Booster Shots

Oddities, musings and news from the health world

Category: drugs

Stupid human tricks: The FDA says don't swallow topical Benadryl

May 12, 2010 |  9:49 am

It's the latest edition of Stupid Human Tricks. The Food and Drug Administration on Wednesday warned consumers about swallowing Benadryl Extra Strength Itch Stopping Gel, a product meant to be applied to the skin. The agency said it had received several reports of adverse effects from people who had mistakenly swallowed the gel. The problem is the topical form of the drug contains the active ingredient diphenhydramine in an amount that is dangerous if swallowed. Adverse effects include confusion, hallucinations and unconsciousness.

The agency also warned that many stores carry their own brand of the product that consumers can also confuse with Benadryl tablets or caplets.

Because of the danger, the drug's manufacturer, Johnson and Johnson, has changed the product label to add a new, prominent statement, "For skin use only."  A sticker on the cap now says the same thing.

The company is also initiating studies to determine why consumers may mistakenly swallow the drug. Apparently, they are not satisfied with the simple answer: stupidity.

-- Thomas H. Maugh II


Should you be reconsidering those heartburn drugs, consider this

May 11, 2010 |  1:12 pm

SalsaMany Americans combat heartburn with drugs. And why not? The drugs are effective, and they don't require much of the heartburn sufferer except a glass of something with which to wash them down. But a new report raises questions about whether immediately resorting to acid-reducing medications such as Prilosec, Nexium and Protonix is the best policy.

As noted in Tuesday's article, Drugs that reduce stomach acid also increase risk of bone fractures, studies show, medications known as proton-pump inhibitors boost the risk of breaks and of contracting the bacterium Clostridium difficile.

The article states:

The family of drugs, which also includes Losec, Zegerid, Prevacid and omeprazole, is widely used to treat conditions in which excess stomach acid causes pain and bleeding, including ulcers, and gastroesophageal reflux disease, in which stomach acid is regurgitated into the esophagus. But the drugs are also widely used to treat simple heartburn, and that is the condition for which they are most widely overused, experts said.

Sigh. The risks are small, but yet again, it appears we might be better off taking charge of our own diet and lifestyle rather than popping a pill at the first twinge. A pity perhaps, but ...

To that end, here's a comprehensive overview from Medline Plus on gastroesophageal reflux disease. Though the condition often does require drugs, some of the same measures that can keep GERD manageable will also thwart heartburn. (There's even a tutorial. Fun, yes?)

For starters, lose weight. If you smoke, stop. Eat smaller meals. Avoid tight clothing. Don't sleep -- or exercise -- immediately after eating.

If that sounds doable -- or even if it doesn't, but small steps are not out of the question -- WebMD offers a wealth of practical advice on coping with heartburn and GERD. Among the offerings: a list of foods that should probably be avoided, a heartburn log to help identify other food triggers, heartburn diet recipes, even ways to barbecue that won't be a prescription for pain.

Here's some additional food-and-GERD advice from HealthCentral, including meal ideas, party guidance and food label tips.

Drug-less control of heartburn may be possible -- if not always pleasant. (That avoid-chocolate-and-spicy-foods advice, for instance.) 

-- Tami Dennis

Photo: Just don't.

Credit: Los Angeles Times


Obesity might be a factor in how kids metabolize drugs

April 27, 2010 |  6:04 pm

Obesity could affect how children metabolize medication, according to a study presented this week.

Hq0328kf Researchers from the University of Minnesota College of Pharmacy tested 16 healthy-weight children and nine obese children ages 6 to 10 to see how they metabolized caffeine and dextromethorphan, the latter a cough suppressant found in over the counter medicines such as Robitussin DM. After analyzing the children's urine and saliva, they discovered that the obese kids did metabolize both substances differently.

Study co-author L'Aurelle Johnson explained the relevance of the findings in a news release: "We have known for years that drugs metabolize differently in obese adults as compared to healthy weight adults," said Johnson. "But, there has been very little, if any, information available that specifically addresses the consequences of obesity on drug metabolism in children. Without this information, our ability to identify optimal drug dosing in children often relies on trial and error approaches." More work needs to be done, she said, to see what effect obesity could have on the absorption, metabolism and elimination of other drugs in children.

