cialis online

FDA Accutane Panel Says to Loosen Restrictions, Despite Risk of Birth Defects

AddThis Social Bookmark Button

Despite the fact that Accutane and other isotretinoin-containing medicines are still being used by pregnant women, a Food and Drug Administration (FDA) advisory panel recommended loosening restrictions on the drugs. Accutane and other drugs in its class are used to treat acne. However, these medications pose a substantial risk of birth defects if taken by pregnant women.

Just days before the FDA advisory panel made its recommendations, a report was released showing that the FDA’s iPledge program was not entirely successful in keeping the drug from expectant mothers. The iPledge program, which became mandatory last year, requires that all patients sign a document informing them of the drug’s risks. Patients must also agree not to share their medication with anyone else, and to make follow up visits with their doctors. The program has special requirements for women of childbearing age, including the requirement that they submit to regular pregnancy tests at their doctor’s office. The prescribing physician is then required to enter the results of the tests into the iPledge database. Women also must sign a pledge promising to use birth control while taking Accutane. In its first year, 122 women in the iPledge program were either pregnant when they started taking Accutane, or became pregnant while doing so. In some cases, the pregnancy test the women took prior to getting their Accutane prescription had a false-negative reading. In two cases, the women actually convinced their doctor to enter fake test results into the iPledge database. But most of the pregnancies were the result of contraceptive failure.

The FDA advisory panel wants to lift some of the restrictions of the iPledge program. For example, under current rules a woman must have a pregnancy test and fill her Accutane prescription within seven days of seeing her doctor. The panel wants to change the rule so that a patient can get an Accutane prescription within seven days of the test. Another rule change would allow a patient to have a second pregnancy test and receive a new prescription if she misses the seven day window. Currently, if a patient does miss that window, they must wait 23 days to take another test before getting Accutane.

The panel also suggested that the iPledge program should encourage Accutane users who do become pregnant to provide the FDA follow-up information on their pregnancies. Of the 122 women who became pregnant, only about a dozen were warned about Accutane birth defects. The FDA panel criticized a questionnaire the iPledge program used for this purpose, saying that it had a “punitive” tone. For instance, the panel did not like the way questions about educational background followed those about contraceptive failure. According to an Associated Press report, one panel member said that the questions implied that a woman became pregnant because she was “stupid”.

The FDA panel said that the proposed rule changes are minor, and should not affect pregnancy rates among Accutane users. They maintained that the alterations would make compliance easier.

In addition to birth defects, Accutane has been linked to Inflammatory Bowel Disorder, as well as psychiatric problems. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. Accutane and the other drugs in its class are only supposed to be used for the most severe types of acne. However, it has long been known that doctors prescribe these medications to patients with milder acne.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


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!
defective-hip-replacement.com

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!
CAT-Scans-Radiation-Exposure.com

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.
WaterContaminationFrom Fracking.com

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 PCBs.com

Great Photography

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

Poligrip Lawsuit

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

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

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

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

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!
www.oil-rig-spills.com

Whistle Blower

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