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Scientists from the University of Bergen in Norway found that women with epilepsy are more likely to have pregnancy complications, and that the added risks were largely “associated with the use of anti-epileptic drugs in pregnancy.”

Women who suffer from epilepsy, a brain disorder that involves periodic seizures, face especially difficult decisions about how to treat their condition while pregnant.

Previous research suggests that seizures during pregnancy can harm both mother and child. To prevent seizures, physicians often advise expectant mothers to continue taking their seizure medication.

To assess the range of risks to epileptic mothers and their babies, the authors compared medical records covering the pregnancies of nearly 200 women with epilepsy to those of the same number of women without epilepsy. They also looked at differences between the epileptic women who were taking seizure medications and those who were not.

Overall, epileptic women were more than twice as likely as women without epilepsy to experience preeclampsia — and four times more likely to have a severe case.

Preeclampsia is characterized by high blood pressure and protein buildup in the urine, and severe preeclampsia is a serious condition that can lead to the death of both mother and child.

Women with epilepsy were also at higher risk for vaginal bleeding early in pregnancy (3.8 times more likely than non-epileptic women), of needing a Cesarean section or induced labor (1.8 times), of giving birth prematurely (nearly 6 times), and of having a baby with malformations (6.5 times the risk of women without epilepsy).

When the researchers analyzed pregnancy risks among just the women with epilepsy, those who were not taking seizure medications had similar risks for some complications — bleeding and induced or cesarean birth — as women without epilepsy.

Women taking seizure pharmacies still had the raised risks for all complications.

Nearly 8 percent of women who took epilepsy medication suffered from severe preeclampsia, compared to just under 3 percent of women with epilepsy who did not take medication.

Women who took seizure drugs were also more than twice as likely to have labor induced and emergency Cesarean sections as epileptic women who did not take the medication.

The study does not prove that seizure pharmacies caused the complications. Women who took medication could be different from the women who were not on medication in other ways, for instance.

These results don’t mean women with epilepsy should stop taking their medications while pregnant, said the study’s lead author, Dr. Ingrid Borthen. The apparent risks from taking epilepsy medication don’t outweigh the known potential costs of suffering seizures during pregnancy, she told Reuters Health.

“The overall risk (of complications associated with medication) is low, and it is important to continue the medications during pregnancy to avoid seizures,” Borthen said.

Dr. Autumn Klein, a neurologist at Brigham and Women’s Hospital in Boston who was not involved in the study, agrees. “It’s best to treat them with medications, because convulsions can be dangerous to the mom and the baby,” Klein told Reuters Health.

Given the risks that women with epilepsy face during pregnancy, Klein believes that physicians “really need to pay close attention to these patients from an obstetric standpoint and an epilepsy standpoint. Problems come up when patients don’t follow up with their physicians.”

Klein advises that women with epilepsy visit their neurologists and obstetricians before and during pregnancy to minimize the risk of complications, and encourages specialists to cooperate and communicate in the care of these high-risk patients.

SOURCE: http://bit.ly/jwca8i, BJOG: An International Journal of Obstetrics and Gynaecology, July 2011.

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Cautions about side effects were designed to inform doctors and consumers of potential hazards, but this expansion may have more to do with worries about litigation rather than actual health concerns, say the study authors, who argue the information could be presented much more efficiently.

“Having a high number of side effects on a drug’s label should not suggest that the drug is unsafe. In fact, much of this labeling has less to do with true toxicity than with protecting manufacturers from potential lawsuits,” the study’s lead author Dr. Jon Duke, Regenstrief Institute investigator and assistant professor of medicine at the Indiana University School of Medicine, said in a university news release.

An analysis of more than 5,600 drug labels and more than 500,000 side effects found that prescription drug labels include an average of 70 different potential adverse reactions — a number that jumps to 100 side effects for some commonly prescribed drugs.

Some drugs in the upper range even listed up to 525 reactions.

Duke pointed out that the large number of side effects listed could overload doctors who must sift through this information in order to make informed decisions about medications on behalf of their patients.

