A Missouri man who took the antibiotic Tequin is suing Bristol-Meyers Squibb and Schering Corporation for blood sugar problems he developed while taking the drug. Patrick Bills alleges that he developed both hyperglycemia and new onset diabetes while taking Tequin for a skin infection.
Tequin, a once-popular antibiotic, was introduced by Bristol Myers Squibb in 1999 to treat bacterial infections like pneumonia, bronchitis, urinary tract infections and sinusitis. By 2001, 3.3 million prescriptions were being written every year in the US for Tequin. It was that same year that researchers began noticing that Tequin could play havoc with blood sugar levels. Between April 2002 and March 2004, researchers at St. Michaels Hospital in Toronto followed 1.4 million patients aged 66 years and older. The researches found that 788 of those patients had to be treated for dangerously low or high blood sugar within 30 days of Tequin therapy. The research found that there was a four times greater risk of life-threatening blood sugar problems among patients treated with Tequin. When the Canadian study was published in the New England Journal of Medicine in 2006, it found that previously-healthy Tequin users had a 17-percent higher chance of developing serious diabetes.
According to a press release issued by his attorneys, Bills began taking Tequin in 2005 for a skin infection. Shortly after, he began experiencing symptoms like extreme thirst, frequent urination and vision changes. In January 2006, Bills was diagnosed with sever hyperglycemia and diabetes. The lawsuit contends that Bills’ illnesses are a direct result of his treatment with Tequin. The suit claims that before taking the antibiotic, Bills had been healthy, and had not experienced any symptoms related to blood sugar problems.
The lawsuit alleges that Bristol-Meyers Squibb ignored mounting evidence of blood sugar problems related to Tequin. It wasn’t until February 2006 that, under pressure from the Food and Drug Administration, the company added a warning label that Tequin should not be taken by diabetics. But the company did not address potential problems for non-diabetics. In May 2006, Bristol-Meyers Squibb announced to its shareholders that it was taking Tequin off the market. Bills’ lawsuit charges that this move was made with little public fanfare, and that Tequin that had already been shipped was allowed to remain on pharmacy shelves. The complaint also alleges that physicians were not given adequate warning by the company and continued to write prescriptions for Tequin.
The lawsuit lists nine different counts against the pharmaceutical company and is seeking both compensatory and punitive damages for Bills.
Researchers have accomplished what might be a cure of type 1 diabetes — at least in mice — and they’re taking the first steps toward a human trial.Type 1 diabetes is the autoimmune form of the disease, affecting about five percent of diabetics. It usually emerges in childhood and occurs when the body’s immune system attacks insulin-producing beta cells in the pancreas.
Now, a three-drug regimen that not only stops the destruction of beta cells but also preserves the function of cells that receive and metabolize insulin has eliminated type 1 diabetes in laboratory mice, said lead researcher Maria Koulmanda, director of nonhuman primate research at the Transplant Research Center, Beth Israel Deaconess Medical Center in Boston.
Her team published its report July 30 in this week’s online edition of the Proceedings of the National Academy of Sciences.
“We stopped the progression of automimmunity. The animals could become normoglycemic,” meaning they had normal levels of blood sugar, Koulmanda said.
Another major discovery is that inflammation appears to play a major role in type 1 diabetes, she added. In fact, one drug used in the treatment regimen reduced the inflammation of cells that metabolize insulin.
“Basically, by blocking inflammation, we were getting the animals to be insulin-sensitive,” Koulmanda said.
Another drug successfully reduced the autoimmune destruction of beta cells, but that was not the key to reversing the disease, she said. Instead, success was linked to blocking inflammatory processes that impair cells’ responses to insulin.
Some of the cells involved in insulin metabolism were found to be resistant to insulin’s effects — a common phenomenon seen in much more common, adult-onset, obesity-linked type 2 diabetes, Koulmanda said. “This is the first time anyone has seen insulin-resistant cells in type 1 diabetes,” she noted.
A course of treatment lasting less than four weeks restored normal blood sugar function in the test mice. In contrast, mice that did not get the treatment died during that month-long period.
Based on these promising results, the first work need to s?art a human trial of the regimen are about to begin, said Dr. Terry B. Strom, director of the Transplant Research Center.
“We have tried something like this for monkey models,” he said. “The results have been very good.”
The next step will be tests to ensure that the regimen is safe for human use.
“We anticipate toxicology trials very soon,” Strom said. “We are making the proteins needed for those trials.”
The fact that success was achieved in the mice trials with a relatively short course of treatment indicates that, for humans, “one might be able to use relatively brief periods of treatment to restore normal function,” he said.
source: HealthDay News
Caraco Pharmaceutical Laboratories Ltd. said it received tentative approval from the United States Food and Drug Administration for the company’s Abbreviated New Drug Application for Repaglinide Tablets USP.
The Detroit-based generic drug company said Repaglinide works by lowering the blood glucose in patients with type 2 diabetes whose hyperglycemia can’t be controlled properly by diet and exercise alone.
Caraco, whose majority owner is Sun Pharmaceutical Industries Ltd. of Mumbai, India, said doses that were approved the by FDA were 0.5 mg, 1 mg and 2 mg tablets. The tentative approval is the bioequivalent to Prandin ®, registered trademark of Novo Nordisk Pharmaceuticals Inc.
“We are extremely pleased to receive this tentative approval,” said Daniel Movens, Caraco’s Chief Executive Officer in a statement. “We believe we have a first to file position on Repaglinide, which could result in 180-day marketing exclusivity. The product was filed with a Paragraph IV certification that we do not infringe and or that the Novo Nordisk patent is invalid. We are under current litigation with Novo Nordisk and expect a favorable conclusion.”