Philadelphia Personal Injury Lawyer - Drug Products

Anemia Drugs Given Stronger Warnings

Jamie Sheller — Wed, 26 Mar 2008 09:59:25 GMT

The makers of Aranesp, Epogen and Procrit have recently been advised by the FDA to expand its black box warnings. The new warnings indicate the risks of death and tumor growth when used by cancer patients with early stage breast cancer or cancer in the head and neck. Aransep, Epogen and Procrit are popular drugs used to treat the blood disorder anemia in patients with kidney failure and those on chemotherapy. http://www.fda.gov/cder/drug/advisory/RHE2007.htm If you, or a family member has been injured by this drug, contact Sheller PC to get more information about your legal rights. We have a team of experienced attorneys who are willing to assist you in every aspect of your case.

Originally posted at InjuryBoard by Jamie Sheller

Heparin contaminated with Counterfeit Ingredient

Jamie Sheller — Wed, 12 Mar 2008 12:53:25 GMT

In January 2008, Baxter Healthcare voluntarily recalled various lots of its blood thinner, Heparin. The recall was due to an increase in reports of adverse patient reactions. These reactions included abdominal pain, decreased blood pressure, chest pain, loss of consciousness, and hypotension. This voluntary recall was followed by a more extensive recall mandated by the FDA in February of 2008.

More recently, Baxter has discovered the root cause of the reported reactions. Testing revealed that a counterfeit ingredient, designed to mimic the real ingredient was linked to the adverse reactions.

"Although magnetic resonance imaging failed to determine what the counterfeit ingredient was, it was nonetheless found that as much as 20 per cent of the heparin's active ingredient was an unknown substance blended with genuine heparin.

The counterfeit ingredient, whatever it turns out to be, is designed to mimic the real thing.
However, it cannot be determined what effect the counterfeit ingredient would have on the human body. Until the substance is identified, the fact remains that patients have been injected with heparin containing up to 20 per cent of raw heparin comprised of some unknown substance.

So far there have been 19 deaths, and up to 785 adverse reaction reports linked to tainted heparin. While 46 deaths have been reported to the FDA, it is believed that 19 appeared to stem from the suspect heparin. Just this week the German health authority expressed concern after patients in Germany were becoming ill.

While the investigation is still in the preliminary stage, it has been reported that the heparin found to contain the counterfeit ingredient has been linked to allergic reactions and / or deaths, while heparin found to be free from the unknown contaminant is associated with patients who have not had adverse incidents.

One can only speculate why such spiking of genuine heparin is happening. An outbreak of blue ear pig disease throughout many provinces in China last year severely impacted swine stocks. Heparin is derived from the intestines of pigs. The counterfeit could have been added in an effort to bolster an anemic supply of raw heparin.

Or, the counterfeiting could have been initiated out of sheer greed.

Whatever the cause or the reason, the fact remains that the counterfeit ingredient was found in heparin sourced from China." http://www.lawyersandsettlements.com/articles/10138/heparin-tainted.html

Originally posted at InjuryBoard by Jamie Sheller

GlaxoSmithKline Escapes Criminal Prosecution

Jamie Sheller — Mon, 10 Mar 2008 11:32:52 GMT

Drugmaker, GlaxoSmithKline, escapes criminal prosecution in Britian, for withholding information about adverse effects of its drug, Seroxat. Seroxat, is marketed in the United States, as Paxil. According to Britian authorities, GlaxoSmithKline had information that Seroxat could increase sucidial thoughts in teens under the age of 18. However, GlaxoSmithKline did not release that information to the Healthcare Regulatory Agency until four years later. GlaxoSmithKline did not believe it had an obligation to notifiy the Agency of the problems since the drug was not approved for use by teens. Since that time, the laws have been changed to make it clear when drugmakers must report adverse events in any study conducted in the country. The Agency now seeks to change the law so that regardless of where a study takes the place, the drug maker must report its results.

Originally posted at InjuryBoard by Jamie Sheller

Tysabri May Damage Liver

Jamie Sheller — Fri, 29 Feb 2008 14:18:09 GMT

Once again the FDA has updated the label on the drug Tysabri. Tysabri, manufactured by Biogen Idec, Inc. and Elan Corp. Plc., is used by pateints with multiple sclerosis. Signs of liver damage occurred in some patients taking the drug. Liver problems may lead to death or the need for a transplant.

