South Carolina Personal Injury Blog - FDA

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

FDA Releases Findings on ADHD Medications, Potential Link to Sudden Death in Healthy Children

Will Parker — Tue, 16 Jun 2009 10:03:03 GMT

The FDA recently notified healthcare professionals that it is providing its perspective on data published in the American Journal of Psychiatry concerning the potential risks of stimulant medications used to treat children suffering from Attention-Deficit/Hyperactivity Disorder (ADHD). This study, which was funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in motor vehicle accidents. The study's authors concluded that there could be an association between the use of stimulant medications and sudden death in healthy children.

Considering the limitations of this study's methodology, the FDA was unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. Accordingly, the FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. However, parents should discuss concerns about the use of these medicines with their child's treating physician. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

The following medications were included in the study: Focalin, Focalin XR (dexmethylphenidate HCl); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

More information is available at the FDA's web site: http://www.fda.gov.

Originally posted at InjuryBoard by Will Parker

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

Doctors: Lawsuits are a "vital deterrent".

Raymond Mullman Jr — Mon, 18 Aug 2008 16:15:47 GMT

CNBC has an interesting story about how doctors believe lawsuits serve as a "vital deterrent" to protect consumers from unsafe drugs. Lawsuits protect consumers if drug companies do not disclose risks to the U.S. Food and Drug Administration before it approves medicines for use, the editors of the New England Journal of Medicine said in a friend-of-the-court brief to the Supreme Court. The FDA "is in no position" to guarantee drug safety, the brief said.

Although the FDA is considered by many "the gold standard" in drug evaluation, the journal editors urged the justices to be skeptical.

"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

The medical editors joined 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy, in supporting Levine's position. Kestrel served in the administrations of former President Bill Clinton, a Democrat, and Republican President George H.W. Bush. Kennedy served in Democratic President Jimmy Carter's administration.

The case is being closely watched because the Supreme Court ruled this year that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.

However, David Vladeck, a lawyer representing Kessler and Kennedy, said the statute that applies to medical devices is different from the law that governs medications.

"The law in the (devices) case had a pre-emption provision," said Vladeck. "Congress has never put a pre-emption provision in the Food and Drug Act."

The Bush administration is supporting Wyeth's position.

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It is ridiculous that drug manufacturers get immunity for dangerous medications when they refuse to disclose all the test results or when they knew of damgerous side effects but did not disclose it to the FDA. The FDA rubber stamps most medications and does not do a thorough job of making sure medications are safe for use.

Originally posted at InjuryBoard by Raymond Mullman Jr