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Cancer Drug Sales Push Genentech Profits Up 12%

But analysts say Avastin sales slowing

(Newser) - Biotech firm Genentech said sales of its blockbuster cancer drug Avastin fueled a first-quarter profit increase of 12%, reports the Wall Street Journal, but the $600 million in sales was below analysts’ projected $622 million, causing some to grumble the drug may have reached a sales plateau. Genentech stock edged...

Berkeley Fights Donation Policy Without Protests

Instead of boycotting, gay students recruit substitute blood donors

(Newser) - Several San Francisco-area campuses have banned blood drives to protest federal policies preventing sexually active gay men from donating blood, but at UC-Berkeley, students are making a point without resorting to boycotts. Instead of withholding blood on grounds the 25-year-old FDA rule is discriminatory, Cal is encouraging gay students to...

J&J Hid Birth Control Patch Risks: Suit

Scientist accused of veiling heart attack, stroke dangers

(Newser) - Johnson & Johnson doctored data to get its birth control patch FDA-approved, according to a class action lawsuit that claims Ortho-Evra caused blood clots, heart attacks, and strokes. A J&J scientist allegedly doctored the data with a "correction factor" for the FDA, lowering estrogen-related risk by 60%: He...

FDA Probes Suicide Link to Asthma Drug

Merck adds new warnings on nervous system side effects

(Newser) - The FDA has opened an investigation of anecdotal links between the popular asthma and allergy drug Singulair and suicidal thoughts. In the past year, manufacturer Merck has added warnings of several possible side effects of  the pill related to the nervous system, including anxiety, depression, tremors, and suicidal thinking. The...

Determine Your Daddy—at the Drugstore

Do-it-yourself paternity kits now on sale nationwide for $30

(Newser) - The sometimes vexing task of determining a child's father can now be solved by plunking down $29.99 at the local drugstore. A Utah company has expanded sales of its do-it-yourself DNA kit to Rite Aids in 30 states after sales soared in sample markets, MSNBC reports. Identigene of Salt...

Feds ID Extra Drug in Baxter's Recalled Heparin

FDA unsure if chemical was behind reactions to blood-thinner

(Newser) - The Food and Drug Administration has identified the extra ingredient found in samples of Baxter’s blood-thinning drug heparin, the Wall Street Journal reports today. Some batches of the drug—recalled in January after reports of allergic reactions—contained over-sulfated chondroitin sulfate, but it is not certain that was the...

8 Worrying Drug Side Effects
8 Worrying Drug Side Effects
Mar 7, 2008 7:14 PM CST

8 Worrying Drug Side Effects

FDA-approved medications pass clinical trials, but the real world uncovers more

(Newser) - Despite rigorous testing, some drugs have side effects that only rear their ugly heads when introduced to the general population. Forbes catalogs some of the weirdest:
  1. Anti-smoking drug Chantix can cause insomnia and nightmares.
  2. Diet drug Alli can have unforeseen gastrointestinal side-effects; these can be counteracted by eating a low-fat
...

Blood Thinner Woes Hit Germany
Blood Thinner Woes Hit Germany
Mar 7, 2008 8:32 AM CST

Blood Thinner Woes Hit Germany

100 may have been sickened by heparin not tied to Baxter

(Newser) - Heparin blood thinners may have sickened as many as 100 people in Germany, health officials report. The FDA is currently investigating the drug after it was linked to 19 deaths and hundreds of allergic reactions in the US, possibly due to contaminants from China. The agency is now recommending that...

Senate Backs Product Safety Crackdown

Sweeping changes in consumer laws

(Newser) - The Senate has passed a tough new product safety measure covering toys, household appliances and thousands of other products. It would ban lead in toys, increase civil penalties for hazardous products tenfold, enable more state regulation and create a database of dangerous items on the market. It also sets up...

FDA Finds Contaminant in Blood Thinner

Substance discovered in heparin, linked to 19 deaths nationwide

(Newser) - The FDA has found a contaminant in samples of heparin, a blood thinner produced mainly in China linked to 19 deaths and nearly 800 allergic reactions in the US, the New York Times reports. The contaminant may be a counterfeit form of heparin added to reduce its manufacturing cost. The...

