Plavix: New Blackbox Warning Label Infomation

Plavix is a prescription drug that thins the blood. It is given to patients with recent heart attacks or strokes to prevent further attacks. The drug is the second most prescribed drug in the world. Lipitor prescribed for high choelesterol is first in global drug sales.

What Are Black Box Warning Labels?

Black box warning labels give critical patient information about the drugs interactions with other foods, medicines and mental conditions. These warnings unheeded could cost you your life or cause life threatening side effects. Always read the medication instructions that come in the box. Go to the Internet and investigate the drug yourself. Drugs often give instructions such as not to take them with alcohol or milk. The drug may need to be taken on a full stomach or at a certain time of day. Follow the instructions carefully. Many patients continue to drink alcohol with medications which increase nasty side effects such as nausea, vomiting, and dizziness.

1^st Black Box Warning:

In November of last year, doctors discovered that Plavix when taken with drugs prescribed for stomach complaints such as Nexium and Prilosec, was a real problem. The main ingredient in the stomach medicines blocked the liver enzyme needed to break down the Plavix. This reduced the effectiveness of the Plavix by half. If you don't know this, you will think you are being protected with the medicine, when you are not. The result could be a killer heart attack or stoke.

2^nd New Black Box Warning for Plavix Patients:

Just this month the FDA added a stronger black box warning to the drug. Patients who are on the medicine already, may not find out this information from their doctor. Doctors and nursing staff are extremely busy, and may miss giving you this information.

Plavix Does Not Work In Some Patients:

There is a certain percentage of the population that cannot utilize Plavix in their blood stream. Plavix to work effectively must be broken down by a certain enzyme produced by the liver. Without that enzyme, the drug does not work to thin your blood. If you are of Chinese descent you are in the greatest risk group (14%). Blacks come next with 4% and whites with 2%. This is all just numbers, so how do you tell if you are one of these patients who cannot metabolize the drug? The only way to tell is by genetic testing. The problem with that is the test costs $500 plus and may not be covered by your insurance. You should not stop taking Plavix unless you are directed by your doctor to do so. You do need to make sure you are not one of those patients listed above.

Plavix is not Superior to Aspirin: Warnings Issued to Plavix Manufacturer:

In seems that Plavix manufactured by the Sanoif-Avenitis and Bristol-Myer Squibb have received several warnings from the FDA. These statements are regarding false and misleading promotional statements in their advertising.

The drug companies own studies show that Plavix is about as effective as Aspirin, not superior, in preventing heart attacks and strokes.

In 1998 The FDA warned the company that its promotion to patients receiving stents was NOT an approved use. The dose being prescribed was nearly 4 times higher than the dose used in the clinical trials which could cause an overdose. The company was also reprimanded for failing to disclose the risks of Plavix to the patients.

In both 1998 and in 2001, the company was reprimanded for minimizing the side effects of the drug in their advertising and brochures and to patients directly. They were warned to stop advertising that Plavix was superior to Aspirin in effectiveness. This fact was not supported by clinical trials. They were given warnings for failing to submit adverse drug reactions and for misleading consumers on the product . They were warned that they were not giving patients the proper information on side effects and risks. They minimized the risks in advertising and in brochures. They were given orders to stop misleading advertisement and claims.

Patients should talk to their physicians:

Ask your doctor to prescribe another blood thinner such as Effient by Eli Lilly and Company.

Call your health plan to see if they will pay for the genetic test. If your insurance will not pay for it, find out how much the test will cost. Adopt life style changes to reduce your heart attack risk.

References:

http://www.app.com/article/20100312/BUSINESS/3120352/0/SPORTS&source=rss

http://www.youhavealawyer.com/plavix/plavix-warning-fda.html