Johnson & Johnson Is Asked By FDA To Add Warnings About Leg, Foot Amputations With Diabetes Drug, Invokana
FDA has asked the Johnson & Johnson to attach new warnings to its important diabetes drug. It can make consumers familiar with the risk of the leg, foot amputations.
A recent report says the U.S. Food and Drug Administration has provided an important instruction to the American pharmaceutical company Johnson & Johnson. J & J is famous for producing medical devices and other pharmaceutical goods. Recently FDA has warned about the possible risk of amputations with the company's diabetes drug, Reuters reported.
Invokana is the original name of Johnson & Johnson's diabetes drug, which is also known as canagliflozin. Results of two important clinical trials showed that leg and the foot amputations happened to the patients who used Invokana to treat type 2 diabetes. The test results indicated that the incident occurred almost twice in patients given Invokana compared to the patients who use a placebo.
The warnings provided by the FDA include one boxed warning that is reserved for probable serious adverse events. Johnson & Johnson's Invokana belongs to SGLT-2 inhibitors, the type 2 diabetes drugs that play significantly in removing the excess amount of blood sugar. Notably, the blood sugar is removed through urine.
Now the first clinical trial results have unveiled an important conclusion about the use of Invokana during a one year period. The results showed that the risk of the amputation in patients who were treated with the drug was equivalent to 5.9 out of 1000. On the other hand, the risk was equivalent 2.8 out of 1000 for the patients treated with placebo. That means some concerns exist regarding the diabetes drug of Johnson & Johnson.
The second trial revealed that the risk for the patients who used Invokana of Johnson & Johnson was 7.5 out of 1000. But, the risk of the placebo users was 4.2 out of every 1000. The FDA said amputations of toe and foot's middle portion are most common, and amputations of the leg include the above and below the knee. So the warnings by the agency will make the diabetes patients familiar with the Invokana of Johnson & Johnson before using them.
Diabetes is now a common disease and a lot of people are the victims of this disease. Even timely intervention and careful medication are necessary to control the type 2 diabetes that can lead to a series of major health problems. According to The Science Times, type 1 diabetes can be treated with the omega-3 fatty acids. Several pharmaceutical companies like Johnson & Johnson manufacture drugs to treat this health problem.
Type 2 diabetes if untreated, can create blindness, kidney and nerve damage. That means the proper and careful medication is necessary to address this health problem. The current warnings by the FDA about the diabetes drug of Johnson & Johnson, Invokana, play an important role to explore the risk of amputations. In a word, now patients can be more conscious before using this drug.