Roaccutane

(Limited Text - Ministerial Extracts only)

Tuesday 3rd December 2013 Westminster Hall

[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 Roche, which first licensed Roaccutane, has withdrawn its product for commercial reasons in a number of countries, including the USA.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.

[Caroline Nokes]

I have sat in on four consultations when Roaccutane has been prescribed. I reassure the Minister that consultant dermatologists tend not to just hand over a leaflet; they stand over a patient while they read it.

[Norman Lamb]

I am grateful to my hon. Friend for her intervention. I am sure that that is the usual practice. However, the concern expressed by my hon. Friend the Member for Beckenham (Bob Stewart) suggests that that may not uniformly be so, though it certainly ought to be.

Since 1998, there has been increasing awareness that Roaccutane may be associated with psychiatric adverse reactions, particularly depression and suicidal behaviour. The assessment of this issue has been complicated by the fact that young people with acne are already at an increased risk of depression, regardless of treatment. All psychiatric adverse reactions were assessed by the working group on isotretinoin in 2005. This working group of the Committee on Safety of Medicines consisted of independent experts, including psychiatrists and dermatologists, who considered the available data from published literature and case reports. All new information on psychiatric adverse reactions has remained under close and regular review since that time.

The product information for Roaccutane, and the other generic alternatives, states that particular care needs to be taken where patients have a history of depression, and that all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. It also states that stopping taking Roaccutane may not lead—as hon. Members have mentioned—to improvement, and therefore further psychiatric or psychological evaluation may be necessary and appropriate.

As it is associated with rare, serious side effects, Roaccutane can only be prescribed by, or under the supervision of, a consultant dermatologist. The British Association of Dermatologists has published guidelines for its members on when to prescribe Roaccutane and how best to monitor patients for adverse effects during treatment. The guidelines recommend that patients be asked about any previous psychiatric illness, and the patient and their family should be made aware that the medicine may affect their mood. Patients should be asked about psychological symptoms at every clinic visit.

I appreciate that, in the case of the constituents of my hon. Friend the Member for North Devon, there appeared to be a rapid deterioration of mental health—certainly, a deterioration that immediately followed the start of taking Roaccutane. Female patients will be asked about such symptoms every four weeks because of the need to rule out pregnancy before a new prescription is issued. The Medicines and Healthcare products Regulatory Agency keeps this issue under close review. Any new information is carefully assessed to see whether there is a need to take action to alert health care professionals and patients.

This debate has provided an important opportunity to update the House on developments relating to the prescribing of Roaccutane, which was last debated about 10 years ago in this place. As with any effective medicine, difficult issues of risk and benefit must be grappled with. Few hon. Members will not have known someone who has suffered, physically or mentally, with the scars of acne—severe and acute acne can be a disabling condition—and few would doubt the serious nature of the potential side effects of this powerful medicine, and their tragic potential consequences. In the short time available, I hope that I have been able to update the House on the measures in place to ensure safe prescribing of Roaccutane.

[Sir Nick Harvey]

I sense that my hon. Friend is reaching his peroration. He has offered us reassurance that the drug is used only under the auspices of specialist doctors and, apparently, only in severe cases, although my constituent’s was a mild case. Is he minded to take any further action at all, because as yet he has not suggested anything?

[Norman Lamb]

I am grateful for that intervention. I was going to suggest, at the end of my speech, that I am happy to talk to my hon. Friend and his constituent, if he wants that, because this concern cannot be dismissed in a half-hour debate. I am happy to look further at his concerns, because they could not be more serious. I recognise that other hon. Members are interested as well, and I am happy to meet others, if that would be of some use. I understand the seriousness of the issue that my hon. Friend raises.

Question put and agreed to.