A May 1 release from the U.S. Food and Drug Administration warns consumers to immediately stop using Hydroxycut products.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant.

One death, of a 19 year-old due to liver failure, has been reported to the FDA.

Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

If you have been harmed by a dangerous or defective drug, you should consider seeking the professional advice of an attorney.

Botox and Botox Cosmetics have been given a new warning label in Canada that indicates that the anti-wrinkle drug can spread to other parts of the body. This potential side effect can be fatal. The new label also states that the drug can cause muscle weakness, difficulties in swallowing, pneumonia, and speech disorders.

The muscle relaxant has been licensed in Canada to treat facial nerve disorders and cerebral palsy, but it is much more commonly used to eliminate wrinkles and other facial age lines. Last February, the FDA linked the spread of Botox in the body to both FDA-approved and non-approved applications of the drug.

The new label stems from an investigation performed by Health Canada last October. Five patients died following Botox injections, and more than eight patients experienced severe side effects. The condition was deemed “distant toxin spread” by Health Canada.

The investigation also determined that doctors downplay the risks involved with Botox injections.

Baxter International Inc. has assumed responsibility in the nation-wide heparin contamination that endangered the health of thousands. Though they have admitted fault for their role in the distribution of the defective drug, Baxter denies any part in “deliberate” contamination.

Reports of serious allergic reactions and deaths associated with heparin doses began late in December of 2007. By January, there were sufficient reports of adverse reactions to prompt Baxter to recall about 10 percent of their annual production of heparin.

The contamination was finally linked to heparin manufacturing plants in China last March. Since then, there have been numerous investigations to find the responsible parties, since Chinese drug manufacturing is significantly less regulated than that in the United States.

The defective drug lawyers at Cappolino Dodd  Krebs LLP take on cases of defective drugs and injury caused by negligent companies. Have you been injured due to faulty pharmaceuticals? call our Texas office today.

As President-Elect Barack Obama’s administration comes together, one very important spot is the choice of  commissioner of the US Food and Drug Administration.

The next commissioner will need to be prepared for the policy and operational issues currently occurring at the FDA. Over the past few years, the FDA has received much criticism about its ability to enact drug-product safety (such as in the case of defective drugs like Vioxx) or adequately regulate manufacturers and the inspection of their facilities (in the contaminated heparin case).

Several names under consideration are Joshua Sharfstein, the commissioner of health for the city of Baltimore; Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic; and Janet Woodcock, the current director of the Center for Drug Evaluation and Research at the FDA, among others.

The Center for Disease Control has confirmed a counterfeit ingredient was in the tainted heparin that caused many allergic reactions and deaths last year.

According to the CDC, drug manufacturer Baxter Healthcare is “the factor most strongly associated with reactions.” In January of this year, Baxter International recalled almost all of its heparin injections in the US after some patients experienced extreme allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening.

The FDA identified 93 deaths and hundreds of cases of allergic reactions associated with the defective drug between January 1, 2008 and March 31, 2008.

According to the CDC study, the agency has identified 152 adverse reactions associated with heparin in 113 patients from November 19, 2007 through January 31, 2008. The CDC said that Baxter heparin was present in 100 percent of case facilities versus 4.3 percent of control facilities.

“Of 130 reactions for which information on the heparin lot was available, 128 (98.5 percent) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3 percent) occurred after the administration of OSCS-contaminated heparin,” the study said.

Defective drugs can cause harm and, sadly, fatalities. If a defective drug has harm you or a loved one, contact an experienced defective drugs attorney for professional insight.

One of the most important jobs of the FDA is to provide the public with clear information about drug safety. Another mission is to reveal what it knows about potentially defective drugs.

How well the FDA is doing with its primary mission is being questioned by Representative Joe Barton (R-Texas) who wrote a letter to the US Government Accountability Office: asking is the FDA telling us everything it knows?

The GAO is being asked to review the FDA’s handling of the contaminated heparin problems of 2007 and 2008. In his letter, Barton notes that the FDA’s statements to the media in July 2008 indicate that the agency had “conclusively linked” deaths of three patients to oversulfated chondroitin sulfate found in specific lots of the drug, which is manufactured by Baxter Healthcare.

Yet when Barton requested information, the agency told him in October 2008 that it was merely “possible” that heparin caused two of the deaths and that it could not assess whether heparin caused the third death, while Baxter’s investigation of the situation concluded that it was unlikely that heparin had caused any of the three deaths.

The FDA did not interview Baxter to get more information about the deaths and that inconsistency troubles Barton.

Could drug companies be cooking the books where it comes to getting FDA approval for new drugs?

Recent research published in the journal Public Library of Science Medicine shows that many drug studies submitted to and read by the U.S. Food and Drug Administration go unpublished.

In addition to that, some that are published sport inconsistencies between the study that was submitted and the study that was subsequently released. Changes included additions and/or deletions, statistical alterations of outcomes and changes in trial conclusions.

In general, reports that show the studied drug in a favorable light are much more likely to be published. Of forty-three trials that showed no benefit to the test drug, only half were published.

This kind of dishonesty in the medical field can be very dangerous, possibly misleading doctors and patients alike while they make important decisions about the patient’s health. Unfortunately, discrepancies such as these can be very hard to detect or prosecute.

The Texas defective drug attorneys at Cappolino, Dodd & Krebs are concerned about your health. Have you been injured by a defective drug? Contact us today.

Labels on the antipsychotic drug Zyprexa don’t warn patients of all its potential side effects.

That’s according to the FDA which says it is looking into requiring the drugs’s manufacturer, Eli Lilly,  to include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.

While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.

Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label. It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

Last month, Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa.  CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.

Watchers of the U.S. Supreme Court seem to agree that the high court will likely rule in favor of a drug manufacturer in a case that saw a Vermont woman loose her arm to gangrene.

However, consumer advocates appeared relieved that the case will affect only situations where there were no allegations that drug companies tried to hide information about potential risks and where the FDA rejected stronger label warnings.

The case, Wyeth v. Levine, has been billed as a major milestone in an effort by the pharmaceutical and other industries to free themselves of unpredictable state court personal injury litigation by embracing instead a single federal regulatory regime — in short, federal pre-emption of state courts.

In 2000, Vermont guitarist Diana Levine went to a clinic seeking relief for her migraine. She was injected with the Wyeth drug Phenergan by means of an intravenous method that was discouraged but not forbidden by the labeling, which had been approved by the Food and Drug Administration.

But based on arguments before the high court Monday, the case could be decided narrowly, giving little guidance about broader pre-emption issues beyond the area of drug labeling.