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  View the entire April 2019 issue in PDF format

  View the entire March 2019 issue in PDF format

  • Study Reveals Increased Risk of Bleeding, Stroke from Combined Use of Oral Blood Thinners and NSAIDs
    (March 2019)
    Millions of Americans take anticoagulants on a long-term basis to prevent the formation of potentially harmful clots. Learn why such patients should avoid using nonsteroidal anti-inflammatory drugs.
  • Caving To Industry, FDA Kills Proposed Safety Rule on Generic Drug Labeling
    (March 2019)
    In his editor’s column, Dr. Michael Carome laments the FDA’s troubling decision to withdraw a proposed rule that would have allowed generic drug companies to promptly update safety warnings in their product labels.
  • Potentially Dangerous Lithium Drug Interactions
    (March 2019)
    Read about the many prescription medications that can interact in dangerous ways with lithium, the drug of choice for treating bipolar disorder, also known as manic depression.
  • Drug-Induced Restless Legs Syndrome
    (March 2019)
    Restless legs syndrome is a common neurological movement and sensory disorder that affects 5 to 10 percent of the population. In this article, we identify some of the many drugs that can cause or worsen this disorder.
  • Review of the Synthetic Human Growth Hormone Drug Somatropin
    (March 2019)
    Somatropin was first approved by the FDA in 1987 for the treatment of short stature in children with growth hormone (GH) deficiency. Find out why we recommend not using somatropin in children with short stature who have normal GH levels; people who develop GH deficiency in adulthood; or in healthy individuals as an anti-aging agent, to improve athletic performance or for body-building.

  View the entire February 2019 issue in PDF format

Additional Information from Public Citizen

  • (April 1, 2019)
    Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.
  • (April 1, 2019)
    Public Citizen petitioned the FDA to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the deadly opioid crisis in the U.S.
  • (April 1, 2019)
    Scott Gottlieb, Food and Drug Administration (FDA) commissioner, today testified about opioids at a hearing of the U.S. Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. His testimony included several misleading statements and omissions.
  • (February 27, 2019)
    Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.
  • (February 1, 2019)
    In testimony before a joint meeting of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – include the risk of dying from cardiovascular disease – but offers no unique benefit. Public Citizen had requested such action in a citizen petition submitted to the agency on June 21, 2018.