Healthsifter by mary desmond pinkowish, since 2003

Which Medication Could You Accidentally Be Overdosing On?

If you guessed acetaminophen, the active ingredient in hundreds of over-the-counter and prescription products, go to the head of the class. Acetaminophen is an effective pain reliever and fever reducer. According to a Wall Street Journal article from last year, nearly 20% of Americans take an acetaminophen-containing drug every week. But taken in excess (or mixed with booze), it can damage the liver. About 450 Americans (a teeny fraction of users) die as a result of acetaminophen toxicity each year, and 60,000 make emergency department visits. The problem is that because acetaminophen is a component of so many brands, it's easy to take too much without realizing it. Maybe you have a sore back so you take a pain reliever. Then you feel a cold coming on, so you take a cold product that also contains acetaminophen. You can see where this is going. A recent study conducted in the London, UK, area showed that only about half of people could say whether particular over-the-counter products contained acetaminophen and what the maximum daily dosage is. Not so good. The FDA recently asked pharmacies to make it easier for consumers to identify acetaminophen by spelling it out on prescription labels instead of using the abbreviation APAP. 

This MedlinePlus article has a list of acetaminophen-containing products.

See what the American Academy of Pediatrics says about using acetaminophen safely in kids. Read more in the Merck Manual.

Antipsychotic Agents Tied to Sudden Cardiac Death: Newer, Older Drugs Pose Similar Risks

Older, or typical, antipsychotic agents like haloperidol (Haldol) or thioridazine (Mellaril) have long been associated with serious side effects like movement disorders and sudden cardiac death (dropping dead). When newer, so-called atypical antipsychotic drugs like clozapine (Clozaril), olanzepine (Zyprexa), quetiapine (Seroquel), and respiridone (Risperdal) came on the market, it seemed that they might be a safer alternative to the older agents. The newer drugs don't cause involuntary movements, but a new study, which included more than 93,000 antipsychotic users and a comparison group of 186,000 people who did not use the drugs, says that the rate of sudden cardiac death is the same with typical and atypical antipsychotic agents.  Overall, these drugs double a person's risk of sudden cardiac death, and the higher the dose, the greater the risk. Young age did not protect against sudden death. Former users of typical or atypical antipsychotic agents, not to worry. The researchers found that rates of sudden cardiac death were the same as in people who never took these drugs.

In an editorial that accompanied publication of this research, two Harvard scientists put the risk in perspective:

How common is sudden cardiac death among adults treated with antipsychotic medications? Some computations can help put this risk in perspective. The incidence rate reported by Ray et al. was 478 events per 166,324 patient-years of use, or 2.9 events per 1000 patient-years. Among patients given higher doses, the rate was 3.3 events per 1000, a level of risk that would be described as between "moderate" and "low," but not "rare." Although this risk might initially appear low, the rate of agranulocytosis among clozapine users has been reported to be 6.8 events per 1000 patient-years, close to twice the rate of sudden cardiac death among users of high-dose antipsychotic medications.

(FYI: Agranulocytosis, failure of the bone marrow to produce infection-fighting white blood cells is another side effect of the antipsychotics.) The authors of the editorial go on to point out that these drugs should probably not be used in people in whom the benefit is sketchy but the risk of death is clear. Very elderly people and kids seem more vulnerable. For others, the benefits clearly outweigh the risk. This study and the editorial were published in The New England Journal of Medicine.

Brain-Enhancing Medications: The New Coffee?

Read Judith Warner's op-ed "Living the Off-Label Life" in the New York Times.  She writes about her changing view of the use of cognition-enhancing medications--like Provigil, Ritalin, and Adderall--by people who don't have a diagnosable medical disorder. Students, academics, and lots of other time-pressured people have been using these drugs for awhile to get an advantage, an edge, making sure the brain is working at absolutely tip-top capacity despite too little sleep and too much work. Is it a bad thing? Maybe not, especially in these times, she says. Her article is a response to an article by Stanford Law Professor Henry Greely and others in a recent issue of the journal Nature, in which they argue against what they see as outmoded ideas about cognitive enhancement. Here is an excerpt from their article:

Today, on university campuses around the world, students are striking deals to buy and sell prescription drugs such as Adderall and Ritalin — not to get high, but to get higher grades, to provide an edge over their fellow students or to increase in some measurable way their capacity for learning. These transactions are crimes in the United States, punishable by prison.

And Warner again from the Times:

But now I do wonder: What if the excessive demands of life today are creating ever-larger categories of people who can’t reach their potential due to handicaps that in an easier time were just quirks? (Absent-minded professor-types were, for generations, typically men who didn’t need to be present — organized and on-time — for their kids.) Is it any fairer to saddle a child with a chronically overwhelmed parent than with one suffering from untreated depression?

And, furthermore, how much can most of us, on a truly meaningful scale, change our lives? At a time of widespread layoffs and job anxiety among those still employed, can anyone but the most fortunate afford to cut their hours to give themselves time to breathe? Can working parents really sacrifice on either side of the wage-earning/life-making equation? It’s disturbing to think that we just have to make do with the world we now live in. But to do otherwise is for most people an impossible luxury.