Feds OK Wyeth's New Antidepressant
Feds OK Wyeth's New Antidepressant
Feb 29, 2008 7:41 PM CST

Feds OK Wyeth's New Antidepressant

Faced with generic threats to its popular Effexor XR, company banking on Pristiq

(Newser) - Antidepressant Effexor XR will soon lose patent protection, and maker Wyeth is hoping Pristiq, the successor drug approved today by the FDA, will soften the financial blow. Higher-ups at the company gush over Pristiq's advantages, including zero acclimation time and no liver interaction, and hope that sales will offset losses...

FDA Clears Avastin for Breast Cancer

Ruling rejects own panel's advice; drug now used for lung, colon treatment

(Newser) - The FDA has approved a drug currently prescribed to treat lung and colon cancer for use on breast cancer patients, the AP reports. The decision defies the advice of the FDA's own advisory panel, which recommended that Avastin not be used to treat breast cancer on the grounds that it...

FDA Approved Wrong China Firm
FDA Approved Wrong China Firm
Feb 19, 2008 6:26 AM CST

FDA Approved Wrong China Firm

Hundreds ill, 4 dead after using heparin from factory never inspected

(Newser) - The Chinese facility that supplied the active ingredient of the blood-thinner heparin, linked to hundreds of adverse reactions and four US deaths, was never inspected by the FDA because the agency confused it with another plant of the same name, the Washington Post reports. The company was given approval based...

FDA Delay Cost 22,000 Lives: Doctor
FDA Delay
Cost 22,000 Lives: Doctor
Feb 15, 2008 7:53 AM CST

FDA Delay Cost 22,000 Lives: Doctor

Agency took a year to pull lethal heart surgery drug Trasylol

(Newser) - A prominent researcher who revealed widespread fatalities associated with the heart surgery drug Trasylol says 22,000 people died because of the FDA's delay in blowing the whistle on the drug after his study was published. Drugmaker Bayer also failed to disclose negative results of its own study. In a...

Chinese Factory Linked to Deadly US Drug

Blood-thinner 's active ingredient from plant not FDA inspected

(Newser) - The active ingredient in a drug linked to four deaths and hundreds of adverse reactions in the US has been traced to a Chinese factory which has never been inspected by the FDA, reports the Wall Street Journal. The drug is a blood-thinner made by Baxter International, a   version...

Deaths Spark FDA Review of Botox Safety

'Off-label' use under scrutiny after fatalities, severe reactions

(Newser) - The FDA is investigating the safety of Botox and a competing medication after learning that the drug might have caused death and breathing problems in children being treated for cerebral palsy, Reuters reports. That's not an approved use for the cosmetic drug; docs administer it because it can block nerve...

US, Chinese Firms Charged in Pet Food Scandal

American owners intentionally sold tainted products, prosecutors say

(Newser) - US authorities today charged an American company and two Chinese businesses with manufacturing and importing tainted ingredients in pet food that killed thousands of cats and dogs last year, the AP reports. Las Vegas-based ChemNutra and its owners face a felony conspiracy charge and 26 misdemeanor counts for selling adulterated...

Puerto Rican Drug Plants Shipped Tainted Pills: FDA

Quality control a problem at factories producing US' top-selling drugs

(Newser) - The Caribbean island that produces 13 of the 20 best-selling drugs in the US has sold tainted pills and is struggling with quality control at its pharmaceutical plants, AP reports.  FDA inspections of 13 Puerto Rican plants between 2003 and 2007 revealed problems such as machinery pins left in...

FDA Plans to Open Outpost in China
FDA Plans to Open Outpost
in China
Feb 6, 2008 6:00 AM CST

FDA Plans to Open Outpost in China

Inspectors could block contaminated food from being exported to US

(Newser) - America's food imports from China are rising and the Food and Drug Administration is planning to start exporting American inspectors to protect the US food supply, Reuters reports. FDA officials hope to open a China office to help them raise food safety standards and to make it easier to act...

School Breaks With Feds Over Gay Rights

San Jose State stops blood drives, cites FDA rule banning gays

(Newser) - Saying a federal directive aimed at keeping gay men from donating blood violates school non-discrimination policies, the president of a California university is stopping blood drives on campus, the San Jose Mercury News reports. In a campus-wide email, San Jose State University president Don Kassing says a ban on such...

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