term course of autoimmune diseases.

Howard J. Worman, M. D.
Division of Digestive and Liver Diseases
Departments of Medicine and of Anatomy and Cell Biology
College of Physicians & Surgeons
Columbia University
New York, NY 10032
April 2000

Question
What are your thoughts of a person with PBC taking Tylenol, Advil, Aleve or plain aspirin for arthritis pain.

Answer
Patients with PBC must consult with their doctors regarding the use of any medications, including over-the-counter ones. Anyone using an over-the-counter medicine must also carefully follow the directions on the label and discuss and questions with their doctors and call their doctors if symptoms persist.

Regarding these particular drugs, acetaminophen (Tylenol) is an extraordinarily safe drug when used as directed and is associated with very few side effects.

Ibuprofen (Advil) and naproxen sodium (Aleve) are also very safe when used as directed but can be associated with stomach upset, an increased incidence of gastrointestinal bleeding and in rare cases kidney problems.

Again, I strongly emphasize that patients with persistent arthritis pain should use medications only as directed by their physicians.

Howard J. Worman, M. D.
Division of Digestive and Liver Diseases
Departments of Medicine and of Anatomy and Cell Biology
College of Physicians & Surgeons
Columbia University
New York, NY 10032
April 2000

Question
I've heard of Alpha Lipoic treatments and wondered what your opinion is on the use and safety in PBC. If it is being used, what is the recommend dosage and treatment?

Answer
Alpha lipioc acid is not approved for the treatment of PBC. It is not established to be effective or safe.

Hugo E. Vargas, M.D.
Medical Director, Transplantation
University of Pittsburgh Medical Center
Pittsburgh, PA
November 1999

Question
What is your opinion on using Milk Thistle as an adjunct to Urso as pharmacotherapy for PBC?

Answer
Milk thistle probably will not hurt PBC patients but the information is very scanty. The problem is compounded by the fact that one product in the market cannot be compared with the next and thus it is difficult to endorse any one in particular.

Nathan Bass, M.D.
Professor of Medicine, Medical Director, Liver
Transplantation Program,
University of California
San Francisco

Question
 Why is it that so many with PBC have terrible bone aches and pains? Is it just PBC or all liver diseases? What do you recommend we take for the pain?

Answer
Many types of liver disease may be complicated by bone thinning, but this problem is clearly worst in PBC. The loss of mineral (calcium) from bone in PBC is the main cause of bone pain, and is most incapacitating when this leads to fractures or collapse of vertebra from the weakening of bone structure. Rarely, an inflammation of the fibrous cover of the bone may also occur (periostitis). The factors causing bone loss in PBC include postmenopausal hormone changes in women, poor absorption of calcium and vitamin D from the digestive tract, and factors that accumulate in the blood stream in cholestasis that inhibit the cells that form the bone, while there is increased activity of the cells that remodel or remove bone tissue. Other genetic factors that determine the way an individual responds to vitamin D may also play a role. The bone pain in PBC can be tremendously disabling, and fortunately, can be prevented by well-timed liver transplantation. Further bone loss should be prevented by appropriate treatment with calcium, vitamin D, hormone replacement and bone-building medications such as alendronate.

The pain should be treated with painkillers as strong as needed, but not non-steroidal anti-inflammatory drugs (e.g., Ibuprofen), as these can cause gastrointestinal bleeding in patients with portal hypertension. Some of the newer so called COX-2 selective drugs like Celebrex or Vioxx may be effective and safer, but are untested in this situation and are considered contraindicated in patients with liver disease. They, occasionally have caused serious internal bleeding. Opiate pain killers will help, but are habit forming and sedating and worsen encephalopathy. This is a difficult problem to treat satisfactorily once it has progressed to an advanced stage.

Andrew Mason, M.D.
Medical Director of Liver Transplantation Ochsner Clinic
Assistant Professor of Medicine, Tulane University Medical Center
Assistant Professor of Microbiology, Immunology, and Parasitology, Louisiana State University Medical Center
New Orleans, La
August 2000

Question
Is there any possible connection between PBC and miticondria disease? I noticed that the doctor initially narrowed in on my diagnosis because of the miticondrial antibodies in my blood test and when I was searching for info on the drug Carnitine that PBC patients are talking about, I kept connecting with sites related to miticondrial disease. The vague descriptions that I have read of some miticondrial diseases do seem to have similarities with PBC. I am considering this as a possible genetic clue to diagnosing a mystery illness with my son since I do have PBC. Am I way off base?

Answer
A recent electron microscopy study reported that mitochondria are more numerous and swollen in PBC patients than controls but I have yet to see the evidence from these studies. It is also possible that the anti-mitochondrial antibodies damage the bile duct cell's mitochondria but there is no formal proof of this. The anti-mitochondrial antibodies are a very specific finding in patients with liver disease and this is why your doctor focused in on PBC.

