Little Rock Personal Injury Lawyer - FDA & Prescription Drugs

Raptiva Linked To Deaths

Chrissie Cole — Thu, 19 Feb 2009 12:08:00 GMT

The FDA has issued a public health advisory concerning progressive multifocal leukoencephalopathy (PML) and the psoriasis drug efalizumab (Raptiva).

PML is a rare but serious progressive neurologic disorder caused by a virus that attacks the central nervous system. Patients with a severely compromised immune system are most at risk from suffering from an irreversible brain function and death. No treatment exists for PML.

There have been three reported deaths linked to PML. A fourth case is being looked at as well.

Patients diagnosed with psoriasis suffer from inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal.

The product labeling for Raptiva was revised in October 2008 to include a boxed warning the risks of life-threatening infections, including PML.

The FDA advises health care professionals to carefully monitor patients on Raptiva, as well as those that may have discontinued use, for any signs or symptoms of the disease.

Originally posted at InjuryBoard by Chrissie Cole

Confusing Allergy Warnings May Do More Harm Than Good

Ryan Scott — Tue, 26 Aug 2008 15:13:01 GMT

Do the phrases "may contain traces of" or "made in the same factory as" help you decide if the food is safe for your allergy?

According to the Food and Drug Administration (FDA) these warnings may be hurting consumers more than they are helping. Starting in 2006, a U.S. law required that foods disclose in plain language when they intentionally contain highly allergenic ingredients such as peanuts or dairy. However, left out of the law are accidental-allergy warnings -- for foods that might become contaminated because they were made in the same factory, or on the same machines, as allergen-containing products.

The FDA's own surveys found the allergic pay more attention to warnings that a food "may contain" an allergen than those "made in the same factory" labels. Yet when University of Nebraska researchers tested nearly 200 products with various accidental-peanut warnings, they found that peanuts were more likely to have sneaked into products labeled "made in the same facility."

The Food Allergy & Anaphylaxis Network, an influential consumer group, counts at least 30 different ways that the warnings are worded — and consumers too often falsely assume that one food is riskier than another because its label sounds scarier.

It seems as though many manufacturers would rather attempt to avoid liability using broad and vague labeling, than implement and stand behind procedures that would make such labeling unnecessary.

So, what to do?

In Canada, health officials have recommended foods bear one of two labels: "May contain X allergen" or "Not suitable for consumption by persons with an allergy to X." By limiting the manufacturer's options to one of the two, at least, the company will be forced to take responsibility for ensuring their product does not contain any allergen, or label the product and face the consequences at the cash register.

Originally posted at InjuryBoard by Ryan Scott

228 Cases of Salmonella Now Linked to Tainted Tomatoes

Drew Dixon — Fri, 13 Jun 2008 14:30:25 GMT

Last week I blogged about the outbreak of Salmonella in several types of raw tomatoes. Today I was made aware of a recent update from the Center for Disease Control and Prevention(CDC) attributing the number of illnesses attributed to Salmonella tainted tomatoes to be 228. Infections have been reported in at least twenty-three states since mid-April, with the last 61 cases found in Florida, Georgia, Missouri, New York, Tennessee, and Vermont.

Although the source of the Salmonella has yet to be found, the Food and Drug Administration warns against raw red plum, red round, and Roma tomatoes from geographic areas it hasn't approved.

At this time the FDA has approved tomatoes from 27 states, Belgium, Canada, the Dominican Republic, Guatemala, Israel, the Netherlands, and Puerto Rico. The safe states are Alabama, Arkansas, California, Colorado, Delaware, Georgia, Hawaii, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Nebraska, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.

The FDA continues to state Cherry tomatoes, grape tomatoes, and tomatoes with the vine still attached are ok to eat and have not been linked to the Salmonella outbreak.

Image Source: Wikimedia Commons

Originally posted at InjuryBoard by Drew Dixon

Red Tomatoes May Contain Salmonella

Drew Dixon — Thu, 05 Jun 2008 15:01:19 GMT

The Food and Drug Administration released an alert earlier this week warning consumers in New Mexico (thanks, Mike) and Texas that a Salmonella outbreak may be related to the consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria, Salmonella serotype Saintpaul, is an uncommon type of Salmonella.

Although the FDA will continue to investigate the specific type and source of the tomatoes, preliminary data suggests that raw red plum, red Roma, or round red tomatoes may be the cause of the outbreak. Tomatoes which have not been implicated and continue to be ok to eat are cherry tomatoes, grape tomatoes, tomatoes sold with vines still attached, and tomatoes grown at home.

Salmonellae are frequent causes of food borne illness, especially from poultry and raw eggs and more generally from food that has been cooked or frozen and not eaten straight away. Although most non-typhoidal strains associated with food-borne infection are self-limiting and do not require antibiotics, complicated or systemic infection and infection with specific serovars are indications for antibiotic treatment and often hospitalization.

More Information on safe handling of produce can be found at w.cfsan.fda.gov/~dms/prodsafe.html.

IMAGE SOURCE: Wikimedia Commons

Originally posted at InjuryBoard by Drew Dixon

Heparin Recall Continues

Frank Bailey — Fri, 09 May 2008 11:11:14 GMT

The FDA has asked for help to spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate.

There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration. Apparantely there is still contaminated heparin in storage areas, emergency kits, dialysis units and automated drug storage cabinets.

The FDA is also informing health professionals about medical devices that contain or are coated with heparin and asking for their help in locating the contaminated heparin.

If you find any of the contaminated heparin the FDA has asked that it be notified.

By working together we can protect each other from encounters with the contaminated heparin.

Originally posted at InjuryBoard by Frank Bailey

Heprin Contamination Deliberate

Frank Bailey — Wed, 30 Apr 2008 16:12:01 GMT

An article in the New York Times outlines how LeRoy Hubley lost his wife and son from an allergic reaction to contaminated heparin. The FDA believes the contamination was deliberate but they have been prevented from inspecting the Chinese plants that made the drug.

So far, 81 deaths have been linked to a contaminant in the blood thinner, Heparin. Dr. Janet Woodcock, director of the FDA said a third of the material in some batches of Heparin was the contaminant.

This may be the worst poisoning episode since 1982 when seven people in the Chicago area died after taking Tylenol that had been laced with cyanide.

David Strunce, the CEO of Scientific Protein Laboratories, the company that supplied the Heparin said it was an “insidious act that seems to us an intentional act upstream in the supply chain.”

I am appalled that the FDA doesn’t do more to find the culprit.

Originally posted at InjuryBoard by Frank Bailey