Fda Warns: Swine Flu Scams Lurk On The Internet
These and other products making bogus claims to prevent or treat swine flu are flooding the Internet as scam artists prey on the publics fears while the vaccine is delayed and real Tamiflu - made by Switzerlands Roche Group - is rationed.
Every problem, it would seem, is a sales opportunity. Some of the products appear to have been pitched for other emergencies, such as one called “Quake Kare” and masks and purifiers sold during the SARS scare.
Federal officials have sent warning letters to promoters of more than 140 swine flu-related products, including well-known alternative medicine advocate Dr. Andrew Weil for [...]
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up [...]
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up [...]
Fda to Study Negative Effects Of Lasik Eye Surgery
The FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience negative side effects following surgery.
The first phase of the project is already under way, with plans for an online questionnaire to help patients gauge their quality of life following surgery, according to an FDA statement.
The project will also include a clinical trial tracking patients who undergo the procedure, which is expected to conclude by 2012.
“This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse [...]
Device Approval Exposes Political Pressure On Fda
In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics Menaflex device.
The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Andrew von Eschenbach to intervene on the companys behalf.
Approval came despite protests by FDA scientists that Menaflex - which reinforces damaged knee tissue - provided little, if any, benefit to patients.
The report marks the first time FDA has openly criticized its own conduct, as Obama appointees try to restore the agencys credibility following [...]
Wyeth Sues Fda to Block Competitor Generic Antibiotic
Madison, N.J.-based Wyeth filed the lawsuit in U.S. District Court in Washington, D.C., seeking a temporary restraining order and a preliminary or permanent injunction.
The lawsuit seeks to prevent Orchid Chemicals & Pharmaceuticals Ltd. of Chennai, India, from selling a generic version of Zosyn that the FDA approved last week. The suit also asks the court to order the FDA to withdraw its approval of Orchids products or any generic versions that arent exactly the same as Zosyn.
Wyeths head of global medical affairs, Joe Camardo, said patient safety is at stake and that Orchids product could lead to preventable medical errors.
“Over [...]
Fda Medical Device Approvals Get External Critique
The nonprofit Institute of Medicine will conduct a two-year review of FDAs so-called 510k review procedure, which allows device companies to quickly launch products similar to those already on the market.
The announcement Wednesday garnered approval from lawmakers on Capitol Hill who have been skeptical of the FDA program.
“I have long been concerned that the 510k process permits too many devices on the market about whose safety and effectiveness even the FDA is uncertain,” said Rep. Henry Waxman. “The result is hundreds of recalls of important devices for serious safety concerns.”
The California Democrat chairs the House Energy and Commerce Committee, which [...]
Fda Ban On Flavored Cigs Takes Effect
The ban on manufacturing, importing, marketing and distribution includes candy-, fruit- and clove-flavored cigarettes, which health and federal authorities say are more appealing to youth. It does not include a ban on menthol or other flavored tobacco products like cigars - issues that the FDA is studying.
“Candy- and fruit-flavored cigarettes are a gateway for many children and young adults to become regular tobacco users,” said Dr. Lawrence R. Deyton, director of the FDAs Center for Tobacco Products.
Citing research studies, Deyton said that 17-year-old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25. [...]
Fda Requires Bullish Amputation Alarm On Sedative
The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.
Wyeth had appealed the case up to the Supreme Court after a Vermont woman named Diana Levine, who once played the guitar and piano professionally, sued because she had to have her right arm amputated after being injected with Phenergan. Levines lawsuit, which claimed she wasnt sufficiently warned of the risks of using [...]
Fda Cracks Down On Ibuprofen Pain Relief Gels
Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.
“These companies have an obligation to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah Autor, director of FDAs office of compliance.
Ibuprofen ointments are often promoted as a safer alternative to pills because they do not carry side effects like stomach ulcers. [...]