Product News and Recalls

Forbes Analysis: Danger Warnings Make Invokana Harder to Sell

investors weary of invokanaThe analysis is in: people are less likely to buy a medication when they’ve been warned that it may increase the odds of them having their leg or foot amputated. And, while this is bad news for Invokana specifically, Forbes would like you to know that Johnson & Johnson – the drug’s manufacturer – will be just fine.

This is the gist of an article that appeared on the Forbes website shortly after the FDA forced J&J to add a warning label to Invokana’s packaging indicating that diabetes patients living in fear of amputations related to their illness may actually put themselves at greater risk of an amputation by taking the drug.

Amputation, however, is just one of the concerns that come with an Invokana prescription. Studies have shown a link between the drug and diabetic ketoacidosis; a condition that develops when too many blood acids – also known as ketones – are present in the patient’s body. Additionally, Invokana use has been linked to acute pancreatitis and an increased risk of bone fractures.

It is the amputation risk that is getting all the attention though. June of last year saw a safety alert released by the FDA indicating that there was evidence to suggest a link between taking Invokana and an increased likelihood of diabetes-related limb amputation. A study concluded that the evidence was quite compelling, although not strong enough to actually find causality. Three out of every 1,000 patients treated with a placebo suffered an amputation related to their diabetes while seven out of every 1,000 Invokana patients in the study would undergo an amputation.

Spring of 2017 saw a new study though, and a new statement from the FDA removed all doubt or uncertainty from their assessment. “Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine [Invokana] causes an increased risk of leg and foot amputations,” the agency wrote. “FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the [Invokana] drug labels to describe this risk.” The warning cited studies that showed that Invokana patients underwent amputations twice as often as those treated with a placebo.

So, while J&J may have some trouble growing its Invokana and diabetes-related businesses, Forbes believes that investors’ money is still safe with the corporation. They are particularly excited by the 10 new drugs that J&J is expected to file for approval for in the next four years. Let’s hope these new drugs help J&J’s consumers more than they harm them.