Posts Tagged 'black box warning'

New Alerts Over Invokana Amputations

invokana increases risk of amputationsThose who suffer from Type II diabetes are well aware of the risks their disease brings. Medical professionals repeatedly emphasize the importance of keeping up with blood glucose levels, regulating the diet, and exercising. The outcomes of maintaining such vigilance are stark in their contrast. Comply, and you can live a fairly normal life. Fail to comply, however, and the consequences can be tragic.

Amputation; generally of the leg or foot, is among ...

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FDA Issues New Warning for Opioid Painkillers for Children

FDA strengthens warnings on opioids for childrenThe New York Times reports that the FDA has strengthened its warnings for opioid medications for children. Specifically, they advise that those 12 and younger are not to take codeine, while those 18 and younger should not take tramadol after certain types of surgery. In addition, nursing mothers are advised to avoid both drugs because they could impact breastfeeding.

As the strongest type of warning levied by ...

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FDA Suggests Black Box Warnings for Victoza and Bydureon

victoza and bydureon may get black box warningsA pair of letters sent out in March by the FDA suggest that Novo Nordisk and AstraZeneca include black box warnings on the labels of their diabetes drugs, Victoza and Bydureon. The letters refer to previous notices sent by the FDA suggesting that the pharmaceutical companies include information about “the risk of medullary thyroid carcinoma” posed by the drugs. Accordingly, both Victoza and Bydureon now ...

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FDA Strengthens Warnings and Changes Prescription Instructions for Feraheme

feraheme given black box warning because of fatal allergic reactionsThe FDA announced in a Drug Safety Communication that it is strengthening warnings that the anemia drug Feraheme can lead to serious and sometimes fatal allergic reactions. The agency has also changed the prescribing instructions for Feraheme and added a Black Box Warning—the FDA’s strongest warning—to the drug’s packaging. The new warning strongly recommends against using Feraheme in any patient who has had an allergic reaction ...

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FDA Advises Leaving Black Box Warning on Pfizer’s Chantix

The United States Food and Drug Administration decided to maintain the black box warning on Pfizer’s smoking cessation drug Chantix (varenicline). The drug continues to carry the very serious black box warning which was first added to the label in 2009.

In seeking the removal of the black box warning, Pfizer relied on a meta-analysis of five studies to argue there is no association between the drug and suicidal thoughts. The advisory panel nonetheless is requiring ...

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FDA: Potiga Risks Include Possible Vision Loss

FDA changes Potiga label to include risk of blindnessThe U.S. Food and Drug Administration (FDA) recently approved changes to the drug label to the anti-seizure medication Potiga. The new warning will alert patients and doctors to the risk of severe retinal pigment changes that can lead to blindness. The label will also warn that the Potiga has been linked with skin discoloration, particularly of the hands, feet and lips.

The revised label ...

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