No need to beef up PPI warnings
Warnings of cardiovascular risk from use of proton pump inhibitors do not need to be beefed up, the TGA has decided.
The regulator has reviewed two recent studies linking proton pump inhibitor use with an increased risk of myocardial infarction and found that neither adequately demonstrated an increased risk that is independent of the patient population in which they are being used.
“As a result, no further action is required at this time,” the agency decided.
The TGA found that neither study was designed to address the possibility that PPI use was itself a marker of increased cardiovascular risk, as information on significant baseline risk factors was not collected.
Additionally, PPIs may have been used when anginal pain was mistaken for pain due to gastro-oesophageal reflux.
“Because of these limitations, these two studies did not demonstrate an increased cardiovascular risk for PPIs that was independent of the patient population in which they were being used,” the TGA said.
It will continue to monitor this issue and encourages health professionals to report cardiovascular adverse events associated with use of PPIs.
The findings were published in the latest Medicines Safety Update.
Biosimilar is similar, but not the same
Small differences between batches of a newly PBS listed biologic medicine are OK, according to a fact sheet recently added to the PBS website.
The fact sheet is part of the TGAs ongoing Biosimilars Awareness Initiative and has been sent to pharmacists and prescribers. Its’ release has been timed to coincide with the 1 December PBS listing of Pfizer’s Inflectra, the first biologic infliximab.
According to the fact sheet, the two brands are “comparable”.
“The TGA approved Inflectra as a biosimilar of Remicade. This means the TGA has determined that Inflectra is as safe and effective as Remicade and can be used to treat the same conditions,” it says.
However, it does state that “small differences can also occur” between batches of the same brand of a biological medicine when the manufacturer changes a manufacturing process or facility.
“Because these medicines contain large, complex molecules, there can be slight differences between brands as a result of differences in manufacturing. This is why they are considered similar, not the same”.
New COPD treatment on PBS
The first tiotropium-based combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) has been added to the PBS.
PBS listed from 1 December, Spiolto Respimat combines 5μg of tiotropium and 5μg of olodaterol in the Respimat Soft Mist inhaler.
“The therapy has been shown to offer improvements beyond tiotropium or olodaterol alone for COPD patients in measures of lung function, breathlessness, quality of life and rescue medication use,” claims its manufacturer, Boehringer Ingelheim.