Originally posted at InjuryBoard by Jamie Sheller

Trasylol linked to 22,000 Deaths

Jamie Sheller — Thu, 21 Feb 2008 12:52:39 GMT

Trasylol, or aprotinin, is a blood clotting drug that is used during open heart surgery. Bayer Pharmaceuticals manufactured this drug beginning in 1993. As early as January 2006, studies were released that reported an increase risk of severe adverse reactions, including kidney failure, heart attack, and stroke in patients treated with this product. One medical researcher opined that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006. In November of 2007, Bayer agreed to temporarily suspend the marketing of Trasylol until further review could be completed.
Please contact an attorney to discuss Trasylol injury by filling out the form on the right hand side of the page.

Originally posted at InjuryBoard by Jamie Sheller

Coaches for Breast Cancer Patients

Jamie Sheller — Wed, 20 Feb 2008 14:50:12 GMT

Recently, the American Cancer Society and National Breast Cancer Coalition began training individuals to coach women who have been diagnosed with breast cancer. These coaches assist with navigating the difficult process of making life changing decisions once a patient has learned of the cancer. Unlike support from family, friends, and other breast cancer survivors, the coaches do not promote any particular solution. Instead, the coaches give an unbiased presentation of the choices ahead. For more information

If you or a loved one has been diagnosed with breast cancer as a result of taking hormone replacement therapy, contact Sheller, PC. We have a team of experienced trial attorneys who can assist you with your legal rights.

Originally posted at InjuryBoard by Jamie Sheller

FDA Takes Action Against Colchicine Marketers

Jamie Sheller — Wed, 13 Feb 2008 15:49:42 GMT

Recently, the FDA announced it will take action against all companies marketing unapproved, injectable colchicine. Colchicine is a drug used to treat gout. This drug is extremely dangerous since fatal doses are very similar to the effective doses. Adverse effects of this drug include death, low blood cell counts, cardiac events, and organ failure. If you or a loved one has been injured as a result of having colchicine injected into your body, please contact Sheller PC to discuss your legal rights. We have a team of experienced trial attorneys eager to assist you.

Originally posted at InjuryBoard by Jamie Sheller

Fosamax -- Still a Public Concern

Jamie Sheller — Thu, 07 Feb 2008 14:00:58 GMT

Fosamx, a drug used for treatment of osteoporosis, has been linked to a devastating condition called Osteonecrosis of the Jaw (ONJ) or Dead Jaw Syndrome. ONJ keeps the jawbones of patients from healing properly after routine dental procedures, and in extreme cases caused jawbones to rot and die. Several independent studies discovered that a number of patients taking Fosamax developed this dangerous and debilitating condition. If you or a loved one has been injured by this drug, contact Sheller, PC to discuss your legal rights. We have a team of experienced trial attorneys who are able to assist you with your case.

Originally posted at InjuryBoard by Jamie Sheller

Is Ortho Evra Contraception Safe?

Jamie Sheller — Tue, 29 Jan 2008 14:36:51 GMT

Just recently, the FDA changed the warnings on the Ortho Evra birth control patch yet again. This time the agency updated the warnings to include the results of a new study. This new study showed that users of the Ortho Evra patch are twice as likely to develop blood clots known as thromboembolism (VTE). Women between the ages of 15-44 are among those facing the greater risk. The FDA recommends that women using the Ortho Evra patch speak with their physicians about the risks associated with the patch and alternative methods for birth control. To learn more about this subject, view the FDA website below.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#orthoevrapatch

Originally posted at InjuryBoard by Jamie Sheller

Chantix Related to Suicidal Thoughts and Behaviors

Jamie Sheller — Thu, 03 Jan 2008 16:37:10 GMT

The FDA has notified health professionals that Chantix, a smoking cessation product, has been associated with erratic behavior in patients. Some patients reported suicidal thoughts and aggressive behavior within days or weeks of taking Chantix. The FDA is reviewing the cases. For more information about Chantix, view this page.

For more information on this subject, please see our section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Jamie Sheller