News Tagged ‘serious adverse events’

FDA warns of contaminated drugs used to treat serious illnesses

fda logo 100x100Foreign particle contamination of several products used to treat rare, serious and life-threatening diseases has prompted a warning by the Food and Drug Administration (FDA). The warning includes products made by Genzyme and marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme and Thyrogen – used to treat serious conditions such as Gaucher Disease and thyroid cancer. The foreign particles found in the medications include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

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FDA recalls dietary supplements believed to contain steroids

bodybuilding supplements 254x300 100x100All lots and expiration dates of 65 BodyBuilding.com brand dietary supplements are being recalled because the Food and Drug Administration (FDA) believes the products contain ingredients that are either classified or the FDA believes they should be classified as steroids. Acute liver is known to be a possible harmful effect of using steroid-containing products.

Steroids also may cause other serious long-term adverse health consequences including shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

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FDA warns about qualaquin use for restless leg syndrome

qualaquin 100x100The Food and Drug Administration (FDA) has issued a warning to health care professionals to use extreme caution when prescribing Qualaquin (Quinine Sulfate), according to the Postmarket Reviews section of the Volume 2, Number 2 2, 2009 issue of its quarterly online newsletter, Drug Safety News (DSN).

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