Parker Waichman LLP

Innohep Alternatives Urged After Study Finds Increased Risk of Death in Elderly

Innohep, a drug used to prevent blood clots, may increase the risk of death for elderly patients.  The Food & Drug Administration (FDA), along with Innohep manufacturer Celgene, have warned doctors to consider alternatives. Innohep was approved for U.S. sales in 2000. It is injected under the skin, and is used with warfarin to treat […]

<"https://www.yourlawyer.com/practice_areas/defective_drugs">Innohep, a drug used to prevent blood clots, may increase the risk of death for elderly patients.  The Food & Drug Administration (FDA), along with Innohep manufacturer Celgene, have warned doctors to consider alternatives.

Innohep was approved for U.S. sales in 2000. It is injected under the skin, and is used with warfarin to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs.  Innohep is used for several days after surgery, while a patient is  unable to walk. It is during this time that blood clots are most likely to form. Innohep  also may be used for other conditions as determined by a doctor.  Since 2001, more than 30 million people worldwide have been treated with Innohep.

In early December, the FDA announced it had begun conducting a safety review of Innohep.  The FDA decided to conduct the review after information  about a clinical study known as Innohep in Renal Insufficiency Study (IRIS) that was stopped in February 2008.  The study’s Data Safety Monitoring Committee had halted the IRIS trial because of an interim finding of an increase in all-cause mortality in patients who received Innohep.  This multi-center European study was designed to evaluate the safety of Innohep, a low-molecular-weight heparin, compared to unfractionated heparin  in treating deep vein thromboses (DVT)  and/or pulmonary emboli (PE) in patients greater than 70 years of age who had impaired renal function.

At the time the study was stopped, 350 patients had completed 90 days follow-up. Of these, 23 of the 176 (13%) patients in the Innohep treated group and 9 of the 174 (5%) patients in the unfractionated heparin treated group had died.  The FDA said that from the information currently available,  there is no clear pattern as to the causes of death. The causes of death do not appear to be related to either over-dosing (bleeding) or under-dosing (blood clots) with an anti-coagulant (a blood thinner), the FDA said.

According to a “Dear Health Care Professional” letter recently issued by Celgene, information from the IRIS study has been added to the  Innohep label under the “CLINICAL PHARMACOLOGY, Special Populations, Elderly”, “WARNINGS” and “PRECAUTIONS, Geriatric Use” sections.  The “ADVERSE REACTIONS” section of the Innohep label has also been updated to include the statement “Spinal epidural hematoma in association with neuraxial anesthesia or spinalpuncture with INNOHEP has been reported.”

According to the FDA, there have been 383 reports of  Innohep side effects and complications worldwide, including 96 deaths, as of Oct. 15, 2008.  The Celgene letter recommends that doctors consider alternatives to Innohep in patients with deep vein thrombosis, life-threatening blood clots in major veins such as in the legs.

According to the Associated Press, Celgene sent another letter to doctors in July warning of an elevated risk of death in patients aged 90 and older. The new letter extends the warning to all elderly patients.

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
Excellent law firm. Thank you Parker Waichman on behalf of my father Eucebio Concepcion for helping us with his worker’s compensation case. It was a great experience, they explained the the process step by step. Thank you so much to Jorge Peniche for being super patient with us!!
Leanna Erazo
4 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Parker Waichman is an excellent law firm. Thank you Christina Morace my Paralegal, assigned to the case for guiding me through the process of filing the necessary paperwork for the 9/11 victims compensation fund. Your knowledge and ability to communicate it to me made the entire process much easier..
allan doyno
3 years ago
5 Star Reviews 150
The only great experience I've had with this company is Joanne Stevens NP & Consultant. If we did not get a response sure enough we would just by calling Joanne, very reliable person you can depend on her to get it done no question ask except for what was need for her to assist us, a person of her character is very hard to find and hope she is recognize for all her hard work, she is the only good experience we have had with this law firm, she should be commended for all the hard work she does and for doing what some lawyers in the firm should be doing............ we thank you from the bottom of our hearts and say how much we appreciate your hard work. Sincerely yours, The Angel Alonso Family
Jeannette Suarez
8 years 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