With regard to carnitine, this is an essential factor that your mitochondria use for energy metabolism. Some patients take carnitine as a dietary supplement with liver disease.

Nancy Bach, M.D.
Specialty Liver Diseases
The Mount Sinai Medical Center
New York, New York 10029
October 1999

Question
Several of our members have made comments about Tylenol being very harmful to the liver. In your opinion, is Tylenol considered dangerous to our livers? Is there an other pain relievers that would be better in your opinion, & what kind?

Answer
While there is no question that excess doses of Tylenol can be deadly, in its recommended dose Tylenol is probably one of the safest medications available. In therapeutic doses, tylenol does not cause liver injury. People who consume alcohol on a daily basis (several drinks/night) have a lower threshold for what is considered therapeutic, so people who are chronic alcohol users should probably avoid Tylenol. This does not apply to most PBC patients (or other non alcoholic liver diseases). I generally recommend limiting Tylenol to <6 regular strength tablets per day (less than 2 grams/day). In terms of safety, for pain management, I prefer Tylenol over drugs such as aspirin or Motrin, Advil, Aleve. Tylenol however is not always the most effective pain medication.

Nancy Bach, M.D.
Specialty Liver Diseases 
The Mount Sinai Medical Center
New York, New York 10029
October 1999

Question
I tend to get nasal and chest congestion that is allergy related. It doesn't happen often, but when it does I take Allegra and Entex, as well as using a Vanceril inhaler. Are these meds safe for PBCers? If not, what is acceptable?

Answer
Allegra (an antihistamine), Entex (a decongestant) and Vanceril are relatively safe drugs for patients with PBC. Drugs similar to Allegra can cause irregularities in the heart rhythms of patients with liver disease. This is because of the way the drug is metabolized or broken down. The medications that you are referring to are unlikely to be a problem in patients with liver disease, however, any medication has the potential to cause toxicity to the liver. You should therefore always discuss medication use with your doctor.

Nancy Bach, M.D.
Specialty Liver Diseases 
The Mount Sinai Medical Center
New York, New York 10029
February 2000

Question
Should aspirin and aspirin-related products be avoided? I usually take Ibuprofen.

Answer
Aspirin, aspirin related products and non-steroidal drugs (including ibuprofen) can be used in PBC, but should be monitored and used judiciously. These medications may cause ulcers, and patients with liver disease are more prone to develop ulcers that are more difficult to treat. These drugs may also interfere with the function of platelets; platelets are important to the clotting process. Lastly, those with advanced liver disease may develop kidney problems and these drugs may have adverse effects on the kidneys.

Nancy Bach, M.D.
Specialty Liver Diseases 
The Mount Sinai Medical Center
New York, New York 10029
February 2000

Question
Since I've been taking prevalite I have been experiencing muscle aches and pains in my back, hips and knees. Could this be a side effect of the drug? I take two packets a day in the morning for the itching. If this is a side effect of the drug, would you advise your patient to stop taking it? Is there something you would prescribe?

Answer
Prevalite (cholestyramine) should not cause the symptoms you describe. However, any drug is capable of causing any side effect in a given individual. Under your doctor's supervision, you might want to discontinue the therapy for a week or so and see if the symptoms resolve. If they do, I would recommend testing the medication again in a few weeks to see if the symptoms are truly due to the Prevalite.

Alfred L. Baker, M.D.
Division of Gastroenterology & Hepatology
Northwestern Memorial Hospital
Chicago, IL
No date given

Question
Are there specific blood tests we should have to determine certain vitamin deficiencies? Can you explain those that PBCers should be concerned with.

Answer
Patients with PBC may develop deficiencies of fat soluble vitamins, vitamins A, D, E and K. Proper absorption of these vitamins depends on adequate quantities of bile salts, secreted by the liver into the intestine, to aid in the digestion and the absorption of the fat components of the diet. In PBC bile salt secretion may be limited leading to decreased absorption of fat soluble vitamins and inadequate circulating levels.

Vitamins A, D and E can be measured in the serum, and if the levels are inadequate supplements can be administered. Vitamin K is not ordinarily measured directly but is rather assayed by measuring the prothrombin time; if this test is abnormal vitamin K levels can be restored by supplementation. Patients should remember that excessive quantities of fat soluble vitamins may be toxic, so supplements should be taken only to bring levels into the normal range.

Alfred L. Baker, M.D.
Division of Gastroenterology & Hepatology
Northwestern Memorial Hospital
Chicago, IL
No date given

Question
I understand that calcium supplements can bind other meds if taken together. Should calcium be taken at mealtime with actigall or should one wait two hours between the two? Is there a difference between calcium carbonate and calcium citrate as far as the timing is concerned?

Answer
Moderate doses of calcium supplements do not interfere sufficiently with the absorption of other nutriuents. Large doses might conceivably inhibit the absorption of some drugs such as Tetracycline. Doses that are ordinarily prescribed range from 1,000 to 2,000 mg per day and do not interfere with absorption. There is no clinical difference between calcium carbonate and calcium citrate in this regard.

