FDA limits acetaminophen in prescription combination products

The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

This is a great way to improve patient safety, but what about over-the-counter medications? So many patients do not realize that a number of over-the-counter cold medicines contain a large amount of acetaminophen. I think these products should have stronger warnings so that patients are not taking double or triple doses of acetaminophen. Some patients are taking a combo cold medicine for their "cold" symptoms, then they'll take a few Tylenol pills for their "headache," and before you know it, they've consumed a large volume of acetaminophen.

Then again, you can't have a Black Box warning on an over-the-counter medication.

You can read the FDA press release here.

Xifaxan (rifaximin) for hepatic encephalopathy

The FDA has approved Xifaxan (rifaximin) for hepatic encephalopathy. Here's the press release:

FDA Approves New Use of Xifaxan for Patients with Liver Disease

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea.

Asian babies and infant jaundice

You've probably guessed that I'm Korean based on my last name Kim. Well, Asian babies frequently have problems with infant jaundice (or newborn jaundice, neonatal hyperbilirubinemia, etc.). This is nothing new in our family. Our first baby (full term) had jaundice and our new baby (who was also full term) also has jaundice. This is probably nothing serious, but it can be a hassle when you have to go back to the hospital (especially during flu season). So, I'm heading to the hospital to get her bilirubin levels checked today. Hopefully, she won't need a bili light like the baby in this picture.

Hepatitis C may be spreading due to a former hospital worker

Here's a follow-up to a sad story on CNN where a hospital worker may have infected numerous patients with hepatitis C. She was abusing fentanyl and using the same syringe on patients. Hospital worker may have exposed patients to hepatitis C.

Can't see the video? Visit my MedicineandTechnology.com to view the video.

Hospital worker may have exposed patients to hepatitis C

This is a very sad and disturbing story. A surgical technician has at Rose Medical Center in Denver has admitted to secretly injecting herself in a bathroom and using unclean syringes as replacements for patients. Kristen Diane Parker had hepatitis C, presumably from IV drug use, and she took patient fentanyl injections and replaced them with saline. She worked at Rose from October 2008 to April 2009. So far, nine patients who had surgery there during that time have tested positive for hepatitis C. That is really a shame. Parker should have gotten professional help for her drug addiction. Now, Parker is in federal custody facing three drug-related charges. If she is found to have done serious harm to a patient, she could face up to 20 years in prison. If a patient dies due to her actions, she could face life in prison.

According to CNN, in a statement to police, Parker said, "I can't take back what I did, but I will have to live with it for the rest of my life, and so does everyone else." Rose Medical Center is contacting 4,700 patients who had surgery at Rose during the time Parker was employed there. Another 1,200 patients may have been infected between May 4, 2009, and July 1, 2009, when Parker worked at Audubon Ambulatory Surgical Center in Colorado Springs.

Hepatitis C can be treated, but the treatment regimen isn't easy to take. Advances in antiviral therapies have improved outcomes for hepatitis C and several new and novel agents are in development. Advances in drug development may lead to a quick and easy cure for hepatitis C. Wouldn't that be nice? I know many people who are infected with hepatitis C due to blood transfusions. We (as the medical community) didn't know how to identify hepatitis C before 1992. It was called non-A, non-B viral hepatitis. We now call it hepatitis C. Chronic infection can lead to cirrhosis and liver failure. It can even lead to liver cancer. To read the CNN story, click here.

Government panel may pull drugs containing acetaminophen

A government panel assembled by the FDA may make some recommendations to pull some very common medications off the shelf. Acetaminophen (common brand name Tylenol) is a very safe drug that is mainly used to treat pain and fevers. However, an overdose of Tylenol can also be lethal because it can destroy the liver. We can live without our spleen, but we can't live without our liver, so that's why a Tylenol overdose can be fatal. Some people die as they wait for a liver transplant.

According to CNN (quoting the FDA), "overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s." Of course, we also know that millions of people safely use Tylenol without any problems. The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness. This includes common drugs like: NyQuil, Pamprin and Allerest. Does this just mean that consumers will learn how to use over-the-counter drugs for off-label purposes? The FDA doesn't have to follow the advisory panel recommendation, so when this is all over, it may all be meaningless.

CNN also reports that the Consumer Healthcare Products Association (CHPA) strongly opposes the elimination of OTC (over-the-counter) acetaminophen containing combination products. Interesting? Click here to read the CNN story.

Percutaneous Hepatic Perfusion

People often get confused when they talk about liver cancer. So many primary cancer spread to the liver and patients often think that they have "liver cancer." It's important to differentiate between primary hepatocellular carcinoma (HCC) and liver metastases (when other tumors spread to the liver). CNN has an interesting story that talks about the latter and appropriately titles the story, "Cancer spread to liver responds to experimental treatment." The title doesn't mislead one to think that we're talking about primary liver cancer. The experimental procedure is called percutaneous hepatic perfusion, or PHP. It targets tumors with a dose of chemotherapy that is up to 10 times stronger than patients could otherwise tolerate. Consider it a form of locally delivered chemotherapy. Seems like "targeted therapy" may need to be redefined when we're out of the molecular world. Another form of local therapy is called tumor ablation or embolization. I won't get into that right now. To read the CNN story on percutaneous hepatic perfusion, click here.