FDA & Prescription Drugs

• Gadolinium Linked to Nephrogenic Systemic Fibrosis

  Staff Writer | September 04, 2007 8:31 AM | 0 CommentsTampa Bay, FL

  Gadolinium is used in magnetic resonance imaging (MRI) dyes to enhance test results. However, the FDA has found that the gadolinium-based dyes are linked to nephrogenic systemic fibrosis, a sometimes fatal that involves the skin, muscle, and internal organs. According to the FDA advisory, signs of dangers include: For the skin--burning or itching, reddened or darkened patches; and/or skin...

• Drug Patch Dangers Often Minimized

  Staff Writer | August 29, 2007 12:32 AM | 0 CommentsTampa Bay, FL

  The popularity of drug patches has led consumers and some health providers to ignore strong warnings about their side effects, even the lethal dangers associated with them. Fentanyl, a drug patch used for pain relief, has been specifically singled out by the FDA. In its July 2005 warning, the FDA urged exreme caution in prescribing this particular patch and it was never to be used to control...

• TV Drug Ads Face More Scrutiny

  Staff Writer | August 23, 2007 9:32 AM | 0 CommentsTampa Bay, FL

  Pharmaceutical companies are required to present a balanced and accurate picture of a drug's benefits and risks. Yet, some critics argue that the visual pictures in television ads distort and overshadow warnings about the drugs. The issue has drawn the attention of federal regulators who plan to study the issue in the upcoming weeks. According to an announcement posted on the FDA website, the...

• Supplement Recalled for Making Cholesterol Claim

  Shannon Weidemann | August 22, 2007 3:04 PM | 0 CommentsTampa Bay, FL

  A company that was touting a supplement as a way to lower cholesterol has recalled the product after the FDA stepped in. Sunburst Organics is recalling Cholestrix because it contains lovastatin. The recalled supplement contains red yeast rice with lovastatin and that can damage kidneys and muscles. The FDA informed Sunburst Organics that because Cholestrix made a cholesterol-fighting claim,...

• Yet More Evidence that Aredia and Zometa Cause Jaw Osteonecrosis(2)

  Brenda Fulmer | August 21, 2007 2:39 PM | 0 CommentsTampa Bay, FL

  The latest study from the Journal of the National Cancer Institute has confirmed that use of IV bisphosphonate drugs Aredia (pamidronate) and Zometa (zoledronic acid) in cancer patients substantially increases the risks of osteonecrosis of the jaw. A number of small studies have previously noted an increased risk, but this was the first study to analyze a larger number of patients.Investigators...

• Drug Spending Rises As Regulation Slows

  Brenda Fulmer | August 20, 2007 2:02 PM | 0 CommentsTampa Bay, FL

  Pharmaceutical companies spent $30 billion in the United States to market drugs over the past decade. With such a huge increase in spending on samples, marketing, and the ubiquitous direct-to-consumer ads, one would think that the FDA's expenditures and its enforcement efforts would have increased as well. Sadly, the FDA sent only 21 warning letters to drug companies in 2006 for deceptive...

• Laxative Linked to Kidney Problems

  Staff Writer | August 20, 2007 10:51 AM | 0 CommentsTampa Bay, FL

  Fellow Injury Board blogger Jennifer Moore has an interesting post about a laxative that is causing kidney problems. The laxative, Fleet Phospho-soda, is an over-the-counter medication used to flush the bowels in preparation for a colonoscopy. The laxative has been on the market for more than one hundred years and the FDA has listed it as safe when taken as a single dose medication. However,...

• Permax Recalled in Canada

  Brenda Fulmer | August 19, 2007 1:41 PM | 0 CommentsTampa Bay, FL

  Sales of Permax, a once-popular drug prescribed for the treatment of Parkinson's disease and restless leg syndrome, will no longer be sold in Canada as of August 30, 2007, according to a joint announcement by Eli Lilly Canada and Health Canada, the Canadian equivalent of the FDA, on August 16, 2007. The recall by the Canadian government follows the withdrawal of Permax from the United States...

• Yet More Evidence that Aredia and Zometa Cause Jaw Osteonecrosis

  Brenda Fulmer | August 18, 2007 2:39 PM | 0 CommentsTampa Bay, FL

  The latest study from the Journal of the National Cancer Institute has confirmed that use of IV bisphosphonate drugs Aredia (pamidronate) and Zometa (zoledronic acid) in cancer patients substantially increases the risks of osteonecrosis of the jaw. A number of small studies have previously noted an increased risk, but this was the first study to analyze a larger number of patients.Investigators...

• Avandia, Actos Get Black Box Warnings

  Staff Writer | August 16, 2007 6:37 AM | 0 CommentsTampa Bay, FL

  The FDA will require black box warnings for both Avandia and Actos, two diabetes drugs, for their link to an increase in heart failure. Both drugs have been known for quite some time to increase the risk of heart failure which is an inability of the heart to properly pump blood. Last month, the FDA convened an outside panel of medical experts to determine whether Avandia increased the risk of...