RSSAll Entries in the "Dangerous Drugs" Category

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Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall – Possibility of Inexact Tablet Counts or Out of Sequence Tablets

Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

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Xigris [drotrecogin alfa (activated)]: Market Withdrawal – Failure to Show Survival Benefit

In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

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Sprycel (dasatinib): Drug Safety Communication – Risk of Pulmonary Arterial Hypertension

Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel, as well as during treatment.

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Virility Max: Recall – Undeclared Drug Ingredient

Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

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Chantix (varenicline)

UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms.

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Trilipix (fenofibric acid): Drug Safety Communication – Label Change

The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone.

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Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury

Potential for patient falls or unanticipated patient movement, which may result in serious injury or death.

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Benicar (olmesartan): Ongoing Safety Review

FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.

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Vitamin D Supplement Products: Medication Use Error

Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant.

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McNeil Consumer Healthcare Over-The-Counter Products: Recall

UPDATED 06/17/2010. Recall expanded to include product lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels.

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Magic Power Coffee: Undeclared Drug Ingredient

Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.