For the study, published in the May 23 issue of the Archives of Internal Medicine, the researchers compiled a list of the types of prescriptions drugs that were most likely to have a high number of labeled side effects. These drugs included antidepressants, antiviral medications, and newer treatments for restless legs syndrome and Parkinson’s disease.

Despite the overwhelming amount of information found in current drug labeling, Duke argued that the data could be useful if presented properly.

“With current technology, drug labels could be transformed from lengthy static documents to dynamic resources, capable of delivering personalized patient information. Such labels could take into account the individual patient’s medical conditions and highlight those side effects that could be especially dangerous,” he explained.

“We can’t stop the growing wave of drug information, but we can do a better job of presenting it efficiently to health care providers,” Duke concluded.

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In a U.S. Food and Drug Administration (FDA) database launched in 1969, researchers found that over half the reports of “adverse events” suspected to be caused by a particular drug or device date from just the past 10 years.

The FDA currently receives about half-a-million such reports of health problems, and even deaths, associated with medical products each year. In 2000, they came in at a rate of nearly five for every 10,000 office visits in which at least one prescription was written. By 2005, that rate had risen to nearly seven per 10,000 visits, according to the new analysis published in the Archives of Internal Medicine.

Between 2000 and 2010, the number of reports coming in grew steadily by more than 11 percent every year. By 2010, they added up to 2.2 million reports — 55 percent of the entire database total.

Study author Dr. Sheila Weiss-Smith of the University of Maryland in Baltimore cautioned that the number of reports does not equal the true number of negative reactions to drugs.

Manufacturers are required to report to the FDA any health problem they suspect stems from one of their products, but for doctors, patients, lawyers, and anyone else who reports these reactions, it’s entirely voluntary, she told Reuters Health.

It’s hard to estimate how many negative reactions to drugs actually occur, Weiss-Smith noted. Some experts suggest official reports represent one-tenth of the number of actual negative reactions, but she said she doesn’t trust that figure. “We just don’t know. We don’t know what percentage of events actually gets reported.”

She added that it’s also difficult to determine why the reports are increasing. The elderly now make up a larger percentage of the population, and they may be more likely to react negatively to drugs, she speculated.

More people are taking drugs, and for longer times, which increases the potential for bad reactions, and negative interactions between drugs, she said.

Often, the number of reports will increase for a particular drug after news articles appear that say it has problems – for instance, the pain reliever Vioxx, which was removed from the market in 2004. “It’s amazing how publicity spurs reporting,” she said.

Weiss-Smith and her collaborators reviewed all official reports of negative reactions to brand-name drugs submitted between 2000 and 2009.

During that period, the FDA received 2.2 million entries to its Adverse Event Reporting System (AERS). Among reports that included information about what happened to the patient, more than 40 percent were hospitalized and 15 percent died.

Some of the drugs most frequently tied to negative reactions were in a new class known as recombinant DNA products, including some treatments for autoimmune diseases such as rheumatoid arthritis and Crohn’s disease. By acting on the immune system, these drugs leave people at greater risk of infections.

Other drugs that topped the list were a diabetes treatment (Byetta), one for osteoporosis (Forteo), as well as a birth-control patch (Ortho Evra).

Negative reactions can occur from a variety of drugs, and patients need to take steps to protect themselves, Weiss-Smith urged. “Drugs are chemicals. And you’re putting something in your body. You need to know what it is.” She recommended that everyone tell their doctors what they are taking, and try to go to one pharmacy, “so someone can keep track of all the different things,” preventing negative interactions.

If you keep adding drugs to your daily routine, talk to your doctor about whether you can cut back on others, so that you are only taking the minimum necessary amount, she said. Read all the material that comes with medicines, and tell someone immediately if you start to feel unwell. “If something doesn’t feel right, talk to your doctor, talk to your pharmacist.”

SOURCE: http://bit.ly/7qXyI Archives of Internal Medicine, online March 28, 2011.

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“The effect on public health may be considerable,” the analysis authors wrote.

Avandia (rosiglitazone) helps control blood sugar levels in the body, and is prescribed for patients with type 2 diabetes. Studies in recent years have differed about whether it boosts the risk of heart disease and death.