Alfred L. Baker, M.D.
Division of Gastroenterology & Hepatology
Northwestern Memorial Hospital
Chicago, IL
No date given

Question
Is it ok to take "Cold Eeeze" Lozenges that contain mostly zinc?

Answer
Zinc containing lozenges, when used in moderation according to package directions, are safe for most patients with primary biliary cirrhosis. Excessive use of these lozenges could conceivably result in a build up of zinc in the blood and prolonged administration say beyond a week or so could have similar effects.

Alfred L. Baker, M.D.
Division of Gastroenterology & Hepatology
Northwestern Memorial Hospital
Chicago, IL
No date given

Question
In regard to loss of vitamin A & D & K and its consequences. Because Vit D is a fat soluble vitamin does that mean it helps break down the fat? What does the lack of these vitamins do? Does food take longer to process because of pbc? Some of us suffer from weight gain and a big belly, could this be one of the culprits?

Answer
Vitamin D is not involved in the absorption of fats, proteins, or carbohydrates which are the foods that contribute to body weight. Vitamin D is not involved in the breakdown of fat in the intestine. It's main function is to promote the absorption of calcium which is necessary for normal bone structure. Vitamin D deficiency can thus contribute to bone softening. Vitamin A helps in normal retinal function, and Vitamin A deficiency can lead to night blindness and other eye disorders. Vitamin K is necessary in the liver's manufacture of some proteins required for normal blood coagulation.

All of these are so-called fat soluble vitamins, and require bile secretion from the liver for proper absorption. As PBC advances, the liver may fail to secrete adequate bile acids, and fat soluble vitamin malabsorption may occur.

A "big belly" would not result from problems with fat soluble vitamins. However, you can ask your physician to measure your fat soluble vitamin levels and to prescribe these substances if needed to prevent the complications I mentioned.

Alfred L. Baker, M.D.
Division of Gastroenterology & Hepatology
Northwestern Memorial Hospital
Chicago, IL
No date given

Question
Do you know which herbs we should stay away from, that will do damage to the liver. What are your thoughts on Milk Thistle?

Answer
I recommend the avoidance of herbs that are manufactured in countries other than the United States and Western Europe because some of these substances contain toxic materials that have resulted in serious adverse effects. Herbs that have known hepatic toxicity include but are not limited to: Germander, and chaparral.

Milk Thistle is widely used by patients with liver disorders. I think it is safe, but little evidence supports its effectiveness. Likewise, there is little evidence to support the use of nutritional supplements in patients with PBC. I do recommend that patients take a multi-vitamin tablet daily, and that fat soluble vitamins be monitored and supplemented as needed. A balanced diet, emphasizing several servings of fresh fruits and vegetables daily, maintenance of normal body weight, and avoidance of excessive saturated fats is a recommendation I make to all of my patients.

Henry C. Bodenheimer, Jr., MD
Chief, Division of Digestive Diseases
Beth Israel Medical Center
First Ave at 16th Street
New York, NY 10003
8/2/2003

Question
What is your opinion of PBCers taking cholesterol lowering drugs, particularly statins? Which, if any, is the safest to take? What about Milk Thistle?

Answer
Statins are particularly effective agents to lower cholesterol. The need for cholesterol lowering agents in PBC is complicated by the fact that the cardiac risk related to cholesterol elevation as a consequence of PBC is not the same as risk from cholesterol elevation in the absence of liver disease. However, some patients with PBC may have independent risk factors for coronary artery disease such as a strong family disease of arteriosclerotic heart disease, diabetes or smoking. Obviously, improvement in diet, avoiding smoking and engaging exercise are the first steps to take. After this weight reduction is often beneficial and medication is used last. A safe although less effective alternative is the use of Welchol, however, if all these steps are ineffective, and risk factors are present I have used statins in patients with PBC. These drugs can be used safely, and since they also have an immune suppressive effect studies are ongoing to look at a potential beneficial effect of statins on the liver disease of patients with PBC. The major concern of statins is they have been associated with elevation of biochemical liver tests.

I recommend that my patients with liver disease who use statins have liver function tests monitored particularly during the first year of treatment. Minor elevations of aminotransferase values (ALT, AST) is not a reason for drug discontinuation but progressive rise is. The development of serious liver injury with statins is quite unusual. Thus, in those patients who are at high risk for development of arteriosclerotic heart disease and who have cholesterol unresponsive to lifestyle modification I would use statins monitoring liver tests periodically.

I am not aware of a significant difference in liver injury among the statins and would treat each of the medications similarly. There is some difference in the immune modulatory activity and some difference in the effectiveness of cholesterol lowering.

Milk Thistle appears to be a safe adjunctive medication although it is of limited value.

END