Arkansas Personal Injury Blog - FDA & Prescription Drugs

Recall - Children's and Infants Liquid Tylenol

Chrissie Cole — Wed, 30 Sep 2009 13:26:00 GMT

Certain lots of Children’s Liquid Tylenol Products have been voluntarily recalled because they may have bacterial contamination.

One of the inactive ingredients tested positive for B. cepacia. However, bacteria were not found in the finished product. While the risk of a serious medical event is minimal, the company decided to recall the products as a safety measure.

According to the CDC, B. cepacia is the name for a group or “complex” of bacteria that can be found in soil and water which is often resistant to common antibiotics.

The following brands are included in the recall: Children’s Tylenol Suspension 4 ounce Strawberry, Children’s Tylenol Pediatric Suspension 1 ounce Cherry, and Infant’s Tylenol Suspension Drops ½ ounce Grape.

Consumer Information: Contact Johnson & Johnson’s McNeil unit at 1-800-962-5357 with further questions.

All 21 recalled Tylenol products and their corresponding lot numbers.

Originally posted at InjuryBoard by Chrissie Cole

FDA Warning Against Diet Pill Long Overdue

Ryan Scott — Mon, 04 May 2009 17:41:23 GMT

According to the Associated Press, the Food and Drug Administration said the maker of the dietary supplement "Hydroxycut" has agreed to recall 14 of its products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, according to the FDA.

Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy. The teenager died in 2007, and the death was reported to the FDA this March. Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.

Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.

I have had my own experience with this over-the-counter "supplement." Hydroxycut was a new (and very popular) supplement when I was in high school. The girls used it to lose weight, and most of the guys who used it did so to make weight for a sport or to get "geeked up" before a practice or game. I tried the drug a couple of times, but I didn't like the way I could feel my heart race. It gave me the jitters.

It seems to me that you don't have to be a doctor to realize that a pill that speeds up your heart rate to the point it is notiecable should be so easy to get and so loosley regulated. Because of its "supplement" status, fifteen-year-olds were using Hydroxycut products. I'm sure the manufactures will note that the warning label says "adults only," but, when has that stopped any teenager?

It is high time we close the giant "supplement loophole" and protect ourselves from the unregulated, immoral corporations that will package poison to make a buck.

Here is a list of the recalled items:

— 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

Source: U.S. Food and Drug Administration

Originally posted at InjuryBoard by Ryan Scott

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

Are You Mixing a Dangerous Medication Cocktail?

Ryan Scott — Fri, 30 Jan 2009 13:00:00 GMT

At least 2 million older Americans are taking a combination of drugs or supplements that can be a risky mix — from blood thinners and cholesterol pills to aspirin and ginkgo capsules — a new study warns.

Among older men, the numbers are particularly alarming — one in 10 are taking potentially harmful combinations, according to the study.

The results aren't always disastrous, but older people are more vulnerable to side effects and drug-to-drug interactions. And patients need to know that just because lots of medicines and supplements don't require prescriptions doesn't mean they're harmless. Nor are some of these safe to take when you're prescribed other medications.

The research, funded by the National Institutes of Health and University of Chicago found ninety-one percent in this age group use at least one medication, often for heart disease and related problems. That translates to more than 50 million people. More than half use at least five remedies, including prescriptions, over-the-counter medicines or supplements.

Virtually every medicine can have side effects, and with so many being used by so many older adults, the potential for harm is high.

For example, warfarin, a potent prescription clot-fighting drug, was often taken with aspirin. Both increase the risk of bleeding, so the odds are even higher when both drugs are taken. The researchers said these risks also occur when warfarin is taken with garlic pills, which some studies have suggested can benefit the heart and help prevent blood clots.

Signs of bleeding problems include bruising easily, hard-to-stop bleeding from the gums or from cuts and blood in the urine.

Other commonly used and risky combinations included:

Aspirin taken with over-the-counter ginkgo supplements, increasing chances for excess bleeding.
Lisinopril, a blood pressure drug, taken with potassium, which combined can cause abnormal heart rhythms. Potassium is often prescribed to restore low levels of this important mineral caused by certain blood pressure drugs.
Prescription cholesterol drugs called statins taken with over-the-counter niacin, a type of vitamin B that also lowers cholesterol. This combination increases risks for muscle damage.

Michael Cohen, a pharmacist and president of the Institute for Safe Medication Practices, called the study an important snapshot of medication use in older Americans. But as someone who takes at least five medications himself, Cohen said the widespread prevalence isn't surprising.

Cohen said his group recently launched a new Web site,http://www.consumermedsafety.org that will allow consumers to enter names of their medications to check for any potentially dangerous interactions.