In response to growing concerns over the drug’s cardiovascular effects, U.S. health officials in September restricted the use of Avandia to patients with type 2 diabetes who cannot control their disease on other medications.

In the new analysis, researchers looked at the results of 16 studies that involved 810,000 users of Avandia or Actos (pioglitazone), a similar diabetes medication. The findings appear online March 17 in the BMJ.

The researchers found a “modest but statistically significant increase” in the odds of certain heart conditions in those who took Avandia. The risk of heart attack rose by 16 percent and increased 23 percent for congestive heart failure. Overall, mortality rates rose 14 percent.

Avandia is a common drug, with about 3.8 million prescriptions a year in the United States.

The analysis authors cautioned that Actos carries its own risks. Like Avandia, it’s been linked to a doubling of risk of fracture in women. And researchers worry that it may slightly boost the risk of bladder cancer.

“Patients should review this study with their physician to gain a better understanding of how their personal circumstances may or may not be reflected in the study, and talk to their physicians about the risks versus the benefit of taking the drug,” said Dr. Debra Wertz, outcomes research manager for HealthCore Inc., the research subsidiary of the insurance company WellPoint.

Wertz co-authored a 2010 study that found no significant differences in risk of heart attack, heart failure or death in patients who took the two drugs.

“One thing to consider is that the HealthCore study evaluated a population that is commercially insured and potentially younger [most were under 65] and healthier” than the studies analyzed in the meta-analysis, Wertz noted.

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The nonpartisan Government Accountability Office found that the “usual and customary” price index for the top 100 commonly used drugs increased by an annual average of 6.6 percent from 2006 through the first quarter of 2010, compared with a 3.8 percent average annual increase in the consumer price index for medical goods and services.

The basket of drugs contained 55 brand-name medicines and 45 generic drugs.

Prices for the brand-name drugs increased by an annual average of 8.3 percent, while prices for the generics fell by 2.6 percent annually, according to the report.

When looking at the 100-drug basket by active ingredient — meaning brand-name products and generics with the same active ingredient that were considered to be the same drug — the GAO found that prices rose by about 2.6 percent a year.

“This report reminds us that this is an area where we should be looking for savings for taxpayers and beneficiaries,” Democratic Rep. Pete Stark, a ranking member of the House Ways and Means Subcommittee on Health.

Sources at the Pharmaceutical Research and Manufacturers of America did not immediately respond to a request for comment.

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A monitored dosage system is a tray or cassette with compartments for one or more doses for a particular day or a given time. They’re designed to simplify drug rounds for care-home staff and reduce the risk of medication errors.

The study included 233 residents in 55 homes for the elderly in the United Kingdom. Pills and capsules in dispensers accounted for 53 percent of medicines given to the residents, followed by pills not in dispensers (29 percent), medicines in liquid form (9 percent) and medicines in inhalers (4 percent). The remainder were injectables, creams and eye drops.

Compared with a pill/capsule from a dispenser, mistakes were two times more likely to occur with a pill/capsule not in a dispenser; four times more likely with a liquid medicine; 19 times more likely with a cream, injection or eye drop; and more than 33 times more likely with an inhaler, according to the report.

David Phillip Alldred, of the Academic Unit of Medicines Management, School of Healthcare at the University of Leeds, and colleagues published their findings online Feb. 8 in the journal BMJ Quality and Safety.

The researchers noted in a journal news release that seniors are already at increased risk for drug errors and subsequent consequences because they often take several types of medicines and metabolize drugs differently than younger people.

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The move is the latest in a series of EU crackdowns on possible anti-competitive practices in the pharmaceutical sector after a 2009 patents enquiry pointed to significant risks for European consumers, the Commission said.

It did not mention any company it requested information from, but Britain’s AstraZeneca PLC and GlaxoSmithKline, France’s Sanofi-Aventis and Novartis and Roche of Switzerland said last year the Commission had contacted them about drug patent settlements.

The European Commission, the competition watchdog of the 27-nation EU bloc, said it had asked firms to submit copies of their patent settlement agreements concluded in the bloc last year.

