Parker Waichman LLP

FDA Releases Quarterly List of Drugs Under Review

U.S. health regulators are currently probing possible safety issues of more than a dozen drugs. The drugs currently under review include the cancer drug Sutent, gandolinium-based contrast agents used in MRIs, and Reclast, which is used treat post-menopausal osteoporosis. The medications were included on a quarterly list released today by the Food & Drug Administration […]

U.S. health regulators are currently probing possible <"https://www.yourlawyer.com/practice_areas/defective_drugs">safety issues of more than a dozen drugs. The drugs currently under review include the cancer drug Sutent, gandolinium-based contrast agents used in MRIs, and Reclast, which is used treat post-menopausal osteoporosis.

The medications were included on a quarterly list released today by the Food & Drug Administration (FDA). The list represents potential safety issues identified between January and March 2009 from the Adverse Event Reporting System. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

The drugs currently under review are:

Ceftriaxone (Rocephin) – Hemolytic anemia was added to the Warnings section of labeling in June 2009
Diclofenac epolamine patch (Flector) – Hypersensitivity reactions
Didanosine (Videx) – Portal hypertension
Entacapone (Comtan) – Colitis
Gadolinium-based contrast agents – Anaphylaxis
Alpha interferon products – Pulmonary Hypertension
Mecasermin products (Increlex, Iplex) – Hypersensitivity reactions
Methylnaltrexone (Relistor) – Gastrointestinal perforation
Minocycline (Solodyn) – Autoimmune disorders in pediatric patients
Promethazine injection – In September 2009 FDA informed manufacturers of promethazine injection to include a Boxed Warning in the labeling to highlight the risk of serious tissue injury when this drug is administered incorrectly.
Sunitinib (Sutent) – Liver failure
Tenofovir (Viread) – Safety during pregnancy
Zoledronic acid (Reclast) – Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.

According to the FDA, inclusion on this list does not mean that the agency has identified a causal relationship between the drug and the listed risk. Nor does it mean that the FDA is suggesting doctors should not prescribe the drug or that patients taking the drug should stop. Patients who have questions about their use of the identified drug should contact their health care provider. The FDA said it will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

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
Positive: Professionalism , Quality , Responsiveness , Value P&W worked on my 9/11 VCF claim and in retrospect I am so happy I chose them over the other firms who do the same. Ashley L. handled my claim and she was wonderful to work with. She was knowledgeable, responsive, and compassionate.
Shoshana Dornhelm
3 years ago
5 Star Reviews 150
Joanne M. Stevens nurse at Parker and Wakeman has been very helpful knowledgeable and tentative to my case. I have questions she has answers she addresses all my concerns. The world needs more case managers like her. Bottom line great nurse, great service, highly recommended. AAA+!+
Lewis
5 years ago
5 Star Reviews 150
Thanks to Jorge Peniche and Parker Waichman who were always aware of my case and that it was resolved in the best way without you I don't know what I would do, thank you
Jhonatan Romerozavaleta
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