Changes To Canadian Labelling Of Tamiflu

Health Canada wishes to inform Canadians that the Canadian labelling for Tamiflu has recently been updated to include new safety information resulting from adverse reaction reports of abnormal or suicidal behaviour in Japanese children or teenagers taking Tamiflu. As of February 28, 2007, there have been no Canadian reports of deaths or psychiatric adverse events such as abnormal or suicidal behaviour in children or teenagers.

Health Canada has also received preliminary information on eight new cases in Japan of self-harm in patients taking Tamiflu, and is aware that Japan has now restricted use of Tamiflu in patients 10 to 19 years old. Further information is expected from the manufacturer, Hoffman-LaRoche Limited, and appropriate measures will be taken if necessary following analysis.

Health Canada is continuing to actively monitor adverse events reported for Tamiflu and will consider the results of the recently announced Japanese review of Tamiflu's safety when available. The connection with the drug in these new cases has not been proven. High fever or other complications from influenza can affect mental state, which in turn can lead to abnormal behaviour.

Canadians taking Tamiflu should consult with their physician if they have any questions or concerns about its use.

Any serious or unexpected adverse reactions in patients receiving Tamiflu should be reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada: email: cadrmp@hc-sc.gc.ca

Risk of bone death for Fosamax users

Q. I take Fosamax for osteoporosis. I need to have a tooth extracted, but I heard that my jaw could die if I do this. Is that true?

A. (from a specialist in oral surgery) The risk of bone death (osteonecrosis) from tooth extraction in patients taking Fosamax is very low. Osteonecrosis is characterized by jaw pain, swelling, loose teeth and exposed jawbone.

In fact, if you are at risk for this condition, keeping compromised or infected teeth in place may actually be enough to cause osteonecrosis to develop even without removing the tooth.

Here's some background about the medication to help you and your dentist make a decision:

Fosamax (alendronate) is the most commonly prescribed bisphosphonate, a group of drugs which are used to maintain bone health and treat osteoporosis.

Bisphosphonates affect the ability of bone to heal from trauma, such as dental extractions. And they all remain in the bone for years. Because the intravenous forms are more potent, their effects on bone are thought to be more significant than the oral forms.

A small number of patients who were on Fosamax have developed osteonecrosis of the jaw. These have been primarily associated with dental disease or a recent dental procedure such as extraction.

But this complication has been much more frequent in patients taking the more potent intravenous medications. In one recent study of patients with osteonecrosis, less than 3 percent of the patients had been taking Fosamax, and 97 percent were on the more potent intravenous forms.

Given that there are more patients taking Fosamax than are taking the intravenous forms, it seems that the risk of osteonecrosis from tooth extractions in the patient taking Fosamax must be very low.

The lowest-risk approach would be to try to keep the tooth by having a root canal or other procedure. On the other hand, if there is infection present or if the prognosis for the tooth is not good, removal is appropriate. Talk to your dentist or an oral surgeon about the risks versus the benefits of tooth removal given your particular circumstances.

Appeals court strikes down Pfizer's patent for Norvasc

My mother takes this. Good news for my mother and bad news for Pfizer. :)

Pfizer Inc.'s patent on the hypertension drug Norvasc was invalidated by an appeals court, opening the way for generic competition. The U.S. Court of Appeals for the Federal Circuit in Washington yesterday held invalid the patent on the drug's key ingredient, amlodipine besylate, overturning a January, 2006, ruling. Pfizer said it may appeal the decision. The patent on the drug expires in September, and Mylan Laboratories Inc. has final approval from the U.S. Food and Drug Administration to market a generic version.

Norvasc is a calcium channel blocker that selectively blocks calcium ion reflux across cell membranes of cardiac and vascular smooth muscle without changing the serum calcium concentration. It decreases peripheral vascular resistance and increasing cardiac output. The generic name is amlodipine.

Pfizer's Celebrex Patent Upheld

My opinion.
It's bad news for patients, but good news for Pfizer.

A federal court in the District of New Jersey (Newark) has upheld Pfizer's three main U.S. patents covering Celebrex, a selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. Generic manufacturer Teva Pharmaceuticals USA had challenged the patents.