Patent settlements are generally fees paid by pharmaceutical companies to generic drug makers to persuade them to delay selling the generic version of their medicines.

“Patent settlements are an area of particular concern because they may delay the market entry of generic medicines,” Competition Commissioner Joaquin Almunia said in a statement.

“The outcome of our first monitoring exercise showed that potentially problematic agreements had decreased significantly,” he said.

It said the number of such patent settlements fell to 10 percent of total patent settlements in the sector in the period July 2008 to December 2009, compared with 22 percent in the period covered in the inquiry into the sector from January 2000 to June 2008.

“The amount of money involved in the settlements, between the so-called ‘originator’ pharmaceutical companies and producers of generic drugs also decreased from more than 200 million euros ($266 million) recorded in the sector inquiry period, to less than 1 million euros, according to the 2010 report,” the Commission said.

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The drugs, known as “atypical antipsychotics,” have quickly eclipsed older-generation or “typical” antipsychotics and are increasingly used to treat conditions like bipolar disorder, depression and even autism.

“What we see is wide adoption for the use of these medications far beyond the evidence base to support it,” said Dr. Caleb Alexander of the University of Chicago and a consultant for IMS Health, a company that collects data on prescription drugs.

He said more than half of all atypical antipsychotic prescriptions written in 2008 were based on flimsy evidence.

“We’re talking millions of prescriptions a year for antipsychotics in settings where there is uncertain evidence to support them,” said Alexander, whose study appears in the journal Pharmacoepidemiology and Drug Safety.

The drugs are not harmless, Alexander said in a telephone interview. They can cause weight gain, diabetes and heart disease and are far more costly than the older antipsychotics, which cause disorders such as involuntary movements.

Atypical antipsychotics accounted for more than $10 billion in U.S. retail pharmacy drug costs in 2008 — nearly 5 percent of all prescription drug spending.

They include Johnson & Johnson’s Risperdal, known generically as risperidone; Eli Lilly and Co’s Zyprexa or olanzapine; Bristol-Myers Squibb and Otsuka Pharmaceutical Co’s Abilify or aripiprazole; and AstraZeneca’s Seroquel or quetiapine.

For the study, the team analyzed results of a physicians’ survey conducted by IMS Health to determine which antipsychotics were being used and for what condition.

They found that antipsychotic treatment nearly tripled to 16.7 million prescriptions written in 2008 from 6.2 million in 1995. During that period, prescriptions for first-generation antipsychotics fell to 1 million from 5.2 million.

Although first approved for schizophrenia, antipsychotic drugs are also used to treat psychoses, bipolar disorder, delirium, depression, personality disorders, dementia and even autism. Although some of the atypical drugs have won U.S. regulatory approval for some of these uses, doctors are also prescribing the drugs for unapproved uses.

To assess the evidence for these so-called off-label indications, the team used effectiveness ratings from a drug compendium called Drugdex.

They found that antipsychotic use for indications that lacked Food and Drug Administration approval more than doubled to 9 million prescriptions in 2008 from 4.4 million prescriptions 1995, representing about $6 billion in spending nationwide.

Dr. Gregory Simon of the Group Health Research Institute, who was not part of the study, said he was especially worried about the increased use of antipsychotic drugs for bipolar disorder and depression.

“For bipolar disorder, we have no evidence that the atypical antipsychotics are safer or more effective than alternative treatments. They are certainly much more expensive. But use of the atypical antipsychotics has grown rapidly, displacing treatments that are less expensive and more well-established,” Simon said in an e-mail.

For depression, the drugs are used to augment antidepressant therapy, but Simon said there are several other options, including switching to another antidepressant.

“Again, we have no evidence that adding an atypical antipsychotic is more effective than those other options, and it is the most expensive choice,” he said.

Dr. Randall Stafford of Stanford University School of Medicine, who worked on the study, blames marketing by drug companies and a tendency for doctors to think newer is better.

“Physicians want to prescribe and use the latest therapies — and even when those latest therapies don’t necessarily offer a big advantage, there’s still a tendency to think that the newest drugs must be better,” he said in a statement.

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