Booster Shots

Oddities, musings and news from the health world

Category: prescriptions

Advice from American Heart Assn. for diabetics taking Avandia

June 29, 2010 | 10:43 am

Avandia heart attack risks stroke rosiglitazone If diabetics who take Avandia aren't confused by now, well, they haven't been keeping up with medical news.

On Monday, three studies were released about the side effects linked to Avandia (also known by its generic name, rosiglitazone), two of which found a worrisome rate of side effects and one that found no new safety concerns. The fate of the drug, which was approved in 1999, will be at stake in July when a Food and Drug Administration advisory committee meets to review the evidence on Avandia's safety. The drug is known to increase the risk of heart failure and bone fractures. But newer data suggest it also raises the risk of heart attacks, strokes and death.

The American Heart Assn. weighed in Tuesday with some advice for people taking Avandia.

" ...the reports deserves serious consideration, and patients with diabetes who are 65 years of age or older and being treated with rosiglitazone should discuss the findings with their prescribing physician. . .

"For patients with diabetes, the most serious consequences are heart disease and stroke, and the risk of suffering from them is significantly increased when diabetes is present. As in most situations, patients should not change or stop medications without consulting their healthcare provider."

The statement goes on to list the association's recommendations, including that the drug metformin should generally be considered the first choice for glucose-lowering drugs. There's also advice on what to do if you're already on Avandia.

-- Shari Roan

Photo: Justin Sullivan / Getty Images


Antidepressants during pregnancy increase risk of sponaneous abortion, study finds

May 31, 2010 | 10:58 am

Taking antidepressants during pregnancy increases the risk of spontaneous abortions by about two-thirds, Canadian researchers reported Monday. The increased risk was greatest with the family of drugs known as selective serotonin reuptake inhibitors (SSRIs), especially paroxetine and venlafaxine, and when more than one family of drugs were used.

Depression in women is most common during the child-bearing years, and estimates suggest that as many as 15% of pregnant women suffer from it. Because of fears about the effects of drugs, particularly psychiatric drugs, during pregnancy, only about 3.7% of women use them during the first trimester. Most studies looking at the use of antidepressants during pregnancy have focused on their effects on the fetus. Small studies of their effects on abortion have produced inconsistent results. Expecting mothers cannot routinely stop using the drugs, however, because that also presents risks to both the mother and the fetus.

Producing a controlled clinical trial examining the effects of the drugs is virtually impossible because few women would be willing to participate, experts said. The only way to get at the data is to examine it retrospectively.

In the new study, Dr. Anick Berard, director of the University of Montreal's Research Unit on Medications and Pregnancy at University Hospital Center Sainte-Justine used information from the Quebec Pregnancy Registry to identify 5,124 women who had a spontaneous abortions between 1998 and 2003 -- before warnings about the risks of the drugs became more common -- and compared them with about 10 times that many carefully matched women who did not have abortions. A separate database provided information about prescriptions the women had filled.

The researchers reported in the Canadian Medical Assn. Journal that 5.5% of the women who had spontaneous abortions had taken antidepressants, compared with 2.7% of those who did not have a spontaneous abortion. Controlling for other factors, that amounted to a 68% increase in risk. The biggest effects were found with paroxetine (brand names Paxil and Seroxat) and venlafaxine (Effexor) or when combinations of drugs from different families were used.

In a commentary in the same journal, Adrienne Einarson, a registered nurse who is assistant director of the Motherisk Program at the Hospital for Sick Children in Toronto, noted that the study had many deficiencies: many spontaneous abortions are not reported to doctors, the researchers did not know if the women actually took the drugs and they did not monitor the extent of the depression. Nonetheless, the increased risk in the study was about the same as that found by Motherisk (a teratology information service) in an earlier study, she said.

The bottom line, it appears, is that the drugs do slightly increase the risk of a spontaneous abortion, but there are so many other factors leading to abortions that the overall risk is probably relatively small.

-- Thomas H. Maugh II


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


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


New treatment kills head lice ... and keeps them dead

February 26, 2010 |  2:15 pm

Mayonnaise, olive oil and petroleum jelly are popular home remedies for suffocating head lice and, at first blush, they appear to work. Unfortunately, lice have external structures called spiracles that protect the entry points to their breathing apparatus. Closing the spiracles protects the lice from the suffocating effects of the home remedies and, when the agent is removed, the lice often appear to have a miraculous resurrection.  A newly approved over-the-counter drug called Ulesfia seems to get around this problem by shocking the spiracles open, according to a report in the journal Pediatric Dermatology.

