Acetaminophen and Liver Injury

Three FDA advisory committees are meeting today to discuss possible ways to try to cut the risk of liver injury from acetaminophen in over-the-counter and prescription products.

You might not know "acetaminophen," because that's the drug's generic name. It's found in many over-the-counter products -- including Tylenol, aspirin-free Anacin, Excedrin, and numerous cold medicines. It's also found in many prescription drugs.

The FDA says acetaminophen is generally considered safe when taken according to the directions on product labels. But taking too much acetaminophen -- even a little too much taken by accident -- can lead to liver injury.

Products containing acetaminophen already note that risk. But today's FDA meeting is happening because some people still take too much acetaminophen.

Today, the three FDA advisory committees will vote on various options, ranging from additional warnings to limiting doses to banning over-the-counter acetaminophen products. The FDA isn't required to follow the advice of its advisory committees.

Makers of acetaminophen products and the Consumer Healthcare Products Association (CHPA), a trade group for the over-the-counter drug industry, have stressed the safety of acetaminophen when used properly and argued for keeping the products on the market, according to media reports.

As the FDA advisory committees weigh their options, here are steps the FDA wants people to take when using acetaminophen to reduce the chance of liver injury:

• Follow dosing directions and never take more than the recommended dose of acetaminophen.
• Do not mix acetaminophen-containing products. For instance, acetaminophen could be in a headache medicine and in a cold medicine; if you take both, you may wind up getting too much acetaminophen.
• Talk to your doctor about acetaminophen if you drink alcohol or have liver disease.
• Be aware that acetaminophen comes in many forms, including drops, syrups, capsules, and pills.
• Check drug labels to see if it contains acetaminophen. If you're taking a nonprescription (over-the-counter) product, check the "Active Ingredients" section of the "Drug Facts" label.
• Know that acetaminophen may be abbreviated as "APAP" on prescription drug labels.
• Don't take acetaminophen for more days than directed.

The FDA notes that acetaminophen can be given to infants, children, and teens, but the FDA reminds parents and caregivers to take these steps, posted on the FDA's web site, for safety's sake:

• Check the active ingredients list on drug labels. Your child should never take more than one medicine containing acetaminophen, whether it's an over-the-counter drug or a prescription drug.
• Read and follow all the directions given by your child's doctor and on product labels.
• Choose the right medicine based on the child's weight and age. Check the "Directions" section of the "Drug Facts" label on over-the-counter products to see if the medicine is right for your child, how much medicine to give, how many hours to wait before giving another dose, and when to stop giving acetaminophen and ask a doctor for help.
• Use measuring tools that come with the medicine. Don't use a spoon that's meant to be used for cooking or eating. If you don't have the measuring tool that came with the medicine, ask your pharmacist for one.
• Keep a record of what doses you gave the child and when.
• Keep all medicines where they can't be seen or reached by children -- a locked box, cabinet, or closet is best.

If you or someone else takes too much acetaminophen, the FDA recommends calling 911 or Poison Control (800-222-1222) right away to find out what to do. Liver injury symptoms may not appear for hours or even days -- and by then, the damage may be severe and could lead to death.

Of course, any medication should be taken as directed. That includes other types of pain relievers besides acetaminophen. For more FDA tips on pain medicines, read A Guide to Safe Use of Pain Medicine.

And tell us, how careful are you when you take acetaminophen? How strictly do you follow the directions on the label -- even when you're, say, hung over or feeling sick?

Michael Jackson Dies from Cardiac Arrest

Michael Jackson, age 50, has died from reported cardiac arrest.

The main cause of cardiac arrest, which means the heart has stopped, is a heart attack.

Although not denying that Jackson died of cardiac arrest, Los Angeles County Coroner spokesman Craig Harvey, after the initial autopsy on Friday, says the cause of death will be deferred until further toxicology tests can be conducted. He anticipates final results in four to six weeks.

Many people confuse cardiac arrest and heart attack. A heart attack is caused when a clogged artery stops blood flow to part of the heart muscle.

Cardiac arrest is different.

While a heart attack is a plumbing problem, cardiac arrest is electrical. The heart is triggered to beat with regular electrical impulses. But if these electrical impulses become erratic — causing an irregular heartbeat called an arrhythmia — the pump may not work.

When you see heroic TV doctors shouting “Clear!” and shocking a flat-lining patient with paddles, they’re dealing with cardiac arrest. They’re trying to electrically jolt the heart back into the correct rhythm.

According to the American Heart Association (AHA), it's estimated that more than 95% of cardiac arrest victims die before reaching the hospital. The treatment is defibrillation, trying to shock the heart back to a normal rhythm.

However, the AHA says that a victim's chances of survival are reduced by 7 to 10 percent with every minute that passes without CPR and defibrillation. Few attempts at resuscitation succeed after 10 minutes.

