PHARMACY

AstraZeneca gets FDA approval for one new Seroquel use

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved AstraZeneca’s bipolar and schizophrenia drug Seroquel as an adjunct to lithium or divalproex, manufactured by Abbott Laboratories, for the maintenance treatment of patients with bipolar I disorder. This is one of five approvals for new indications that the company is looking for the drug.

Earlier this month, AstraZeneca submitted an application for Seroquel XR tablets to treat generalized anxiety disorder, including maintenance of the anti-anxiety effect.

In January, the company filed two separate applications to the FDA for Seroquel XR to treat manic and depressive episodes associated with bipolar disorder. The following month, it filed an application seeking approval for the treatment of major depressive disorder with the drug as monotherapy, adjunct therapy and maintenance therapy. The FDA is reviewing those submissions.

Global sales of Seroquel in 2007 were $4.02 billion, the company said.

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Drug producers give to help disaster victims

BY Drew Buono

NEW YORK Drug makers all over the world are working with international relief groups to send cash and medical supplies to victims of the cyclone in Myanmar and the earthquake in China, according to the Associated Press.

Among the donations:

  • Merck is giving about $500,000 in cash for Chinese victims, including two-to-one matches of donations from U.S. employees, plus $500,000 worth of antibiotics, heart medicines and vaccines, including shots to prevent infectious diseases.
  • Pfizer has given about $700,000 in cash and another $700,000 worth of medical products to earthquake victims in China, and has employees volunteering with the Red Cross there. Employees have given another $128,000 for China, which Pfizer is matching.
  • Abbott Laboratories is giving $250,000 for aid in Myanmar and is sending about $250,000 worth of adult and pediatric antibiotics and vitamins there, some of which arrived late last week; in China, it’s giving $1 million, roughly half cash and half in antibiotics and adult and pediatric nutrition products.
  • Baxter International has given $150,000 to help victims in Myanmar and is preparing to supply hundreds of thousands of intravenous solutions to hard-hit areas there.
  • Johnson & Johnson has given cash donations, consumer health care products and medicines to the Red Cross Society of China and plans to give cash to groups working in Myanmar.
  • Bristol-Myers Squibb is donating at least $500,000, mostly for China, where it also is sending 10,000 one-week supplies of antibiotics, infant and child nutritional products, and employee donations of blankets, clothing and camping equipment.
  • GlaxoSmithKline has given about $1.4 million for China and $100,000 for Myanmar.
  • Roche has sent 53,000 doses of an antibiotic to the Sichuan province.
  • Wyeth has donated antibiotics, infant formula, Centrum vitamins and an undisclosed amount of cash to China.
  • Eli Lilly is sending $300,000 in cash and $800,000 worth of medicines, mainly antibiotics, most of it to groups operating in China. It may later send insulin and mental health medicines.

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Research links ED and diabetes with later heart conditions

BY Drew Buono

WASHINGTON According to new findings in the Journal of the American College of Cardiology, men with type 2 diabetes who have problems maintaining an erection may foretell heart trouble, as reported by Reuters.

In one study, Italian researchers found that among 291 men with type 2 diabetes, those who also had erectile dysfuncion had twice the risk of suffering a heart attack, stroke or other cardiovascular complication over the next four years.

At the start of the study, all of the men had had evidence of “silent” heart disease—meaning they had plaque buildup in their arteries on imaging tests, but no heart disease symptoms, such as chest pain. Having ED seemed to pinpoint those men who were at particular risk of a complication. There was some good news though: Taking cholesterol-lowering statins appeared to reduce the risks associated with ED by one-third, according to the researchers.

In the second study, Hong Kong researchers found that among diabetic men with no indications of heart disease at the outset, those with ED were 58 percent more likely to die of heart disease, or have a heart attack or other non-fatal cardiac “event.”

“Erectile dysfunction is an important warning sign of future adverse heart events or even death,” study chief Peter Chun-Yip Tong, of the Chinese University of Hong Kong, told Reuters Health. The main reason, he explained, is that ED is an early manifestation of the blood vessel damage caused by diabetes and other risk factors for heart disease, such as high blood pressure.

Tong recommended that all men with diabetes tell their doctors if they begin to have problems getting or maintaining an erection. They can then have a comprehensive assessment of their cardiovascular risk factors, such as measurements of their blood pressure, cholesterol, waist size and kidney function, and work on getting those under control.

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