Avanthi Inc., and KVK Tech Inc,, were warned by the Food and Drug Administration (FDA)’s Office of Prescription Drug Promotion (OPDP) about the marketing materials displayed at two scientific conferences in 2017 for their diet drug Lomaira. The agency said the displays contained multiple statements about the benefits of the drug but did not say anything about the potential risks, which include serious drug interactions and a deadly lung disease.
“By omitting the risks associated with Lomaira, including serious and potentially fatal risks, the panel fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the OPDP stated in the warning letter.
Lomaira contains the active ingredient phentermine, which was half of the popular diet pill fen-phen. The drug was pulled off the market in 1997 after the other ingredient in the drug, fenfluramine, was linked to serious heart problems. The agency said it is still not known whether phentermine carries similar risks when used alone.
Phentermine, however, has been linked to dangerously high blood pressure, pounding heartbeats or fluttering in the chest, and shortness of breath, and can be fatal at high doses. It is a category X pregnancy drug, meaning it can be harmful to developing fetuses of pregnant women who take the drug. Phentermine can also be habit forming and should not be shared with anyone with a history of dug abuse or addiction.
The OPDP also took issue with Avanthi for talking up Lomaira without mentioning that the medication is only intended for short-term use, and that each patient should weigh the benefits of use against the risks.
“These omissions are particularly concerning from a public health perspective due to the serious health risks associated with Lomaira,” the warning letter stated.
FDA Warning Letter