For consumers
(1300 633 424)
Mon-Fri | 9am-5pm AEST
Your call will be answered by healthdirect Australia
For health professionals
Find out the active ingredient and other brand names of your medicines with the NPS Medicine Name Finder
For a medicinewise Australia
Independent. Not-for-profit. Evidence based.
Site Tools
Why new medicines aren’t always better than older medicines Just because a medicine is new, does that mean it’s better?
Many people think because a medicine is new, it must be better than older medicines for the same condition — but this is not always the case. Read how to work out whether a new medicine is the best option for you.
Many people think because a medicine is new, it must be better than older medicines for the same condition – but this is not always the case.
For a medicine to be approved, it must have been through clinical trials that show that it provides a benefit (i.e. it works) and what its side effects are. Mostly clinical trials compare the medicine with a placebo (i.e. a dummy pill with no active ingredient), but it is not always clear how well it compares to other medicines, simply because there is not enough information available.
When a medicine has been available for only a short time (e.g. less than 5 years), there are some reasons to be more cautious about taking it. Our knowledge about a medicine’s benefits and side effects grows with time, and new medicines have not been taken by a large number of people over a long period. This means side effects that are rare, that happen after long-term use, or that only occur in certain types of people may have not yet come to light.
The medicine rofecoxib (Vioxx) came on to the market in 1999 as a treatment for pain in arthritis. At first, it seemed that it was similar to other arthritis medicines used for pain relief, but with a lower chance of causing stomach ulcers and stomach bleeding. However, after 5 years, it became apparent that rofecoxib increased the risk of heart attack and stroke for some people taking it. It was then withdrawn from sale.
If you and your health professional are not happy with the results from your current medicine or with the alternatives, then it may well be worth considering a new medicine. Otherwise, there is probably no reason for you to rush into making a change.
Less is known about who will benefit and who will get side effects
Clinical trials for new medicines are usually carried out in fairly restricted groups of people. They often exclude people who are older, who are in general poor health (other than with the condition the medicine is expected to treat), who perhaps drink more than the recommended limits for alcohol or who are taking a number of other medicines. There may be good reasons for these restrictions – including the safety of the trials’ participants, but it does mean that little is known about using the medicine in such people.
For example, a trial of a medicine to treat high blood pressure may be carried out only with people under 65 whose only health problem is high blood pressure. Whether the medicine works as well in older people with multiple health problems will not be so certain until the medicine is used more widely in the community.
New medicines need to be tested for safety before they are approved, but in most cases they are tested in no more than a few thousand people. This means rare side effects (i.e. those occurring in fewer than 1 in 1000 people) will usually not show up until more people have taken the medicine. The result? It can look like new medicines have fewer side effects than older ones, just because there is not as much information and experience with them.
Fewer direct comparisons in clinical trials
The best way to compare different medicines is through head-to-head trials; that is, trials that directly compare the effects of two medicines. This type of trial gives the fairest comparison between two medicines because the people taking each medicine will have been carefully chosen to have very similar health problems, and the effects of each medicine will be assessed in the same way.
However, trials that directly compare medicines are usually only done several years after a medicine has been approved for use. And sometimes they are never done at all.
Video: New versus older drugs — why I go for the tried and true
©2011 NPS
Run time: 0:34m (6.8 MB)
Video transcript
Because they take an extremely large sample, from memory, I think it was something like 12,000 people, or it was a couple of thousand people, had taken it and the incidence rates were very low, it indicated to me that it had been well researched.
And the other thing that was important for me was that it had been used for quite a while — it wasn’t a new drug on the market, which I would naturally be quite wary of. I don’t want my kids to be the guinea pigs; I would like to see the rates of any serious side effects occurring.
Weigh up the benefits and risks
You should not be influenced to take something simply because it is new. New medicines should be considered the same way as any other medicine — by weighing up both its benefits and risks for your situation. With new medicines, you need to bear in mind that there may not be enough good information available to help you do this.
Related topics
For more information
Medicine Update
Medicine Update lets you know about new medicines and new PBS listings. Each issue provides an independent assessment of current information and research about a different medicine.
I’m the kind of person that likes to keep up-to-date with everything. I read the news a lot and I’m interested in new medicines and health developments. I look after myself and stay active. I’m careful with what I eat and drink because I’ve got type 2 diabetes, but I think I’m managing it well. It doesn’t seem to affect me too much, besides nausea every now and again. I’ve had diabetes for over 10 years now and take my regular tablets, metformin (brand name Diabex) and gliclazide (brand name Diamicron).
Related information
I really like reading what other people with diabetes have to say, and I have a favourite online forum I use. The other day someone mentioned sitagliptin (brand name Januvia), a new medicine for type 2 diabetes. He said he felt really good on it and I wondered if it could be for me. My current tablets give me a bit of nausea. It’s not as bad now as when I first started taking them, but I’d still rather not have any at all. From what he said, sitagliptin sounded like a better medicine.
I was really interested in trying sitagliptin for myself. I booked an appointment with my doctor to ask her more about it. To be honest, she didn’t seem to be as excited about it as I was. She asked me if I had any problems with the medicines I’m on now, and I told her that, besides the nausea, they were fine.
I asked her how good sitagliptin was, and she said it was approved to treat type 2 diabetes, and that clinical trials (road-testing in groups of people) have shown that it is effective for lowering blood sugar levels. That’s what you want, I thought. But then she told me less is known in general about new medicines because fewer people have used them. For example, she said, we don’t know if sitagliptin reduces the long-term complications of diabetes, like damage to blood vessels, which can lead to heart attack, stroke or other serious complications. Metformin, one of the medicines I’m taking now, does do that.
As for side effects, she said that the common side effects with sitagliptin are headaches and cold-like symptoms, but she also said it might have some rare side effects we don’t know about yet. Apparently, there have been reports of pancreatitis, when the pancreas gets inflamed, in some people who had started on sitagliptin. My doctor said it wasn’t clear yet if sitagliptin really caused this rare side effect though. ‘It takes time for enough people to use the medicine to establish what all the benefits and all the side effects are,’ she said.
I had thought new medicines would have to be better than older ones to be approved, but she said that new medicines weren’t necessarily better than older ones — they only have to be more effective than a placebo to be approved.
I felt a bit confused, so my doctor said it might help to write down the positives and negatives, and how important they were to me, using the Personal decision guide for medicines — this is what it looked like when I’d written everything down:
* = doesn't matter too much * * * * * = matters a lot
Writing the pros and cons down actually made things clearer, and it helped me decide I was more comfortable sticking with metformin for now.
This is a fictional account for educational purposes.
Related information
- For more information about diabetes, see Managing diabetes with drugs and non-drug interventions.
- For more information about sitagliptin, see Medicine Update August 2010: Sitagliptin (Januvia) for type 2 diabetes.
Next steps
Date published: 2011-01-24 00:00:00
Reasonable care is taken to provide accurate information at the date of creation. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries. Where permitted by law, NPS disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer.
References to brands should not be taken as an endorsement by NPS.
