Acne Medicine 'Accutane' Causing Birth Defects, Depression, Suicides

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Accutane, a medicine for acne, is causing birth defects, depression and suicides, allege researchers. Dr. David Graham, associate director of the FDA's office of drug safety, named Accutane as one of the drugs he says should be restricted or withdrawn from the market, according to this article in the Washington Post. In a Tampa, Florida legal case against Hoffmann LaRoche, a host of documents on Accutane's effects has been produced by the drug maker. Unfortunately, federal judge James Moody ruled that documents filed in the case could not be "passed on" to others who have similar legal cases pending.

The drug has caused scores of birth defects, which are acknowledged by the company in its product information. According to a report of Vera Hassner Sharav of the Alliance for Human Research Protection, the FDA in 2002 had knowledge of 173 suicide reports associated with Accutane. The manufacturer says the drug is safe.

Hold on a minute. An acne drug associated with deadly side effects? Acne is by no means a life-threatening condition. Babies being born deformed for life, hundreds, and possibly thousands of young people committing suicide? What could induce our health authorities to allow deadly drugs such as Accutane on the market, when on the other side they are campaigning to limit the availability of vitamins, minerals and other nutrients?

Money? Double standard? I haven't been able to make sense of this...

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org

Judge James Moody, A federal judge in Tampa, Florida, ruled against plaintiff lawyers who sought to share internal documents belonging to Hoffman-LaRoche that show the company knew about the increased suicide risk associated with the acne drug, Accutane.

The company’s own safety experts had recommended in 1997 changing the US label to reflect the evidence that Accutaine “probably caused” depression and other psychiatric illnesses in some patients.”  USA Today reported (December 7, 2004) that Hoffman’s head of regulatory affairs testified in court that the marketing division argued that such a warning would “impact on marketing strategy and product liability.” The marketing division prevailed and no such warning was issued.  (see: http://www.ahrp.org/infomail/04/12/07.php)

Accutane is one of five drugs that FDA’s senior safety officer, Dr. David Graham, named in his Senate testimony as a possible candidate for withdrawal from marketing.

USA Today published a chronology of Accutane findings:

For example, in 1999, Roche told the FDA that none of the 168 reports of suicidal behavior can be directly linked to Accutane.

In 2000, during an FDA dermatology committee meeting, the agency confirmed that 147 suicides were linked to patients taking Accutane.

In 2002, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a congressional committee that the agency had received reports of 3,104 adverse psychiatric events involving Accutane and that the FDA knew of 173 suicide reports associated with Accutane.

Furthermore, USA Today reported that in 1988, Godfrey Oakley, director of the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control, wrote that "40 infants born alive after first trimester exposure to Accutane have died ... because of the developmental errors that Accutane caused." Oakley argued that "we simply need to remove the drug from the market."

In 2004, The Alliance for Human Research Protection asked Keith Altman, Adverse Drug Reaction Statistics Analyst, to analyze FDA's Medwatch database for drug-linked suicides by children under 18 years of age.

He found that between 1989 and June 2003, there were 216 reported drug-linked suicides in under 18 year olds. Of these, 72 suicides were linked to Accutane. The next highest number of suicides - 55—involved Prozac.

Since MedWatch reflects approximately 1% of actual adverse drug events, 72 Accutane suicide reports represent 7,200 suicides. And 55 Prozac-related suicide reports represent 5,500 suicides.

The judge indicated that attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. One wonders what standard the judge uses to determine when a drug hazard is “a matter of public safety?”

One also wonders why the FDA had failed to require disclosure to physicians that Accutane posed an increased suicide risk?

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org



Acne Drug Memos Kept Secret Despite Suits

January 28, 2005 8:49 PM EST

(go to original)

TAMPA, Fla. - Lawyers suing the makers of Accutane over allegations the acne drug increases the risk of suicide cannot share the company's internal memos and other documents with the public or federal regulators, a judge ruled Friday.

