Wyeth and Amgen bolster fatal infection warning on skin drug

From CNN:
Drugmakers Wyeth and Amgen Inc. have bolstered warnings about tuberculosis and other life-threatening infections on the label of their skin-disorder drug Enbrel.

The new boxed warning, the most serious a drug can carry, indicates patients taking the drug have contracted infections that led to hospitalization and death. The same language previously appeared in bolded text, which is considered a less serious warning.

Infections included tuberculosis, a disease which attacks the lungs, as well as bacterial sepsis, which can cause severe fever and inflammation. ...more

Osteoporosis drug linked to irregular heart beat

I found this to be a real shocker. I don't see any reason to make any significant changes in clinical decisions -- yet. But it's fascinating that these types of adverse events can be discovered years after the introduction of a medication. And there is no clear connection between the mechanism of action of the drug and atrial fibrillation in any way. I suspect more research will be conducted to follow up on this.

From CTV News:
Women who take popular osteoporosis drug alendronate, known more commonly as Fosamax, are twice as likely to develop a common form of irregular heartbeat compared to those who have never taken it, a new study suggests.

Researchers analyzed data from more than 700 women who had been diagnosed with atrial fibrillation, or irregular heartbeat, in a three-year period and compared them to a control group of more than 900 randomly selected women.

They found a nearly two-fold increase in risk for developing atrial fibrillation among those women who had ever taken alendronate.

The findings were compiled by researchers from Group Health and the University of Washington by analyzing records of patients enrolled in Group Health, a Seattle-based non-profit health-care centre. The study was published Monday in the journal Archives of Internal Medicine. ...more

Studies allege Merck manipulated Vioxx data; journal calls for ethics overhaul

From the Canadian Press:
Two new studies suggest drugmaker Merck and Co. manipulated data on its withdrawn drug Vioxx, was slow to disclose adverse events associated with the painkiller and used academic researchers to enhance the credibility of scientific studies largely written by Merck employees.

The articles were based on company documents made public as a result of thousands of lawsuits levelled against Merck and Co. after it withdrew the former blockbluster medication from worldwide markets in September 2004 because studies revealed people who used it were at higher risk of heart attacks and strokes.

They were published Wednesday in the Journal of the American Medical Association, which also ran a damning editorial calling on everyone in the business of clinical research to pull up their socks, starting with doctors.

"The profession of medicine in every aspect - clinical, education and research - has been inundated with profound influence from the pharmaceutical and medical device industries," editor Dr. Catherine DeAngelis and deputy editor Dr. Phil Fontanarosa wrote. ...more

'Suicidal' urges among reactions to stop-smoking pill

From the Ottawa Citizen:
Nearly half of reported suspected drug reactions in people taking the popular anti-smoking pill Champix involve psychiatric reactions, including seven people who became suicidal while on the drug, a new federal report shows.

In the first eight months after Pfizer Inc. began marketing its smoking cessation drug last April, Health Canada received 107 reports of adverse drug reactions suspected of being associated with Champix.

Of these, 46 involved psychiatric reactions including aggression, depression and suicidal thinking. Others involved amnesia, abnormal dreams, anxiety, insomnia, and abnormal thinking. 'Suicidal' urges among reactions to stop-smoking pill

Possible link between flu drugs, deaths and hallucinations

From the Calgary Herald:
Health officials are investigating whether Relenza - a drug provinces have stockpiled in case of a pandemic flu outbreak - can be linked to fatal reactions or abnormal behaviour in children.

Dr. Patricia Huston, interim director of pandemic preparedness for the Public Health Agency of Canada, confirmed Monday that pandemic flu experts are studying the matter with Health Canada.

The investigation is a response to recently updated safety warnings issued by the U.S. Food and Drug Administration (FDA) or Relenza. In March, pharmaceutical giant GlaxoSmithKline updated Relenza's safety labels after children in Japan were reported to suffer from delirium, hallucinations. Some died after injuring themselves. ...more

FDA cites 62 reports of possible heparin deaths

From Reuters:
U.S. regulators have received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or low blood pressure, the Food and Drug Administration said on Tuesday.

Those are the problems that prompted Baxter International Inc to recall most of its heparin products in February. ...more

Drug Makers Near Old Goal: A Legal Shield

From the New York Times:
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. ...more

Psychiatric drugs causing weight gain: doctors

From the Vancouver Sun:
The very drugs millions of Canadians are taking to get through their day can cause dramatic weight gain, doctors are warning.

Psychiatric drug-related weight gain "is a huge problem," says Dr. David Lau, chair of the diabetes and endocrine research group at the University of Calgary and president of Obesity Canada.

