Posts tagged drug products

• FDA Cracking Down on Unapproved Drugs

  Brenda Fulmer | October 06, 2007 9:30 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  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...

• FDA Cites Cold Medicine Dangers for Children

  Joe Saunders | September 29, 2007 9:26 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Cold and cough medicines purchased over the counter for children under six years of age can cause serious side effects, including death, concluded an FDA analysis of the safety of children's cold and cough medicines. The FDA has had 54 reports of children's death as a result of using decongesants containing pseudoephedrine, phenylephrine and ephedrine. The FDA has told companies marketing...

• FDA continues warnings about buying drugs on the internet

  Brenda Fulmer | September 28, 2007 11:00 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  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...

• FDA Warning Issued for Pain Drug Fentora

  Joe Saunders | September 27, 2007 10:45 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Fentora, used to treat pain in cancer patients, has drawn an FDA warning as a result of deaths in patients who were given the improper dosage or Fentora was incorrectly substituted as a pain management pharmaceutical. The FDA warning stated that Fentora should not be used in cancer patients who are unable to tolerate other opioiddrugs. Fentora was approved by the FDA last year for cancer...

• Drug Consortium to Study Relationship Between Genetics and Drug Safety

  Joe Saunders | September 27, 2007 10:38 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  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,...

• FDA to Study Potential Link between ADHD Drugs and Cardiovascular Problems

  Joe Saunders | September 24, 2007 1:52 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  The potential link between such ADHD drugs as Adderall, Concerta, Ritalin, and Dexedrine and cardiovascular disease and strokes will be studied by the FDA. According to the September 17 FDA News item:"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not...

• Congress Gives FDA More Power to Monitor Drug Safety

  Joe Saunders | September 21, 2007 8:18 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Congress has passed legislation giving the FDA new powers of oversight concerning the pharmaceutical industry including more authority to require changes to drug labels, demand additional safety studies and limit the distribution of medications when safety concerns arise. The new legislation includes an interesting twist in that it may limit protection of pharmaceutical companies for drugs that...

• First Florida Vioxx Trial Underway in Tampa

  Brenda Fulmer | September 19, 2007 1:37 PM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Jury selection and opening statements have now been completed in the trial of Refik Kozic v. Merck, the first Vioxx case to proceed to trial in the State of Florida. Refik Kozic, a current resident of Jacksonville and a former long-term resident of Tampa, filed his lawsuit against Merck in 2003 for injuries relating to the heart attack that he suffered after ingesting Vioxx daily for 9 weeks. ...

• NY State and Big Apple Sue Merck for Fraud

  Staff Writer | September 18, 2007 11:42 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  NY Attorney General and son of former Governor Mario Cuomo, Andrew Cuomo has filed a lawsuit against Merck and Co. for fraudulently concealing safety information about the embattled drug Vioxx. NY joins ten other states who have sued the company for failing to disclose safety information about Vioxx. NY city Mayor Michael Bloomberg has also joined the lawsuit which seeks restitution for tens...

• Cephalon Criticized for Aggressive Marketing Tactics with Actiq

  Staff Writer | September 14, 2007 6:48 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Cephalon had already been criticized for its inappropriate and aggressive marketing techniques when it sent a "Dear Doctor" letter to physicians warning them about the possible side effects in Fentora. These side effects include 4 deaths, one a suicide. Actiq and Fentora were approved for cancer patients only. Yet, as we've seen before, the drugs are marketed more broadly than their intended...