Archive for June, 2010

Pfizer Will Pull Ineffective Leukemia Drug

Federal health regulators said Monday that the drugmaker Pfizer has agreed to pull a leukemia drug off the market after a follow-up study showed it failed to slow the disease. The Food and Drug Administration cleared the drug Mylotarg in 2000 under its accelerated approval program, which grants speedy access to drugs that show early promise. The drug was cleared for patients older than 60 with relapsed acute myeloid leukemia, a bone marrow cancer.

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Tylenol Recall Broadens; Includes Extra Strength, Benadryl

A Tylenol recall issued last year by the Johnson & Johnson unit of McNeil Consumer Healthcare because of chemical contamination has been expanded for a second time to include Benadryl Allergy Ultratablets and Extra Strength Tylenol. The latest recall includes four lots of Benadryl Allergy Ultratab tablets in 100 count bottles sold in the U.S. with lot numbers AJA008, ADA194, ABA022 and ABA264, and one lot of Tylenol Extra Strength Rapid Release Gel Cap with lot number ASA202.

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Pfizer Recalls IV Drugs that Could Kill Patients

Pfizer said Thursday it is recalling intravenous drugs with floating matter in them, warning they could potentially kill weakened patients, after U.S. regulators warned about the worries earlier this week. The products — made by Claris Lifesciences and distributed in the U.S. by Pfizer — are the antibiotics metronidazole and ciprofloxacin and a drug used to prevent nausea and vomiting caused by surgery and chemotherapy, named ondansetron.

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FDA orders new asthma drug warnings to take effect

U.S. health regulators have finalized new warnings for controversial inhaled asthma drugs, but exercised new powers to order the changes on products made by GlaxoSmithKline Plc and AstraZeneca Plc. The warnings, expected since February, say medicines known as long-acting beta-agonists, or LABAs, should never be used on their own to treat asthma, Food and Drug Administration officials said on Wednesday. While some of the companies accepted the changes, the two British drugmakers resisted, agency officials said.

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