Farrah Fawcett Dies

Actress Farrah Fawcett died today at age 62, having fought anal cancer since 2006.

People reports that Fawcett died at St. John's Health Center in Santa Monica, Calif., where she was being treated for complications from anal cancer. Her partner, Ryan O'Neal, was among those with her when she died.

Fawcett went public with her struggle against anal cancer in a documentary that aired on NBC in May.

In that documentary, Farrah said, "Cancer is a disease that is mysterious, headstrong, and makes its own rules, and mine to this date is incurable. I know that everyone will die eventually, but I do not want to die of this disease. I want to stay alive."

Feel free to leave your comments, thoughts, and feelings about Fawcett here.

Generic Plan B Pill for Women 17 and Younger

The FDA has approved the first generic version of the emergency contraceptive Plan B (levonorgestrel). It will be available by prescription only for women aged 17 and younger.

Plan B -- the brand-name drug -- is already available without a prescription to women aged 18 and older. In April, a federal judge ordered the FDA to lower the age limit for Plan B to age 17, and the FDA said it would not appeal that ruling, but that Plan B's maker, the drug company Duramed Pharmaceuticals, Inc. -- would need to file an application first.

But the new generic levonorgestrel product requires a prescription, and it's specifically approved only for women aged 17 and younger.

A woman aged 18 and older could get a prescription for the generic product, but that would be an "off-label" use, because the generic product specifies the age range of the patients for whom it's approved.

Why not just make the generic product available without a prescription?

Because Duramed Pharmaceuticals has a patent on Plan B's nonprescription sales until Aug. 24, 2009. The new generic product is made by a different company, Watson Laboratories Inc., and even after Duramed's patent expires, the generic product won't automatically become available without a prescription -- Watson Laboratories would have to seek FDA approval for that. The FDA won't say whether such an application has been filed.

As for brand-name Plan B, it's a nonprescription drug now, and is no longer approved as a prescription drug for women 18 years and older.

Nonprescription drugs are often called "over-the-counter" drugs, but Plan B isn't out on store shelves; it's stocked behind pharmacy counters.

There is no age limit on how young is too young for the new generic, prescription-only levonorgestrel product. But a doctor would have to prescribe it; young women or girls can't get it otherwise.

Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. "It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection," states an FDA news release.

What's Your Molecular Age?

Researchers report the development of a new blood test that they say may show your "molecular age," as opposed to your chronological age.

That test measures levels of a protein called p16. A new study shows that p16 levels rise as people age, that smokers have higher levels of p16 than nonsmokers, and that people who exercise have lower levels of p16.

The test isn't available to the public yet. But if it was, would you want to know your "molecular age"?

Let's say you took the test and found out your molecular age was greater than your chronological age, suggesting that your aging process is on the fast track. Or maybe you'd find out that the opposite is true, that your clock isn't ticking quite as fast as you thought.

What would you do with that information? Would it spur you to make lifestyle changes to try to stave off aging, or would you be looking for reassurance that your healthy habits are paying off?

The U.S. population is getting older. Nearly one in five U.S. residents will be at least 65 years old in 2030, and the number of people age 85 and older is expected to triple between 2008 and 2050, according to the U.S. Census Bureau's predictions.

How are do you feel about aging? Is it something that bugs you, something you accept, or a little bit of both? Or is age just a number to you? If you're doing something that you believe will help you age well, tell us.

Personal Health Care Reform

Health care reform is a hot topic this year, and President Obama outlined his vision for health care reform yesterday in Chicago at the annual meeting of the American Medical Association (AMA).

In his speech to the AMA, Obama made these main points: health care reform is an economic must, people will be able to keep their doctors and current health insurance plans, the government won't tell doctors how to practice, and all Americans must be able to get affordable health insurance.

Acknowledging that reforming health care will be "difficult," Obama said that "there's probably healthy debate within the AMA" about how it should be done.

Obama drew some boos when he said he didn't support caps on malpractice awards, explaining that he felt such caps "can be unfair to people who've been wrongly harmed." But he also said that it would be hard to make certain changes in health care "if doctors feel like they're constantly looking over their shoulders for fear of lawsuits."

The AMA later released a statement responding to Obama's speech.

"The AMA is committed to achieving reform this year so that all American have affordable, high-quality health coverage," AMA President Nancy Nielsen, MD, said in the statement.

Nielsen said the AMA is "very pleased that President Obama has expressed an openness to medical liability reform as part of comprehensive health reform."

She didn't mention his stance on malpractice caps, and the AMA statement didn't endorse or criticize Obama's approach to health care reform.

The AMA noted that Obama got a standing ovation when he told the hall full of doctors that "you did not enter this profession to be bean counters and paper pushers. You entered this profession to be healers -- and that's what our health care system should let you be."

Obama also emphasized preventive care.

