cialis online

Botox Maker Sues FDA

AddThis Social Bookmark Button

The maker of Botox wants to be able to give doctors information about its unapproved uses, and has filed a federal lawsuit against the Food & Drug Administration (FDA).   The company is claiming that rules forbidding it from doing so violate  its First Amendment right to free speech.

Allergan’s Botox is approved to treat facial wrinkles,  eye muscle disorders and excessive underarm sweating.   According to Reuters, Allergan is currently testing Botox for a variety of uses including treatment for upper limb spasticity in stroke victims as well as for migraine headaches.

In April, the FDA mandated a boxed warning for  Botox and other botulinum toxin injection treatments regarding the risk of adverse events when the effects of  the drugs spread beyond the injection site. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for muscle-spasm conditions, an off-label  or unapproved use.

As we’ve reported in the past, doctors are free to prescribe off-label, but the Food, Drug and Cosmetic Act of 1938 prohibits drug makers from promoting such uses.  According to The Wall Street Journal, they may provide doctors with accurate information about off-label uses – such as scientific studies – if a doctor requests such material.

Critics of off-label promotion say such marketing practices are harmful, as the vast majority of off-label uses have not been subjected to enough cientific scrutiny to ensure their safety.  Even so, off-label prescribing is common.  According to The Wall Street Journal, a 2006 study in the Archives of Internal Medicine found that 21% of drug use is off-label.

In a statement discussing its lawsuit,  Allergan said the FDA’s ban on off-label promotion was particularly difficult since the agency had required the Botox safety update. “To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique,” the company’s statement said. “Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution.”

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.