Pain Patch Overdose Risk - Health Canada Update

Manufacturers changing dosing instruction of pain patch

Several manufacturers of a patch containing a chronic pain drug are changing dosing instructions to address potential overdose risks.

The five manufacturers of Fentanyl Transdermal Systems and Health Canada said the patches contain a high concentration of the long-acting narcotic fentanyl.

Last February, 25 mcg/hr Duragesic patches sold by Janssen-Ortho Inc. and 25 mcg/hr Ran Fentanyl Transdermal System Patches sold by Ranbaxy Laboratories were voluntarily recalled for overdose risks.

The patches treat persistent, moderate to severe chronic pain in people already taking narcotic pain relievers.

Fentanyl can cause serious and life-threatening breathing problems if too much is taken, Health Canada warned Wednesday.

The new dose conversion guidelines are to be used to convert adult patients from their current oral or injection therapy to the fentanyl transdermal patch, says an advisory to health-care professionals.

People using the patches without any problems should not stop or decrease their dosage without talking to their doctors.

The notice applies to:

• Duragesic ® (Fentanyl Transdermal Systems).
• CO Fentanyl.
• Novo-Fentanyl.
• RAN-Fentanyl Transdermal Systems.
• Ratio-Fentanyl Transdermal System.

Patients using fentanyl patches should seek emergency medical help immediately if they:

• Have trouble breathing, or have slow or shallow breathing.
• Have a slow heartbeat.
• Have severe sleepiness.
• Have cold, clammy skin.
• Feel faint, dizzy, confused or cannot think, walk, or talk normally.
• Have a seizure.
• Have hallucinations.

Any serious or unexpected adverse reactions in patients receiving fentanyl transdermal systems should be reported to the manufacturers or Health Canada.

Source: CBC.ca

Optimum Sleep Pill Potential Addiction

Health Canada on Wednesday warned consumers not to use the sleep supplement Optimum Health Care Sleep Easy because it may be addictive after being taken for as little as a few months.

The product contains the drug clonazepam. It is not listed on the label and should only be taken under the supervision of a health-care professional.

"Consumers who may still have this product in their homes are advised to consult with a health-care professional before they stop taking the pills, because of the risk of serious withdrawal symptoms," Health Canada said in its advisory.

The sleep aid has not been authorized for sale in Canada but was sold at Vancouver's Optimum Health Care.

People with the neuromuscular disorder myasthenia gravis, sleep apnea, or allergies to drugs known as benzodiazepines such as Valium should not use sleep aids containing clonazepam. Pregnant women should not rely on sleep aids containing clonazepam unless absolutely necessary while the elderly and those with a history of substance abuse should use them with caution.

Side effects linked to products containing clonazepam include dizziness, drowsiness, confusion, depression, memory loss and hallucinations. No associated adverse reactions have been reported in Canada.

Consumers should return the product to the retailer. For more information, consumers can call Health Canada at 1-866-225-0709
Source: CBC.ca

FDA holding out on Obesity Drug Approval

The Food and Drug Administration (FDA) in the United States appears to be holding back on it's decision to grant approval for a weight loss drug. The FDA says the drug Acomplia has adverse effects in some people in that it can prompt suicidal behavior and cause other psychological side effects. The FDA's review of the drug comes before a panel of experts are about to vote on whether Sanofi-Aventis' obesity treatment should be given approval and although the federal agency is not obliged to follow the experts advice it more often than not does. A definitive decision by the FDA is scheduled to be issued regarding Acomplia on July 27. The FDA says clinical studies by the French drug maker indicated that patients taking Acomplia daily showed significant weight loss after two years. However the FDA is concerned that 26 percent of patients in the trials taking Acomplia experienced adverse psychiatric events, including depression, anxiety and insomnia, compared with 14 percent of patients on a placebo. The FDA also says there is a possible link between Acomplia and suicidal behavior; in studies of the weight loss drug, Sanofi reported one patient committing suicide and eight having suicidal thoughts while among patients taking the placebo, Sanofi reported two suicide attempts and five instances of suicidal thoughts. The FDA also says there was a slightly higher rate of dizziness and headache among Acomplia patients, at 27.4 percent, compared with 24.4 percent patients on placebo. Acomplia is a potential blockbuster drug despite the hiccups in getting it approved. It was originally presented in 2005 as an anti-obesity pill and an anti-smoking treatment but was rejected by the FDA for anti-smoking use until more information on it's psychiatric side effects were provided. Known generically as rimonabant, the drug is already sold in 18 countries under the name Acomplia. European Union regulators have approved Acomplia for overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes, but not for smoking use. If approved Sanofi plans to market the drug under the name Zimulti in the U.S. Source: www.news-medical.net

Drug and Nutrient Depletion Effects

Source: Men's Health June 2007

Stimulant Warning

Cramming students cautioned against taking stimulant without prescription

University students hitting the books for final exams in Calgary are popping prescription stimulants that carry the risk of side-effects, doctors warn.

