FDA reports deaths with diabetes drug Byetta
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FIGHTING DIABETESCloser look: Diabetes 'revolution' is cutting both waysTrends: Diabetes strikes younger ages | Do you have pre-diabetesEating right: renovated diet weapons | RecipesTreatment: Living with diabetes gets easier | Islets could be key to a cure | Drug requires label warning MILLIONS AT RISK
Fast facts about diabetes in the USA:
People with diabetes: 24.1 million
People with pre-diabetes: about 56 million
The cost of diabetes in the USA: $174 billion a year
Source: Centers for Disease Control and Prevention
YOU CLICKED: WEEK’S MOST POPULAR HEALTH STORIES1: Brown recluse spider makes venomous presence known2: For strokes, bypassing closest hospital might be best | Stroke centers near you3: Lower vitamin D, higher risk of death4: Use of anti-snoring device rises5: Skinny doesn't mean healthy6: Prescription drugs more accessible to teens than beerNo. 7-10: Good news on breast cancer, bad on women’s self-conceit WASHINGTON (AP) — Federal regulators are working on a stronger label for a widely used diabetes mix with drugs marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings.The Food and Drug Administration said Monday it has received six new reports of patients developing a risky form of pancreatitis in the same proportion that long as infectious Byetta. Two of the patients died and four were recovering.
Regulators stressed that patients should stop taking Byetta immediately if they perform the operations indicated in signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is actual difficult to distinguish acute pancreatitis from less dangerous forms of the condition.
The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. None of those cases were fatal, but Byetta’s makers agreed to add information about the reports to the drug’s label.
However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.
Amylin and Eli Lilly uttered in a statement that patients taking Byetta have shown “very inimitable condition reports of pancreatitis with complications or with a fatal consequence.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients. The pancreas produces particular important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.
The FDA said doctors should consider prescribing other medications to patients with a history of pancreas problems.
Byetta competes adverse to blockbuster drugs from GlaxoSmithKline PLC and Takeda Pharmaceuticals in the $24 billion global market as being diabetes medications, according to health care research fixed IMS Health.
More than 700,000 patients with type 2 diabetes have used the injectable drug since it was launched in June 2005. It is jointly developed and manufactured by San Diego-based Amylin and Eli Lilly.
Byetta’s $636 the great body of the people in sales made up through 80% of Amylin’s total revenue last year. The drug accounted for just 3% of Eli Lilly’s sales. The companies are developing a long-lasting version of Byetta that could be injected once weekly, instead of twice daily.
Robert Baird & Co. analyst Thomas Russo cautioned investors that concerns nearly pancreatitis could affect the FDA’s review and requirements for the new version. Russo rates Amylin “outperform,” but uttered in a note to investors he could revise that rating as to a greater degree information becomes available.
Shares of Amylin Pharmaceuticals fell $4.45, or 13%, to $29.76 Monday, while Indianapolis-based Eli Lilly dipped 73 cents to $48.05.
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