She added, "Collectively, such knowledge concerning key factors that impact activity of drug metabolizing enzymes in children will have a significant positive impact on the development of optimal drug dosing regiments in children in order to maximize efficacy, while minimizing potential adverse drug effects, in the treatment of serious diseases such as cancer."

The study was presented at the American Society for Pharmacology and Experimental Therapeutics annual meeting, part of the Experimental Biology conference in Anaheim.

-- Jeannine Stein

Photo credit: Gregorio Borgia / AP


Nurses administering medications can't pardon the interruption

April 26, 2010 |  1:00 pm

Nurses are busy, busy people. If you're a patient, you can help the nurse do his or her job by keeping mum when they are conducting important tasks. A study published Monday found that nurses make more medication errors when they are interrupted during the task.

Nurse1 Interruptions are known to increase on-the-job mistakes. But the researchers, from Australia, sought to understand the impact of interruptions on nurses. They observed 98 hospital-based nurses over 505 hours. The nurses administered a total of 4,271 medications during those hours. Only 19.8% of these administrations were free of two kinds of errors: procedural mistakes, such as failure to read labels or check patient identification; and clinical errors, such as administering the wrong drug, dose or formulation.

However, interruptions occurred in 53% of all administrations. When nurses were not interrupted, procedural failure rates were 69.6% and clinical error rates were 25.3%. When they were interrupted three times, the rates went up to 84.6% for procedural errors and 38.9% for clinical errors. The errors became more severe the more times the nurse was interrupted during the task.

Some interruptions, such as tending to a monitor alarm, are necessary. But the study found that only 11% of the interruptions were positive. "While it is clear that some interruptions are central to providing safe care, there is a need to better understand the reasons for such high interruption rates," the authors wrote.

"The frequency of interruptions during medication administration suggests a lack of understanding of the importance of this process and of the deleterious effects of interruptions on patient safety," Julie Kliger, of the Integrated Nurse Leadership Program at UC San Francisco, wrote in an editorial accompanying the study. "Perhaps more significantly, it alerts us to a widespread lack of respect for the medication administration process."

The study was released Monday in the Archives of Internal Medicine.

-- Shari Roan

Photo credit: Irfan Khan / Los Angeles Times


Don't just flush those leftover meds

April 22, 2010 |  3:48 pm

Lottapills Unused medications create a dilemma -- what to do with the things? They obviously shouldn't be left lying around accessible to bored teenagers or curious kids. Nor should they be flushed; medication traces are already showing up in the water supply. But just dumped in the trash...? Maybe they should be taken back to a pharmacy.

The National Community Pharmacists Assn., which represents independent community pharmacists, and Sharps Compliance, a medical waste management company, is offering a disposal method that may provide more peace of mind than the traditional "toss 'em in the rubbish bin and hope for the best" approach.

Go to www.disposemymeds.org for a list of pharmacies that will dispose of those meds for you. There are 800 participating pharmacies in 40 states, but it's a big country. Even in the L.A. area, you might have to search beyond a 5-mile radius to find one.

For people who can't find a pharmacy or would have to travel too far, the site offers a link to the Office of National Drug Control Policy's guidelines on medication disposal.

That, in a way, seems to bring consumers back to where many started -- at a bit of a loss. Among the tips are to take unused drugs to a collection program, of which there seem to be precious few. (Kudos, guys, for this one.)

But the guidelines do include useful advice as well -- such as, if you must trash the pills, mix them with kitty litter first. 

-- Tami Dennis

Photo credit: Los Angeles Times


Some anticonvulsant drugs increase suicide risk

April 13, 2010 |  1:00 pm

Two years ago, the U.S. Food and Drug Administration published information showing that people taking anticonvulsant medications, drugs used to treat epilepsy, have twice the risk of suicidal behavior and suicidal thoughts. A study published Tuesday in the Journal of the American Medical Assn. confirms that finding and identifies a handful of medications that appear to carry the most risk.

