Archive for the 'Warning' Category

Study says warnings may boost sales for dangerous drugs

A new study in Psychological Science details a phenomenon in which graphic and detailed warnings by the Food and Drug Administration may eventually boost sales for potentially dangerous drugs, such as Zoloft. Some patients over the long-term said they were more likely to buy drugs like Zoloft after hearing side effects warnings, because it increases their trust in the company — unaware the warnings are required by the FDA.

Read more about Zoloft warnings…

Liver failure warning added to Zithromax label

The U.S. Food and Drug Administration’s Warnings and Precautions, Contraindications, and Adverse Reactions sections of the labeling for Zithromax were updated in January 2011, to include liver failure. The drug, commonly referred to as “Z-Pak,” has been on the market since 1998.

Read more about Z-Pak side effects…

Fresenius employee allegedly lied to FDA, hid data

A Fresenius Medical Care (FMC) employee lied to the Food and Drug Administration and hid data, according to an FDA warning letter sent earlier in the month. According to the letter, one FMC employee tried to hide test results by shoving them into his pocket in front of FDA investigators.

Read more about the FDA warning letter to Fresenius…

FDA submits warning letter to Stryker over quality concerns

The Food and Drug Administration (FDA) has sent a warning letter to Stryker Corporation related to quality concerns at one of its facilities. The agency’s letter also warned the orthopedic implant company that it had been marketing devices without approval and failed to notify the FDA of a product recall.

Read more about the FDA Stryker warning letter…

FDA Issues New Warnings On Zithromax

The US Food and Drug Administration issued a new warning about the antibiotic azithromycin (Zithromax, ZMax, “Z-Pak”, NYSE:PFE, and various generic manufacturers). In today’s “drug safety communication”, the FDA warns of possible fatal heart rhythm problems associated with the drug.

Read more about the antibiotic warning…

FDA warns of new fake batch of cancer drug Avastin

The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year.

Read more about the counterfeit cancer treatment drug…

FDA warns against combining sodium oxybate with alcohol, CNS depressants

The Food and Drug Administration (FDA) is warning healthcare professionals that patients taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem) should not consume alcohol or use central nervous system depressants.

Read more about the Xyrem warning…

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