Cardiac safety concerns for obesity drugs aren't a new phenomenon: Fen-Phen and Meridia were notoriously yanked from shelves for troubling side effects. But companies selling a new generation of drugs--such as Eisai's Belviq and Takeda's Contrave--are quick to cite studies showing their products are safe for patients' hearts.
And overall, an analysis by AdverseEvents shows the new obesity meds are holding their own, safety-wise. Still, postmarketing data flag some serious cardiovascular and neuropsychiatric side effects that are worth watching, the healthcare informatics firm says.
The healthcare informatics firm scoured the FDA's postmarketing safety reports and found a number of psychiatric and cardiovascular side effects--as well as other problems--for Vivus' ($VVUS) Qsymia, Eisai's Belviq and Orexigen and Takeda's Contrave. Qsymia was the most risky drug, AdverseEvents concluded, with 20 cases of angle-closure glaucoma, or increased pressure behind the eye; 17 cases of mental impairment and 11 cases of suicidal ideation. Qsymia was also linked to four cases of pneumonia and three cases of deafness.
Eisai's Belviq, which AdverseEvents deemed the least risky option of the three, had 14 cases of suicidal ideation and 10 cases of mental impairment. The drug was also linked to 5 cases of atrial fibrillation and four cases of loss of consciousness, the report stated. Both Belviq and Qsymia are in postmarketing cardiovascular trials to determine their long-term cardiac safety, the AdverseEvents report noted.
The side effects mentioned in AdverseEvents' report do not necessarily indicate any immediate problems with the meds, Chief Product Officer Bob Kyle told FiercePharma. The drugs are not without risk and require further monitoring, he said. But "they're showing pretty safe profiles for now," Kyle added.
Eisai stands by Belviq's safety, telling FiercePharma in an email that it "actively monitors the safety profile of its products through a variety of methods." The company's surveillance includes collecting and reviewing spontaneous reports, "monitoring of the literature, and analysis of clinical trial data," a company spokeswoman said.
Vivus is singing a similar tune for Qsymia, saying the side effects mentioned in AdverseEvents' report "can be easily recognized and safely managed by prescribers," the company told FiercePharma in an email. The cases of suicidal ideation linked to the drug "are events that have been shown in clinical trials not to occur in excess of placebo," it added.
"Vivus believes that the benefit/risk profile of Qsymia is favorable for overweight and obese patients who are in need of treatment, as demonstrated through a comprehensive clinical program leading to FDA approval in 2012 as well as postmarketing experience in well over 300,000 patients since launch," the company said.
Even though Orexigen ($OREX) touted early cardiac data for Contrave earlier this year, AdverseEvents found some worrisome side effects for the drug in its report. Contrave had two cases of inflamed pancreas, 9 cases of suicidal ideation, 7 cases of convulsion and three cases of loss of consciousness in the firm's analysis of postmarketing safety data.
"Patient safety is Takeda's first priority, and as a company, we are committed to the ongoing monitoring and evaluation of safety information for Contrave," a Takeda spokeswoman told FiercePharma in an email.
And RBC Capital Markets' Simos Simeonidis agrees with Kyle's assessment, saying the data mentioned in AdverseEvents' report "is not especially troublesome."
"Safety has not been a major overhang," Simeonidis told FiercePharma. "Given this drug class' prior history, it's something doctors have to overcome because a lot of them are thinking of Fen-Phen and the safety those drugs have. I wouldn't be quick to draw conclusions."
- access AdverseEvents' report here (sub. req.)
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