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More timely drug and device recall information

Dangerous drugs and medical devices are recalled every day by the Food and Drug Administration (FDA). Given the risks these have on the health and safety of patients, you might think that these are done as quickly as possible. But the process is actually takes a long time.

The FDA has moved to speed up the process significantly. In the future, it won’t wait for a formal notice to inform doctors and patients alike that a formal recall is pending.

How a recall is issued

The FDA issues its recall notices weekly. The primary source for them is their Enforcement Report, which includes all of the formal notices necessary for doctors, pharmacies, and everyone to take action.

Included in every recall notice is a classification of the reasons for recall. These are:

  • Class I: A high risk of adverse health consequences or death. Examples include a defective pacemaker or anesthesia that is impure.
  • Class II: An intermediate risk, usually temporary effects not likely to be serious. This can include mis-labeling for persons who have dietary requirements.
  • Class II: A low risk of adverse health effects. This might include undeclared additives in a label or anything else that is not likely to cause serious harm.

The time it takes to classify a recall can be weeks, or even months. That causes delays which put many patients at risk of an adverse effect from a defective product if it is found to be a Class I immediate threat to health.

New procedures

Starting immediately, the FDA will include “not yet classified” reports in their weekly report. The information is intended to allow doctors and patients to determine their own exposure and risk based on what information is available.

This will dramatically speed up the time that this information reaches the hands of those who need to know it.

Adverse effects

If you have experienced adverse effects from a new drug or device, the first thing you need to do is find out if it has been recalled. It is likely that you are not the only one suffering from the adverse effects.

It is important to stay informed when starting a new treatment. While drugs and devices can work wonders, many things can go wrong during the approval and manufacturing processes. You should consider consulting an experienced medical malpractice attorney if you suspect that your new prescription or device is doing harm.

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