"That starts with each of us taking more responsibility for our health and for the health of our children. It means quitting smoking. It means going in for that mammogram or colon cancer screening. It means going for a run or hitting the gym, and raising our children to step away from the video games and spend more time playing outside ... [and] cutting down on junk food," Obama said.

A transcript of Obama's AMA speech is posted on the White House's web site.

What are your hopes and fears for health care reform? Do you think personal lifestyle choices have a place in the debate? If so, how far would you push the "responsibility" issue?

Swine Flu Pandemic: Panic Now, Avoid the Rush?

Obviously, the answer is no.

Believe me, I'm definitely not making light of swine flu. Yes, it's a serious problem. People have died. But keep in mind that about 36,000 people die every year from garden-variety flu. Do you panic each fall when flu season starts?

The fact that swine flu is now officially a pandemic doesn't mean you should do anything differently -- as long as you were already doing the right things.

It also doesn't mean swine flu has become more deadly. A pandemic means that the infection has spread around the world. But we know that swine flu rarely causes serious illness, with about 13,000 cases and 27 deaths in the U.S.

Don't panic. But take action.

Hopefully, when swine flu surfaced a couple of months ago, you started doing all the right things, if you weren't already. If you stopped, I hope the fact that we have an official swine flu pandemic will spark you to start again. And don't stop this time!

Flu prevention -- both for swine flu and garden-variety flu -- should be a lifestyle and not a reaction to an outbreak. Get in the habit of doing what we know helps prevent spread of swine flu and other respiratory infections.

• Wash your hands regularly with soap and water, especially after coughing or sneezing. Or, use an alcohol-based hand cleaner if soap and water are not available.
  
• Avoid close contact -- that is, being within six feet -- with people who have flu-like symptoms.
• Avoid touching your mouth, nose, or eyes. That's not easy to do, so keep those hands clean.
• If you have flu-like symptoms -- fever plus at least cough or sore throat or other flu symptoms -- stay home for seven days after symptoms begin or until you've been symptom-free for 24 hours -- whichever is longer.
• The CDC does not recommend using a face mask or respirator in community or home settings. However, the CDC says that people at increased risk of severe flu illness may consider wearing a N-95 respirator or face mask in crowded settings in communities where swine flu is circulating or when taking care of a person with flu-like illness. It's not known whether face masks actually protect against flu transmission.
• People who have or are suspected of having swine flu should wear a face mask, if available and tolerable, when sharing common spaces with other household members, when outside the home, or when breastfeeding.

Now that there's an official swine flu pandemic, are you going to take extra precautions to avoid getting infected?

Parental Depression a Family Affair

When a parent gets depressed, it can cast a cloud over the whole family, and the whole family should be addressed in treating parental depression.

That's the bottom line from a new report, released today by the National Research Council and the Institute of Medicine.

The report is full of policy and research recommendations. But on a very practical level, the report makes it clear that parental depression affects children -- and that depression can be treated.

The sooner depression treatment starts, the better, notes William Beardslee, MD, of the psychiatry department at Children's Hospital in Boston.

"We really think getting treatment early is important," Beardslee says.

Beardslee says during one of the parental depression studies he worked on, a mother told him that when she was depressed, her after-school routine with her young son nosedived.

When that mother wasn't depressed, she would help her son with homework, play with him, and give him a snack. "She said, 'When I get depressed, all that just goes out the window and I plop him down in front of the TV set," the mother told Beardslee. "Our work with her was around how she could, despite depression, keep in place the structures that really helped this boy."

"The fundamental point," says Beardslee, "is that we need to view parents who are depressed as parents first and help them with that," besides treating their illness.

Another committee member, Mareasa Isaacs, PhD, executive director of the nonprofit National Alliance of Multi-Ethnic Behavioral Health Associations, says she's heard depression myths from parents that hinder them from seeking help.

"We know parents often feel they're going to lose their children," Isaacs says. "There are a lot of stigma-related messages that need to be changed for everyone to feel safe and comfortable in getting treatment."

Warning signs of parental depression are just like the warning signs of depression in people without kids. Symptoms of major depression include:

• Persistent sadness, pessimism
• Feelings of guilt, worthlessness, helplessness, or hopelessness
• Loss of interest or pleasure in usual activities, including sex
• Difficulty concentrating and complaints of poor memory
• Insomnia or oversleeping
• Weight gain or loss
• Fatigue, lack of energy
• Anxiety, agitation, irritability
• Thoughts of suicide or death
• Slow speech; slow movements
• Headache, stomachache, and digestive problems

Symptoms of dysthymia (milder, but long-term depression) are less intense and fewer in number, but long-lasting -- and of course, deserve treatment.

Have you or someone you know faced parental depression? If so, what was the toughest part -- figuring out that it was depression, finding help, or just getting through the day? Or is the depression going untreated?