Judge John C. Lifland ruled that the patents covering the active ingredient, pharmaceutical composition, and method of use for Celebrex are valid, enforceable and infringed by the generic manufacturer's product. The decision, which may be appealed, prohibits Teva from launching a competitor drug in the U.S. until December 2015.

Celebrex is used to:

• relieve symptoms of osteoarthritis (the arthritis caused by age-related “wear and tear” on bones and joints)
• relieve symptoms of rheumatoid arthritis in adults
• manage acute pain in adults (like the short term pain you can get after a dental or surgical operation)
• treat painful menstrual cycles
• reduce the number of colon and rectum growths (colorectal polyps) in patients with a disease called Familial Adenomatous Polyposis (FAP). FAP is an inherited disease in which the rectum and colon are covered with many polyps. Celebrex is used along with the usual care for FAP patients such as surgery and exams of the rectum and colon.

Tamiflu Not for Teens

Japanese doctors were warned on Wednesday against prescribing Tamiflu to teenagers after several young patients taking the bird flu-fighting drug reportedly exhibited dangerous behavior.

The Health Ministry issued emergency instructions Tuesday to a Japanese Tamiflu distributor, Chugai Pharmaceutical Co., to warn doctors not to give the drug to teenagers, a Chugai official said on condition of anonymity, citing protocol.

Chugai began distributing warnings to doctors, hospitals and pharmacies across Japan on Wednesday, the official said.

Martina Rupp, a spokeswoman for Swiss manufacturer Roche Holding AG, said the company didn't understand the Japanese government's rationale for the action.

'No causal relationship has been established between Tamiflu and these reports, and we don't see this as an appropriate course of action,' Rupp told The Associated Press.

Concerns over Tamiflu, also known as oseltamivir, have spiked in Japan after a boy and a girl, both 14, fell to their deaths from their condominiums while taking the drug in separate incidents in February.

The U.S. Food and Drug Administration has said it received more than 100 reports of delirium, hallucinations and other unusual psychiatric behavior, mostly in Japanese children treated with Tamiflu, between Aug. 29, 2005, and July 6, 2006. The Japanese government has not released detailed figures.

The FDA added a new precaution to Tamiflu's label in November, bringing the U.S. label more in line with the Japanese one that already warned that such abnormal behavior could occur.

Both Roche and the FDA have said that severe cases of the flu can spark the abnormal behavior displayed by some patients.

Two 12-year-old boys also taking Tamiflu both broke legs after jumping out of their houses in separate incidents in February and March, the official said.

Tamiflu, one of the few drugs believed to be effective in treating bird flu, is widely used in Japan to treat influenza.

The Associated Press

What is Tamiflu?

It is not really a vaccine, but an anti-viral flu drug. Taking it within the first 2 days of the start of flu symptoms (including bird flu) can help make the flu less severe and may make you less contagious to others also. The generic name is oseltimivir.

Facts About Antibiotic Resistance

With recent news about "super bugs," you may wonder if antibiotics are still effective, and whether they will work for you when you need them. You're not alone-there is a lot of confusion about antibiotics-what they do and don't treat, and why they sometimes stop working. It is important to know that antibiotics are effective only if they are prescribed and taken correctly.

Two main types of germs cause most infections-viruses and bacteria. Antibiotics are a type of medicine that can kill or stop the growth of bacteria and help cure the infections they cause. Some people think that antibiotics can be used to treat viral infections, such as a cold or the flu. However, it is very important that you not take an antibiotic for a cold or the flu-doing so can contribute to what experts call "antibiotic resistance." To help you understand when you need to take antibiotics and how you should use them, here are answers to some of the most commonly asked questions about antibiotics and resistance.

Q. What is antibiotic resistance?

A. Antibiotic resistance is the ability of bacteria to resist the effects of an antibiotic. When this occurs, medications used to treat infections caused by bacteria become less effective or not effective at all. When antibiotics are used incorrectly, such as when they are taken when not needed, bacteria can develop new ways to fight the medicine, and they become resistant to antibiotic medications. This can lead to more visits to the doctor, more medication, higher medical bills or even a visit to the hospital.

Q. Do currently available antibiotics still work?

A. Yes. There are still many effective antibiotics available. The best antibiotic is the one that kills the bacteria and stops the infection the first time. Antibiotics are most effective when taken as prescribed by your doctor.

