Tag Archives: FDA

More Leucovorin Woes

A September 2nd update from the FDA cites manufacturing delays at Bedford Laboratories and Teva Pharmaceuticals  for leucovorin shortages. Here at the Colorectal Cancer Coalition, we’re hearing from patients who are not receiving leucovorin during their chemotherapy because it just isn’t available. Bedford says that they will be releasing some 350 mg and 200 mg vials in September and are working on other presentations.  Teva is allocating 100 mg vials and says that the 350 mg vials are on back-order with an expected release date in the fourth quarter of 2010.

Four-Fold Increase In Salmonella Infections Traced to One Egg Producer

Check the eggs in your refrigerator! The FDA, collaborating with the Centers for Disease Control, the Department of Agriculture, and state health departments, have traced a nationwide spike in Salmonella Enteritidis (SE) infections to a single firm in Iowa. Eggs shipped from Wright County Egg of Galt, Iowa after May 16,2010 have been recalled. The CDA received approximately 200 reports of Salmonella Enteritidis every week in late June and early July, more than four times the usual 50 weekly reports over the past five years.

Miracle Mineral Solution Can Cause Serious Harm

The FDA has warned the public that Miracle Mineral Solution (MMS) makes  a dangerous, industrial strength bleach when mixed as directed and can cause serious health problems. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. FDA recommends Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible.

Urgent Recall of Alfalfa Sprouts

The FDA has announced that Caldwell Foods is recalling raw alfalfa sprouts linked to an outbreak of salmonella in ten states. The sprouts are sold under the brand names Caldwell Fresh Foods in 4-oz plastic cups, 1-lb plastic bags, 2- and 5-lb plastic bags in cardboard boxes with a Caldwell Fresh Foods sticker Nature’s Choice in 4-oz plastic cups California Exotics brands in 5-oz plastic clam-shell containers FDA reminds the public that children, the elderly, pregnant women, and people with weakened immune systems should avoid all kinds of raw sprouts, even those grown at home.

Salad Bar Romaine Lettuce Recalled Because of E.Coli Outbreak

Freshway Foods is recalling bagged romaine lettuce sold to wholesalers, food service outlets, and in-store salad bars and delis because of a possible link to illness caused by E.coli bacteria.  The recall is being supported by the FDA. Freshway does not produce prepackaged romaine or salad mixes sold to retail consumers in supermarkets.  These products are not included in the recall, but consumers are warned not not to eat “grab and go” salads sold in store salad bars and delis at Kroger, Giant Eagle, Ingles Markets, and Marsh stores. To date 19 cases of E.coli  infection have been confirmed in Michigan, Ohio, and New York, including 12 people who were

Tamper-Resistant OxyContin Approved by FDA

The Food and Drug Administration has approved a new form of pain-reliever OxyContin designed to reduce tampering and abuse. It is difficult to cut, crush, chew, or dissolve the new pills, preserving the slow release of the active ingredient, oxycodone, over time.  If a potential abuser tries to dissolve the pills in water, they form a gummy mass that cannot be injected. After the new formulation is on the market, the FDA will require Purdue Pharma, the manufacturer of OxyContin, conduct a study of how well it meets the goal of reducing abuse and misuse.  Purdue also must develop a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication

FDA Warns Against Raw Milk Due to Bacterial Outbreak

The Food and Drug Administration has warned consumers against drinking raw milk.  At least 12 cases of campylobacteriosis have been reported in Michigan traced to unpasturized milk.  The milk came from the Forest Grove Dairy in Middlebury, Indiana. Symptoms include diarrhea, abdominal pain, and fever. The FDA points out that “the harmful bacteria in raw milk can be especially dangerous for pregnant women, the elderly, infants, young children and people with weakened immune systems.”

FDA Approves Risk Management Plan for ESAs

Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA. ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke. ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care

FDA Warns About Maalox Mixups

Think that Maalox Total Relief is the same as the traditional Maalox liquids? It isn’t, and the FDA wants you to know that. Although both are available over the counter, they are intended to treat different medical conditions.  Maalox Total Relief contains bismuth subsalicylate, which is related to aspirin and can cause bleeding and other serious side effects.

FDA approves highly concentrated liquid morphine for severe pain

In good news for cancer patients at the end of life,  the Food and Drug Administration has approved a concentrated liquid morphine to relieve acute and chronic pain in patients where other opiates are no longer working. Although concentrated doses of liquid morphine have used to manage pain for opiate-tolerant patients for some time, the oral concentrated dose was not FDA approved. The FDA has worked with Roxane Laboratories, the only manufacturer of the 20mg/mL formulation, to be sure that adequate supplies are available to patients in need.