Of course, over-the-counter products containing the neurotoxin permethrin and prescription drugs containing malathion and lindane are also available. Because these contain neurotoxins, however, they can be used only every 10 days or so and are not appropriate for very young children. Reinfestation often occurs much quicker and the lice, furthermore, appear to be developing resistance to the pesticides.

Ulesfia, manufactured by Shionogi Pharma Inc. of Atlanta, is based on a lotion that suffocates the lice, but it also contains a 5% concentration of benzyl alcohol that shocks the spiracles open. Phase 2 and phase 3 clinical trials conducted for Shionogi by  the drug-testing company Global Health Associates of Miami compared use of Ulesfia to use of the lotion only in 250 children with head lice. A caregiver applied the lotions to the hair for 10 minutes at the beginning of the study and a week later. Company president Terri L. Meinking and her associates reported in Pediatric Dermatology that 91.2% of those using Ulesfia had no lice on Day 8 and 75.6% had none on Day 14. Among those using only the lotion, 27.9% had no lice at Day 8 and 15.5% had none on Day 14.  Irritation of the application site was the most commonly reported side effect, affecting 2.3% of users. 

"Because benzyl alcohol lotion kills by suffocation, resistance should not be an issue," Meinking said in a statement.

-- Thomas H. Maugh II


Reconsidering antiepileptic medications as a treatment for bipolar disorder

December 7, 2009 |  1:28 pm

A study coming out in tomorrow’s edition of Archives of General Psychiatry may prompt doctors and patients to reconsider the merits of using antiepileptic drugs to treat people with bipolar disorder.

Neurontin Just last year, the U.S. Food and Drug Administration issued an alert that antiepileptic drugs -- such as Neurontin (generic name gabapentin), Lyrica (pregabalin), Topamax (topiramate) and Tegretol (carbamazepine) -- increased the risk of suicidal thoughts and behaviors. That’s particularly important for patients with bipolar disorder, because they already have a higher risk of suicide compared to healthy people.

But the new analysis finds that bipolar people who took one of 11 antiepileptic medications had the same rate of suicide attempts -- 13 per 1,000 patients per year -- as those who didn’t take any drugs for their condition. That rate was slightly lower than for bipolar people who took lithium (18 suicide attempts per 1,000 patients per year). It was also much lower than the rate of suicide attempts among bipolar people in the year before they began taking antiepileptic medications (72 per 1,000 patients per year).

The findings are based on records of 47,918 patients with bipolar disorder who were included in the PharMetrics medical claims database. The study was conducted by researchers from the Center for Health Statistics at the University of Illinois at Chicago and the Columbia University College of Physicians and Surgeons in New York. Two of the researchers have produced expert testimony for Pfizer Pharmaceuticals in litigation involving Neurontin. Pfizer purchased the dataset from PharMetrics for $15,000 but was not involved in the research and didn’t influence or review the results, according to the researchers.

The work was funded by grants from the National Institute of Mental Health and the Agency for Healthcare Research and Quality.

You can read the FDA’s 2008 statistical review of antiepileptic drugs and suicidal ideation and behavior here. The most up-to-date info from the agency is online here.

-- Karen Kaplan

Photo: Perhaps this drug is safer, and more useful, than thought. Credit: Pfizer Inc.


U.S. cholesterol levels going down

November 17, 2009 |  1:00 pm

Statins The development of statins, a class of drugs that lower bad cholesterol, have made a big effect. A study published today found that the prevalence of American adults with high levels of LDL cholesterol (that's the bad kind) fell by about one-third from 1999 to 2006. Paradoxically, the study also found that a huge number of people still have excessively high levels of bad cholesterol, are not being treated for it or may even be unaware of their levels.
 
The study, published in the Journal of the American Medical Assn., examined LDL cholesterol levels among more than 7,000 men and women across four study cycles: 1999-2000, 2001-2002, 2003-2004 and 2005-2006. Rates of high LDL cholesterol decreased from 31.5% in 1999-2000 to 21.2% in 2005-2006.
 
Yet researchers from the federal government found that many people had elevated rates of bad cholesterol, particularly those at the highest risk for developing heart disease. Fewer than 70% of adults nationwide were screened for cholesterol levels in the 2005-2006 period. During that time period of the study, 64.5% of people received cholesterol screening, 39.6% were screened but were untreated or inadequately treated and 24.9% were not told the results of screening.
 
In two commentaries accompanying the study, experts noted that cholesterol screening guidelines have become too complex and should be simplified so that more people receive statins. Dr. J. Michael Gaziano and Dr. Thomas A. Gaziano noted in one editorial that the last set of cholesterol guidelines, published in 2002, was 280 pages long. The guidelines are not only complicated, they are far from perfect, sometimes leading doctors to prescribe statins to someone with elevated LDL cholesterol but who has an overall low risk of heart disease and not prescribing drugs to someone with normal LDL cholesterol but who has an overall high risk of developing heart disease.
 
