The sale and implantation of Essure in the United States is facing a new set of federally-mandated restrictions, and the government has left the enforcement of that mandate to the company that manufactures the device being restricted.
In response to a decline in demand for its female sterilization solution that quite literally spans the globe, Bayer ceased sales of Essure in every market on the planet except the United States ...
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Those 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 ...
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The 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 ...
continue reading...A 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 ...
The 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 ...
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 ...
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