Female Contraception

Oral Isotretinoin is a teratogenic drug. This means it can cause birth defects if it is taken during pregnancy.

It is extremely important that female patients that are considering oral isotretinoin ensure that they do not become pregnant for the duration of their treatment.

Oral isotretinoin prescription for patients with no childbearing potential (this is classified as males, post-menopausal women and patients who are not sexually active) is a lot easier to monitor as there is zero chance of pregnancy.

Any sexually active female of childbearing age will have to consider contraception. This will be discussed during your consultation with your prescriber. If you are a female of childbearing potential that is sexually active you MUST use an appropriate form of contraception to prevent pregnancy whilst taking oral isotretinoin and for one month after the course of isotretinoin is completed.

Appropriate forms of contraception are as follows:

  1. The coil (Intra uterine Device – IUD) eg. Copper coil
  2. Hormone Secreting Coil (Intra Uterine System – IUS) eg. Mirena coil
  3. Contraceptive Implant – This is a longterm implant inserted under the skin by your doctor in family planning clinic and provides effective contraception for a period of typically 3 years (please check with your provider) before requiring removal and replacement.
  4. Combined Oral Contraceptive Pill (NOT MINIPILL) is satisfactory when combined with a barrier contraceptive (condom, femidom, vaginal cap/diaphragm). The combined oral contraceptive pill must be used together with a barrier method as it is not as reliable form of contraception as the IUD or IUS or contraceptive implant.
  5. Longterm abstinence from sexual intercourse.

Taking oral isotretinoin without appropriate contraception:

At Dermacne we respect female choice when it comes to contraception. However if you are not using any form of contraception or relying solely on barrier methods such as condoms then you have to understand the following:

Falling pregnant while on oral isotretinoin carries an extremely high risk of foetal deformity and brain development abnormality. You are very likely to give birth to a physically deformed and mentally disabled baby. Brain development abnormality and physical deformity such as facial, ear, eye and skull deformities are well known to be triggered by oral isotretinoin. This can lead to long term severe mental and physical disability in the affected child. If you conceive whilst on oral isotretinoin there is a high likelihood of these types of deformity and longterm disability in your child.

Termination will be an option but this is both mentally and physically traumatic to the mother. The consequences of pregnancy whilst on oral isotretinoin have a severe impact on everyone involved in the process. It is therefore essential to prevent pregnancy during oral isotretinoin treatment.

Whilst we at Dermacne respect your freedom of choice when it comes to contraception we can only offer accurate advice and support for your decision. As with all medical treatments risks of oral isotretinoin must be weighed against benefits of treatment. Failure to use appropriate contraception is a risk.

Pregnancy Prevention Program

All patients will on oral isotretinoin will be entered into the Pregnancy Prevention Program (PPP). This is a legal requirement that is enforced by the MHRA. It is not a choice. You will also be asked to confirm you have understood the risks of falling pregnant whilst on Accutane. You are obliged to let us know if any situation regarding pregnancy risk changes or anything that may result in your PPP classification group changing.

Following your initial consultation at Dermacne if isotretinoin is deemed suitable you will be classified into one of the following categories.

PPP not applicable – no childbearing potential

No requirement for pregnancy testing. Prescription may be extended for longer than 30 days (up to 12 weeks if no other side effect monitoring required) once patient is stable on treatment.

PPP group A – no expected risk of pregnancy (see above)

Pregnancy testing not mandated. Prescription may be extended for longer than 30 days (up to 12 weeks if no other side effect monitoring required) once patient is stable on treatment.

PPP Group B – on highly effective contraception (IUD, IUS or implant) for at least 4 weeks

Pregnancy testing will be done at clinic appointments and patients are advised they may wish to do monthly pregnancy tests at home because no contraceptive is 100% effective. Prescription may be extended for longer than 30 days (up to 12 weeks if no other side effect monitoring required) once patient is stable on treatment.

PPP Group C – on effective contraception (a hormonal contraceptive pill or hormonal injection PLUS a barrier method i.e. condom, female condom or vaginal cap) for at least 4 weeks

Pregnancy testing is mandated monthly prior to issue of prescription. Prescription will be limited to 30 days and will need to be picked up within 7 days of the pregnancy test and prescription being issued.

If you fall into PPP class C then monthly pregnancy tests are mandatory requirement. For this purpose you will have pregnancy test kits issued with your medication. You will be required to send a photo of your negative pregnancy test prior to a new prescription being issued.