Bentonville Personal Injury Lawyer - FDA & Prescription Drugs

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

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

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

Use of Heparin Concerns the Food and Drug Administration

Drew Dixon — Thu, 24 Apr 2008 12:39:00 GMT

The Food and Drug Administration recently asked the makers of many kinds of medical devices that contain the drug Heparin to test their supplies. The concerns came after a number of serious allergic reactions were linked to medical devices which contained Heparin.

The FDA's statistics showed 62 deaths associated with the severe reaction in the 15 months from January 2007 through last month -- an increase from the agency's previous count. Of these reported deaths, 47 came in the four-month period from November, 2007 to February, 2008.

China is the world's leading supplier of heparin, a blood thinner often made from a substance in the intestines of pigs. The FDA has identified the contaminant as a modified form of a common nutritional supplement. That substance is cheaper to produce than Heparin; leading to suspicions that it may have been intentionally added somewhere along a complex and lightly regulated supply chain in China.

Heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood. While heparin does not break down clots that have already formed, it allows the body's natural clot lysis mechanisms to work normally to break down clots that have already formed. Heparin is most commonly used for anticoagulation for the following conditions:

· Acute coronary syndrome, e.g. Myocardial infarction

· Atrial fibrillation

· Deep-vein thrombosis and pulmonary embolism

· Cardiopulmonary bypass for heart surgery

For More Information Please Visit the Food and Drug Administration Website www.fda.gov.

Originally posted at InjuryBoard by Drew Dixon