Gardasil’s fainting warning is more prominently warns that fainting can occur following administration of the vaccine. The FDA reports some Gardasil fainting victims have suffered from jerking movements and other seizure-like activity. Additionally, some have had severe injuries from falling.

Gardasil, manufactured by Merck & Co. of New Jersey, was approved by the FDA in June 2006. At the time of its approval, Merck & Co. said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The U.S. Centers for Disease Control and Prevention (CDC) recommends that all young girls age of 11 and 12 receive the Gardasil vaccine. Gardasil is approved for females age nine to 26.

Gardasil has been controversial because Merck & Co. has attempted to make it mandatory and because of lingering questions about its safety. From June 2006 through January 2009, 9,749 adverse reactions have been reported. Twenty-one of the reports were deaths. Additional side effects include: 10 miscarriages, 78 severe outbreaks of genital warts, and 6 cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS).

The FDA reports approximately 13 % of Gardasil side effects reported to VAERS describe fainting. Fainting is a common side effect associated with vaccines. Fainting often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Though the fainting side effect has been on the label since 2007, the prominence of the warning is being increased because of continued fainting reports.

The FDA has asked Merck & Co. to list fainting risks under the "Warnings and Precautions" section of the Gardasil label. The revised label reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Any adverse reports associated with Gardasil should be reported to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

Please see: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm

Labels: attorney, CDC, fainting, FDA, Gardasil, lawyer, sunchaser swing set

On May 1, 2009, the Food and Drug Administration (FDA) issued two statements about Hydroxycut-branded dietary supplements. In a public advisory, the FDA urged consumers to immediately stop use of Hydroxycut. It talked about the risk of liver injury that had been correlated with Hydroxycut use.

On the same day, the FDA issued a letter to healthcare professionals, describing Hydroxycut products as a "serious public health risk." It talked about reports of 23 cases of liver damage associated with the use of Hydroxycut, some leading to full liver failure, and one to patient death. The letter asked doctors to report liver damage associated with Hydroxycut and review previous cases of hepatitis, characterized by liver injury, to see if they were associated with Hydroxycut use.

In preparing its statement, the FDA informed Iovate Health Sciences, Inc, the manufacturer of Hydroxycut, about its findings. How, exactly, a recall was decided on seems unclear. According to Iovate health Sciences, the company "initiated a voluntary recall when it became aware" of the FDA's findings. According to the FDA statement, "Iovate has agreed to recall" all 14 varieties of Hydroxycut named by the FDA. These varieties are:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Not all varieties of Hydroxycut have yet been found to be associated with liver damage, but in many cases, injury reports take a long time to reach the FDA. The Hydroxycut-associated death occurred in 2007, but did not reach the FDA until March 2009.

With doctors reviewing past cases of liver damage, it is likely that more cases will be linked to Hydroxycut use. If you suffered liver damage while using Hydroxycut, schedule a Hydroxycut injury lawsuit consultation with the pharmaceutical liability lawyers at Schlichter, Bogard & Denton today.

Labels: attorney, drugs, FDA, Hydroxycut, liver damage

Schnucks announced a voluntary recall yesterday on Schnucks brand olives as some of the jars may contain shards of glass.

The recalled olives come in 5.75 ounce jars with the UPC code: 04131819003, and a date of "best by" 02/06/11.

For more information, see http://www.schnucks.com/pressreleases/pressrelease.asp?id=6.

If you or someone you love has been injured by a defective product, you may be entitled to compensation. Contact the expert lawyers at Schlichter, Bogard and Denton for a free consultation.

Labels: attorney, attorneys, glass, lawyer, lawyers, olives, recall, Schnucks, shnucks spanish olives, spanish olives

Hundreds of women throughout the country are the victims of serious injuries caused by the NuvaRing. They have suffered strokes and blood clots, and many of them died. 150 or more women or their families have filed lawsuits against Organon, the maker of the NuvaRing, for the injuries and deaths it has caused.

The NuvaRing is a vaginal contraceptive ring that provides monthly birth control by inserting it against the cervix. It uses a type of synthetic hormone that is different from the one used in traditional birth control pills and is more dangerous.

If you or someone you love has been hurt by the NuvaRing, you may be entitled to compensation. Contact the expert attorneys at Schlichter, Bogard & Denton for a free consultation.

nuvaring@uselaws.com
nationalinjuryattorneys@uselaws.com
314-621-6115

For more information, see the following links:

Woman warns others not to use NuvaRing

Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device

Wrongful Death Lawsuit Filed Over NuvaRing

Labels: attorney, birth control, blood clot, contraception, death, DVT, lawyer, Nuva Ring, NuvaRing, stroke, thrombosis