Bydureon Side Effects, Adverse Reactions, & Benefits

Bydureon Side Effects: Weekly injection for type 2 diabetes drug Bydureon gets FDA nod, but with many constraints. The most common side effects are mild to moderate. Nausea, occurring at the start of the treatment and decreasing over time. Vomiting, diarrhea, constipation. Headache, low blood sugar levels. Itching at the site of the injection.

Meanwhile, four main studies lasting six months or more and involving 1,525 type 2 diabetes patients showed that the once-a-week diabetes injection effectively lowered sugar levels in the bloodstream.

Cited by the European Union’s Committee for Medicinal Products for Human Use (CHMP), those findings prompted the European Medicines Agency, EU’s health regulator, to approve early last year, in April 2011, Bydureon, the new diabetes injection.

And, only last month and after two previous rejections in 2010, the United States Food and Drug Administration finally approved the use of the more convenient diabetes injection—with a caveat that it was to be used as “an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.” It’s not been approved by Health Canada.

Bydureon, made by Amylin Pharmaceuticals Inc, is injected once a week, unlike similar drugs, even the company’s seven-year old diabetes medicine, Byetta, which have to be injected twice a day.

Despite the convenience the new injection offers, the U.S. health regulator has always been less enthusiastic over it, concerned over possible serious side effects.

When the FDA turned down the drug, twice in 2010, its most serious concern was that Bydureon may contribute to heart rhythm abnormalities and it asked the drug maker to study this.

Amylin complied, and a new study done in San Diego suggested this was not the case, says New York Times Health Writer Andrew Pollack in his report on the diabetes drug’s FDA approval. It wasn’t clear, however, which medical institute carried out the research.

And although it’s approved the drug, the FDA is also requiring Amylin to conduct yet another clinical trial to assess whether Bydureon increases the risk of heart attacks and other cardiovascular problems. The company has again agreed, and a trial is underway.

More about Bydureon Side Effects after the jump.