Q. Can an antibiotic be used to treat the cold or the flu?

A. No. Antibiotics only treat illnesses caused by bacteria. Colds and the flu are caused by viruses. Taking antibiotics when you have a virus may cause more harm than good. Your doctor can determine whether your infection is caused by a virus or bacteria.

Q. I was prescribed an antibiotic the last time I was sick, so is it safe to assume that I should probably take an antibiotic again?

A. No. Often, people become confused about whether they should treat the sniffles, a cough and aches with just rest and fluids, or with an antibiotic. Doctors report that many patients see them to request antibiotics even though antibiotics might not be appropriate. Your doctor will decide if an antibiotic is appropriate for you. DO NOT take leftover antibiotics or an antibiotic that was prescribed for someone else. Taking antibiotics when not needed may increase your risk of getting an infection that resists antibiotic treatment.

Q. If I feel better, can I stop taking my antibiotic?

A. No. Take your antibiotic exactly as prescribed-and that means finishing the entire course, even if you feel better. Stopping treatment too soon, even if you feel better, also contributes to resistance because the bacteria may be left to grow and multiply. Taking the complete course helps to make the medication effective, allowing it to kill the bacteria causing the infection and reduce the risk of resistance. If you feel worse or experience a side effect while taking an antibiotic, please consult your doctor.

Remember, antibiotics are strong medications that can stop infections and save lives. Talk to your doctor about whether or not you need an antibiotic and how to use it correctly.

Allergy drugs

Allergy drugs are all over - nasal antihistamines, oral antihistamines, decongestants - possibly it's time to get the facts on your allergy medicines.

Allergy medicine is available over the counter and it is prescribed widely by physicians all around the world. Pick up a journal there's ads, the TV is complete of ads - these products are heavily marketed and choosing the one that's going to work is an absolutely different game.

There are four allergy drug categories - oral antihistamines, nasal antihistamines, nasal sprays and decongestants. Let's have a look at every four categories.

Nasal antihistamines are newer and available through prescription and are a great allergy drugs for the correct situations. They work for 12 hours and are steroid free. It is believed because of inhalation the dosage absorbed is better. Side effects is drowsiness, headache, and post nasal drip.

Oral and nasal decongestants are another allergy medicines choice that is commonly used for those that have post nasal drip, runny noses, fever, sinus issues, pollen, itching, and sneezing. They are available in both prescription and OTC and in tablets, drops, sprays, and liquids. However the ingredient phenylpropanolamine which was found in older decongestants has been banned. Current decongestants include Sudafed, Triaminic, Ornade, and Entex. Decongestants can make you jittery, elevate your blood pressure, and make sleeping difficult. Sudafed should be in every medicine cabinet.

Nasal sprays. The non-steroid formulas are considered very safe and work best if you started a few weeks before the allergy season. Steroid formulas are available through prescription and are more effective and include Flonase, Nasonex, and Beclovent. Side effects include cataracts, hypertension, headache, weight gain, and nasal ulcers.

The last allergy medication we'll look at is oral antihistamines. Oral antihistamines are by far the most common allergy medicine prescribed by physicians. The block the histamines which is the chemical that is responsible for most of your symptoms. They do not give permanent relief but as an allergy drugs they do provide relief for itching, sneezing, hives, and nasal drip. Antihistamines can cause drowsiness and make it difficult to concentrate. You can actually be given a DUI if you are driving and taking this medication. Some of the OTC antihistamines are Benadryl, Atarax, Dimetapp, Tavist, Chlor-Trimeton, and Claritin. In fact Benadryl should be in every medicine cabinet.

But wait we've had a look at a variety of allergy medicines but there are also several natural remedies and an allergy medication that contains no harsh chemicals is likely to make your body much happier.

Besides considering a natural allergy medication you might also consider giving your body's immune system a boost with the right supplement. After all the cause of allergies is an immune system that is misfiring.

And that means that an allergy medication isn't always the solution to the problem. Sure it will reduce the symptoms but it is doing nothing to actually get to the bottom of the problem.

Once you get the facts on allergy drugs you are in a much better position to make educated choices that work for you, your type of allergy, and your person situation. Choose what's best for you.