Drug Abuse
Merck says Vioxx risk unchanged by data correction
|
|
Merck & Co said on Monday that it stands by the original findings of the study that led to the withdrawal of its pain drug Vioxx from the market, despite a correction to the description of how some of the data were analyzed.
Merck said it still believes the data from the study confirm that the increased risk of heart attack and stroke from Vioxx begins only after the medicine has been taken for 18 months. However, The New England Journal of Medicine cast doubts on that conclusion earlier on Monday by issuing an early release of a paper by a Harvard biostatistician. He concluded that the data were misinterpreted and the 18-month risk cut-off point for increased cardiovascular risk was not valid.
Journal corrects conclusion of Vioxx risk study
|
|
A critical study showing the heart attack and stroke risk of Merck and Co.‘s now-withdrawn arthritis drug Vioxx contained statistical errors that incorrectly showed that the risk changes over time, The New England Journal of Medicine reported on Monday.
The journal and the authors, including a team at Merck, are issuing a correction to the May 2005 study to show the risks do not, as originally shown, greatly increase after 18 months.
In fact, it is not possible to tell when the risk of heart attack or stroke shoot up, Journal editor Dr. Jeffrey Drazen said.
Are we over-dosing on antibiotics?
|
|
Dutch researchers say that a three day course of antibiotics is just as effective as the usual seven to 10 days course when it comes to treating common pneumonia.
The researchers believe that a shorter course of antibiotic treatment may also help curtail the growing problem of antibiotic-resistant bacteria.
Lead researcher Dr. Jan M Prins, an internist in infectious diseases at the Academic Medical Center, in Amsterdam says it appears that three days of medication is sufficient in children, and it now appears to be the same for adults with mild to moderate-severe community acquired pneumonia.
Heart Drug Side Effects More Common in Minority Patients
|
|
Nonwhite patients are more likely than white patients to have troublesome side effects from two common types of drugs used to fight high blood pressure, stroke and heart attack, British researchers report.
But the finding has to be viewed with caution, because experts say it’s not clear whether race or other factors, such as more limited access to health care, may be to blame.
“It is impossible to know how much of the observed differences could be accounted for by factors such as these vs. underlying genetics,” said Carlotta M. Arthur, a psychologist and an Andrew J. Mellon fellow at Smith College in Northampton, Mass.
Merck faces grandmother in next Vioxx trial
|
|
Merck & Co. will be back in court in Atlantic City, New Jersey, next week as the next Vioxx liability trial gets under way with the drug maker facing a 68-year-old grandmother who blames the withdrawn pain drug for her 2004 heart attack.
Elaine Doherty says she used Vioxx daily for three years to treat pain from arthritis of the hands and knees and continued to take the medicine after suffering a heart attack in January of 2004.
“She had no idea that Vioxx could cause heart attacks,” Michael Galpern, one of Doherty’s attorneys, told Reuters. “She relied on Merck’s untruthful advertisements and she continued to take it up until it was withdrawn.”
EU paves way for drugs modified for children
|
|
Drugs specifically adapted for pediatric use will become more widely available in the European Union starting next year, following the adoption of new rules released by the European Parliament on Thursday.
More than half the medicines currently used to treat children have only been tested on adults and are not authorized for use specifically on infants, making it difficult for doctors to estimate the right dosage or predict side effects.
Many cancer drugs, such as carboplatin, are widely used to treat children on an “off-label” or unlicensed basis, cancer specialists say.
Avoid ADHD drugs, Canada tells heart patients
|
|
Canada’s health ministry on Friday warned individuals with hypertension (high blood pressure), heart disease, clogged arteries (atherosclerosis) or hyperthyroidism not to take drugs used to manage attention-deficit hyperactivity disorder (ADHD).
Health Canada said that in rare cases, patient with these conditions could suffer “rare heart-related side effects” from these drugs. In a statement, it warned people who are already taking these drugs not to stop before consulting their physician.
“All ADHD drugs stimulate the heart and blood vessels… The effects are usually mild or moderate, but in some patients this stimulation may—in rare cases—result in cardiac arrests, strokes or death,” said Health Canada.
Concerns for inexpensive fertility drug appears to be unfounded
|
|
Concerns about the use of letrozole, an easy-to-use and inexpensive drug for the treatment of infertility, appear to be unfounded, according to a major study.