Researchers led by a team from Brigham and Women's Hospital in Boston, analyzed data from almost 300,000 people who had begun taking an anticonvulsant. They recorded reports of suicide, attempted suicide or violent deaths in the first 60 days of use. The patients were ages 15 or older. The study found an increased risk of suicidal acts and violent deaths for the drugs gabapentin, lamotrigine, oxcarbazepine, tiagabine and valproate when compared with a standard anticonvulsant, topiramate. For example, there were 5.6 cases of attempted or completed suicide per 1,000 person-years among gabapentin users, 10 cases per 1,000 person-years among oxcarbazepine users and 14.1 cases per 1,000 person-year among tiagabine users compared with topiramate users. The increased risk began about 14 days after the start of treatment.

No one knows why certain anticonvulsants increase the risk of suicidal behavior, however, they are known to produce mood and behavior changes. The FDA requires anticonvulsant drug products to carry a label with information about the suicide risk. Perhaps a stronger warning, such as black box warning on the medication, is warranted. Certain anticonvulsants such as gabapentin have soared in popularity in recent years, often used off-label for psychiatric disorders and various pain conditions. The drugs may be effective to treat disorders other than epilepsy, but they are not without risk.

-- Shari Roan


High blood pressure treatment just got cheaper

April 8, 2010 | 10:43 am

For many of the one-in-three American adults who have high blood pressure, a cheaper alternative to brand-name medications is about to come available.

Losartin, the angiotensin II receptor blocker marketed under the brand names Cozaar and Hyzaar (the latter of which combines losartin with the diuretic hydrochlorothiazide) for more than a decade, will become available in generic formulations, following an FDA decision announced this week.

Four drug makers have won the FDA's blessing to make and market the hypertension drugs in generic forms. Wasting no time, the first firm to receive broad FDA approval to market the generic drug, Teva, announced Thursday the launch of its losartin potassium-film-coated tablets in 25-milligram, 50-milligram and 100-milligram strengths.

If you're a patient being treated with other brand-name angiotension receptor blockers for hypertension --Atacand, Avapro and Diovan -- you may have to wait for less expensive drugs. Atacand won't be available in generic form before 2011 at the earliest, and Avapro and Diovan are not expected to reach the market in generic form before 2012.

The FDA's Office of Generic Drugs states flatly that generic drugs are the same as the brand-name first-to-market drugs they copy -- same active ingredient, same means of action, same safety and effectiveness profile -- they're just way, way cheaper. But the formulations in which those active ingredients are packaged do change when they are reproduced as generics. For a very small number of people and with a few types of drugs, pharmacologists acknowledge that that can make a difference in how -- or even how well -- a drug works (you can read more about this here).

So, if the size, shape, color or brand marking of your regular prescription blood pressure medication changes in the next few months (and if it suddenly becomes less expensive), rejoice over your lower bill. But also, be sure to ask the pharmacist if you have been switched to a generic version of the drug your physician originally prescribed. And for a couple of weeks after switching to a generic, check your blood pressure a bit more regularly to make sure your hypertension is still under control with the medication.

One more warning: There are five other classes of medications used to treat high blood pressure, and all do so by different means than the angiotension II receptor blockers. Insurance companies and pharmacy benefits managers are aggressive in trying to switch patients to a new generic drug if it can save money, even if it means switching a patient to a new class of drugs. The practice is called therapeutic substitution. Sometimes, it can often save you money while managing your condition just fine. But for some individuals, another class of medication won't work as well or may not be recommended.

Again, ask your pharmacist if you don't recognize the medication you're getting, and check with your physician if the switch is something you haven't discussed.  

You might never guess you have high blood pressure, because it's a medical problem with few discernible symptoms. But it seriously increases your risk of stroke and a range of other cardiovascular diseases. You should check out this series of L.A. Times Health articles for everything you need to know about blood pressure.

