medicalcannabisawareness's blog

NASAL SPRAY UNDER REVIEW - LINKED WITH SEIZURES AND DEATHS.

A nasal spray designed to stop kids wetting the bed is under review by Australian authorities after US regulators linked it with seizures and death.

The drug, desmopressin, has been found to trigger potentially-fatal attacks in some people who have used the intranasal formulation.

The US Food and Drug Administration (FDA) has received 61 reports of serious adverse events, including two deaths, and warns it should no longer be used.

It said children were particularly at risk of the seizures, which are caused by hyponatremia, or an abnormally low concentration of sodium in the blood.

A spokeswoman for Australia's Therapeutic Goods Administration said the authority "was aware of the issue" and would review the product in light of the new reports.

This would ascertain whether warnings should be strengthened or the product listed as restricted use, she said.

Desmopressin is made by several manufacturers and comes in a variety of formulations, including tablets.

The FDA had received 61 reports of hyponatremic-related seizures associated with the use of desmopressin. The nasal spray was used in 36 of the cases, with 25 involving children.

More than half of all affected were also taking another medication, making it difficult for authorities to establish a definite causal link.

The formulation in no longer approved in the US and the FDA has warned all other formulations should be used cautiously in patients who are on other medication or might need to drink more fluids because of activities such as exercise.

The drug works by limiting the amount of water that is eliminated in the urine and is used to prevent excessive thirst, urination and dehydration caused by injury, surgery and certain medical conditions including a form of diabetes. 

Daily Telegraph Dec. 07

PHARMACEUTICAL DRUG LINKED WITH SUICIDE, DEPRESSION, AGITATION ETC...... 

A DRUG designed to curb cigarette cravings will carry new warnings of links with suicidal thoughts when it goes on sale in Australia next month.

Packs of Champix tablets will now contain extra information warning that some patients have suffered from depression, agitation and suicidal thoughts while taking the drug.

Doctors also have been mailed letters informing them of the changes, triggered by adverse effects reported to US authorities. The medication, the first of its kind to reduce the intensity of nicotine cravings, is due to be launched on January 1.

Smokers will be able to get one three-month treatment course a year under the Pharmaceutical Benefits Scheme (PBS).

The Therapeutic Goods Administration (TGA) said today it had reviewed reports submitted to the US Food and Drug Administration and order drug company Pfizer to issue "Dear Doctor" letters.

"(Pfizer) has also amended the Champix product information to include the same post-marketing information as in the US prescribing information," a TGA spokeswoman said.

The new warning states that "there have been reports of depressed mood, agitation, changes in behaviour, suicidal ideation and suicide in patients attempting to quit smoking while taking Champix".

"Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure."

Both the TGA and Pfizer have they do not know whether Champix itself, nicotine deprivation or some other factor could trigger the psychiatric reactions.

"The TGA will continue to monitor the situation," the spokeswoman said.

Champix is marketed as Chantix in the US, where it hit the headlines after a highly-publicised case of a Texas musician who began taking the drug, then was shot dead after reportedly engaging in aggressive behaviour.

The drug works by stimulating the same receptors in the brain as nicotine, relieving the cravings and withdrawal symptoms of those giving up.

It will be the third pharmaceutical therapy available for smoking cessation, joining the drug Zyban and nicotine replacement treatments like patches and gum.

Daily Telegraph 11th Dec. 07

GARDASIL - SERIOUS REACTIONS BY TEENAGE GIRLS.....

WITH almost 500 Australian teenage girls suffering serious reactions to the cervical cancer vaccine Gardasil, parents should be worried about its safety.

Reports of women collapsing, convulsing in seizures, breaking out in severe rashes and even worse - death - are enough for any mother or father to prevent their young girl from being immunised.

And it also proves a dilemma for women in their 20s who must weigh up whether to risk an adverse reaction or chance it, like millions of women who, until now, have never been offered the potentially life-saving drug.

But perhaps they need to consider another alarming statistic.

Every year more than 200 Australian women die from cervical cancer. At the same time another 800 women are diagnosed with the disease.

Since Gardasil became available more than 2.2 million doses have been administered. Any severe reaction linked to a drug is cause for concern but when it can save a life, then perhaps the risk needs to be taken.

When Gardasil hit the market in May this year, its inventor, former Australian of the Year Ian Frazer called on parents to consider vaccinating their daughters.

Leaving their girls unvaccinated could expose them to the sexually transmitted human papillomavirus, he said.

"It is entirely their (parents') right to decide if they would like their child to be vaccinated. Hopefully they will be able to reconsider eventually as the vaccine is designed to protect against disease and the reality is it has to be given early in life - if they wait too long the benefit could be lost.

"It would be a pity if that opportunity was lost because of fainting."

The drug's manufacturer CSL claims the medical and scientific evidence suggests the benefits of Gardasil far outweigh the number of cases of girls fainting.

Five hundred women becoming ill from the vaccine is nothing to be taken lightly.

But nor is the 200 mothers, daughters and girlfriends who could still be alive today if they had the chance to be guarded for life.

HEART DISEASE DRUG TRIAL STOPPED AMID DEATH FEARS.....

Tue Dec 5, 2006

A trial of an experimental drug for heart disease has been abruptly stopped after it was found patients could die from taking it.

The drug called Torcetrapib was being trialled worldwide, including on 1,300 Australians in 20 centres nationwide for the last two years.

A spokesman for the manufacturer of the drug, the US-based Pfizer company, says there were two parts to the trial - one section using the common heart drug Lipitor and the other section using the new drug, Torcetrapib.

While Lipitor works by lowering cholesterol, the new drug worked by raising the good cholesterol in the body.

A spokesman says in the US there were more deaths with people using the new drug, forcing the independent board monitoring the trial to recommend cancelling it worldwide.

A spokesman for Pfizer Australia says there was a telephone hook-up with Australia's Therapeutic Goods Administration (TGA) yesterday to make sure all patients stop taking the drug immediately.

He says there is no indication of any deaths in Australia as a result of the drug but there will be further investigations.

Pfizer Australia cardiovascular medical director Dr Peter Stewart says the trial was stopped because data collected in the United States showed an increased risk of death with the new drug.

He says he does not know at this stage if Australians involved in the trial had the same risk.

"There were 1,300 patients in the trial in Australia," he said.

"Half of those patients would have been on the experimental drug, half of them would have been on the comparator drug.

One of Australia's leading heart researchers says it is disappointing major problems have emerged in the trial.

Executive director of the Victor Chang Cardiac Institute, Professor Robert Graham, says there was a lot of hope for the new drug.

He says initial trials showed it did not just prevent future build-up of bad cholesterol but worked at getting rid of old build-ups - a major factor in heart disease and stroke.

"We've not had any way of doing this before, so this new class of drugs, which inhibits this transfer protein have looked like the holy grail," he said.

Professor Graham says the dose could have played a part.