FDA & Prescription Drugs

• Avandia Heart Risks Known Years Ago

  RLF Staff | May 25, 2007 8:28 AM | 0 CommentsDallas, TX

  Accoring to a report by the New York Post, a leading diabetes doctor sent the Food and Drug Administration a letter to the FDA warning of the heart risks of the drug Avandia seven years ago. According to documents from 2000 and 2001 the FDA reprimanded the drug's maker for playing down safety concerns. The documents, found in a reporter's search of the FDA's database, indicated that the...

• Avandia Poses risk of Heart Attack and Other Heart Disease

  RLF Staff | May 21, 2007 4:39 PM | 0 CommentsDallas, TX

  FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes. The clinical studies...

• FDA Recommends Suicidal Warnings Added to Anti-Depressants

  RLF Staff | May 17, 2007 10:33 AM | 0 CommentsDallas, TX

  FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes...

• ED Products True Man and Energy Max Dangers

  RLF Staff | May 15, 2007 7:37 AM | 0 CommentsDallas, TX

  FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared...

• FDA Warning: Counterfeit Internet Drugs

  RLF Staff | May 02, 2007 6:51 AM | 0 CommentsDallas, TX

  The FDA received information showing that 24 apparently related websites operated outside the US may be involved in the distribution of counterfeit prescription drugs. On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose weight and maintain weight...

• Permanent Injunction against PharmaFab Inc., PFab LP prescription and otc drugs

  RLF Staff | April 26, 2007 1:01 PM | 0 CommentsDallas, TX

  FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required...

• FDA RECALL - V.MAX Erectile Dysfunction (ED) supplement(2)

  RLF Staff | April 03, 2007 7:50 AM | 0 CommentsDallas, TX

  Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may...

• FDA RECALL - V.MAX Erectile Dysfunction (ED) supplement

  RLF Staff | March 19, 2007 3:47 PM | 0 CommentsDallas, TX

  From MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramBarodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED)....

• Warning to Cardiologists About Drug-Eluting Stents

  RLF Staff | January 31, 2007 6:44 AM | 0 CommentsDallas, TX

  physicians must be cautious in how they use drug-eluting stentsA statement warning cardiologists when treating arteries with drug-eluting stents was issued by The Society for Cardiovascular Angiography and Interventions (SCAI).The SCAI supports use of drug-eluting stents, but stated that physicians must be cautious in how they use them. Doctors need to carefully select patients who would benefit...

• Fosamax Lawsuit Possibility

  RLF Staff | January 23, 2007 7:26 AM | 0 CommentsDallas, TX

  A report in Medical News Today outlined some of the dangers or Fosamax:The following information has been reported related to Fosamax:-- Fosamax causes a rare disease called osteonecrosis of the jaw, (ONJ)-- New cases are cropping up each day where a patient's jawbone rots and dies-- The American Association of Endondontists issued a statement recommending that dental surgeons should check on...