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Safety Alert For Four Diabetes Drugs

FDA Issues Kidney Warning for Four Diabetes Drugs

The Food and Drug Administration (FDA) of the United States has issued a warning that four common diabetes drugs may cause potentially life-threatening harm.

Canaglflozin, sold by Janssen Pharmaceuticals as Invokana and Invokamet and dapagliflozin, sold by AstraZeneca as Farxiga and Xigudo XR are thought by the FDA to be more damaging to the kidneys than previously suspected.

Around one and a half million prescriptions were written for canagliflozin and dapaglifozin between October 2014 and September 2015.

The FDA discovered that during the period between March 2013 and October 2015 101 patients were admitted with kidney damage related to the two drugs. Of those people one-fifth were hospitalised and four died. This was a significant enough number for the federal agency to investigate and issue a health warning.

They also said that the labels of the drugs will be revised. The new labels will include the information about the potential kidney damage and will also include recommendations on what people can do to mitigate the damage and reduce the risk.

They also warned that the acute kidney damage can present itself in a few forms including decreased urine or a swelling of the feet or legs. They also found that most people who suffered from kidney damage as a result of taking the drug did so within a month of their first dose.

The FDA advised doctors who have diabetes patients to be more cautious about prescribing these drugs. It’s important for a doctor to consider any previous kidney damage the patient has suffered or any predisposition to kidney damage they have shown. This includes things such as increased blood volume, chronic kidney insufficiency, congestive heart failure, and other ailments that put the kidneys at risk of being damaged through medication.

Invokana contains only one active ingredient; canagliflozin. This canagliflozin is combined with another active ingredient, metformin, to create Invokament. Both of these drugs were approved in 2013 and 2014 respectively and were used to treat patients with Type 2 Diabetes by controlling their blood sugar levels. Diabetes is caused by excessive blood sugar and is controlled through diet and medication.

The FDA released a report in May of 2016 that said they discovered patients from a clinical trial looking into the effects of Invokana and Invokamet were about twice as likely to require amputations as the participants taking placebos.  The report said that five in 1,000 patients who take a 300mg dose of canagliflozin on a daily basis needed amputation. The equivalent of seven in 1,000 patients taking a dose of 100mg needed amputations; higher than the 3 in 1000 patients taking placebos that needed amputation.

The amputations in question were of the toes, feet, and legs. The FDA said that they needed to conduct further study to determine if canagliflozin does in fact increase the risk of needing an amputation. For now patients shouldn’t stop taking the drug under their own volition. Instead they should consult with their doctor first and seek medical advice.

The agency said that patients who are currently taking one of these drugs, especially canagliflozin, should consult their doctor right away if they begin to feel any tenderness or swelling that wasn’t there before. They should also consult their doctor in the case of sores, ulcers, or infections in their legs or feet. Early detection is the key to avoiding complications in the future.

IMPORTANT: Always consult your doctor before discontinuing these diabetes drugs or any medication.

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