Study examines mishandling of insulin pumps by teenagers
WASHINGTON According to a new study performed by the Food and Drug Administration from 1996 to 2005, teenagers using insulin pumps to treat Type 1 diabetes often mishandle the devices which can lead to death and other injuries, according to published reports.
Insulin pumps are the size of a cell phone and worn on a belt or pocket. They send insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place.
The federal review of use by young people found 13 deaths and more than 1,500 injuries connected with the pumps. In some cases, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote. Some teens didn’t know how to use the pumps correctly, dropped them or didn’t take good care of them.
While some teenagers want to switch from insulin injections to pump therapy to gain more flexibility in their lives, doctors said device problems such as a blocked tube can lead quickly to dangerous episodes of high blood sugar.
“In a matter of a few hours, all the insulin in the body disappears. Metabolically, the child starts to spiral out of control,” said John Buse, the American Diabetes Association’s president for medicine and science.
“The FDA takes pediatric deaths seriously,” said the agency’s Judith Cope, lead author of the analysis. “Parental oversight and involvement are important. Certainly, teenagers don’t always consider the consequences.”
Type 1 diabetes affects an estimated 12 million to 24 million people worldwide and occurs when the body attacks insulin-producing cells in the pancreas.
Mylan, Teva to begin shipping generic Requip
PITTSBURGH Mylan Pharmaceuticals has received approval from the Food and Drug Administration for its application for Ropinirole hydrochloride tablets and has announced it will begin shipping the drug immediately. Teva also announced the availability of its version of the tablets.
The drug is the generic form of GlaxoSmithKline’s Requip, which is used to treat moderate-to-severe primary restless leg syndrome. The generic will be available in 0.35 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg strengths.
According to IMS Health, the drug had sales of about $518 million in 2007.
Teva’s Q1 results show more than 25 percent sales increase
JERUSALEM Teva has released the results of its first quarter 2008, according to published reports.
Profits for the company fell by 57 percent to $147 million, but that was in large part to a $382 million acquisition charge the company suffered for buying the biotech company CoGenesys.
Teva did have a net income of $529 million, which beat the analysts’ forecast. Sales in North America increased by 27.3 percent for the quarter to $1.4 billion.
“The year is off to a strong start for Teva across all of our major businesses. It was a particularly outstanding quarter for Copaxone, which crossed the $500 million mark in in-market quarterly sales and became, for the first time, the number one global multiple sclerosis therapy,” said Shlomo Yanai, Teva’s chief executive officer.