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.

FDA Revokes Approval for Breast Cancer Drug

Posted November 18, 2011 by M. Miller

The F.D.A. is revoking its approval of the drug Avastin for breast cancer. This comes after concluding that it “has not been shown to be safe and effective for that use.”

Roche, the maker of Avastin, states it will remain an approved treatment for certain other types of cancer.

Current breast cancer patients have pleaded desperately for the approval to be retained, as they feel the treatment is keeping them alive.

J & J Removing Toxic Chemicals from Baby Products

By Moe Taheri

November 17, 2011 – The AP (11/16) reported, “Amid pressure from activists, Johnson & Johnson said Wednesday that it is continuing efforts to remove traces of two harmful chemicals from its baby products around the world. An international coalition of consumer and environmental groups has been pressing J & J since May 2009 to remove two potentially cancer-causing chemicals from products.”

It is disturbing to see J & J increasingly caught up in a recall of their products, especially baby products which ironically are designed to protect the most vulnerable consumers. Formaldehyde-based products are known carcinogenic agents. For a pharmaceutical company such as J & J to incorporate them as preservatives in baby care products is reckless behavior. As an iconic American institution, one that has enjoyed a good reputation and enormous success both in the U.S. and around the globe, it is unconscionable to see J & J use such harmful chemicals in consumer products. What is even more alarming is that it takes actions by consumer advocacy groups to expose J & J’s unsafe conduct and force them to remedy these harmful products.