J&J directed to add new warnings to diabetes drug Invokana

J&J directed to add new warnings to diabetes drug Invokana

The U.S. Food & Drug Administration (FDA) on Tuesday directed Johnson & Johnson (J&J) to add new warnings to its widely-used diabetes drug called Invokana.

The FDA’s directive surfaced just a week after a jury in Missouri ordered J&J to pay $110 million to Virginia resident Lois Slemp, who alleged her ovarian cancer was caused by the company’s talc-based products.

Clinical trials have shown several cases of leg and foot amputations in type 2 diabetes patients who were treated with the drug Invokana, as against to those who were given a placebo.

Researchers also found that the risk of amputation in patients treated with Invokana in one year was equivalent to 5.9 out of every 1,000 patients as compared with 2.8 out of every 1,000 patients who were given a placebo.

The federal agency said warnings should include a boxed warning that is reserved for the most serious likely adverse situations of a drug.

J&J has been embroiled in trouble for the last many years over the ingredients it uses in toiletries and cosmetic products. In 2011, it was forced to remove chemicals of concern from some baby products. Last year, an Alabama woman named Jacqueline Fox died from ovarian cancer after using the company’s Baby Powder.

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