Roaccutane

Bob Stewart Excerpts

Tuesday 3rd December 2013 Westminster Hall

[Sir Nick Harvey]

My hon. Friend makes an important point. The point when people are at the greatest risk can be as long as six months after taking the drug. In the case of John Medland, the impact was swift and profound, but in other cases, it has occurred some time later.

[Bob Stewart (Beckenham) (Con)]

Is it possible, therefore, that there is a link? If the drug is a toxic chemotherapy agent, it may well have a permanent effect on the brain. Consequently, after the person stops taking the drug, it can affect their personality. Could that be the reason?

[Sir Nick Harvey]

My hon. Friend tempts me beyond my limited medical expertise, but the logic of what he is describing sounds convincing. The other point to be made about the delay in some cases is that the numbers on the incidence of suicide and psychotic disorder that I quoted a few minutes ago are highly likely to be gross underestimates. For example, just this morning, I had a telephone call from someone in Cornwall who had heard a morning bulletin on his local BBC radio station referring to this debate. He said that for the first time, the penny dropped with him. He had attempted suicide and been forced out of the Royal Navy, but he had never before put the two things together. With the benefit of many years’ hindsight, he realised that it happened just months after he had used Roaccutane to deal with acne. I therefore think that it is fair to say that we are looking at numbers far greater than we first thought.

--- Later in debate ---

[The Minister of State, Department of Health (Norman Lamb)]

I congratulate my hon. Friend the Member for North Devon (Sir Nick Harvey) on securing this debate, and I say right at the start that I take the issue that he raises extremely seriously. I cannot begin to imagine what families have gone through after suffering such tragic losses, but if I was in their shoes, I would be campaigning and fighting, just as they are. I applaud the work that they have done in raising an issue that is obviously of intense concern to them.

Roaccutane is the brand name for the drug substance isotretinoin—my hon. Friend and I have both had some difficulty in pronouncing it. During my speech, I will refer to “Roaccutane”, although it is one brand name of that drug. I am grateful to my hon. Friend for providing this opportunity to update the House on issues relating to the prescribing of this medicine. I will aim to address the serious concerns that have been raised about the safety of Roaccutane, including the adverse psychiatric effects that my hon. Friend and other Members have expressed concern about.

Roaccutane is a derivative of vitamin A that is used for the treatment of severe and resistant acne; it is important to stress that. My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) made the point that it is used only in those cases.

Acne is a common condition that affects around 80% of adolescents at one time or another; it affects adults more rarely. Although acne is not life-threatening, it can have a significant impact on the lives of sufferers. In its severe forms, acne can be both extremely debilitating and distressing, causing real disfigurement and permanent scarring. It can also have a genuine impact on someone’s mental health. Many forms of acne will respond well to treatment with topical preparations or systemic antibiotics. For severe and resistant acne, however, effective treatment options are more limited.

Roaccutane has been authorised in the UK since 1983. It is available worldwide and has been used by millions of people. Roche, which first licensed Roaccutane, has withdrawn its product for commercial reasons in a number of countries, including the USA. However, other brands of the same drug—so-called generic drugs—are still available in those countries. It is a highly effective oral treatment for severe and resistant acne. However, all effective medicines are associated with a risk of side effects in some people. I appreciate that the side effect, or potential side effect, that we are talking about is of the most serious nature possible.

Unfortunately, it is impossible to predict which individuals will suffer a side effect from a medicine, but a medicine will be issued a licence only if it is considered that the benefits of treatment in the licensed indications outweigh the risks of side effects. The risks and benefits of Roaccutane were carefully considered at the time of licensing and, because of the known safety profile of this drug, it is licensed for use only for severe forms of acne that are resistant to other treatment. Since licensing, the safety of Roaccutane has been closely monitored by the Medicines and Healthcare products Regulatory Agency, with expert advice from the Commission on Human Medicines.

Roaccutane is a medicine that is highly effective at doing what it is designed to do. It is associated with some serious side effects. Roaccutane is harmful to the unborn foetus and therefore must not be taken during pregnancy. When Roaccutane is taken, common side effects include dryness of the skin and the lining of the mouth, nose and eyes. The dryness of skin that is associated with Roaccutane can take the form of cheilitis, which is cracking or inflammation of the lips. This condition can become very severe, chronic and debilitating in some patients. There has also been significant concern about the possibility that Roaccutane may be associated with psychiatric adverse effects, such as depression and suicidal behaviour.

Roaccutane is licensed for use only for severe forms of acne that are resistant to other treatment. This narrow indication for use is not the only restriction on its use in the UK. As my hon. Friend the Member for Romsey and Southampton North said, it can only be given by, or under the supervision of, a consultant dermatologist. The intention behind restricting prescribing in this way is to ensure that the health professionals with the most experience, and who are best placed to give patients advice about the important safety issues related to the drug’s use, make the prescribing decisions.

To underpin the discussions between prescriber and patient, all licensed medicines have a summary of product characteristics, which contains important information for prescribers, and are accompanied by an information leaflet for patients.

[Bob Stewart]

The nephew of a constituent, Elliot Brandon, was prescribed this drug by the doctor, but neither he nor his mother were given any indication that there might be side effects. That has to be stopped. We have to correct that, as soon as possible.

[Norman Lamb]

I was going to make that point. It is important that proper advice is given to patients when a drug is prescribed. My hon. Friend raises a serious concern on behalf of his constituent. I accept his point. The patient information leaflet is an essential document if the patient is to be fully aware of the possible risks of treatment and make informed choices about their care. Of course, unless they are directed to it and advised to read it by the clinician, the chances are that they will never read it. That is an important point.