FDA & Prescription Drugs

• Children's Cold Medicines Face Scrutiny

  Joe Saunders | October 21, 2007 10:42 AM | 0 CommentsTampa Bay, FL

  Multi-symptom cold medicines for children have come under increasing fire recently from public health advocates as well as the FDA. In a few instances, these cold medicines have been linked to children's deaths. Now, some advocates are calling on an outright ban of the products. The problem with the multi-symptom products is that they contain a wide variety of drugs used to treat different...

• Gadolinium Contrast Dye and Nephrogenic Systemic Fibrosis

  Joe Saunders | October 15, 2007 5:04 AM | 0 CommentsTampa Bay, FL

  Gadolinium, a contrast dye drug used to enhance MRIs, has been linked to a serious and sometimes fatal disease called nephrogenic systemic fibrosis. The skin disease affecting the kidneys is particularly dangerous for those with severe or acute kidney insufficiencies. The threat is serious enough that the FDA required a boxed warning for the drug and warned healthcare officials to screen...

• Ultrasound Imaging Drugs to Get Black Box Warning from FDA

  Joe Saunders | October 09, 2007 6:57 AM | 0 CommentsTampa Bay, FL

  Ultrasound imaging drugs, particularly Definity made by Bristol-Myers Squibb and Optison from General Electric have drawn the attention of the FDA due to reports of deaths and serious cardiopulmonary reactions. These drugs are used to help doctors with difficult ultrasound tests that prove inconclusive in attempting to diagnose cardiac problems. The new black boxes will alert doctors to avoid...

• Pharmaceutical Companies Find Allies with Media Firms

  Brenda Fulmer | October 08, 2007 9:37 AM | 0 CommentsTampa Bay, FL

  A new bill was recently passed which gives the FDA power to require drug companies to submit TV ads for review before they run. The bill doesn't go far enough, however, since the Agency can only recommend changes, not demand them. Early drafts of the bill gave the FDA authority to block a drug company from advertising medications that contained serious safety concerns. Consumer drug ads have...

• Finally, Lilly Adds Strong Warning Re. Zyprexa

  Joe Saunders | October 08, 2007 6:24 AM | 0 CommentsTampa Bay, FL

  After years of mounting evidence that their schizophrenic drug Zyprexa had harmful side effects, drug manufacturer Eli Lilly added a strong warning on the label for Zyprexa. Critics of the drug Zyprexa have been arguing since 2004 that the drug causes significant weight gain as well as elevated blood sugar levels, elevating the risk for diabetes in users. Zyprexa has been heavily marketed in...

• FDA Cracking Down on Unapproved Drugs

  Brenda Fulmer | October 06, 2007 9:30 AM | 0 CommentsTampa Bay, FL

  In late September, the FDA announced that it intends to start cracking down on manufacturers of unapproved drugs that are being marketed in the United States. The Agency announced in particular that it was focusing on companies that are marketing and distributing unapproved cough medications that include the active ingredient hydrocodone. This same ingredient is included in the narcotic drug...

• HRT Sales Representative Whistleblower Admits Improper Promotion

  Brenda Fulmer | October 05, 2007 11:30 AM | 0 CommentsTampa Bay, FL

  The Reno trial involving three breast cancer survivors who are suing Wyeth is now nearing the end of its fourth week. The Nevada plaintiffs are suing Wyeth, the manufacturer of Prempro and Premarin, after they each developed breast cancer attributed to their long-term use of combination hormone replacement drugs. Brett Hendricks, a former sales representative for Wyeth, provided riveting...

• FDA continues warnings about buying drugs on the internet

  Brenda Fulmer | September 28, 2007 11:00 AM | 0 CommentsTampa Bay, FL

  The FDA has previously warned about the risks of buying drugs and other medical products over the internet which could be fake, sub-potent, counterfeit, or not approved by the FDA. Some of the drugs most susceptible to counterfeiting are expensive drugs that are sold in large volumes including cholesterol-lowering medications and "embarrassment drugs" (drugs for conditions that patients may not...

• Drug Consortium to Study Relationship Between Genetics and Drug Safety

  Joe Saunders | September 27, 2007 10:38 AM | 0 CommentsTampa Bay, FL

  In a move that is widely seen as a step in the right direction for consumer safety, a consortium of pharmaceutical companies and academic institutions will combine forces to study data concerning the link between genetics and drug safety. The pharmaceutical companies involved in the group include: Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG,...

• Ketek Safety Concerns Persist

  Brenda Fulmer | September 24, 2007 5:14 PM | 0 CommentsTampa Bay, FL

  For months, there have been growing concerns over the safety of Ketek, an antibiotic that has caused liver failure in a number of patients. Ketek (telithromycin) is part of the ketolide class of antibiotics, and was approved by the FDA in April of 2004. The drug has been shrouded in controversy due to Congressional investigations into irregularities with regard to the approval process,...