For some of us, saddled with brains ill-adapted to this era, and taxed with way too many demands and distractions, pharmacological Calvinism may now be a luxury, too.

FDA Drug Safety Information: One-Stop Shopping

Have you ever gone to the FDA web site hoping you'd easily find the drug safety information you're looking for? A mess, right? It's looking better today. The FDA has a new page called the "Postmarket Drug Safety Information for Patients and Providers." It's a compilation of links that takes you approved drug labeling and package inserts, product medication guides (which are often excellent), all current warning letters and medication recalls, and to the MedWatch adverse event reporting system. This is a big improvement for consumers and health care pros alike.

Is the FDA Too Cautious Now?

Provocative article in today's Wall Street Journal: Avery Johnson and Ron Winslow consider whether what some people see as an overreaction the Vioxx debacle has bogged down the drug pipeline. Their summary of the article:

•  What's New: Some drug-industry executives think the FDA has become more conservative about approving new drugs.

•  The Background: Merck's withdrawal of Vioxx in 2004 prompted criticism that the FDA wasn't vigilant enough about safety.

•  What It Means: Some companies are changing their drug-development plans because of the regulatory climate.

An interesting observation concerns TV ads we all see for various prescription drugs. According to one line of reasoning, people like you and me see the ads and assume that because a drug is marketed directly to us on TV, it must be safe. Sort of like the shampoo and cereal that were advertised before and after the drug.  Some people then badger their doctors to prescribe the drug. Even if the doctor has misgivings about it, he or she will often cave under this kind of pressure. Bad. This isn't necessarily what you want your doctor to do because it may not be in your best interest.

Johnson and Winslow also discuss the discrepancy in drug availability between the US and Europe:

"The industry points to the growing discrepancy between drug approvals in the U.S. and Europe as evidence that the FDA has become too cautious. Europe's drug regulator, the European Medicines Agency, has greenlighted a number of drugs recently that haven't received the nod in the U.S... The FDA has delayed approval of Glaxo's cancer vaccine, Cervarix, and Schering-Plough's sugammadex, a drug designed to be used after surgeries to quickly undo the effects of muscle relaxants, and rejected Merck's pain medicine Arcoxia. Cervarix and Arcoxia are on the market in Europe, while sugammadex has been recommended for approval there."

Remember: There are no risk-free magic bullets.

Are Generic Drugs Really Created Equal?

The question of whether all generic drugs are really fully equivalent to their branded counterparts keeps rearing its head. John Grohol covers it today at PsychCentral, taking off from yesterday's Wall Street Journal article on the same topic by Melinda Beck. Quoting here from Grohol's post:

"...a generic can be formulated differently enough to result in a 100% difference in time to obtain therapeutic levels in your blood, and still be considered “equivalent” to the brand name version.

If this is “good enough” for the FDA, then perhaps it’s time to re-examine the bioequivalence guidelines. Because such a difference has been significant enough to generate numerous reports of generic problems, not only in this one generic medication, but in many others as well. The pressure to prescribe a generic over a brand-name is only going to increase as the cost difference is significant."

Beck's article has some pointers about monitoring your response to generic medications, how to report adverse effects, and pointers on identifying tablets that may be "off."

Evil Twins: Sound-Alike Drug Names

AMNews takes on sound-alike drug names and recounts some horror stories, like the doctor who intended to order a high blood pressure drug but actually ended up ordering a sedative with a sound-alike name. The two drugs in question were clonidine and clonazepam, respectively. Big diff. Big. In this particular case, the computer system must have been partly to blame, because it abbreviated both drugs as CLON.

There are supposedly more than 3,100 drug pairs (6,200 individual drugs) with sound-alike names for sale in the United States. Fortunately, these drug mix-ups, which have doubled in incidence over the past three years compared with the previous three-year period, actually cause harm infrequently--about 1.4% of the time. Somebody often catches the mistake, a pharmacist for example. Members of the  Institute for Safe Medication Practices would like doctors to include the reason for the prescription on the order, so that they can make sure it makes sense. Think of the earlier example--if the pharmacist had noted that the doctor ordered a sedative to treat high blood pressure, the mistake would have been detected long before the wrong med got to the patient. The FDA has also heightened its attention to the names of new drugs and reportedly now rejects 30% to 40% of proposed names because they are sound-alikes.

You should check your Rx labels, too. I assume you know what the doctor ordered (you should--write it down if necessary), and check the label before you leave the pharmacy.

Generic Drug Doubts

As someone quoted in this LA Times article says, saying you don't love generic drugs is like saying you don't love your mother. But an increasing clamor from doctors and patients is making people wonder if it's time to take another, closer look at generics to determine if all of them really are equivalent to their branded counterparts. Drugs in question include epilepsy medications, heart drugs, and antidepressants.