Parker Waichman LLP

FDA Approval Does Not Guarantee that Drugs are Safe or Effective

Approval Does Not Guarantee Drugs Safety. When the U.S. Food and Drug Administration (FDA) approves a drug, it does not necessarily mean that the drug is safe or effective for your condition. According to an investigative report by the Milwaukee Journal Sentinel, FDA approval does not guarantee safety or efficacy. The investigation showed that in […]

Drugs Safety

Approval Does Not Guarantee Drugs Safety. When the U.S. Food and Drug Administration (FDA) approves a drug, it does not necessarily mean that the drug is safe or effective for your condition.

According to an investigative report by the Milwaukee Journal Sentinel, FDA approval does not guarantee safety or efficacy.

The investigation showed that in the last decade, diabetes drugs such as Januvia, Byetta and Victoza have been linked to 3,000 deaths and roughly 20,000 hospitalizations.

The Journal Sentinel and its partner MedPage Today reported that none of the 30 new diabetes drugs have been shown to decrease the risk of heart attacks, strokes, blindness and other key complications.

According to Kearney Hub, the FDA approves diabetes drugs and other medications based on a surrogate measure, an interim measure for an eventual clinical outcome such as saving lives.

For diabetes drugs, a surrogate measure may show that the drug lowers blood sugar

For diabetes drugs, a surrogate measure may show that the drug lowers blood sugar and gets approved. Manufacturers do not actually have to prove that the drug prevents blindness or other complications.

Surrogate measures stem from changes made to FDA rules two decades ago, Kearney Hub reports. The agency faced pressure from politicians and drug companies, who wanted drugs on the market faster. The profits from diabetes drugs are exorbitant, with sales reaching $23 billion in 2013.

According to Journal Sentinel, this figure is larger than revenue from the National Football League, Major League Baseball and the National Basketball Association combined.

Kearney Hub points out that while a number of drugs can help people, others are marketed under questionable premises. One example of this is prescribing diabetes medications for so-called “pre-diabetics”.

The trend to offer drugs to patients to delay a diagnosis of diabetes

“The trend to offer drugs to patients to delay a diagnosis of diabetes without making them healthier is a significant problem,” said Dr. Victor Montori, a diabetes expert at Mayo Clinic, to Kearney Hub. “Almost half of those included in the definition of patients with pre-diabetes won’t develop the disease in 10 years.”

There are a few things patients can do to potentially reduce the risk of an adverse event, Kearey Hub reports. Patients should take a look at a drug’s “black-box warning”, which is placed when it is associated with serious or life-threatening side effects.

Dr. Montori recommends that people should talk to their doctors about whether or not a particular drug is necessary and whether there are any other options. Kearney Hub also advises consumers to be aware of the side effects.

Patients can also check the website of http://dailymed.nlm.nih.gov/dailymed/index.cfmDailyMed, operated by the National Library of Medicine and the FDA, pharmacist Larry Sasich said to Kearney Hub. The site contains current product labels and medication guides for drugs that are associated with significant public health concerns.

Need Legal Help Regarding Drugs Safety?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
It was a pleasure working with Michelle Josama and Michael Zaransky. Michelle was very pleasant and courteous. Michael was very professional. Both made me feel like they really care. I would highly recommend them. Great team.
Crystal Moore
5 years ago
5 Star Reviews 150
Thank you Parker Waichman LLP and especially paralegal Benita Rollis who guided me through the whole process. She was very professional, courteous and always called me back when I had any questions. I was very satisfied and highly recommend Parker Waichman LLP.
Denise Saraceno
2 years ago
5 Star Reviews 150
Parker Waichman has been very helpful in handling all aspects of my case to a successful resolution. They are very skilled in what they do and I was extremely impressed with the professionalism of the paralegal Benita Rollins who kept me informed every step of the way, was very efficient and followed up on every detail. I would highly recommend Parker Waichman for your legal needs.
Herbert Miller
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038