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South Florida Rehabilitation Consultants
Newsletter
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| Dear Fulvia, |  Hello, How are you doing? Hopefully prepared for the summer. Enjoy these relaxing months ahead. We have included in this edition some information about warnings on commonly used medications. Hope this is useful to you. South Florida Rehabilitation Consultants, Inc. is a private Physical, Occupational and Speech therapy practice dedicated to helping our clients improve function and achieve their goals.
Sincerely,
Fulvia Barrera, MBA, PT
South Florida Rehabilitation Consultants
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 FDA'S MEDWATCH SAFETY ALERTS: FEBRUARY 2011
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After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
- Online
- Regular Mail: Use postage-paid, pre-addressed FDA form 3500
- Fax: 1-800-FDA-0178
- Phone: 1-800-332-1088
MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.
Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.
Label Mix-Up Prompts Recall of Phenobarbital Tablets, Hydrocodone Bitartrate and Acetaminophen Tablets
An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets was found incorrectly labeled as Phenobarbital Tablets. Both products are manufactured by Qualitest Pharmaceuticals.
The recall includes the following products:
To read more please click |
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ARTIFICIAL SWEETENERS: UNDERSTANDING THESE AND OTHER SUGAR SUBSTITUTES | |
Whether your goal is cutting calories or eating healthier, options for sugar substitutes abound. Understand their pros and cons to make an informed choice.
By Mayo Clinic staff
If you're trying to reduce the sugar and calories in your diet, you may be turning to artificial sweeteners or other sugar substitutes. You aren't alone.
The popularity of artificial sweeteners and other sugar substitutes is on the rise as manufacturers and consumers seek lower calorie alternatives to regular white sugar without sacrificing sweetness.
Today, artificial sweeteners and other sugar substitutes are found in a variety of food and beverages marketed as "sugar-free" or "diet," including soft drinks, chewing gum, jellies, baked goods, candy, fruit juice and ice cream. In addition, other sugar substitutes are being touted as healthier sweeteners than regular sugar, even if they don't have fewer calories, such as honey and agave nectar.
Just what are all these artificial sweeteners and sugar substitutes? And what's their role in your diet?
To read more please click |
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FDA WARNS MARKETERS OF UNAPPROVED 'CHELATION' DRUGS |
Federal regulators are warning eight companies to stop selling so called 'chelation' products that claim to treat a range of disorders from autism to Alzheimer's disease.
The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson's disease or any other serious illness.
Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.
FDA compliance expert Deborah Autor says the companies are preying on people made vulnerable because of serious illness.
"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," says Autor.
In letters dated Oct. 14, FDA warns the companies that they are facing possible legal action if they continue to make unsubstantiated claims. The firms that received the letters (along with the chelation products they market) are:
- World Health Products, LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
- Hormonal Health, LLC and World Health Products, LLC: Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test
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POSSIBLE FRACTURE RISK WITH OSTEOPOROSIS DRUGS | |
The Food and Drug Administration (FDA) is warning there is a possible risk of a rare type of thigh bone (femoral) fracture in people who take drugs known as bisphosphonates to treat osteoporosis.
The agency warned patients and health care professionals of this risk on Oct. 13, 2010, because the rare type of femoral fracture has been predominantly reported in patients taking these prescription medications.
FDA says the possible risk of thigh fracture will be reflected in a labeling change for bisphosphonate medications that treat osteoporosis and in a medication guide that will be required to be given to patients when they pick up their prescription.
Bisphosphonates are a class of drugs that slow or inhibit the loss of bone mass. They have been used successfully since 1995 to prevent and treat osteoporosis and similar diseases. Osteoporosis is a disease in which the bones become weak and are more likely to break.
FDA says it is not clear whether bisphosphonates are the cause of the unusual bone breaks known as subtrochanteric femur fractures, which occur just below the hip joint, and diaphyseal femur fractures, which occur in the long part of the thigh.
To read more please click |
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