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100 Drugs Linked to Houston Research Facility Violations

Destiny Baker3 years ago

ProPublica has reported that the U.S. Food and Drug Administration has declined to release the names of 100 drugs linked to a Houston facility owned by Cetero Research, a firm that committed such gross violations during its research that years of trials and tests are essentially useless.

ProPublica was able, however, to get the names of six drugs affected. While two of the drugs have had follow up research conducted after finding out about the scandal, the following four drugs linked to the Houston facility have not been commented on by the FDA.

Temodar IV (Temozolomide)

  • Temodar IV is a chemotherapy drug that is used to treat brain cancers.
  • Cetero Houston analyzed what ProPublica describes as a pivotal trial that led to the FDA approving the drug.
  • Information from the trial is still used on the product's label and has not yet been removed from peer reviewed publications on the efficacy of the drug.
  • Side effects and adverse events include:

    • Seizure
    • Bladder Pain
    • Higher Risks of Infection
    • Flu-like Symptoms
    • Death
    • View complete list

Torisel (Temsirolimus)

  • Torisel is used to treat renal cell carcinoma (a type of kidney cancer).
  • Cetero Houston was involved in testing the drug’s effects on heart rhythms.
  • Side effects and adverse events include:

    • Fever
    • Chest Pains
    • Severe Stomach Pain
    • Loss of Movement in Side of Body
    • Death
    • View complete list

Lazanda (Fentanyl)

  • Lazanda is a nasal spray that operates as a pain killer.
  • Cetero Houston tested how the drug behaved when paired with decongestants.
  • All information on the drug's label regarding its reactions to decongestants are based on this study.
  • This information led to FDA approval and has been used in court records.
  • Side effects and adverse events include:

    • Weak or Shallow Breathing
    • Rapid Heart Rate
    • Congestive Heart Failure
    • View complete list

Generic Tramadol

  • Generic Tramadol is a powerful painkiller.
  • Cetero Houston conducted three of the drug's clinical trials meant to prove drug’s equivilance to a brand-name a comparison.
  • The clinical trials led to FDA approval and information from the trial is still printed the product's label.
  • Side effects and adverse events include:

    • Seizure
    • Convulsions
    • Shallow Breathing
    • Weak Pulse
    • Hives
    • Suicide
    • View complete list

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