"You can see patients gaining 10, 20, 30, 40 pounds," Lau says.

Not everyone taking antidepressants, mood stabilizers or newer generation antipsychotics will gain weight, he stressed. What's more, he said new antipsychotics, so-called "atypical antipsychotics" have been "tremendous in terms of bringing back the functionality of people with schizophrenia, bipolar disorders and depression." ...more

One Thousand Lives A Month, Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier

From CBS News:
This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.

As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.

But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.

How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month. ...more

Hospitals may have to report bad drug reactions

From the National Post:
Hundreds of hospitals across the country would be forced to inform federal authorities whenever patients had serious reactions to drugs and medical devices under a controversial plan Health Canada is quietly proposing.

The regulator notes that as many as 45,000 hospital patients a year suffer from sometimes fatal side effects to the treatments meant to help them, yet only 2% of the incidents are reported.

The tentative proposal is already meeting resistance, though, with critics arguing that making reporting mandatory is a "quick fix" that by itself will not generate the desired flow of safety information.

"Simply passing a law that says, 'It's mandatory' I don't think is going to remove the barriers that are there to improved reporting," said Jeff Poston of the Canadian Pharmacists Association, whose members produce most ad-verse-reaction reports currently. "I don't think it's really a solution." ...more

Natural remedies ‘potentially harmful’

From the National Post:
Half the pharmacists surveyed by Alberta researchers said they had seen evidence of dangerous interactions between natural health products and prescription drugs, a "startling" result that suggests natural remedies cause many more harmful side effects than once thought, a new study concludes.

Most of those pharmacists, however, failed to report the side effects to Health Canada's adverse-reaction database, the study indicated. The findings point to an "urgent need" for additional safety data on herbal and other natural products used by millions of Canadians, said the University of Alberta scientists behind the research.

"This [study] leads us to believe that natural-health product [NHP] adverse events are far more common than previously suspected," said their paper, just published in the journal Annals of Pharmacotherapy. "The majority of Canadians use NHPs and our data confirm that this use may carry unrecognized risk." ...more

Unsafe sleepwalking, sleep driving linked to pills

From CBC News:
Rare, bizarre and potentially dangerous side-effects of some prescription sleeping pills have prompted the U.S. Food and Drug Administration to warn patients and doctors about the medications, including one that is available in Canada.

The FDA has linked the best-selling sleep-inducing drug zopliclone, sold in Canada under the brand name Imovane, to sleepwalking behaviours. The agency has also linked the drug to sleep driving — driving a car while not fully awake after taking a sedative-hypnotic drug, with no memory of doing so.

In the U.S., the FDA said there have been dozens of reports of bizarre behaviour during sleep among people who have taken a sleeping pill called Ambien. While Ambien is approved for use in Canada, it is not available for sale ...more

More adverse drug reactions being reported

From Canada.com:
A growing number of Canadians are reporting adverse reactions to the drugs they’re taking, a troubling trend that Health Canada says has been on the rise for the last several years.

More than 10,500 new cases of adverse drug reactions were reported to Health Canada in 2006, mainly by health professionals, an increase of 108 cases compared to the previous year. Health Canada also received more than 250,000 reports last year of adverse reactions originating in other countries from drugs that are marketed in Canada, a jump of 43 per cent from 2005. ...more

Cancer patients at risk for dangerous drug interactions: study

This article has a few good points, including some good advice for patients:

Ms. Kwong advises patients to:

—Always carry an up-to-date list of medications and their dosages, including over-the-counter and alternative therapies.

—Try to have prescriptions filled by the same pharmacy: electronic software will alert the druggist of potential drug interactions.

—Make sure to keep different doctors or pharmacists apprised of any changes in prescriptions.

Because of drug interactions, cancer patients can be challenging from a pharmacist perspective. However, solving these types of clinical puzzles can really show that the pharmacist is a drug information specialist.

From the Globe and Mail:
Many cancer patients are at risk for potentially dangerous drug interactions because of the number of different medications they take for multiple conditions, say Canadian researchers, who caution that steps must be taken to avoid these dicey combinations.

In a study appearing Wednesday in the Journal of the National Cancer Institute, researchers at Princess Margaret Hospital in Toronto found that almost 30 per cent of 405 cancer patients studied were taking drugs that put them at risk for at least one adverse drug interaction.

At least 9 per cent of the interactions could have had severe effects — including being potentially fatal — and 77 per cent were of moderate severity and could have resulted in serious health problems, the study showed. About 8 per cent of patients received duplicate medications. ...more