No reason for women to stop using Ortho Evra patch
The company at the centre of a patient safety scare over the contraceptive patch Ortho Evra said this week that the incidence of reports of adverse events, such as deep vein thrombosis, associated with the patch were consistent with those from other hormonal contraceptives.
Manufacturer Janssen-Cilag said that it was aware of reports of the deaths
of six patients worldwide who had been using the patch but was unable
to say what contribution, if any, the product had to their deaths. Its
head of medical affairs Gill Hamilton said she was not aware that any
of the cases were linked to patients in the UK.
Dr Hamilton was unable to confirm media reports that the Food and Drug
Administration in the US was considering 17 patient deaths that may be
linked to Ortho Evra. She said: “We are aware of six separate cases
worldwide, associated with death, since the drug was made available in
2002. It may be that the reports of 17 cases to the FDA are duplicate
reports.”
Dr Hamilton also said that the incidence of reports of adverse events
associated with Ortho Evra were consistent with those from other hormonal
contraceptives and the safety warnings on its patient information leaflets.
She said: “The risks and benefits of Ortho Evra are consistent
with what we already have on the labels — we don’t need to
tell women to rush off to see their GP. The risks of DVT with Ortho Evra
are less than the risks of DVT in pregnancy.”
A spokeswoman for the Medicines and Healthcare products Regulatory Agency
said it had received two reports of adverse drug events associated with
Ortho Evra since the treatment became available in the UK last May. Neither
of the cases was fatal. One patient suffered DVT while another had a
pulmonary embolism but, she added, that did not mean that the drug was
responsible.
The Ortho Evra patient information leaflet clearly warns about the associated
risks of DVT and pulmonary embolism and it was up to individual patients
to weigh up the individual risks and benefits.
There was no reason for women to stop using the patch, the MHRA spokeswoman
added. |
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