Diabetes Drugs Linked to a Higher Risk of Macular Edema

June 12, 2012 – A ten-year study recently concluded that thiazolidinedione drugs, such as Avandia and Actos, may increase the risk of macular edema, a serious eye condition that can lead to blindness. It noted that the incidence of macular edema in studied patients on these drugs was more than double that of patients who were not on thiazolidinediones. At times during the study, there were more than six times the amount of studied patients who experienced macular edema after using a thiazolidinedione, compared to patients not on these drugs. Read more about this study at: Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes, JAMA

Drugs & Devices: How Big Pharma Puts Patients at Risk

June 1, 2012 – American Association for Justice Trial Magazine June 2012
Drugs & Devices: How Big Pharma Puts Patients at Risk

“Bad Actos” by Howard L. Nations and John M. Restaino

“The safety of Actos, an oral diabetes drug that increases the body’s sensitivity to insulin, has been increasingly called into question since 2010. That was when the FDA announced that it was “reviewing data from an ongoing, 10-year epidemiological study designed to evaluate whether Actos (piolitazone) is associated with an increased risk of bladder cancer.”  Read the rest of the article in Trial Magazine.

MedWatch – Zithromax (azithromycin): FDA Releases Statement on Risk of Cardiovascular Death

By Amber Stanford

May 26, 2012 – The FDA has recently recognized a new study released in the issue May 17, 2012 of the New England Journal of Medicine that reports a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug at all. The FDA intends to further review this research any findings.

Warning: Potential for Overdosing with Baby Pain/Fever Medicine

By Cindy L. Nations

December 22, 2011 – Three days before Christmas, the FDA issued a warning about  a new concentration of liquid acetaminaphen for infants.  The pain and fever medication has long been available in 80 mg/0.8 mL and 80 mg/mL strength.  The drug is now also available in 160 mg/5mL strength.  If  the new concentration is not noted, parents or caregivers could accidentally give too much medication to the infant, resulting in tragic consequences.  Liquid acetaminophen is in several popular medicines, including Tylenol, Little Fevers,  Triaminic Infant Pain Reliever, Pedia Care, and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

FDA Considers Stronger Warnings for Yasmin and Yaz

By Moe Taheri

December 9, 2011 – Yaz and Yasmin may cause a significantly higher risk of blood clots compared to older birth control pills. These recent medical findings were reviewed yesterday by an FDA advisory committee that is evaluating the risks and benefits of Yaz and Yasmin. An FDA safety report prepared for the committee recommends a stronger warning about the “very real” possibility of an increased risk of blood clots.

Dr. Kessler, a former ranking member of the FDA, previously gave testimony that Bayer intentionally withheld important safety data to mislead FDA officials. This testimony was not considered at the committee hearings because it was submitted after the deadline. The FDA also barred the testimony of Dr. Sidney Wolfe as an FDA advisor due to a conflict of interest. Dr. Wolfe is a leading drug safety advocate with Public Citizen where Yaz is listed as a “do not use” medication.

Bayer’s failure to adequately warn about the risk of blood clots associated with Yaz and Yasmin has resulted in hundreds of lawsuits. The Nations Law Firm represents women who have suffered serious and potentially life-threatening injuries from Yaz and Yasmin.

Merck to Pay $950 Million to Settle Vioxx Probe

By Moe Taheri

November 29, 2011 – Last week Merck & Co. agreed to pay $321.6 million in criminal fines to resolve investigations into Merck’s illegal and fraudulent activities related to its pain killer Vioxx. Federal and state prosecutors alleged that Merck committed Medicare and Medicaid fraud and engaged in deceptive marketing and off-label promotion of Vioxx, most notably promoting Vioxx to treat rheumatoid arthritis before it was FDA-approved for such use. DOJ officials slammed Merck and other pharmaceutical companies for ignoring FDA rules which are the impetus of drug safety. Merck also agreed to pay $628.4 million in a civil settlement agreement.

Vioxx, a popular pain killer, was approved by FDA in 1999 only to be recalled in 2004 when it was linked with substantial cardiovascular risks. In 2007, Merck agreed to pay $4.85 billion to settle several thousand civil suits brought by Vioxx patients who had suffered cardiac injuries.

It is unfortunate that reckless and often criminal behavior has become standard operating procedure in the pharmaceutical industry. This sector must be held accountable and held to a high standard because of both the impact their products have on patients’ lives, and the enormous financial gains they enjoy from their product sales.