Another approach to treating cholesterol, said the authors of the other commentary, is to prescribe generic statins to all adults based on age. This approach may be justified, they said, in light of the large number of people who could benefit from statins but are not getting the medication; because statins have been shown to be safe and because generic versions of the medications are inexpensive. 

However, that approach may overly simplistic, said Michael Gaziano and Thomas Gaziano. Arbitrary, fixed LDL thresholds for prescribing statins should be abandoned, they said.

"The guideline should begin with simple risk assessment with the goal of classifying patients into only two strata: those for whom lipid-lowering therapy should be considered and those for whom it is not warranted," they wrote. "The use of a simplified risk-based approach could increase the ease of implementation of treatment and increase the number of patients receiving beneficial lipid-lowering therapy."
 
-- Shari Roan
 
Photo credit: Bob Chamberlin / Los Angeles Times


Most antibiotics appear safe during pregnancy, study finds

November 2, 2009 |  2:38 pm

Expecting Doctors assume antibiotics to be fairly safe during pregnancy -- and their use is quite common -- but data comparing classes of drugs are scant. Researchers at the Centers for Disease Control and Prevention decided to clarify the safety and the risks.

Using the National Birth Defects Prevention Study, they analyzed data on more than 13,000 women whose babies had birth defects, comparing their antibiotic use before and during pregnancy to that of almost 5,000 women whose babies didn't have birth defects.

Penicillins, erythromycins and cephalosporins didn't raise any red flags. Two cases of birth defects were associated with erythromycins; and penicillins and cephalosporins were associated with one case each.

The researchers wrote: "Determining the causes of birth defects is problematic. A single defect can have multiple causes, or multiple seemingly unrelated defects may have a common cause. This study could not determine the safety of drugs during pregnancy, but the lack of widespread increased risk associated with many classes of antibacterials used during pregnancy should be reassuring."

But sulfonamides, among the older antibiotics, and nitrofurantoins, often used to treat urinary tract infections, gave the researchers pause. These drugs were associated with "several" defects, they said.

The new research appears in the Archives of Pediatrics & Adolescent Medicine. Here's the abstract -- and more on pregnancy and birth defects from the CDC.

The data don't indicate cause and effect, but rather -- the researchers stress -- a reason for further inquiry.

They point out that participants might not have recalled exactly when they took the drugs or even the correct name of those drugs. Further, the authors wrote: "Another limitation is that it is not possible to determine whether the birth defect is associated with the antibacterials used or the underlying infection."

As they say, more inquiry is needed.  

-- Tami Dennis

Credit: Los Angeles Times


Do your part for antibiotic resistance -- don't bother with a prescription

September 17, 2009 | 10:57 am

Staph Without prescription-drug websites, our ability to contribute to antibiotic resistance might be more limited by now.

In a new study, researchers at the University of South Carolina noted that doctors are trying to do a better job of prescribing antibiotics only when warranted. (Sniffles or a cough rarely qualify.) But they wondered about folks who diagnose and treat themselves. So a few Google and Yahoo searches later, they found what could be a significant contributor to the development of more deadly germs.

In short, they learned, antibiotics are darned easy to get online.

Among 138 sites selling the drugs without a prescription, 36% didn't even go through the formalities of requiring some sort of official diagnosis; 64% offered prescriptions based on those less-than-stringent health questionnaires.

Good, old-fashioned penicillin? Not a problem. It was available on 94% of websites, they reported; macrolides could be found on 96%. Fluoroquinolones and cephalosporins could be had on almost 62% and 56% of the sites, respectively.

The researchers wrote in their conclusions:

"This reservoir of antibiotics is likely to be used inappropriately—the Web sites promote self-diagnosis and self-medication, and antibiotics are likely to be used in inappropriate dosages. Furthermore, the quantities available and the interval between ordering and receiving the medication suggest that these transactions will likely be used by individuals storing the drugs for future self-diagnosis and treatment or for sale."

This doesn't bode well.

(Antiviral resistance could become a problem as well, as staff writer Shari Roan recently noted in her story on the drugs used to fight the new pandemic H1N1 virus.)

The new study is published in the current issue of Annals of Family Medicine.

-- Tami Dennis

Photo: Some strains of the bacterium Staphylococcus aureus are becoming resistant to antibiotics, leading to hard-to-treat infections.

Credit: Visuals Unlimited



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