Originally posted at InjuryBoard by Ryan Scott

FDA Advisory Notices: Drugs Linked to Suicidal Thoughts

Sach Oliver — Fri, 26 Sep 2008 09:47:00 GMT

In just the past few months, the FDA has released several advisory notices to both doctors and the public about drugs linked to suicidal thoughts or actions, including Singulair, epilepsy drugs and the smoking-cessation drug Chantix. Reports have also been filed on antidepressants, the influenza drug Tamiflu and the acne medicine Accutane.

After concerns were first raised about possible links between antidepressants and suicide about four years ago, the FDA commissioned researcher Kelly Posner, the principal investigator at the Center for Suicide Risk Assessment at Columbia University in New York, to help determine any suicidal risk posed by medications. Her quantitative tools and questionnaires to assess suicide risk are being applied to drugs already on the market and those still in testing.

"We know that whether or not these drugs actually cause suicidal thought or action is a question we have to answer, but up until now, none of the clinical trials for the drugs were set up to address the question,’’ says Posner. "Either way we have to get the right answers. It’s critical to know about drugs that pose risk, but debunking false notions of risk is equally important to the public health.’’

Finding a link can present other issues. This became evident when the FDA, based on a review of antidepressant clinical trials, found a slight increase in suicidal thinking among children and young adults taking antidepressants such as Paxil and Prozac. The rate in those taking antidepressants was 4 percent, twice the rate of those taking a placebo. The information was added to the label of antidepressants within the last few years, pushing many doctors to stop prescribing the drugs for many of their patients.

Laughren says the FDA hopes that by using Posner’s methods, they may be able to find categories of people who might be at risk for suicide on a particular drug and more carefully determine who should stay clear of the drug and in whom it can safely be prescribed.

At least in theory, there are some possible explanations for why some of the drugs in question might be associated with suicidal thoughts or action, says Jason Noel, director of clinical pharmacy services at Rosewood Center in Owings Mills, Md., a residential facility for people with developmental disabilities. Singulair, for example, has a similar chemical pathway to steroids, which are drugs that can affect behavior and mood.

The FDA is conducting a safety review of Singulair, which is also used to treat asthma, that is expected to take about another eight months.

When Kate Miller of Queensbury, N.Y., filled a new allergy drug prescription for her 15-year-old son, Cody, last July, she hoped it would improve his bothersome allergy symptoms. Now, Miller is wondering whether a possible side effect of the drug, Singulair, caused Cody — who she describes as a happy, athletic teenager — to take his own life about a month later.

Last week, Kate Miller and her husband, David, met with FDA officials in the office of Congresswoman Kirsten Gillibrand (D-N.Y.), who is pushing to help find answers on Singulair and other drugs that have been linked to suicide.

Adding to the confusion of how to determine the possibility that a drug can cause suicidal thinking or action is the fact that suicide and suicidal thinking is, sadly, fairly common in the United States. Suicide is the fourth leading cause of death for adults between the ages of 18 and 65, according to the most recent data from the National Center for Health Statistics, accounting for about 26,500 deaths in that age group in 2005. For those ages 15 to 24, suicide is the third leading cause of death.

For all ages, suicide rates increased just under 1 percent between 2000 and 2005, but children and young adults ages 10 to 24 experienced an 8 percent increase between 2000 and 2004, following a decrease in the 15 years prior to 2000, according to the Centers for Disease Control and Prevention in Atlanta. Ileana Arias, head of the CDC's National Center for Injury Prevention and Control, says the agency doesn’t have an explanation for the increase.

Originally posted at InjuryBoard by Sach Oliver

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

Accutane Linked to Depression

Drew Dixon — Tue, 27 May 2008 16:54:46 GMT

The use of isotretinoin, the active ingredient in the acne medicine Accutane, is believed to more than double the risk of depression. In a report in the Journal of Clinical Psychiatry, Doctors from CHU Sainte-Justine Research Centre in Montreal have performed the first study to find a statistically significant link between isotretinoin and depression.

While depression is likely to be a rare side effect of isotretinoin, current guidelines should be modified to include psychiatric assessments before and during a patients use of Accutane.

If you or a loved one have taken Accutane here are some common symptoms of depression to look for:

1. Loss of interest in daily activities

2. Loss of appetite or weight changes

3. Changes in sleep

4. Loss of energy

5. Concentration problems

6. Irritability

7. Aches and pains

People suffering from depression often show distorted thinking. Everything looks bleak to them, and they hold extremely negative views about themselves, their situation, and the future. Trapped in their pessimism, they obsess over their problems and blow them out of proportion. Unable to see a light at the end of the tunnel, they may even start to see suicide as their only way out.

For more information on depression, please check out the Dr. Robert E. Elliott Foundation at www.robertelliottfdn.com.

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