Dear Health-Conscious Friend,
The list of health dangers from FDA-approved products just keeps growing
The watchdog agency has issued warnings about allergic reactions to chemicals in lung inhalers. Theyre also urging you to be careful with denture cleansers, too.
But on a positive note, the FDA succeeded in identifying the suspicious substance that sickenedand even killedsome heparin users. Unfortunately, their discovery is too late for at least 62 folks
It seems as though this cycle of product approval and subsequent warnings is becoming business as usual!
Read about all this and MORE in todays Monday Edition of Health News Weekly!
COPD Inhaler May Boost Stroke Risk
Heres some news that could take your breath away! A respiratory inhaler used for chronic obstructive pulmonary disease (COPD) may heighten the risk for stroke.
German drug maker Boehringer Ingelheim said safety checks identified a possible increased stroke risk for patients who use the Spiriva® HandiHaler®.
According to a statement from the Food and Drug Administration, the inhaler contains the chemical tiotropium bromideused to treat the spasms associated with COPD. But the agency said they need additional information for a more complete evaluation.
Boehringer Ingelheim said the Spiriva® HandiHaler® is a once-daily, long-term maintenance medicine. The FDA said the company has analyzed safety data from 29 placebo-controlled clinical studies involving 13,500 patients with COPD.
In 25 of the clinical studies, patients received the Spiriva® HandiHaler® to treat their symptoms. In the other four, patients were treated with Spiriva® Respimat®a similar formula approved for use in Europe.
Preliminary study data suggests eight patients per 1,000 patients treated for one year with Spiriva® were at risk of experiencing a stroke. This compares with six patients per 1,000 patients treated for one year with a placebo.
The data suggest two patients for each 1,000 patients using Spiriva® over a one-year period are at risk of any type of stroke due to the product.
The FDA said it was working with the drug maker to evaluate the potential link. The agency cautions patients using Spiriva® not to stop using the medication without talking to their doctors.
Denture Cleansers May Trigger Allergic Reactions
The Food and Drug Administration (FDA) is advising denture wearers to watch for allergic reactions from denture cleansers. The warning comes after some people reported rashes, hives, breathing problems and even a drop in blood pressure after using the products.
The FDA has received more than 70 reports of allergic reactionsand at least one death linked to denture cleansers. Some of these reactions occurred when patients misused denture cleansers by gargling with or swallowing the products.
The agency website names an ingredient called persulfate as the most likely cause of the problems. This chemical is part of the cleaning and bleaching process.
The FDA is asking manufacturers of denture cleansers to change the product labels. The agency wants to stress the importance of using the products to clean dentures in a containerand to NEVER use them in your mouth.
Here are some safety measures the FDA recommends if you use denture cleansers:
- Read all instructions carefully.
- Never chew, swallow or gargle with denture cleansers.
- Always thoroughly rinse dentures and other dental appliances before placing in the mouth.
- Remember that reactions may not occur right away.
- If symptoms do occur, remove dentures and contact your dentist.
- Ask your dentist about alternative denture cleaning methods.
Allergic reactions to persulfate may begin right away or after many years of use, and they may worsen with repeated use of the products. The FDA said people at risk include those who are allergic to persulfates and those who cant read or understand product labels.
Fast Fact
Want to reduce your risk of experiencing abnormal cell growth and other diseases? If you eat meat as part of your meals, try including more lamb, skinless turkey and chicken. These meats are low in fatand may help you trim your waistline too!
FDA Identifies Deadly Heparin Contaminant!
U.S. health officials say theyve identified the contaminant found in the blood thinner heparin. The drug was linked to hundreds of allergic reactionsand possibly 62 deaths in the United States.
The FDA identified a manmade chemical called oversulfated condroitin sulfate as the contaminant. But health officials are unsure how the substance got into the heparin.
Whats more, they say they cant be sure its to blame for the allergic reactions and deaths.
But Dr. Janet Woodcock, director of the FDAs Center for Drug Evaluation and Research, said this substance was the only contaminant found in samples of the blood thinner supplied by Baxter Healthcare Corporation.
Oversulfated chondroitin sulfate mimics heparins qualities. It is a modified form of chondroitin sulfatea natural substance made from animal cartilage often used to treat arthritic joints.
But, oversulfated chondroitin sulfate is man-made and doesnt occur naturally.
Scientists found the contaminant in heparin samples the FDA tested from Scientific Proteins Changzhou SPL plant in China.
This plant supplied Baxter with the active ingredient in heparin. Woodcock said it was also found in Baxters heparin products in the United States.
Tests showed the contaminant made up anywhere from 2 to 50 percent of the active pharmaceutical ingredient in some samples.
Woodcock said the FDA is unsure if the heparin was contaminated deliberately or accidentally. But she noted that oversulfated chondroitin sulfate is less expensive than the active pharmaceutical ingredient in heparin.
Since the end of December, there have been 785 reports of allergic reactions associated with Baxters heparin. This compares with fewer than 100 reports of adverse reactions in all of 2007.
There also have been 103 deaths among heparin users, with 62 being tentatively linked to the contaminant. However, since the lots of Baxters heparin were recalled Feb. 28, no new deaths have been reported.
Woodcock said the FDA has been testing imported heparin entering the United States since March 14.
Health E-Hints
Could Your Snoring Indicate
A Serious Health Problem?
Snoring is a problem that increases with ageand is common among both men and women. But did you know that LOUD snoring has been linked to three serious health problems?
You snore when airflow through your mouth and nose is blocked. The sound is caused when tissues at the top of your airway strike each other and vibrate.
A study authored by Marta Novak, MD, PhD, of the Institute of Behavioral Sciences at Semmelweis University in Budapest, Hungary found that loud snorers had:
- 40 percent greater chances of having hypertension
- 34 percent greater odds of having a heart attack, and
- 67 percent greater chances of having a stroke.
Quiet snoring was associated only with an increased risk for hypertension in women.
If youd like to reduce snoring, you can try 1) losing weight if youre overweight, 2) cutting back on alcohol or sedatives at bedtime, and 3) sleeping on your stomach or side.