The FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic.
FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA’s “Early Communication about an Ongoing Safety Review” for Agency recommendations and additional information for healthcare professionals.
The FDA has stated it decision to take enforcement action against any company marketing injectable Colchicine that is unapproved. Anextremely toxic drug, Colchicine is used to treat gout and can very easily be given in excessive doses, resulting in serious side effects, low blood counts, organ failure, cardiac events and even death.
The FDA has received 50 reports of events involving injectable Colchicine, 23 of which resulted in death.
The FDA states, “Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.” For information please visit this web site: http://resource4thepeople.com/recalleddrugs/colchicine.html
The government announced Wednesday that the 10,000 patient ACCORD clinical trial involving diabetes treatment has been halted 18 months early due to increased risk of patients death. The trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%.
The results bring into question the methods used of lowering blood sugar actually protects the heart and is very likely to call the safety of the diabetes drug Avandia into question, yet again.
Although the research does not indicate a link between Avandia use and increased deaths, Steve Nissen, who linked Avandia use to increased risk of heart attacks, states, ““It’s very hard to sort out,” and “We’ve got to be careful not to jump to conclusions.”. Nissen went on to say “Clinicians have been taught that getting to lower blood sugar is better” and “its really going to shake things up”.
Avandia was recently back in the news, when it was foundthat Dr Steven Haffner, admitted leaking information about a study linking the drug to a 43% greater risk of heart attacks to GlaxoSmithKline PLC 17 days before the article was published in the New England Journal of Medicine, last May.
If you have lost a loved one to suicide due to use any of the antiepileptic drugs listed and would like to learn your legal rights, please contact us by calling toll free at 1-866-242-0905. Or visit the “In the news” tab on this website: http://www.resource4thepeople.com/defectivedrugs/
January 31, 2008 The FDA announced a recall to consumers and healthcare professionals that NuCel Labs has voluntarily recalled all Eye Drops and Eye/Wash Products. This is a nationwide recall due to testing which indicated potential bacteria and particulate matter making the products non-sterile. Use of the products poses an unacceptable risk of eye infections and in rare cases blindness or loss of vision.
There are presently no reported injuries and consumers are asked to discontinue use and immediately return the product to NuCel Lab. If you or a loved has been injured from using these products please seek immediate medical attention.
On Tuesday, January 22 2008 Merck/Schering-Plough announced the pulling of all TV advertisements for the drugs Zetia and Vytorin. Zetia alone is a Merck/Scherin anti-cholesterol drug and Vytorin is a drug that contains both Zetia and Zocor(simvastation).
At least one of the ads boasted that Zetia was far greater than less expensive statin drugs for lowering cholesterol. These ads stated this even though Merck/Schering’s ENHANCE testing data proved that neither Zetia or Vytorin performed better than and statin alone.
The ads are pulled as mounting consumer reports of severe and potentially life threatening side effects appear to be growing related to rhabdomyolysis, a rare a potentially fatal disease involving degeneration and destruction of skeletal muscle, as well as serious liver related injuries and damage, thrombocytopenia, hepatitis and pancreatitis.
UPDATE: 1/29/2008. FDA WARNING: If you use a Cordis Corp. Fire Star & Dura Star balloon catheters, ask your doctor about this warning.This warning is for the following:
Fire Star and Dura Star catheters lots 13173912 through 13315455, plus 52 additional lots above 13315455.
The problem:
There is 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.
If you are one of thousands of people in the United States who depends on a hip implant to get around and maintain your routine, you need to take notice of the recent action taken by the US Food and Drug Administration (FDA), as the government is in effect cracking down hard on one
of the leading manufacturers of hip implants and hip and joint replacement parts.
The FDA recently sent the manufacturer of the hip implants in question, Stryker Corp. of Kalamazoo, Michigan, an extremely stern,six-page letter detailing the problems that have been discovered with the company’s manufacturing process and other issues that need to be corrected immediately. For an overview of the problems visit the Stryker Hip Implant Defect page.
A man was charged with drunk driving dui on a lawn mower in New Zealand Tuesday according to police. Richard Gunn, 52, was driving the lawn mower down a street in the northern New Zealand town of Dargaville late Monday evening when police stopped him, police spokeswoman Sarah Kennett said.
Gunn’s breath alcohol level was at more than twice the legal limit for drivers, police said, and he previously had lost his driver’s license. Gunn said he has been using the lawn mower to get around town since losing his license.
“I thought I was safe,” he told TV One News.
Even bicycles went faster than the lawn mower’s 5 mph, he said. “I’ve watched them go past me.”
Gunn was scheduled to appear in court later this week on charges of careless driving, driving while disqualified and driving with excess breath alcohol. He faces a potential prison term if convicted.
Police impounded the lawn mower for 28 days.
A similar incident was posted in this video last year that captured attention on the popular video site youtube.
Authorities say 25 people have been hurt, several seriously, after a commuter bus accident and burned off a freeway near the Nevada-California state more… line. Investigators aren’t sure what caused the crash.
