Severe sleep apnea increases risk of death
WASHINGTON Sleep apnea can do more than interfere with a sound sleep—it can also increase risk of death, according to a report.
The report, published in the journal Sleep, was the result of an 18-year study that found sleep apnea increased the risk of death from any cause by causing the person’s health to deteriorate over time.
The research team that conducted the study examined 1,522 men and women aged 30 to 60. Among the control group, the death rate was 2.85 per 1,000 people each year. Among those with mild to moderate sleep apnea, it was 5.54 and 5.42 per thousand, while the rate was 14.6 per thousand among those with severe sleep apnea. More than 40 percent of deaths among those with severe sleep apnea resulted from cardiovascular disease.
The National Heart, Lung and Blood Institute estimates that sleep apnea affects 12 million to 18 million Americans.
Greg Babe named new head of Bayer Corp.
PITTSBURGH Bayer’s United States subsidiary has a new leader, who will act as representative for North America, the company announced Thursday.
Greg Babe will become president and chief executive officer of Bayer Corp., the U.S. division of Germany-based Bayer AG, beginning Oct. 1. He will replace Attila Molnar, who is retiring after spending 30 years with the company.
Babe will continue as president and chief executive officer of polymer and plastic producer Bayer MaterialScience, a position he has had since 2004. Before that, he was president and chief executive officer of Bayer Corporate and Business Services.
Babe has a Bachelor of Science degree in mechanical engineering from West Virginia University. Molnar, a native of Germany, has a doctorate in chemistry from Erlangen University and began working for Bayer in 1978 as a plant manager in Leverkusen, Germany.
FDA siezes more than $24 million in unapproved drugs
ROCKVILLE, Md. The Food and Drug Administration on Wednesday executed its second product seizure in a week, having confiscated $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. after United States Attorney Catherine Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.
The seizure followed an inspection of several of the company’s plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.
“The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”
Earlier this year, FDA had found KV Pharmaceutical was violating a May 29, 2007 edict that required companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.
Wednesday’s seizure falls only one week after the FDA confiscated $74,000 in Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals of Miami, Fla.