Former deputy commissioner of the U.S. Food and Drug Administration (FDA), Joshua Sharfstein, is calling for tougher limits on how patients can get the new obesity drug, Contrave. This recommendation is in response to the medication’s manufacturer, Orexigen, making allegedly false claims that the drug prevents heart attacks and strokes.
Contrave is a new drug to help obese or overweight patients lose weight, and is a combination of two drugs (naltrexone and bupropion) that can decrease appetite. The medication should be used with diet and exercise. It shouldn’t be used if you have an eating disorder, a history of seizures, take narcotic medications, are pregnant or breastfeeding, take another form of bupropion, or have several other chronic conditions. Common side effects include trouble sleeping, nausea, irritability, dizziness, and headache.
The controversy stems from data Orexigen released last year claiming that Contrave had benefits to the heart, but the analysis only looked at the first 25 percent of the study’s data. Orexigen leaked this data against instructions from the FDA, which caused the study to be deemed no longer scientifically valid enough to prove Contrave was safe for the heart. However, the FDA did eventually approve the medication before a new trial had started. Full data from the original study has not shown heart benefits, and future results aren’t expected until 2022.
The former deputy commissioner believes the manufacturer is providing misleading information to patients and the FDA needs to counter it using available tools. One tool is requiring Contrave be dispensed using a Risk Evaluation and Mitigation Strategy (REMS). The purpose of a REMS program is to provide patients with the exact risk they’re taking when they use a medication so they can make informed decisions. If a REMS program is implemented for Contrave, then patients would receive material about how the medication’s cardiovascular risks are still largely unknown.