The attorneys had sought to make public as many as 1 million documents produced by Hoffman-La Roche Inc., saying the disclosure was needed as Accutane's safety comes under increased scrutiny by the U.S. Food and Drug Administration.

U.S. District Judge James Moody rejected the request, saying attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. But in a victory for the plaintiffs, he said the drug maker cannot redact documents before handing them over to the attorneys.

Moody, based in Tampa, is presiding over the management of dozens of lawsuits filed nationwide over Accutane, used by about 5 million Americans.

The drug, which has been dispensed in the United States since 1982, has been blamed for increased rates of suicide and gastrointestinal diseases in some users and birth defects in babies born to mothers who took Accutane.

Hoffman-La Roche contends the drug is safe, although it recommends that users be screened for depression. The company notes that teenagers and young adults, the groups most likely to use the drug, have higher suicide rates than the general population.

The documents at issue include internal company discussions about the safety of the drug and how to handle allegations of an increased suicide risk.

Hoffman-La Roche attorney Ed Moss said the company fought the release of the documents mostly out of concern for protecting Accutane's "recipe," and that federal officials already have internal documents relating to the drug's safety.

"We are not trying to hide documents from the public," Moss said. "We have given everything in the world to the FDA."

FDA scientist David Graham testified before Congress last year that Accutane was one of five dangerous drugs that should be restricted or removed from the market. In November, federal regulators toughened rules on Accutane, requiring doctors and pharmacists who dispense the drug to register patients on a central database.

Among the Accutane cases is a $70 million lawsuit brought by the mother and grandmother of Charles Bishop, the 15-year-old who stole a small airplane and crashed into a Tampa high rise in January 2002. His family blames his use of the drug for bringing on the dramatic suicide, but the company contends that he was a troubled young man and it is not to blame.

Hoffman-La Roche Inc., based in Nutley, N.J., is the United States prescription drug unit of the Swiss drug maker Roche Group.

See also:

Roche puts Accutane profits over Lives of Consumers
In 1985, Accutane's package insert directed at doctors first mentioned reports of depression in patients taking the acne drug, which means that more than 20 years ago, Hoffman-LaRoche at least suspected there might be a risk of depression and suicide by persons taking the drug.

However, Roche's financial records show that the company is not about to let a little thing like the death of its customers get in the way of corporate profits, because the drug is still a best seller and young people with no history of depression who take it are still killing themselves.

One Man's Quest to Uncover the Toxic Secrets Behind Accutane

FDA puts stricter controls on acne drug
By Ricardo Alonso-Zaldivar - Los Angeles Times
WASHINGTON — Federal regulators yesterday unveiled a high-tech system to restrict distribution of Accutane, an acne drug taken by thousands of Americans. The drug has been particularly effective against severe acne, but has long been known to cause birth defects and is now being studied for a possible connection to teenage suicides.

22 August 2005: FDA poses stricter regulations for the acne drug Accutane
It is hoped that birth defects and miscarriages associated with the skin care drug Accutane will decrease under tight new laws from the FDA.

Family blame acne drug for death
From BBC News - 20 September 2005: The family of a student who hanged himself have blamed a drug he was taking to treat acne. David Roberts, 21, had been taking Roaccutane for two months when he hanged himself near his Liverpool home. Coroner Andre Rebello recorded a narrative verdict and said there was not enough evidence to link the death with the drug. Roaccutane's manufacturer Roche insists there is no proven relationship between the drug and depression. However, Mr Roberts' father, Fred Roberts, said he could think of no other explanation for the tragedy.

Accutane - Another Case of Too Little Too Late
Accutane is prescribed to treat a type of severe acne called nodular acne which causes red, swollen, tender lumps to form under the skin. Accutane is supposed to be used only when all other treatments, including antibiotics, have failed. The treatment usually lasts 4 or 5 months, at a cost of about $3000, including lab tests and doctor's visits. The drug is manufactured by Roche Pharmaceuticals and is also marketed under the generic names Amnesteem, Claravis, Isotretinoin, and Sotret. The FDA estimates that about 100,000 prescriptions for the drug are written in the US each month. Accutane has