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.”

Ventilators Recalled Over Shutdown Issues

Medtronic’s NewPort is recalling their ventilators following equipment failures.

Earlier this week the FDA released information on the recall of Medtronic’s NewPort ventilators. Ventilators help ease the breathing of individuals with respiratory problems. Typically the devices are used during procedures where general anesthesia is in use.Ventilators

The company is not new to controversy, particularly with their ventilators. The company recalled around 600 of their Puritan Bennett 980 ventilator systems in 2o15. This specific product was typically used in hospitals and aim to provide constant breathing support for adults, children, and premature babies.

According to the FDA notice, 7,576 devices in the US are being recalled. All the recalled ventilators were manufactured between March 2010 and January 2017 and were distributed between March 4, 2010 and Feb. 2, 2017.

Ensure patients on the Newport HT70 and HT70 Plus ventilators are appropriately monitored by trained caregivers as described in the Operator’s Manual.

Last month, the company announced a strategy for customers to maintain use of the product.

“A patient connected to the ventilators requires the constant attention of trained caregivers to the patient’s condition.

    • Always have an alternate power source and means of ventilation available when the ventilator is in use in case of a mechanical or system problem.
    • Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph) when the Newport HT70 or HT70 Plus ventilators are in use on a patient.
    • If able, use the appropriate remote alarm/nurse call cable (CBL3223 or 10104494) to project ventilator alarm states outside the patient room. This alarm will annunciate even with an unexpected reset. Consult the Operator’s Manual or call Technical Service for further information on this accessory.
    • If, at any time, the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact your health care provider or physician immediately.”

If you would like to speak with a lawyer, on behalf of yourself or a loved one who may have been impacted by the ventilator shutdown, the Medical Claim Legal team is here to assist you. Don’t wait,  contact us today.