In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action?
Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a multiple myeloma drug.
In more detail, from the Celgene Corporation Prescribing information for Pomalyst (accessed 6/3/15):
POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Pomalyst Case Evaluation
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On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, "Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity", which stated:
A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports.
This May 2015 MHRA Drug Safety Update included this detailed information about each of these Pomalyst side effects:
The review concluded that this side effect is common (ie occurs in between 1/10 and 1/100 patients who take [Pomalyst (pomalidomide)]). In most cases, this side effect occurred in patients with cardiac disease or cardiac risk factors and within 6 months of starting [Pomalyst (pomalidomide)]. The review also concluded that [Pomalyst (pomalidomide)] can cause atrial fibrillation, which may precipitate cardiac failure.
Interstitial lung disease
[Pomalyst (pomalidomide)] can cause ILD and related events such as pneumonitis. The review concluded that this side effect is common (ie occurrs in between 1/10 and 1/100 patients who take pomalidomide). Onset of respiratory symptoms is usually within 6 months of starting treatment. However, there have been cases where ILD occurred approximately 18 months after starting [Pomalyst (pomalidomide)]. ILD usually resolves with steroid treatment and stopping [Pomalyst (pomalidomide)].
It is already known that [Pomalyst (pomalidomide)] can elevate alanine aminotransferase and bilirubin levels. The review found that [Pomalyst (pomalidomide)] can also cause serious hepatotoxicity, mainly acute hepatitis. Hepatitis was considered an uncommon side effect (ie occurrs in between 1/100 and 1/1,000 patients who take [Pomalyst (pomalidomide)]). There have also been reports of acute liver failure in patients receiving [Pomalyst (pomalidomide)]; however the review could not determine if [Pomalyst (pomalidomide)] caused the liver failure in these cases. The risk of serious hepatic events appears to be highest in the first 6 months of treatment, therefore regular liver function monitoring is recommended during this period. The available data do not provide sufficient evidence to support specific guidance on monitoring frequency.
We will continue to monitor the safety profile of Pomalyst (pomalidomide) including watching for any similar side effects warnings by the FDA.