The Associated Press reports that California-based Amgen has added the warnings about accelerated tumor growth on each container of Aranesp, Epogen and Procrit (Procrit is made by Amgen but sold by New Jersey-based Johnson & Johnson). There are already similar alerts about other types of cancer on the drugs' labels, the wire service said.
The decision to expand the warning comes less than a week before the U.S. Food and Drug Administration was scheduled to review the risks of using the drugs, which increase the production of red blood cells at a rapid rate, restoring a patient's energy, at least temporarily.
On Nov. 8, 2007, the FDA approved new black box warnings on labels of the three ESAs. The warnings detailed the dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival, the FDA said.
Drug Maker Withheld Diabetes Link to Schizophrenia Drug, Expert Witness Says
The pharmaceutical firm Eli Lilly knew about serious side effects from its best selling anti-psychotic drug Zyprexa as early as 1998 and should have warned physicians that using the drug could cause diabetes, an expert witness testified in an Alaska lawsuit March 7.
According to the New York Times, Dr. John Guriguian, a diabetes specialist and reviewer for the U.S. Food and Drug Administration for more than 20 years, said that Lilly had evidence of the link between Zyprexa, introduced in 1996, and diabetes, but put "profit over concern of the consumer."
The State of Alaska is suing Eli Lilly in an attempt to recover Medicaid costs it incurred by treating schizophrenia patients who developed diabetes after taking Zyprexa, the newspaper reports.
Alaska claims that although the drug company knew by 1998 that Zyprexa caused weight gain and blood sugar changes in many schizophrenia patients, the company deliberately withheld the information from the FDA, the Times reports.
In fact, a 2002 company internal memo specifically instructed its sales representatives not to discuss diabetes concerns with U.S. doctors, the newspaper reports. "We will NOT proactively address the diabetes concerns," the Times cites an internal Lilly memo as saying.
Lilly denies that it withheld any information from the FDA and that the issue of linking Zyprexa's use with diabetes is still subject to clinical review and debate, the newspaper reports.
Many Later-Stage Premature Babies Require Long-Term Care
About a third of premature babies born between 29 and 33 weeks still need specialist care at age 5, says a French study that looked at 400 full-term babies (40 weeks) and 1,800 born before 33 weeks.
It was already known that very early birth greatly increases the risk of physical and learning problems later in childhood. But this new study suggests that many children born at a later stage of prematurity still require long-term care, BBC News reported.
All the children in the study underwent physical and mental assessments at age 5. As expected, those born before 28 weeks had the highest disability rate (195 children/49 percent), but the actual number of children with disabilities was highest among those born between 29 and 33 weeks -- 441 children/36 percent.