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$1.5 billion Abbott fine shows government more serious about penalizing...
Off-label promotion is apparently second nature to healthcare companies. Last year, the entire industry paid $1.45 billion to settle all charges, including allegations of off-label promotion. This...
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Senate Probes Drugmakers Over Painkillers
Senate Probe suggests there is growing evidence that drugmakers “may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs’ safety and effectiveness.”
View ArticlePress Announcements FDA issues warning letter to makers of AeroShot...
The U.S. Food and Drug Administration today issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the...
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Toxic Shock: FDA Warns J&J Over Vaginal Products
The warning letter stems from an FDA inspection conducted last December and January at a facility in Skillman, New Jersey, and was issued after J&J sent four separate responses this past winter and...
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FDA Warning Letter - EpiPen DTC Ad
Pfizer gest an FDA Warning letter for their 60 second ad "Max's Birthday Party" because it is false and misleading because it overstates the efficacy of the drug product. According to the letter, this...
View ArticleFDA Drug Safety Communication: Cefepime and risk of seizure in patients not...
The U.S. Food and Drug Administration (FDA) is reminding health care professionals about the need to adjust the dosage of the antibacterial drug cefepime in patients with renal (kidney) impairment....
View ArticleFDA Warns Acorda Therapeutics - Ampyra Video is False or Misleading
The FDA sent a letter to Acorda Theapeutics based on a video presented on the Lifetime Morning show "The Balancing Act," where a woman with disabilities caused by MS showed how Ampyra helped her to...
View ArticleValeant's Cold Sore Cream, Zovirax, Marketing Materials Misleading
The webpage is misleading because it overstates the efficacy and makes unsubstantiated superiority claims about Zovirax. Zovirax is a cream approved for use with recurrent herpes labialis...
View ArticleFDA Warns of Serious Risks with Victoza Usage
You should note the following potential serious risks of VICTOZA®:There is potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) associated with VICTOZA® VICTOZA® may...
View ArticleEndo Warned - Vantas Brochure Misleading
Endo Pharmaceuticals was warned last week with regards to marketing materials relating to its prostate cancer drug, Vantas. According to the FDA, the Vantas brochure fails to state that paralysis may...
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J&J Loses A Preemption Case Over Infant Tylenol
In a setback to Johnson & Johnson, the US Supreme Court yesterday declined to review a case in which a family successfully argued that the healthcare giant should have included sufficient warnings...
View ArticleMisuse of Opana ER results in 121 hospitalizations and 201 deaths, according...
The AdverseEvent RxFilter process identified 1,726 serious adverse events which listed Opana as a suspect drug during the period 11/1/97 to 6/30/12, while 928 of these reports listed...
View ArticleFDA: Texas company involved in Rick Perry's stem-cell procedure it is...
The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry‘s adult stem-cell procedure that it is illegally marketing an unlicensed drug.In a warning letter, the...
View ArticleFDA Pulls "Plug" on PATANASE Detail Aid
Alcon Caught Illegally 'Plugging' PATANASE Nasal Spray to Docs The FDA's Office of Prescription Drug Promotion (OPDP) sent a 'untitled' letter to Alcon Research regarding a PATANASE 'detail aid', which...
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What We Have Suspected Has Been Confirmed - Women with Breast Implants Beware!
Women are finally realizing possible long term complications of breast implants with the recent release of the FDA’s warning regarding the potential link between breast implants and a rare type of...
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FDA requires lower recommended doses for certain drugs containing zolpidem...
The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new...
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F.D.A. Warns St. Jude Medical Over Defibrillators
The medical device maker St. Jude Medical said Monday it had received a warning letter from the Food and Drug Administration about problems with manufacturing and quality control at a California plant...
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FDA Warns of Liver Injury Risk with Tolvaptan
Three cases of serious but reversible increases in hepatic enzymes in a clinical trial involving tolvaptan (Samsca) have prompted the FDA to warn of potential liver injury with the drug.
View ArticleSamsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
According to a panel of liver experts, Samsca could potentially lead to irreparable or fatal injury to the liver. Samsca is indicated for the treatment of...
View ArticleFDA Warns Consumers to Avoid Doubling Up on Acetaminophen Products
On January 24, 2013, the FDA issued a consumer alert warning patients to avoid doubling up on prescription and over the counter medications containing acetaminophen.
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