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When The FDA Finds A Drug That Has An Insufficient Warning Label



Insufficient or misleading drug warning labels written by pharmaceutical companies have led to severe adverse complications including birth defects, heart and lung conditions, cancer, organ failure and death.

What Is Prescription Drug Labeling

The primary purpose of prescription drug labeling is to provide healthcare professionals complete information in order to appropriately and safely prescribe prescription drugs. The FDA requires that prescription drug labels contain an accurate summary of the safety and effectiveness of the drug, based on data obtained from its use on humans. Labels are rejected by the FDA if implied claims or suggestions are offered without evidence to support the effectiveness of the drug.The FDA has implemented changes in prescription drug labeling to provide detailed information to healthcare professionals and consumers. The new labeling format requires a concise summary of the medication to be included in the Full Prescribing Information section of the label.

  • The complete product name and exact date of initial U.S. approval
  • Any recent changes or updates that have been added to the label
  • Complete boxed warning containing all reported adverse complications
  • Indications for uses of the drug
  • Dosage and methods of administration, including dosage forms and strengths
  • Contraindications
  • Warning and precautions, setting forth serious adverse complications
  • Adverse reactions, including a list of all common side effects
  • Possible drug interactions
  • Use of the drug in specific populations
  • A detailed patient counseling information statement

FDA Requirements For Warning Labels

In the United States, a boxed warning, also known as a black box warning, appears on the package insert for certain types of drugs. An FDA black box warning is the strongest available on prescription drugs. The purpose of the warning is to inform healthcare professionals and consumers that clinical studies have revealed that the drug carries a high risk of potentially life-threatening adverse reactions, including death.

Insufficient Drug Labels

Pharmaceutical companies routinely hire experts to write their drug information labels. Important information regarding dangerous side effects is often omitted. Many drug labels written by drug companies do not contain accurate or complete information regarding adverse reactions. Labels fail to mention the safety and efficacy of the drug. After initial FDA approval of a new drug, the manufacturer's proposed prescribing label is submitted to the FDA for approval. The FDA may not be aware of misleading or inaccurate information.

FDA Actions Regarding Insufficient Drug Labels

Serious medical complications are usually discovered during post-marketing safety studies, long after a drug has been on the pharmaceutical market. Once reports of adverse reactions begin to surface, the FDA can launch an investigation to determine the safety of the drug and the veracity of the reports. The FDA may request that the pharmaceutical company voluntarily revise its drug information label. If the company fails to comply with the request, the FDA can issue an updated warning label or can include a black box warning. If the pharmaceutical company continues to mislabel a drug or provide misleading information, the FDA can misbrand the drug or remove it from the market, either conditionally or permanently.

Should I Contact A Lawyer If I Have Suffered Adverse Complications Caused By An Insufficient Drug Warning Label

If you have suffered serious complications after taking an insufficiently-labeled or defective drug, you have rights. Your defective drug lawyer can help you obtain financial compensation you deserve. You may be entitled to reimbursement for past, current and future medical expenses. You may be able to recover compensation for lost wages and potential loss of future earnings. You may also be entitled to non-economic damages for emotional distress.

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