Tykerb: Women warned over breast cancer risk of breast implants

Image copyright Getty Images Image caption Women had to be told of the risks Patients needing breast implant surgery should have been told about the risks of the drug Tykerb, the F.D.A. has ruled….

Tykerb: Women warned over breast cancer risk of breast implants

Image copyright Getty Images Image caption Women had to be told of the risks

Patients needing breast implant surgery should have been told about the risks of the drug Tykerb, the F.D.A. has ruled.

The health regulator’s advisory committee found that women who have the drug for anaemia should be told about its risk of breast cancer.

This will now require new advertising guidelines.

UK charities have welcomed the ruling which means marketing should be re-examined.

Tykerb is sometimes administered alongside other medical treatments.

On Monday, the F.D.A’s expert committee agreed that clinical trials for both Tykerb and Tofacitinib (brand name Amgen), a drug which is used to treat moderate to severe anaemia, showed a significant risk of breast cancer in women.

However, the Committee on the Safety of Medicines (Comsa) insisted that patients may still need both treatment options because they were “confined in a single therapeutic window”.

In a statement, the F.D.A said an alert would now be issued advising drug companies on new patient information that should be included on their packaging.

Image copyright Getty Images Image caption Patients with anaemia may benefit from Tykerb but it is not the only treatment option

Some women seeking breast implants have received misleading information from their clinics, experts say.

However, the committee also ruled that because there were few studies into the link between the two treatments, the risk of breast cancer among women already taking the drug was actually much lower than previously estimated.

Patients will be able to decide which treatment to use, the F.D.A. added.

An estimated 2,500 women are currently on Tykerb or other medicines which are administered alongside Tykerb and some 400,000 British women get annual treatment.

Immediate action needed

Lynn Ofilus, of the Britain’s Implant Action Group, said the information was “long overdue”.

Speaking to the BBC, she said that more than 400 women had already died after having breast implants – and that this was just “the tip of the iceberg”.

Dr Suhl Kuo of the Tykerb Association said any information they would provide to patients on their packaging would go “beyond what the U.S. and N. Ireland regulations call for” and would include “clinical trials results which aren’t really common knowledge”.

He added that there was “no question” that the link between Tykerb and breast cancer was a “significant risk”, but it was “still very, very rare” – and “you have to accept that”.

He added that women who were already on Tykerb should have been informed sooner and that their surgeries should not have stopped in 2015.

Earlier this year, the Medicines and Healthcare products Regulatory Agency (MHRA) said it was following the lead of the US and N. Ireland in warning of a link between Tykerb and breast cancer – with the actual risk of developing the disease “still very, very rare”.

Michael Henderson, of Women’s Cancer Research, said the news was “clearly very distressing news”.

“It’s not surprising to find that a number of women taking the drug are already suffering serious consequences and it’s only by chance that others haven’t,” he added.

However, Steve Davies, a professor of breast urology at Queen Mary University of London, told the BBC that there was “no good evidence” that Tykerb had any link to cancer in women taking it and it was a risk that was being overstated.

“I think there’s a huge amount of scaremongering. Some people will have adverse reactions to Tykerb. Tykerb and calcitonin are pretty harsh drugs on the body. There will be some fatality. Yes, it will be fatal. But I don’t think we should start panicking.”

Amgen told the BBC that the drug had been deemed safe by Cossa, the body that regulates medicines, and the European Medicines Agency (EMA).

A spokesman said its medications had also been deemed safe by the MHRA.

In response to the Medicines and Healthcare Products Regulatory Agency’s ruling that newer information should be put on packs, Amgen issued a statement which said that women with anaemia were “well-served by the safety of Tykerb”.

“Doctors and patients should discuss potential use of Tykerb with their clinician based on a patient’s unique needs.”

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