Byetta Diabetes Drug Warning by FDA

The FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.

Update Aug. 27 The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who’d been taking the medication.

Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.

The FDA is warning patients taking Byetta that there have been “very rare case reports of pancreatitis with complications or with a fatal outcome.”

Six more reports of patients developing pancreatitis while taking Byetta. Two patients died and 4 were recovering.

Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very 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. At that time 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 said in a statement that patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.

The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.

If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals”

Byetta Lawyers are available for free consultations for people who have been affected by the side effects of this drug.

Tampering with Gerber Baby Food a “Malicious Hoax”

Ap- We’ve all seen numerous videos on YouTube, but what would you do if you watched a video from someone who claimed he had put poison in baby food with the intent to “kill black and Hispanic children?” According to the Food and Drug Administration (FDA) that is exactly what happened.

Anton Dunn, 42, posted a video on the Internet which made its way to YouTube. He apparently went by the name Trashman and recorded three videos. In the video Dunn brags about controlling Gerber employees and directing them to put poison in millions of baby food bottles.

In some of the videos he claims to have used cyanide and rat poison and that there were four babies that have already died. Dunn says his motive for poisoning the baby food is to try to “cut down on the black population.”

The FDA and Gerber Products Co. found that there has been no tampering of any Gerber product. Nestle Nutrition, Gerber’s parent company, believes that Dunn’s claims were all a “malicious hoax.” They added that “the safety of Gerber and Nestle Nutrition products is our top priority.”

Dunn is being charged with “sending threats in interstate commerce and falsely claiming to have tampered with a consumer product.” He could be looking at a 10-year prison sentence if he is found guilty.