Archive for September, 2009

FDA Doubts Repros’ Proellex Can Be Safe

Repros Therapeutics said the Food and Drug Administration in a letter doubted whether the company would be able to identify a dosing regimen for Proellex that will be both effective for any of the intended indications and free of an unacceptable risk of serious liver toxicity. Proellex was developed to treat uterine fibroids and endometriosis.

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British girl dies after cervical cancer vaccine

British health officials temporarily suspended a vaccination program in an English city Tuesday after a 14-year-old girl died a few hours after being vaccinated against the virus that causes cervical cancer. Natalie Morton died in a hospital Monday, a few hours after being the given the Cervarix vaccine, which protects against two strains of the human papilloma virus that causes cervical cancer. The National Health Service in Coventry said it paused the program for two days to give staff administering the vaccine training in how to answer questions from anyone concerned about its safety.

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FDA Issues Warning About Tamiflu

The FDA has issued an alert to doctors and pharmacists about potential dosing errors of liquid Tamiflu, the medicine used to treat the H1N1 influenza and regular flu symptoms. The FDA has had reports of overdoses and underdoses, but no fatalities.

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Philips recalls defibrillator units over malfunction risk

Philips Healthcare has announced that it is recalling approximately 5,400 HeartStart FR2+ automated external defibrillator units. Philips has received several reports of memory chip failure among the recalled defibrillators. This could cause the defibrillators to fail and render them unable to deliver life-saving therapy to patients.

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Increased Risk of H1N1 From Seasonal Flu Vaccine?

Swine flu vaccine shotA Canadian study is making waves across the international press after reportedly finding evidence of an increased risk for swine flu infection among people who have taken the seasonal influenza vaccine. The research is preliminary and has not been peer-reviewed yet, but governments and the media are taking notice. According to an article by ABC News and other reports, the work suggested that people who had received a seasonal flu shot were about twice as likely to catch the swine flu compared with people who had not taken the shot.

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FDA: Merck’s Januvia may have pancreatitis risk

The Food and Drug Administration¬† said on Friday that there may be a connection between Merck & Co.’s diabetes treatment Januvia and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.’s Byetta. Still, the agency reaffirms it is unclear whether the connection is between the treatment and pancreatitis or whether diabetes patients in general are at an increased risk. The FDA said there were 88 cases of acute pancreatitis reported in Januvia patients between October of 2006 and February of 2009. The agency is working with Merck to include new warning information on the drug’s label.

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Some Lots Of Children’s Tylenol Being Recalled

The maker of Tylenol is voluntarily recalling some of its children’s and infants’ products because some ingredients in the medicines didn’t meet the company’s testing standards. The company began recalling the products in August after an examination of bulk materials showed one of the inactive ingredients used in the medicines didn’t meet internal testing specifications. The products being recalled were made from April 2008 and June 2008.

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