If a drug is bad for us our doctor wouldn’t prescribe it, right? Don’t medications have to go through rigorous studies and be approved by the FDA before they are put on the market?
Unfortunately, doctors aren’t always aware of the full list of adverse effects associated with each drug and the FDA isn’t as strict with regulations as one might hope it would be. Here’s what you should know about Invokana and FDA recalls.
Invokana (canagliflozin) was put on the market in March 2013 and was not fully tested to determine the long term potential effects that could harm patients. As a new type 2 diabetes drug that worked in a unique way (it’s called a sodium glucose co-transporter 2 or SGLT2 inhibitor), it should have been closely monitored by its manufacturer, Janssen Pharmaceuticals, to determine any adverse effects that could occur overtime; it was primarily evaluated to see if there was a decrease in glucose levels. In only five years of being on the market, the FDA has had to publish FOUR warnings and has required that Invokana and Invokamet post black box warnings (the highest warning given by the FDA) on the packaging to warn patients of injuries that may occur after taking this drug. Here are the potential injuries that you should be aware of:
One of the problems with the FDA is that it’s much easier to get a product or drug on the market than to have it taken off. When a pharmaceutical or medical device company wants to put a new product on the market, it’s their responsibility to test it and submit the findings to the FDA for the approval process. [The Center for Drug Evaluation and Research (CDER) is the branch of the FDA that monitors approval. Their purpose is to make sure that drugs marketed in this country are safe and effective. However, CDER does not themselves test the drugs in question.] However, if a company spends a few million dollars on a product which then has the potential to make hundreds of millions of dollars, would they really be willing to disclose information that would hinder their approval? Not only would they lose the money they already invested, but they would also impede the chance to make a fortune.
Secondly, only about 10% of the cases of patients who have adverse effects are actually reported. “The weaknesses of the system are that the quality of the reports aren't that great. They come from many different sources - They may have a lot of detail. They may have a little detail - Sometimes we can't get back to the reporter to get the details that we need to really fill in the cases,” states Dr. Steven Galson, the current director of the FDA’s CDER. “The other problem is that the actual reporting rate is low, which means [that of] a lot of the cases of adverse events that happen, we really only see a fairly small proportion of them.”
The reporting levels are so low because 1) doctors are inundated with paperwork and don’t have the time to fill them out and 2) it’s really confusing for the average patient to navigate through the questions. This process is called a MedWatch Voluntary Report. Not only is it six pages to fill out online, but you need to know the drug’s name that you took, the company that makes it, if it’s compounded (who knows what that means?), the lot number of the drug, and the NDC number (um….?).
Talk to your doctor today about the risks that are involved with canagliflozin and discuss if the benefits outweigh the risks in your particular situation. Just because Invokana and Invokamet haven’t been recalled, doesn’t make them safe drugs.
