Sacramento Personal Injury Lawyer - defective drugs

TWC Global LLC, Inc. Issues a Recall of Axcil and Desirin

Jenny Albano — Sat, 22 Sep 2007 19:23:20 GMT

TWC Global LLC, Inc., in conjunction with the FDA, is recalling Axcil and Desirin products marked as dietary supplements because they include potentially dangerous unlabeled ingredients.

FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers who have diabetes, high blood pressure, heart disease of have high cholesterol may take nitrates for their condition. These consumers often have problems with sexual dysfunction and may take these type of products to improve sexual performance.

Axcil and Desirin are sold throughout the U.S. on the Internet. The pills are sold as a 15-capsule blister pack packaged in a box.

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

Originally posted at InjuryBoard by Jenny Albano

Bodee LLC, Inc. is Recalling Zencore Tabs Due to Undeclared Ingredients

Jenny Albano — Sat, 08 Sep 2007 09:11:14 GMT

Bodee LLC, Inc., in conjunction with the FDA, announced they are recalling the dietary supplement Zencore Tabs because of undeclared ingredients.

Representatives of the FDA found these undeclared ingredients during lab analysis and stated that the ingredients are potentially harmful to consumers.

FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declares another lot of Zencore Tabs contains sildenafil, the active ingredient of another FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Some consumers with conditions such as diabetes, who have high blood pressure, high cholesterol, or heart disease many need to take nitrates. Erectile Dysfunction is a common problem for men with these ailments, and some consumers may seek these kinds of products to better their sexual performance.

Zencore Tabs were sold in health food stores and through mail order across the U.S. and Canada. The product comes in a 2-capsule blister pack which is packaged in a booklet with five booklets in one box.

Bodee and the FDA are recommending that any consumer who is using Zencore Tabs should cease use immediately and should seek medical care if they are experiencing any problems. The company is working with the FDA to make sure their product will be safe in the future.

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

Originally posted at InjuryBoard by Jenny Albano

Permax Recall

Staff Writer — Sat, 31 Mar 2007 14:37:36 GMT

The FDA has requested the Parkinson's disease drug Permax to be pulled from the market after studies showed Permax has been linked to heart valve damage and increased risk of heart attack.

At least 14 patients have needed to have heart valves replaced, but an FDA official says be believes that number to be higher.
Patients are being told not to stop using the drug abruptly, and to consult with their doctor about either a switch to another drug or about a gradual reduction in the amount of pergolide.

The agency's official estimates that over 12,000 people use Permax to treat symptoms of Parkinson's

Originally posted at InjuryBoard by Staff Writer

Trasylol Increases a Patients Risk of Death

Laura Mackie — Mon, 19 Feb 2007 12:31:35 GMT

According to a study recently published ( February 7, 2007) in the Journal of the American Medical Association, there is a significant increase in the possibility of death for patients taking the anti-bleeding drug known as aprotinin following cardiac surgery. Although aprotinin was approved by The Food and Drug Administration (FDA) in 1993, more recent advice by the agency has been to closely monitor patients using the drug. Their concerns focus on the safety of administering anti-bleeding drugs to post cardiac surgery patients. Bayer Pharmaceuticals, who markets apropinin as Trasylol, revealed just last year, that they have information which shows an increase in the risk of death, organ damage and heart failure from using the drug.

The best information to date indicates a 48% increase in the risk of death when compared to patients taking the drugs aminocaproic acid and tranexamic acid. The group of doctors who conducted the two most recent studies on the matter, suggested that prescription of aprotinin among patients undergoing CABG surgery is not prudent, since safer and cheaper alternatives (aminocaproic acid and tranexamic acid) are available.

If you or a loved one has suffered injury as a result of taking this medication, please contact a legal professional for assistance in determining what rights for recovery you may have under the law.

Originally posted at InjuryBoard by Laura Mackie

Novel Drug therapies create new morbidity

Ed Smith — Mon, 23 Oct 2006 16:07:06 GMT

During the recent Fourth INternational Conference on Inflammnatory bowel diseases, an Italian physician, Dr. Eduard Strange stated tha it is not surprising that this treatment [Remicade] is associated with side effects, including severe infections such as tuberculosis, and opportunistic infections including listeriosis, histoplasmosis, and many others (published as case reports or in the large clinical trials). In addition, autoimmune diseases including lupus erythematodes or multiple sclerosis have been observed as sequelae to the medication. Also, lymphomas and various cancers have been found at varying intervals after starting the medication, although a causal relationship is difficult to prove. [bold added]"

He also quoted a study showing the mortality rate to be between 2% and 2.8%. For the vast majority of people, he concluded, the risks of taking remicade outweigh any benefits.

Originally posted at InjuryBoard by Ed Smith

Ortho Evra and "confidentiality agreements" - We may never know how many have been injured.

Ed Smith — Wed, 18 Oct 2006 17:23:25 GMT

In what may be viewed by some as a "disturbing" business practice, the maker of the Ortho Evra birth control patch appears to be 'settling Ortho Evra lawsuits almost as quickly as they are filed', in exchange for confidentiality agreements which prevent the persons settling from discussing the facts of their cases (and, in doing so, preventing the public from becoming better educated as to the nature, extent, and number, of patients who have sustained serious personal injury and even death as the result of use of Ortho Evra.).

The likely reasons for the rapid settlements are twofold and clear: (1) the manufacturer (Johnson & Johnson, a division of Ortho-McNeil Pharmaceutical Inc) wants to keep a lid on things by requiring 'confidentiality'; and (2) the causal relationship between the injuries and the product are easily determined.

As described in the article entitled J&J Can't Settle Ortho-Evra Cases Fast Enough:

" . . legal experts say J&J attorneys are fully aware that the cause of the injuries and death alleged in the lawsuits will be easy to prove because the plaintiffs have a "signature disease," described as a condition closely linked to the use of a drug that is otherwise very rare. In this instance, they point out, blood clots, heart attacks and strokes are extremely unusual in teenagers and women of childbearing years, with the only commonality among the victims being the Ortho Evra birth control patch.

That September 28, 2006, article goes on to state:

Despite having first-hand knowledge of the number of women being injured and killed, the FDA did not officially alert the pubic to the high risks associated with the patch until November 10, 2005, when a "Black Box" warning was added to the product label that said the device could expose women to estrogen levels 60% higher than oral contraceptives and that the increased dosage was associated with a greater risk of blood clots.
Unfortunately for the thousands of young women who have already died or been injured, this action by the FDA represents another case where the agency charged with protecting consumers from the profit driven pharmaceutical industry has done too little to late.

Originally posted at InjuryBoard by Ed Smith

Bone Death in Women taking osteoporosis Drugs

Ed Smith — Wed, 18 Oct 2006 17:16:42 GMT

It was recently reporter that there is a link between women taking certain bone strengthening drugs known as bisphosphonates, including ( Fosamax, Actonel, Boniva, Skelid, Didronel, Zometa, Aredia, and Bonefos) and death of bone tissue.

The study was printed in the Harvard Women's Health Watch (September 2006).

The above drugs are widely prescribed for osteoporosis and also to treat bone pain incancer patients. In the short run, biophosphonates increase bone density, but in the long run they seem to impair new bone formation.

Originally posted at InjuryBoard by Ed Smith