Citing potential lethal effects on children, an FDA official has called for Sanofi-Aventis, the maker of Ketek, to halt clinic trials. The drug is being tested for ear infections and tonsilitis in nearly 4,000 infants and children in more than a dozen countries. The drug has been linked to liver failure, blurred vision, and loss of consciousness in adults. More than 5 million US prescriptions have been written for Ketek in the past two years.
Merck acknowledged Tuesday that a statistical analysis test used to reach the conclusion, published in a March 2005 New England Journal of Medicine article, did not support its theory of potential heart problems only after 18 months of continuous Vioxx use. The test actually showed there was 7 percent chance that Vioxx posed an equally high heart attack risk before and after the 18-month window, the Times reported.
Singapore health officials have strongly criticized ReNu with MoistureLoc maker Bausch & Lomb for its tardy response to a growing health crisis. According to the Singapore health authorities, three months ago, they had established a strong statistical connection between Bausch & Lomb’s ReNu With MoistureLoc cleaner and Fusarium eye fungus infections.
Singapore officials are now openly critical of the company for not acting faster. They criticize the company for being slow to recall the solution even after their own research yielded what they said was compelling evidence of a link between the MoistureLoc solution and a spate of infections there.
The “Perfect Storm” analogy are not my words but the words of Bausch & Lomb Chief Executive Ron Zarrella. He made the comments in the wake of a CDC investigation that seems to point more significant blame on Bauch & Lomb eye solution products than first thought. It may be that all Bausch & Lomb eye solution products are suspect in the wake of the fungal fusarium keratitis outbreak. Here’s Ron Zarrella unplugged: “We’re looking at every possibility,” Chief Executive Ron Zarrella said in a videotaped message posted on the company’s Web site. “Some of our experts believe it’s possible that a number of factors could have come together to create a kind of perfect storm to allow this fungus to take hold.”
In the midst of bad news from its painkiller Vioxx, Merck & Co. now has to face similar fallout from its osteoporosis drug Fosamax. Fosamax, prescribed to treat osteoporosis, may have caused the jaw of a Floridian woman to rot. Officials originally believed osteonecrosis, defined as a rotting jaw, was confined to specific chemotherapy drugs. Fosamax and the chemotherapy treatments are in the same class of drugs. In 2004, the FDA learned Fosamax and similar drugs may cause osteonecrosis. Yet in spite of this knowledge, Merck failed and refused to change its label warning.
A consumer watchdog group is petitioning the Food and Drug Administration to remove the prescription obesity drug Xenical (orlistat) from the market.
Public Citizen says the drug may lead to a higher risk of aberrant crypt foci (ACF), which is believed to be a factor in colon cancer.
The group says data from the manufacturer of orlistat, Roche Pharmaceuticals, and recent studies show the drug causes ACF in rats.
HealthDay News reports that Public Citizen is concerned that the FDA will approve over-the-counter sales of the drug in the U.S.
Celebrex, the only remaining Cox-2 inhibitor drug on the market, has been linked to a two-fold increase in the likelihood of causing a heart attack in patients using the drug. Pfizer, the manufacturer of Celebrex, put a black box warning on the product last August. In spite of the warning, the drug remains on the market. The first Celebrex product liability trial will begin in Alabama this June. The plaintiff suffered a stroke after taking Celebrex.
In an editorial published just hours ago, the New England Journal of Medicine blasts Merck for withholding key data regarding heart attacks caused by the use of their drug Vioxx. According to the statement released by the Journal, “we learned that relevant data on cardiovascular outcomes had been deleted from the VIGOR manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes. The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about the article’s conclusions.
This recent development occurred as a result of plaintiffs’ lawyers deposing the executive editor of the Journal and subpoenaeing documents from Merck.
Alycia Brown was an eighth-grader in La Crosse, Wisconsin when she died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.
A federal law suit has now been filed in Madison by her parents who claim the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.
Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14 year old is now the youngest known victim.
The girl’s mother had feared that her daughter was having sexual relations. The patch was decided upon because the girl was afraid to have a birth control shot because she was afraid of needles. The mother wanted to avoid the possibility of Alycia ruining her life with an unwanted teenage pregnancy. What happened, however, was far worse.
Only last week did Ortho-McNeil finally acknowledged the fact that women who use its Ortho Evra birth control patch are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.
Ortho-McNeil now admits that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.
Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch. Two weeks ago, CBS News presented a story concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.
According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.
In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.
Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.
An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.