The study was co-authored by Dr. Togas Tulandi, Director of Division of Reproductive Endocrinology and Infertility, McGill University Health Centre (MUHC) and Chief of Obstetrics and Gynecology at the Jewish General Hospital, and Professor of Obstetrics and Gynecology at McGill University. Their findings, which are currently available in an early online edition of Fertility and Sterility, showed that babies whose mothers were treated with letrozole had the same rate of birth defects as those whose mothers were treated with clomiphene citrate - the low-risk, first-line treatment for infertility for more than 40 years.
“We found no statistically significant difference in the overall rates of major and minor malformations or chromosomal abnormalities between newborns in the two groups,” says Dr. Tulandi. “Our findings indicate concerns about a link between letrozole and birth defects are unfounded. This is significant because it confirms that letrozole can indeed be used in the treatment of infertility without increasing risk to the fetus.”
Drug trial victim may lose fingers and toes
|
|
A man who fell into a coma in London last month during a clinical trial of TeGenero’s monoclonal antibody TGN1412 has said he may lose parts of his fingers and toes, the UK’s News of the World newspaper reported on Sunday.
“I’m told it’s like frostbite and my fingers will just fall off,” Ryan Wilson told the newspaper in an interview.
Photographs in the newspaper showed Wilson in bed at Northwick Park Hospital, in northwest London, where the trial took place, with his blackened feet and hands.
Merck faces punitive phase of Vioxx trial
|
|
The punitive phase of a trial involving Merck & Co.‘s drug Vioxx was set to start on Thursday after a jury found the drugmaker failed to warn Vioxx users of heart risks and ordered it to pay a 77-year-old plaintiff at least $4.5 million in damages.
Merck shares fell 4.2 percent to $34.48 in premarket trade Thursday after the jury in Atlantic City, New Jersey, found that Vioxx had been a substantial contributing cause of a heart attack suffered by John McDarby. The jury determined the drug was not a significant cause of a heart attack suffered by a second plaintiff, Thomas Cona.
Credit Suisse analyst Catherine Arnold said Wednesday’s split verdict should lead to weakness in Merck shares.
Parkinson’s drug link to gambling probed-newspaper
|
|
Medical researchers are investigating suspicions that drugs prescribed to treat Parkinson’s disease could turn patients into compulsive gamblers, the Washington Post reported on Sunday.
Scientists at the Food and Drug Administration have found a strong association between pathological gambling and the drugs, which boost the level of dopamine in the brain, according to the newspaper.
US reports two more deaths after abortion pill
|
|
Two additional deaths have been reported after women took the abortion pill known as RU-486 or Mifeprex, U.S. regulators said on Friday.
The Food and Drug Administration said it has not been able to determine the cause of the newly reported deaths. Four previously reported fatalities were linked to a bacterial infection that developed after the women took the abortion pill, which is sold by privately held Danco Laboratories.
U.S. reports deaths of attention drug patients
|
|
U.S. regulators were told of 24 deaths among patients who took Shire Pharmaceuticals Group Plc’s attention deficit drug Adderall through 2003, according to a report released on Wednesday.
Another 16 deaths were reported through 2003 in patients who took other attention deficit drugs known as methylphenidates, said the report prepared by Food and Drug Administration staff. Ten deaths were reported among other drugs in the amphetamine class, it said.
Blood-thinner linked to osteoporotic fractures
|
|
The long-term use of warfarin, a drug commonly prescribed to reduce the risk of blood clots, appears to increase the risk of fractures associated with osteoporosis, a bone-thinning condition that usually increased with age, according to a report.
As the study authors note, warfarin prevents coagulation by blocking vitamin K, which is needed to activate certain clotting factors. Because vitamin K is also used to activate proteins involved in bone formation, drugs like warfarin may increase the risk of fractures, the researchers report in the Archives of Internal Medicine.
US says two flu drugs unlikely to work
|
|
U.S. doctors should stop using two antiviral drugs to treat this season’s influenza because the dominant strain has become resistant to the drugs, health officials said on Saturday.
The alert about antiviral pills amantadine and rimantadine applies to the seasonal influenza, not the H5N1 avian flu strain that experts fear could mutate and cause a global pandemic.
