FDA Focuses on Reducing Preventable Harm from Medications

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

FDA Holds Symposium Aimed at Reducing Rates of Known Adverse Events

On June 15, 2017, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES) is holding a one day public symposium focused on reducing preventable harm from medications. The agency notes that, while some patients experience side effects despite taking the drug correctly, there are some cases of drug injury that were preventable.

Parker Waichman LLP is a national personal injury law firm with decades of experience successfully representing clients in drug injury lawsuits. The firm continues to offer free, no-obligation legal consultations to individuals with questions about filing a drug injury lawsuit.

The symposium, titled “Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting” will discuss ways to reduce these preventable injuries and deaths after patients leave the doctor’s office or hospital. Attendees will include representatives from state and federal regulatory agencies, insurers, patient advocacy groups, prescribers, pharmacists, patients, caregivers, manufacturers and others.

Each year, preventable adverse drug events kill at least 1.5 million people in the United States, according to the National Academy of Medicine (formerly known as the Institute of Medicine).

A May 16, 2017 FDA blog post titled “Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone,” discusses the symposium, and its importance. “Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor prescribed it, and a patient can still experience adverse events. When it comes to drugs, not all risks are known – even after approval,” writes John J. Whyte, M.D., M.P.H. “Sadly, however, harm from medications also may come from known risks that could have been prevented.” Dr. Whyte is the Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research.

Drug safety involves multiple facets. Pharmaceutical companies must label their products properly so patients and doctors are aware of the risks, side effects and any dangerous interactions. Similarly, patients need to read the drug label and take the medication as instruction. Even regular over-the-counter drugs, such as acetaminophen, can be deadly if the wrong dose is given.

Lawsuits Filed over Drug Adverse Events

Lawsuits are regularly filed against pharmaceutical companies over drug adverse events. These claims fall under product liability, where a manufacturer is held liable for selling an allegedly defective or dangerous product.

Generally, plaintiffs suing over drug injuries allege that the drug maker knew or should have known that the drug would cause injury, but failed to warn patients or the medical community. Plaintiffs allege that, if they drug had been properly labeled, they would not have agreed to take the drug.

For example, lawsuits are being filed over the chemotherapy drug Taxotere. Plaintiffs in the litigation suffered from permanent hair loss. Although hair loss is a known side effect of chemotherapy, plaintiffs allege that the hair loss was presented as being temporary. The sudden permanent loss of hair has caused psychological damage, Taxotere suits allege.

In other drug injury news, AstraZeneca and Bristol-Myers Squibb are being sued over the diabetes drug Onglyza. Plaintiffs allege that the drug caused heart failure. Onglyza plaintiffs allege that the companies failed to accurately test their products for heart risks, despite requests from the FDA.

Onglyza’s main active ingredient in saxagliptin, which is also present in the diabetes drug Kombiglyze XR (saxagliptin and metformin extended release).

Plaintiffs allege that saxagliptin is defective, and increases the risk of heart failure. Onglyza and Kombiglyze XR users suffered congestive heart failure and other problems, allegedly due to the defective nature of the medication. Some lawsuits are wrongful death claims filed on behalf of people who died after taking the diabetes medication. The lawsuits allege negligence, failure to warn, breach of warranty of merchantability, and breach of express and implied warranty.

Plaintiffs are seeking damages for medical expenses, lost wages, economic damages, pain and suffering, and emotional distress.

Lawsuits are also being filed over testosterone products, which present heart risks. Plaintiffs allege that drug makers marketed testosterone products for “Low-T”, which is not a true medical condition. Product liability lawsuits have been filed over Androgel, Axiron and other products.

Filing a Drug Injury Lawsuit

If you or someone you know is interested in filing a drug injury lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).