-- Melissa Healy


Highly touted heart drug Multaq not as good as generics, cardiologists say [Updated]

April 5, 2010 |  3:39 pm

Dronedarone, a highly touted drug targeted at atrial fibrillation and sold under the brand name Multaq, is only half as effective as the generic drug amiodarone and does not appear to have fewer side effects, researchers from the Cedars-Sinai Medical Center reported Monday. It should be used only as a second- or third-line drug if all others fail, the team reported in the Journal of the American College of Cardiology. The report, which is based on an examination of existing clinical trials rather than new research, represents further bad news for what was once thought to be a potential blockbuster drug with billions of dollars of annual sales.

[Updated: 5:15. The post wrongly said that the report appeared in the American Journal of Cardiology.]

"Atrial fibrillation is a huge public health issue," said Dr. Sanjay Kaul of Cedars-Sinai, lead author of the new report. Kaul is a member of the Food and Drug Administration's advisory panel that considers cardiovascular drugs, and he writes occasional review articles about drugs that are considered by the panel when he believes that not all the information considered in the advisory meetings makes it out to the general public through conventional publication. Dronedarone is an important medication to have all the facts, he said, because atrial fibrillation affects an estimated 2.3 million Americans, accounting for 71,000 deaths each year.

Atrial fibrillation refers to the rapid, abnormal beating or fluttering of the heart when electrical signals in the atrium become erratic. During fibrillation, the heart cannot pump blood effectively, allowing it to pool in the heart and potentially form clots that can embolize and cause strokes. Mild fibrillation may be symptomless, but the problem can cause fatigue and dizziness and, in the longer term, congestive heart failure.

The two most common approaches to medical therapy are called rate control and rhythm control. Rate control is aimed at the fact that the heart is attempting to beat too rapidly, so that each contraction is ineffective. Drugs such as beta-blockers and digoxin are used to slow down the heart, so that more blood can be forced through the body. Blood thinners such as warfarin are also used to inhibit clotting. Rhythm control uses drugs, primarily amiodarone, to alter the electrical output of the heart, regularizing the heartbeat. Clinical trials comparing the two approaches have yielded contradictory results, and there is little consensus about which approach is better.

Other approaches that may be used when medical therapy is not effective include the use of implanted defibrillators to shock the heart back into normal sinus rhythm and catheter ablation, in which physicians use a technique similar to angiography to destroy heart tissue responsible for the abnormal electrical activity.

Amiodarone, which is sold generically and under the brand name Cordarone, is an effective medication for controlling fibrillation. But it has severe potential side effects, including damage to the thyroid and lungs. Dronedarone was developed by Sanofi-Aventis as an alternative to amiodarone. It has a similar structure, but animal tests suggested it had fewer complications. The first clinical trial of the drug, in patients at moderate- to high-risk for hospitalizations and death from atrial fibrillation, showed that it doubled the rate of death, and the study was terminated prematurely. The FDA rejected the marketing application and suggested the company find applications where the benefit would exceed the risk.

A second major trial in patients with low to moderate risk found that the drug reduced hospitalizations resulting from atrial fibrillation, but not deaths. The FDA approved the drug, but allowed it to be marketed only for reducing hospitalizations.

European regulatory authorities demanded a head-to-head study of amiodarone and dronedarone. That study, which has yet to be published, found that dronedarone was only half as effective as amiodarone in preventing hospitalizations and deaths, but that it was slightly better tolerated -- although the difference was not statistically significant.

"The overall assessment is that dronedarone has only modest efficacy and no clear-cut safety advantage," Kaul said in an interview. Amiodarone, in contrast, has "a huge cost advantage."  Multaq costs about $9 per day, and generic amiodarone costs pennies. "It's cheap, so why would you want to use an expensive, ineffective alternative?"

[Updated, 5:15. The post originally said "inexpensive" and it should have said "expensive."]

Kaul also thinks the side effects of amiodarone are a red herring. They appeared when a 400-milligram dose of the drug was routinely used, "but over the last 10 years, we have been using a 200-milligram dose and don't see the problems. I personally haven't seen any example of lung toxicity in the last 10 years."

The Cedars-Sinai team wrote that dronedarone should be considered when first-line treatments fail or create problems, or when patients are particularly concerned about the potential for side effects. But they argued that it should not routinely be used for first-line therapy. "I personally don't think that is a prudent strategy," Kaul said.