Dextroamphetamine, sold as Dexedrine, or "dex," is prescribed to treat narcolepsy, or sudden sleep attacks, and for people with attention deficit hyperactivity disorder, to help them focus and concentrate better. For those who do not have ADHD, the drug works like a stimulant.

"I think it is a time-release kind of drug, so it just slowly goes through your body," said a first-year business student at the University of Calgary, who did not want his name used because he buys Dexedrine for five dollars a pill from a friend with ADHD.

"Before you know it, well geez, I've done four hours of hard-core studying and I remember every bit of information," he said, adding he thinks the drug has helped him to achieve higher marks. "I take it before an exam so I'm extra focused."

Dexedrine should not be taken without a prescription, said Dr. Prem Chengalath, a physician in Calgary.

"It has side-effects. It has addictive properties as well," Chengalath said. "Anything which gives you a high is going to give you a low, and sometimes it could be a very bad low."

Taking Dexedrine without a prescription may also lead to disrupted sleep patterns, loss of appetite and elevated heart rate, said Debbie Breckner, director of the university's Wellness Centre. It's not recommended for coping with stress or dealing with exams, Breckner said.

It is not known how many students are using Dexedrine to study. Robin Tribble said its use is widespread among her friends in first year, who live in residence. Some of the people are now dependent on Dexedrine for studying, Tribble said.

Tribble questions Dexedrine use, saying it is unrealistic for students to plan to use it to deal with stressful situations for the rest of their lives.

Officials at the wellness centre are not overly concerned, saying their doctors have not seen an increase in discussions with students who may be using Dexedrine.

Source: CBC.ca

Parkinson's Drug Withdrawn from Market

Health Canada is informing Canadians that Permax, a drug used for the treatment of Parkinson's disease, has been withdrawn from the U.S. market amidst concerns about an association with cardiac valvulopathy, a condition involving inflammation or stiffening of the heart valves.

Children's Cold Medicine Investigation

U.S. investigating children's cold medicines: report

Common children's cold and cough medicines are coming under scrutiny from U.S. federal drug regulators, who say the remedies and their recommended doses have not been studied enough in children, the New York Times reported Friday.

Dr. Charles J. Ganley, a top Food and Drug Administration official, said the agency was "revisiting the risks and benefits of the use of these drugs in children," especially those younger than two years old, the paper reported.

Most over-the-counter cold and cough medicines have been insufficiently tested in children, said Ganley, the director of the FDA's office of non-prescription drug products.

"We have no data on these agents of what's a safe and effective dose in children," he told the Times in an interview.

The FDA said it could not yet determine whether new regulations would result from the safety review, according to the newspaper.

A group of pediatricians and public health officials asked the agency Thursday to bar drug manufacturers from marketing remedies such as Toddler's Dimetapp, Infant Triaminic and Little Colds to children under six.

Cold medicines killed 3 children: study

A recent study by the U.S. Centers for Disease Control and Prevention showed that in 2004 and 2005, more than 1,500 children under two had experienced serious health problems — and three died — after taking common cold medicines.

The American College of Chest Physicians last year recommended avoiding giving cough and cold medicines to children, especially young ones.

In above-normal doses, cold medicines can lead to heart arrhythmias, and some have been linked to hypertension and stroke when taken in high doses, the Times reported.

In rare cases, children have had medical problems after taking recommended doses, the article said.

The president of the Consumer Healthcare Products Association, which represents companies that sell over-the-counter cold drugs, noted that the medicines had FDA approval and had been used for decades. They should be taken only in recommended doses, association president Linda A. Suydam said.

The pediatricians who petitioned the FDA Thursday acknowledged that children's cold medicines were generally safe in recommended doses, but they said overdoses were common because many children were given more than one medicine, among other reasons.

They also questioned the drugs' effectiveness in children.

Many cold and cough drugs won FDA approval decades ago, when the agency's standards were less strict, the Times reported.

Source: CBC.ca

Sleeping Aid Recall

Potentially habit-forming herbal sleep aid recalled

Health Canada issued an advisory Friday warning consumers against taking an herbal sleep aid because it could be habit-forming.

The federal agency says Sleepees contains the drug estazolam, which is not declared on its label. The supplement has not been authorized for sale in Canada.

The distributor, Vancouver-based Our World Network Inc., has stopped selling the herbal sleep aid and is recalling the following Sleepees product lots: B39054006, B39069004, B39035001, B38883003, B38893003, OWN 961, OWN-042606, OWN 980, OWN 913.

Estazolam, which should only be taken when prescribed by a health-care practitioner, can be potentially addictive when taken for as little as a few months.

"Consumers who may still have this product in their homes are advised to consult with a health-care professional before they stop taking the capsules, because of the risk of withdrawal symptoms," Health Canada said in a release.

Side-effects include depression, hallucinations

Side-effects linked with the use of estazolam may include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

No adverse reactions associated with the use of Sleepees have been reported in Canada.

Consumers should return the product to the place of purchase. For more information, people can call Health Canada's public enquiries line at at (613) 957-2991, or toll-free at 1-866-225-0709.

Source: CBC.ca