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FDA approval doesn’t guarantee a medication is safe

On Behalf of | Dec 31, 2019 | Pharmaceutical Litigation

Over the last year or so, some highly popular medications for acid reflux, high blood pressure and diabetes have been recalled. Potential safety concerns have also prompted investigations by the Food and Drug Administration. The recent recalls by numerous manufacturers of medications containing ranitidine, such as Zantac, has many patients here in Ohio and elsewhere wondering whether they can take legal action against manufacturers even though the medications received FDA approval at one time.

Pharmaceutical litigation is a complex process, but the first thing Ohio residents may need to know is that receiving approval from the FDA does not protect a drug manufacturer from pharmaceutical litigation. Additional testing continues after a drug enters the market to make sure it does not present any harm to patients. Of course, nearly every drug has some sort of side effects, but the problems that lead to recalls and litigation tend to go well beyond the known side effects.

In some cases, a medication’s value to patients outweighs the potential for harm. These drugs often come with specific warnings and are carefully manufactured to ensure that nothing else could cause harm. Manufacturers of these medications are not often subject to lawsuits. Others may escape lawsuits because they could not have known of the potential adverse effects.

However, that does not mean that a manufacturer of ranitidine or any other medication can avoid claims when their products cause substantial harm to individuals. They cannot hide behind FDA approval or years worth of supposedly satisfactory testing results. It could take years before the potential for harm is adequately identified despite numerous studies and testing. Even so, once the harm is identified, consumers and patients here in Ohio and elsewhere would benefit from exploring the possibility of seeking restitution for the harm done by a presumably safe medication.


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