FDA Requests Lorcaserin Withdrawal, Scant Disclosure

FDA yesterday requested that Eisai withdraw lorcaserin (Belviq®) from the market due to a small increase in cancer observed in a large cardiovascular safety study. Eisai disagreed with the request but complied with the request nonetheless. We have no data to help us understand what is going on.

Is FDA over-reacting to a spurious observation? Or is the agency acting wisely and cautiously? It’s impossible to know because the disclosure of facts is scant.

What We Do Know

What we do know is this. FDA says that they saw a difference of 0.6% in the incidence of cancer in patients receiving lorcaserin in the massive CAMILLA-TIMI study. This was a study to evaluate cardiovascular safety, not cancer risk. It enrolled 12,000 patients, randomly assigned to lorcaserin or placebo.

This study found no increase in cardiovascular risk but it also found a reduction in the risk of diabetes for the patients who received lorcaserin. That’s an important outcome.

We also know that the NEJM publication of this study signaled no difference in cancer risk. With only three years of data, the incidence of any cancer was 3.59 percent for lorcaserin. It was 3.50 percent for placebo. Now, with longer follow-up, the FDA says the incidence is 7.7 percent in the lorcaserin group. It’s 7.1 percent in the placebo group.

Differing Interpretations

FDA says that this observation warrants withdrawal of the drug from the market. Eisai disagrees, saying:

Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA. The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated.

Transparency Lacking

Nonetheless, Eisai is bowing to the FDA and withdrawing the drug. No hearing. No publication of a risk-benefit analysis. Essentially, no transparency in the basis for this decision.

This decision might be precisely correct. But we deserve to see full disclosure of the basis for it. This bit of news represents a near complete failure of transparency in drug safety decision making.

Click here for the notice from FDA, here for the press release from Eisai. For further reporting, click here.

Dark Smoke, photograph © Andrew Magill / flickr

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February 14, 2020