Parker Waichman LLP

FDA to Take A Closer Look at Plavix

The U.S. Food and Drug Administration (FDA) will be working with the maker’s of the anti-stroke medication Plavix to enable a better understanding of the drug and its effects on the body, especially when taken with another class of drugs, said MedWatch.  The LA Times reports that Plavix is the world’s second-best selling drug and […]

The U.S. Food and Drug Administration (FDA) will be working with the maker’s of the anti-stroke medication <"https://www.yourlawyer.com/practice_areas/defective_drugs">Plavix to enable a better understanding of the drug and its effects on the body, especially when taken with another class of drugs, said MedWatch.  The LA Times reports that Plavix is the world’s second-best selling drug and had global sales of $7.3 billion in 2007.

A prior study found that patients taking the clot reducer Plavix (Generic: Clopidogrel bisulfate) experienced more than 12 times as many ulcers as those patients who were treated with aspirin plus a heartburn pill.  It is believed that up to half of those patients who are now taking Plavix do so because their doctors assume that Plavix is safer on the stomach than aspirin, said that study’s lead author, Dr. Francis K. L. Chan.  Of note, the American College of Cardiology and the American Heart Association recommends Plavix therapy instead of aspirin therapy for those heart and stroke patients at risk of developing ulcers.

The study also suggested that the drug’s guidelines should be changed, and that many of those patients taking Plavix should consider switching to aspirin plus a heartburn pill, Dr. Chan said.  Dr. Chan’s study looked at 320 patients whose ulcers had healed.  He treated half with Plavix and half with aspirin plus Nexium, a heartburn pill. Thirteen of the patients taking Plavix, or 8.6 percent, experienced renewed ulcer bleeding during the year; just one patient, or 0.7 percent, of those taking aspirin and Nexium developed an ulcer bleed.

The FDA advised healthcare professionals this week that it ordered the makers of Plavix—Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership—to collaborate with the agency on studies that are hoped to reveal deeper information on the possible effects of genetic factors, said MedWatch and on possible drug interactions, said the LA Times.  In particular, the study will be looking at the effect of PPIs—proton pump inhibitors—on Plavix, since it is unclear which, either, or both of these factors are involved, reported MedWatch.  PPIs, which are taken for the treatment of acid reflux, are described by the LA Times as medications which suppress stomach acid production.  Nexium, Prevacid, Aciphex, and Protonix are some examples of prescription PPIs and Prilosec OTC is an over-the-counter PPI.

Medwatch confirmed that the FDA knows of reports which indicate that clopidogrel efficacy is uneven, with results differing in some patients over others.  The FDA expects that it could take several months to conduct the studies.  MedWatch urged healthcare providers to re-evaluate the need to start or continue PPIs in those patients being treated with clopidogrel; likewise, patients taking the combination or considering the combination are advised to speak to their healthcare providers, and to bear in mind that Prilosec OTC can be taken without a prescription.

The LA Times reported that the FDA move came about because of reports that clopidogrel’s cholesterol reducing efficacy seemed to be compromised in some patients.  The FDA also noted that genetic factors might be involved and other drugs could also affect how the drug is metabolized in the body, said the LA Times.  PPIs seem to reduce the breakdown of some drugs by the liver and may increase the concentration of diazepam (Valium), phenytoin (Dilantin), and warfarin (Coumadin), said the LA Times.

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 You guys are exceptional very professional and understanding I would recommend your to anyone who needs help navigating the legal system
Denise Brown
2 years ago
5 Star Reviews 150
The Office staff at Parker Waichman has been extremely responsive to all of my questions and concerns, someone is always checking in with me to see how we are feeling, how treatments are going, it puts your mind at rest and they don't allow you to stress out about the small details because they take care of all of them. I am very grateful to have Joanne, Jillian and Cristen helping my family through this. Even the reception staff are always cheerful and pleasant, it is such a pleasure speaking with them.
Kathy Oliva
8 years ago
5 Star Reviews 150
Positive: Professionalism , Quality I want to say thank you to Denny Tang for handling my case. He’s a great attorney, always responsive and pleasant to speak with. Thank you for everything.
Leyla Coello
3 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