Indianapolis Personal Injury Lawyer - FDA & Prescription Drugs

P&G Warned Over Vicks Products With Vitamin C

Chrissie Cole — Fri, 30 Oct 2009 19:40:00 GMT

On Friday, the U.S. Food and Drug Administration (FDA) sent Proctor & Gamble Co. a warning letter regarding the illegal marketing of two Vicks cold and flu medicines.

The warning, involves Vicks DayQuil Plus and Nyquil Plus, both with vitamin C. According to the agency, the combinations of drug and dietary ingredients have not been proven safe and effective and therefore cannot be marketed legally.

Additionally, the agency said it had previously determined that there was insufficient data to support vitamin C is safe and effective in preventing or treating the common cold.

Earlier in the month, the FDA issued a similar warning but it was quickly retracted. An FDA spokesman said Friday that the letter was “issued prematurely – prior to the completion of an internal process.”

Some OTC drugs are permitted to be marketed without FDA approval, but the products in question failed to comply with its rules and first must be evaluated and approved under the agency’s new drug approval process, according to the AP.

Originally posted at InjuryBoard by Chrissie Cole

Defibrillators Recalled By Philips

Chrissie Cole — Tue, 29 Sep 2009 15:32:00 GMT

Philips is recalling HeartStart FR2 automated external defibrillators due to a memory chip failure that could cause the device to malfunction.

There have been no reports of any injury associated with the recalled devices. The defects were found during internal tests, according to the company.

Defibrillators are used by healthcare workers to help restart a patient's heart when they suffer sudden cardiac arrest.

The recall involves FR2 AEDs, with the following model numbers: M3860A and M3861A. Also involved in the recall are devices distributed by Laerdal Medical with model numbers: M3840A and M3841A.

Customers can use the serial number look-up tool on the Philips Web site — http://www.philips.com/FR2PlusAction — to find out if their FR2" is part of this recall.

The company has notified the FDA of its recall.

Originally posted at InjuryBoard by Chrissie Cole

Super Kids Enriched White Bread Recalled By Kroger

Chrissie Cole — Thu, 27 Aug 2009 12:47:00 GMT

Kroger brand Super Kids Enriched White Sandwich Bread sold in 13 states has been recalled by The Kroger Co., because it may contain milk that is not listed on the labels.

People who are allergic to milk products may have a serious or life-threatening reaction if they consume this product unknowingly. For consumers that do not have an allergy to milk, there is no safety issue.

The bread was recalled in the following 13 states: Alabama, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Virginia and West Virginia.

Included in the recall are Jay C Food stores in Indiana and Food 4 Less stores in Illinois and Indiana. Consumers can return the bread to stores for a replacement or refund.

Consumer Information: Kroger toll-free at (800) 632-6900. For more information, please visit www.kroger.com/recalls.

Originally posted at InjuryBoard by Chrissie Cole

Seven Sickened With Swine Flu

Chrissie Cole — Fri, 24 Apr 2009 22:33:00 GMT

Although they had no contact with pigs, seven people in two states have been struck with an unsual strain of swine flu.

This virus was found among five people in California and two in Texas. Health officials are concerned that the virus is being transmitted person-to-person since California individuals had contact with one another.

This unusual strain appears to be resistant to two common flu treatment drugs, however Relenza and Tamiflu appear effective.

Currently there are 800 suspected cases of swine flu in Mexico, reports The World Health Organization (WHO).

Mexican officials have closed schools and are urging people with flu-like symptoms to stay home when possible.

For more information about the swine flu, please refer to the CDC’s Web site which is updated regularly.

Originally posted at InjuryBoard by Chrissie Cole

FDA - Raptiva Linked To Three Deaths

Chrissie Cole — Sun, 01 Mar 2009 18:51:00 GMT

A Public Health Advisory, recently issued by the FDA confirms three deaths, and possibly a fourth from progressive multifocal leukoencephalopthy (PML), a rare brain infection, in patients using the drug, efalizumab (Raptiva) made by Genentech, Inc.

The labeling for Raptiva was updated in October 2008 to include a Boxed Warning, highlighting the risks of life-threatening infections, including PML.

Genetech was also directed Genentech, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to include a medication guide intended to educate patients about the drug’s associated risks.

PML is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death. No treatment exists for PML.

The FDA is reviewing the latest information and will take appropriate measures to ensure that the risks of Raptiva do not outweigh its benefits, and that patients prescribed Raptiva are fully aware of the signs and symptoms of PML.

Originally posted at InjuryBoard by Chrissie Cole