-- Thomas H. Maugh II


In 2009, antipsychotics proved quite popular, not to mention profitable

April 1, 2010 |  5:05 pm

Lipitor Americans are plunking down more money than ever to medicate themselves. In 2009, according to a new report from market research specialist IMS Health, we spent 5.1% more on drugs than we did in 2008 -- for a total of $300.3 billion.

Here's the company's press release, with a quick overview of prescribing trends and what's driving the growth in sales, and an Associated Press story.

To cut to the chase, go straight to the list of the top therapeutic classes of drugs. Sitting pretty in the No. 1 position are antipsychotics, with $14.6 billion in sales. They're followed by proton-pump inhibitors at ($13.6 billion) and lipid regulators ($13.1 billion).

Speaking of lipid regulators (called "cholesterol drugs" by most people), the bestselling single drug was Lipitor, with $7.5 billion in sales. It was followed by Nexium ($6.3 billion) and Plavix ($5.6 billion). Here's the list of the top 15 drugs, in terms of sales.

Want more data? There are also other drug charts -- all offering useful snapshots of today's medical field and, perhaps, society in general.

For a look at the marketing of a newer generation of antipsychotics, there's this L.A. Times article: Atypical antipsychotics: too hard a sell? It begins:

"About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.

Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.

What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder."

For an explanation of the larger trends in our love affair with prescription drugs, there's this backgrounder from the nonprofit Kaiser Family Foundation. Note the related links to information on pricing, overall healthcare  costs, the comparison between U.S. and Canadian prices and more...

-- Tami Dennis

Photo: It's not an antipsychotic, but Lipitor is no slouch in the sales department. It led all drugs in sales.

Photo credit: Associated Press


Many more people not getting their medications, study finds

March 18, 2010 | 10:10 am

It is probably a sign of the bad economy, but more Americans than ever are not getting the prescription drugs they need, according to new data prepared by Wolters Kluwer Pharma Solutions of Bridgewater, N.J., which monitors drug sales in the United States and abroad. Insurance companies are also increasingly refusing to pay for brand-name drugs, further limiting patients' ability to get prescriptions filled, and generic drugs are becoming more popular than ever.

A study released just last month found that about a quarter of prescriptions written by doctors are not filled by patients, particularly for medications for symptomless problems, such as high blood pressure and high cholesterol. Even when prescriptions are taken to the pharmacy, 6.3% of them were abandoned in 2009, a historically high percentage and an increase of about a quarter over the number from 2008, according to Wolters Kluwer. A prescription is considered abandoned if it is submitted to be filled, but not picked up. The abandonment rate for brand-name drugs was 8.6% in 2009, up 23% from the previous year and 68% since 2006.Lipitor

The situation is further aggravated by the refusal of many insurers to pay for certain drugs, especially those that are brand-named. Such denials were actually down 1.4% in 2009, but were still 22.5% higher than in 2006. Combining patient abandonment and payer denials, 14.4% of all new prescriptions went unfilled last year.

Surprisingly, patient co-pays for prescriptions have risen only modestly, from $26 on average in 2006 to $31 in 2009, according to the company.

Generic drugs now account for two-thirds of all new prescriptions, according to Kluwer Wolters. There were 2.6 billion prescriptions for generics filled in 2009, compared with 1.3 billion for brand-name drugs. That represents a 2.7% increase in total prescriptions over the preceding year and an 11.4% increase since 2006.

The top 10 brand-name drugs in 2009 were Lipitor, Nexium, Plavix, Singulair, Synthroid, Lexapro, ProAir HFA, Crestor, Advair Diskus and Diovan. Sales of Lipitor were down 11.7%. The only gainers among the group were Plavix (3.9%), Proair HFA (56%), Crestor (24.5%) and Advair Dikus (0.9%).

-- Thomas H. Maugh II

Photo: Although the number of prescriptions written for Lipitor declined 11.7% in 2009, it remained the most commonly prescribed drug, with more than 59 million scripts written. Credit: Mel Evans / Associated Press



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