On Thursday, the FDA panel of scientific advisors issued a report that
said the drug PPA should not be classified as safe and may increase the risk
of hemorrhagic stroke in people, primarily women, under the age of 50. The
drug constricts blood vessels and may seriously raise a person's blood
pressure, which could cause a hemorrhage.
For a number of years CHPA’s Phenylpropanolamine Working Group has been studying, and providing FDA materials on, the safety and effectiveness of PPA as an over-the-counter (OTC) appetite suppressant. Members market all the major national brands and house brands of appetite suppressants and cough/cold products that contain PPA. Submissions to FDA have included reports from effectiveness trials, which led to FDA’s approval of PPA as an effective ingredient for weight loss through the OTC Review, and study reports and other information supporting the safe use of PPA as an appetite suppressant. As part of this overall effort, CHPA members agreed in 1992 to FDA’s request for additional epidemiologic information on the safety of PPA and funded the HSP study, which was conducted by principal investigators from Yale University. These documents were reviewed in a panel meeting on 19 October 2000. The conclusion of the panel was that PPA may be unsafe. Read a portion of the documents submitted by the manufacturers of diet, cold and sinuse medications that contain PPA in in today's Vidyya.
The leading producer of over-the-counter cold medications in the US, has assured consumers that none of its Tylenol or Motrin brand cold/flu or sinus products contain phenylpropanolamine (PPA). The company is issuing the statement after major news networks showed the products in their news casts. The products have never contained PPA and patients can be assured that these products are safe. Contact information for patients with questions is available in today's issue of Vidyya.
Nobex Corporation, formerly Protein Delivery, has announced that the Company has been awarded two Small Business Innovation Research (SBIR) grants of $100,000 each from the National Institutes of Health (NIH). The grants will accelerate the development of two different Nobex drug candidates, one for the alleviation of severe pain and the second for the treatment of obesity.
Targeted cryoablation, a procedure developed by Endocare, Inc., is the use of cryoablation (application of extreme cold to destroy tissue) in
combination with ultrasound and temperature monitoring to precisely destroy cancer cells in and around the prostate gland. A physician completes the first freeze cycle, then immediately administers another treatment to
help ensure that all cancer cells are killed. The entire procedure lasts about one to two hours. The procedure met with final FDA approval this week.
As always, we hope you enjoy the issue.