Controversy Ridden Accutane Pulled from Pharmacy Shelves

Pete Strom — Tue, 30 Jun 2009 14:52:36 GMT

Roche Holding AG announced last week that it is pulling its popular acne medicine Accutane from the U.S. market citing economic reasons for its decision.

Accutane was released on the market in 1982. It is estimated that about 13 million people took Accutane before the patent expired in 2002, making it Roche’s second-best selling medicine. Roche claims that after the patent expired, it faced serious challenges from its competitors reducing its market share to less than 5%.

Although the company cites economic reasons, Accutane has always been cloaked in controversy. Controversy surrounding the drug first began in the late eighties when Accutane was linked to serious birth defects.

In 2002, Roche and the Food and Drug Administration launched what became an unsuccessful tracking program designed to reduce the number of pregnant women taking the drug. Nearly 80 percent of pregnancies reported by women taking Accutane during the tracking program’s first year ended in elective abortion because of concerns over the high rates of birth defects.

Accutane has also been reported to cause psychiatric problems including depression and suicide. In 2004, lawmakers and Michigan Representative Bart Stupak sent a letter to Health and Human Services urging the agency to take the drug off the market after Stupak’s 17-year-old son committed suicide while taking Accutane four years prior. Lawyers for John Mullarkey, a 20 year old man currently facing murder charges for the death of his 16 year old girlfriend, claim that he was suffering from an Accutane fueled depression when the deaths occurred.

Roche currently faces nearly 5,000 product liability lawsuits. Recently, the company lost several lawsuits to plaintiffs who claimed Accutane caused them to develop inflammatory bowel disease. Juries have awarded over $33 million to multiple victims across the United States.

Accutane has already been pulled from the market in 11 other countries. June 25th, 2009 was the last day for distribution in the United States. Although Accutane is no longer available from Roche directly, it may still be available at pharmacies.

Strom Law Firm is a personal injury and criminal defense law firm centrally located in Columbia, South Carolina. Our firm proudly handles personal injury, criminal defense, defective products, class actions, pharmaceutical liability, toxic torts, medical malpractice, nursing home neglect, workers compensation, social security, veteran's benefits, qui tam, predatory lending, tax investigations, business litigation, and wills and estates. Our lawyers proudly edit the Columbia, South Carolina Injury Board as well as the Strom Law Blog as a pro bono effort to provide the public valuable information. Our lawyers are licensed in: South Carolina, New York, Georgia, Florida, and the District of Columbia.

Originally posted at InjuryBoard by Pete Strom

Bayer HealthCare Illegally Markets Unapproved Drugs

Amanda Wick — Tue, 28 Oct 2008 15:42:41 GMT

Today the U.S. Food and Drug Administration sent Warning Letters to Bayer HealthCare regarding two aspirin products. According to the FDA, Bayer has illegally marketed two over the counter products: Bayer Women’s Low Dose Aspirin and Bayer Aspirin with Heart Advantage.

Both products contain aspirin plus either phytosterols or calcium and are unapproved new drugs. ”New drugs” must be approved by the FDA through a new drug application in order to be legally marketed.

These tablets are also a combination of a drug and a dietary supplement. When these two functions are combined into a single tablet, the product is considered a drug and is regulated by the FDA. Because the FDA considers these products new drugs, they must undergo the FDA’s drug approval process before they can be marketed and sold over the counter.

Before these products receive FDA approval, they must meet a number of different requirements. First, the drugs must be approved for all uses. This includes any secondary uses such as reducing the risk of heart disease and fighting osteoporosis, as these drugs claim to do. Second, they must also contain clear directions that can be followed by consumers without guidance by a health care professional.

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said that “[because over the counter] drugs are widely used by consumers, without the supervision by a doctor or other health care professional, the overuse or misuse of these aspirin containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations.”

Although the FDA is not aware of significant adverse events associated with these products, people who took these drugs while they were on the market may suffer adverse side effects. If you haven taken these drugs and suffered adverse side effects, you should seek medical care and discuss the situation with your doctor.

Originally posted at InjuryBoard by Amanda Wick

Columbia Personal Injury Lawyer - FDA

Controversy Ridden Accutane Pulled from Pharmacy Shelves

Bayer HealthCare Illegally Markets Unapproved Drugs