Monday, June 30, 2008

Mommy's Bliss Cream Recall



Mommy's Bliss Nipple Cream. Mommy's Bliss Nipple Cream is promoted as an all-natural product to help soothe and heal dry or cracked nipples. The U.S. Food and Drug Administration has warned that the product contains the preservatives chlorphenesin and phenoxyethanol, which could cause serious side-effects, including difficulty breathing and dehydration, if ingested by nursing infants.
Source: Health Canada

Remedy Warning for Arthritis Tablet - Health Canada

3rd Generation In Homoeopathy Arthrit Indica Tablet. The product is labelled for "intense joint pain." The Health Sciences Authority of Singapore has warned consumers not to use the product because it contains nimesulide, a pharmaceutical ingredient that has been associated with liver damage

Source: Health Canada

Friday, June 27, 2008

Long Distance Running Benefits - New Study

Will running ruin my knees?

Studies show that non-runners are more likely to develop osteoarthritis than those who regularly pound the pavement


This is a fear that stops many would-be runners in their tracks and lurks in the back of the mind of even the most experienced runners. Running and injuries go together like shin splints and ice, so it's entirely reasonable to wonder about the prospects of long-term damage.

These fears should be put to rest by a pair of long-term studies due to be published this year.

In next month's Skeletal Radiology, a team of Austrian radiologists presents knee MRIs of seven runners who had taken part in a previous MRI study before running the Vienna marathon in 1997. The use of MRIs offers a significant diagnostic advantage compared to earlier studies that relied on X-rays.

The results were clear: no new damage in the knee joints of the six subjects who had continued running in the intervening decade. "In contrast, the only person who had given up long-distance running showed severe deterioration in the intra-articular structures of his knee," the authors note.

An even more long-term study at Stanford University has been following 45 runners and 53 non-runners since 1984. All had been taking regular X-rays. The latest results, which will appear in a future edition of the American Journal of Preventive Medicine, show that after 18 years, 20 per cent of the runners had developed osteoarthritis in the knee, compared with 32 per cent of non-runners.

These studies raise a possibility that several earlier studies have proposed: Running may help preserve the joints. But that's not a conclusion that can be drawn at this point, says Eliza Chakravarty, lead author of the Stanford study.

"I don't think I would strongly recommend running for the purpose of protecting the knees."

One drawback with both studies is selection bias. The runners in both cases were committed recreational runners who had a history of being able to run without serious problems.

Data for non-runners who are considering taking up running are harder to come by - a gap that was partly addressed by a large-scale study that appeared last year in the journal Arthritis & Rheumatism, involving 1,279 subjects from the famously long-running Framingham Heart Study.

Rather than studying "runners" versus "non-runners" the researchers examined the general study population, looking for associations between exercise (including running) and the development of knee osteoarthritis over a nine-year period. They found no link, suggesting even overweight non-runners can start exercising without putting their knees at risk.

In sharp contrast, though, the American College of Sports Medicine recently reported that each additional pound of body mass puts four extra pounds of stress on the knee, so packing on a pound a year for about a decade increases your chances of developing arthritis by 50 per cent - a fairly powerful argument for running to keep off weight and protect your knees.

Of course, the decision doesn't have to be strictly utilitarian. As one of the Vienna study participants (who was preparing to run his 37th marathon) put it in a recent e-mail to lead author Wolfgang Krampla, "Even if minor aches and pains occur over the years, the gain in joie de vivre far outweighs them."

Alex Hutchinson is a former member of Canada's long-distance running team, and has a PhD in physics.

Source: GlobeandMail.ca

Wednesday, June 25, 2008

Gardasil Marketing Machine Silenced by FDA

FDA bars Merck from marketing cervical cancer vaccine to women age 27-45


Drug maker Merck & Co. said Wednesday that the U.S. Food and Drug Administration has rejected expanding the use of the cervical cancer vaccine Gardasil to include women ages 27 to 45.

The federal agency cited "issues that preclude approval" within the expected time frame for a review, Merck said.

Gardasil was approved in 2006 for girls and women between nine and 26 years old to prevent cervical cancer caused by the human papillomavirus, or HPV. The agency's current action does not affect this population's use.

The FDA decision bars Merck from marketing Gardasil to women ages 27-45, but does not prevent those women from getting the vaccine from their doctors.

Merck said that the agency identified several issues related to the application in a "complete response" letter, including stating that the data submitted does not support extending Gardasil's use to include non-vaccine HPV types.

Merck also reaffirmed its goal of attaining compound annual growth in its businesses of between four per cent and six per cent from 2005 through 2010.

Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market. It is outselling another vaccine, Cervarix, from GlaxoSmithKline PLC, in worldwide sales, analysts said, garnering over $1 billion in sales since its June 2006 U.S. launch.

"This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything," WBB Securities analyst Steve Brozak said. "I think this is one where they would rather err on the side of getting another 23 pounds of documents."

New Jersey-based Merck said it has already had discussions with the FDA and plans to respond next month.

In afternoon trading Wednesday, its stock was down eight cents, or 0.2 per cent, to $36.95 US in New York.

Gardasil is approved in Canada for use in women aged nine to 26.

Source: CBC.ca

Friday, June 20, 2008

Anti-Smoking Drug's Adverse Effects

Smoking drug Champix linked to adverse psychiatric effects: Health Canada


Health Canada has issued a warning about adverse neuropsychiatric effects linked to Champix, a drug intended to help smokers butt out for good.

A number of patients taking Champix (varenicline tartrate) have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, Health Canada said Friday in an advisory.

The medication acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

Champix, made by Pfizer Inc. and sold under the brand name Chantix in the United States, has been sold in Canada since April 2007. In the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported. In that period, more than 708,500 prescriptions for the drug have been filled across the country.

Health Canada issued the following guidelines to the public:

  • Tell your doctor if you have experienced depression or other mental health problems before taking Champix, as these symptoms may worsen while taking the drug.
  • Stop taking Champix and tell your doctor right away if you, your family or caregiver have noticed any of these symptoms, if you experienced these symptoms in a way that is not typical for you or if you have thoughts of self-harm or of harming others.
  • Champix has not been studied in people with mental health problems, and therefore your doctor will be monitoring you closely for new or worsened emotional or behavioural problems while on the medication.

"Quitting smoking can also be associated with changes in mood and behaviour, with or without taking medication to help quit," said the federal department in its advisory. "A doctor or pharmacist should be consulted should these symptoms or those described above be experienced, since guidance has been provided to health-care professionals on how to use Champix in patients, including those patients who may also have mental health problems."

Health Canada, which published an article concerning Champix in the Canadian Adverse Reaction Newsletter in April, said any case of serious change in mood or behaviour or other serious or unexpected adverse reactions in patients receiving Champix should be reported.

Source:CBC.ca