An anti-acne drug, mainly prescribed to teenagers, is to be investigated by the Irish Medicines Board because of possible links with depression and suicide. Roaccutane, manufactured by Roche Pharmaceuticals, has been linked to a case involving a 20year-old UCD student who committed suicide last year. The family of the student has called for an international study of links between the drug and suicide.
In the US, new warnings are to be given to patients taking Roaccutane. The US drug safety authority, the FDA, has issued a statement advising of "important new safety information". It had "isolated reports of depression, psychosis and rarely, suicidal thoughts and action".
A statement said that although the drug already included information regarding depression as a possible adverse reaction, it felt "health-care providers and others needed additional information as a result of adverse event reports" it had received.
Mr Mark Rodgers, managing director of Roche Pharmaceuticals in Ireland, said the company was in discussion with the regulatory authorities worldwide. It had no immediate plans to change the information given to patients taking the drug.
"We have no plans to change the data sheet here while we are still in discussions with the regulatory authorities. We will come to a considered conclusion always with the patient in mind," he told The Irish Times.
Safety advice in the US is to be changed by Roche. The adverse reactions section of the product information will include warnings about psychiatric disorders, stating that the drug "may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide". It will say discontinuation of the therapy may be insufficient and further evaluation may be necessary.
The company said reports of such adverse reactions were uncommon but, because of their potential consequences, doctors "should be attentive to any new behavioural signs and symptoms". The FDA also said it was difficult to identify the exact cause of these problems. Such problems, it said, could already be more common among the people likely to be taking it, teenagers with acne.
The chief executive of the Irish Medicines Board, Dr John Kelly, said the board was aware of the FDA communication on Roaccutane. "We are reviewing this and have taken up the matter with the company. Depending on this re view the matter may be discussed further with our European colleagues."
He said Roaccutane should be given "only by or under supervision of" a consultant dermatologist, and the data sheet should contain the precaution that "some patients have experienced mood changes including both reduction and precipitation of depression".
Roche estimates there have been more than 16 million "patient exposures" to Roaccutane since it was introduced to the market in the early 1980s. Generally patients are treated for up to four months. Mr Rodgers said it had up to 600 cases of depression recorded internationally and 26 suicides.
The company believed, following extensive research, there was a "lack of a causal link" between Roaccutane and suicide. The majority of those who committed suicide had a "relevant medical history". "However, one can never tell with an individual patient where there is a predisposition that a link may not occur. With a single individual case it can't be ruled out, just as it could not be ruled out if any drug were being taken at the time."
The drug, which is intended for people with severe acne, is generally prescribed for teenagers. Roche estimates that hundreds of people are taking it in Ireland. He said the company already had a warning in the drug data sheet concerning depression, and on the information sheet given to patients there were warnings of possible mood changes.
Mr Rodgers said the FDA had "taken a particular step" in relation to Roaccutane. "Obviously some expert thinks there may be a link or thinks it might be judicious to contain this warning. European authorities tend to be a bit more circumspect but no less careful."