New Pharma Rules May Backfire

(Orlando) – Doctors seemed a little taller at this year’s annual meeting of the American Society of Clinical Oncology (ASCO), which started Saturday and ended Tuesday.

The reason: The drug company industry's ban on logo-laden pens, mugs and other giveaways to doctors.

In years past, attendees swarmed the enormous exhibits hall, rushing from booth to booth, trick or treating for tchotchkes ranging from personalized ballpoint pens to MP3 players.

Weighed down by overstuffed bags stamped with the logo of one drug company or another, their gaits unsteady as they struggled to balance their new toys, the doctors appeared – well, shorter.

Fast forward to 2009. Under a voluntary code of conduct from PhRMA, the drug-industry trade group, drugmakers are to abstain from noneducational freebies, such as pens or mouse pads. The policy, which went into effect at the beginning of the year, came amid criticism that nominal gifts influence -- or appear to influence -- physicians’ prescribing patterns.

Excuse my cynicism, but I find it hard to believe that my doctor would prescribe me one drug over another simply because he has a promotional keychain.

What did happen is that exhibit areas – not just at ASCO, but at all the major medical meetings – have become ghost towns. Doctors’ conference bags have become lighter. They seem taller.

There is also an unintended consequence of the new regulations, says Len Lichtenfeld, MD, deputy medical director of the American Cancer Society (ACS).

Traffic is down not only at drug companies’ booths, but at those of nonprofits like ACS that aim to stamp out cancer and patient advocacy groups as well. He’s worried the regulations will have a backlash on groups like his.

Meanwhile, through a loophole in the policy, drugmakers continue to fund lavish all-you-can-eat dinners for attendees. (The policy reads: “A [drug] company should not provide meals directly at continuing medical education [CME] events, except that a CME provider at its own discretion may apply the financial support provided by a [drug] company for a CME event to provide meals for all participants.”)

And drugmakers continue to pay doctors huge sums for research and consulting. The list of conflicts-of-interest (COI) – meaning the authors have a financial stake in the company that makes the study drug -- on some clinical trials runs a full page. And just like the fine print on advertisements, the COI list often goes unnoticed.

“They’re worried about me taking a pen and these people are taking in hundreds of thousands of dollars for research,” Lichtenfeld told me at dinner the other night (yes, I paid my own way).

Maybe PhRMA should consider refining the rules – so that doctors and drugmakers can truly stand taller.

Charlene Laino
WebMD Guest Blogger

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Rethinking Pregnancy Weight in Obesity

Pregnancy weight gain may not be necessary for obese women, provided they get solid nutritional advice throughout their pregnancy.

That's according to researchers including Yvonne S. Thornton, MD, MPH, clinical professor of obstetrics and gynecology at New York Medical College in Valhalla, N.Y.

Thornton and colleagues have just published a study about pregnancy weight gain in obese women.

It's a topic Thornton knows personally, not just professionally. Her own struggles with weight inspired the study.

"I've had a lifelong battle of being overweight," Thornton tells WebMD.

Thirty years ago, during her first pregnancy, Thornton says her doctor gave her prenatal nutrition advice. But Thornton, herself a doctor specializing in maternal-fetal medicine, says she set that advice aside.

"I was so happy to get pregnant. I just ate everything," she recalls. "I need protein; let me get some spare ribs and barbeque sauce. I need dairy products; let me get some Haagen-Dazs.' You know? And I gained 67 pounds."

After her son was born, Thornton joined Weight Watchers, and she lost some weight, but she was still overweight when she learned she was pregnant again.

"I said, 'I'll be danged if I'm going to gain another 67 pounds,'" Thornton says. She decided to focus on eating healthfully, and she kept her weight steady during her pregnancy.

"I didn't gain; I didn't lose any weight," Thornton says. "I stayed 200 pounds the entire pregnancy. At the end, just before my daughter was born, I gained a half a pound." She says her daughter, who was born healthy, is now a Stanford University graduate.

"I said to myself, 'It worked for me. Why can't it work for other patients?' And that planted the seed of doing this randomized clinical trial," says Thornton, cautioning that her approach is geared only to women who are obese when they become pregnant.

In Thornton's study, obese women still gained weight while pregnant, but not as much when they followed personalized eating plans and kept food diaries that got reviewed at each prenatal checkup.

But overeating during pregnancy is "ingrained" in society, Thornton says.

"It's the only time in a woman's life when society will give her the license to be looking like Frosty the Snowman," says Thornton. "How many times can we take the opportunity to do that? And so, many women do. But I still profess that it is not the time to overeat."

Still, the new guidelines from the Institute of Medicine (IOM) recommend that obese women gain 11-20 pounds while pregnant.

Where do you stand? Should obese women just focus on eating healthfully, instead of the numbers on the scale? Or does it help to have a specific weight range as a benchmark?