FDA & Prescription Drugs

• Zyprexa Gets Stronger Warnings

  Scott Kappes | October 09, 2007 1:08 PM | 0 CommentsGalveston Bay, TX

  Last Friday Eli Lilly and Co. announced that they will be pumping up the warnings on the anti-psychotic drug Zyprexa. Zyprexa is used to treat schizophrenia and bipolar disorder. The drug has been seen to induce weight gain, increase blood sugar levels and cholesterol among other concerns. The new warnings will give a more accurate representation of these potential risks associated with the use...

• Ultrasound Contrast Agents To Get FDA Warnings

  Courtney Mills | 2007-10-09T12:37:38 | 0 Comments

  The federal government is planning on requiring warnings for certain contrast agents used with ultrasound technology. These contrast agents are used to improve diagnoses of heart problems in patients evaluated with ultrasound imaging equipment.The contrast agents are sold under the brand name Definity, by Bristol-Myers Squibb, and Optison, of General Electric. Physicians inject the imaging...

• Lilly Ordered to "Immediately Cease" Cymbalta Promotion

  Scott Kappes | 2007-10-09T10:42:01 | 0 Comments

  Last week the FDA order Eli Lilly and Co. to stop disseminating advertising material for the popular antidepressant Cymbalta, they characterized as misleading. The FDA posted the letter sent to Lilly on their website last Tuesday claiming that the advertising mailer for Cymbalta overstates the effectiveness of the drug and fails to point out the serious potential dangers associated with the...

• Ultrasound Imaging Drugs to Get Black Box Warning from FDA

  Joe Saunders | 2007-10-09T06:57:59 | 0 Comments

  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...

• Novartis Chief Executive Says FDA Succumbing to Political Pressure in its Attempt to Increase Drug Safety

  Joe Saunders | 2007-10-09T05:09:39 | 0 Comments

  During the three day Clinton Global Initiative, Novartis Chief Executive Dan Vasella said that the FDA was buckling under political pressure to monitor the safety and efficacy of new pharmaceuticals. HIs comments were made in the wake of rising awareness of overly aggressive marketing tacticts by pharmaceutical companies at the expense of consumer safety. Two Novartis drugs, Prexige and Galvus...

• Doctors to be Warned About Imaging Agent Risks

  Scott Kappes | 2007-10-08T17:37:17 | 0 Comments

  Today it was announced that the FDA will be issuing warnings to doctors about the risks associated with certain imaging agents used to better view the heart in an echocardiograph. The FDA has been investigating reports of serious cardiopulmonary reactions and even deaths associated with the imaging agents. The agents in question are manufactured by Bristol-Myers Squibb Co. under the name...

• Message Boards Show Chantix Effects are Real

  Scott Kappes | 2007-10-08T10:20:45 | 0 Comments

  Every day I am finding more and more people who have experience drastic side effects while using the drug Chantix, side effects which are not listed in the Chantix warning label. Chantix is a new drug, manufactured by Pfizer, to purportedly help people quit smoking. The results experienced by many of the people who have taken this drug range from severe depression, psychotic episodes and...

• Pharmaceutical Companies Find Allies with Media Firms

  Brenda Fulmer | 2007-10-08T09:37:58 | 0 Comments

  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 | 2007-10-08T06:24:14 | 0 Comments

  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 | 2007-10-06T09:30:04 | 0 Comments

  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...