Antiepileptic Drugs increase the risk of Suicidality
January 31, 2008
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
Popularity: 64% [?]
Doctor Accused of Leak to Drug Maker
January 31, 2008
The New York Times is on fire today with great articles about the pharmaceuticals.
A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.
Popularity: 55% [?]
Tainted Drugs Tied to Maker of Abortion Pill
January 31, 2008
A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.
Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.
Popularity: 29% [?]
Eli Lilly to pay $1 billion to Federal and State Governments
January 31, 2008
Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments.
If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines.
Popularity: 44% [?]
Financial Ties Are Cited as Issue in Spine Study
January 30, 2008
Some of the nation’s most prominent spine surgeons hailed it as a medical breakthrough.
In a study of nearly 240 patients with lower back pain, the doctors said that the Prodisc, an artificial spinal disk, had worked much better than conventional surgery in which patients’ vertebrae were fused…
As it turns out, Dr. Zigler had more than a medical interest in the outcome. So did doctors at about half of the 17 research centers involved in the study. They stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.
Popularity: 46% [?]
For F.D.A., a Major Backlog Overseas
January 29, 2008
The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.
Popularity: 33% [?]
Leukine (sargramostim)
January 28, 2008
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.
Popularity: 37% [?]
Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
January 28, 2008
Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.
Popularity: 37% [?]
D.C. passes drug rep licensing law
January 14, 2008
The District of Columbia Council voted 7-6 to pass a law requiring pharmaceutical company sales representatives to be licensed. The final bill was stripped of a provision that would have also banned the practice of data mining the prescribing activities of doctors. While New Hampshire, Vermont, and Maine have laws banning or limiting the data mining practice, no other state or territory has licensed drugs reps.
Popularity: 37% [?]
Trichloroethylene is a probable risk factor for Parkinson’s disease and parkinsonism
January 11, 2008
Trichloroethylene is a probable risk factor for Parkinson’s disease and parkinsonism, a study here found. The finding came from a study of 31 workers at an industrial plant, including three workers with Parkinson’s disease exposed to high levels of trichloroethylene, and from animal experiments, Don M. Gash, Ph.D., of the University of Kentucky, and colleagues reported online in the Annals of Neurology.
Trichloroethylene, a degreasing agent widely used in industry and the military, is also found in drinking water, surface water, and soil as a runoff from manufacturing sites. The chemical has been identified as an environmental contaminant by the Environmental Protection Agency.
Popularity: 55% [?]
The Crime of Tort Reform
January 10, 2008
Dave Stewart’s 72-year-old mother went to Stanford University Medical Center for double knee-replacement surgery in April. Four days later, she was dead.
To Stewart, an anesthesiologist, it seemed a classic case of medical malpractice. After the operation, his mother developed sharp abdominal pain that she described as “10 on a scale of 1 to 10,” according to her medical records.
The hospital failed to diagnose the cause of her pain and continued to treat her with narcotics. Her vital signs became unstable and she was moved to the intensive care unit, but she died of complications from an untreated bowel obstruction. State regulators cited the hospital in the case this fall.
Stewart and his two sisters decided to sue, and they approached two dozen lawyers. One after another declined to take the case, always for the same reason: It wasn’t worth the money.
In 1975, California enacted legislation capping malpractice payments after an outcry from doctors and insurers that oversized awards and skyrocketing insurance rates were driving physicians out of the state.
The law limited the amount of money for “pain and suffering” — usually the physical and emotional stress caused from an injury — to $250,000. There is no limit on what patients can collect for loss of future wages or other expenses.
This is a great article from the LA Times. The fact that tort reform creates a judicial system that discriminates against the poor and the elderly is revealed in this article.
As bit of background, when an attorney decides to take a case there are multiple considerations. A major consideration is the amount of damages that could be recovered. Simply put, damages can be thought of as economic (based primarily on how much the person was earning at the time of the accident) and non-economic damages. Non-economic damages include recovery for “pain and suffering”. Tort reform focuses on limiting the amount of recovery for pain and suffering through caps. For example, if a jury returned a verdict for $1,000,000.00 for pain and suffering in a state with $300,000.00 cap than the verdict will be reduced to $300,000.00.
The thing is caps on pain and suffering do not rise with the costs of litigation. Therefore, economic damages are critical to determining whether or not an attorney will take a case in a state with caps on non-economic damages.
As a result, individuals that were not earning much when they were injured in a state with caps will not find legal representation. For example, a cashier working for $12.00/hr gets paralyzed by a drunk driver in a state with caps on pain and suffering. As a result of the caps, the amount of money that she can recover is tied closely with the amount of money she could make over the rest of her “working life”. At $12.00/hr that could only amount to a few hundred thousand dollars. With the costs of trial and living rising substantially, attorneys will not take a case where the economic damages are not substantial thereby excluding our paralyzed cashier and the rest of the working poor and the elderly from the legal system. Is that fair? Is it fair that insurance companies who provide medical malpractice insurance to doctors show increased profits year after year and pay out less and less while raising premiums? Read this article and think about it.
Popularity: 37% [?]
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
January 10, 2008
The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called “bio-identical hormone replacement therapy,” or “BHRT” products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer’s disease, stroke, and various forms of cancer.
FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
“We want to assure that Americans receive accurate information about the risks and benefits of drug therapies,” said Dr. Janet Woodcock, FDA’s chief medical officer and acting director of the agency’s Center for Drug Evaluation and Research. “In addition to today’s regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs’ risks and whether they’re getting effective treatment.”
The pharmacy operations receiving warning letters use the terms “bio-identical hormone replacement therapy” and “BHRT” to imply that their drugs are natural or identical t