FDA Drug Approvals Present Safety Risks About 1/3 of the Time

A significant number of FDA drug approvals eventually face safety issues.

If you even pay minimal attention to pharmaceutical news, you know that the industry seems to be plagued with recalls and legal disputes. New data mirrors this. Reports indicate that around 1/3  of FDA drug approvals have safety issues. That’s right 1 and every 3 FDA drug approvals put the consumer at risk. Drug approvals

With increased pressure to to shorten the drug approval process, 19 drugs have received FDA-approval this year. That number is almost as many drug approvals as in the entirety of 2016.

After the drug approval the impacted drugs were subject to recalls, added warning labels, and safety advisories. From the Mylan EpiPen recall to the phantom Motrin recall, consumers were put at risk unbeknownst to themselves or the FDA, apparently.

This is troubling as patients put their confidence in these FDA drug approvals. Although most of the concerns were not risky enough to warrant a recall, in the time period reported only 3 drugs required being removed from the market.

An author of the study, Dr. Nicholas S. Downing, elaborated on the findings. He noted that drug approvals typically come after a trial on 1,000 patients, often times it is difficult when the product is put up against real-world factors.

A patient’s race, gender, ethnicity, weight, and previous medical conditions can all be factors for the way in which drugs impact them.

Experts assert that there is not reason for alarm, but that the new study is a good argument for continuous monitoring of the safety of drugs “throughout their life cycle.”

Zimmer Biomet Receives FDA Class I Recall for Shoulder Device

The Zimmer Biomet shoulder device is facing a class 1 recall from the FDA.

Due to a “higher fracture rate than stated” the Food and Drug Administration (FDA) has issued a class one recall of the Zimmer BiometZimmer biomet reverse shoulder device. Such recalls are reserved for products that “will cause serious adverse health consequences or death.”

This medical device recall, the most serious recall category, was issued this February. The recall reportedly included 3,662 devices.

Zimmer Biomet
Notice that risk managers received related to Zimmer Biomet recall.

The company acknwledged that these shoulder trays, all manufactured prior to September 2011, would fracture easily.

Risks included a need for revision surgery. According to experts, such surgeries might lead to permanent loss of shoulder function, infection and even death.”

Patients that may have received the Zimmer Biomet device may be entitled to compensation for their pain and/or suffering. For more information about filing a claim through Medical Claim Legal, complete a claim form at this link.