Dangers of Accutane + Alternatives

I was on accutane, and i was very depressed and suicidal while on it. Please read about the dangers in accutane, the corruption in getting the drug approved through the FDA, and the mislabeling. Dermatologists, like all doctors, get pursuaded by "drug reps" (see www.sideeffectsthemovie.com, http://www.newstarget.com/z008291.html, http://www.drug-companies.net) and financially benefit from overprescribing certain drugs.

"Once on Accutane, BJ ccomplained of sore joints and headaches. The dermatologist said this was a normal side effect of the drug and to make sure BJ took his Accutane with a meal. BJ died on Mother's Day, May 14, 2000, at the age of 17, from a self inflicted gunshot wound.

I wondered why were we not told about the risk of depression or suicide? Why didn't BJ's patient pamphlet mention anything about possible depression, suicide ideation or suicide? More important, why weren't these warnings on BJ's Accutane package?"

-Congressman Bart Stupak

Opening Statement

12/11/2002

"Safety Issues Surrounding Accutane" (http://www.house.gov/stupak/accutanestate.htm)

http://www.accutane-side-effects.net

Accutane is Roche's number one selling product, with an estimated 5 million Americans using the acne medication since 1982.

Accutane has been linked to at least 240 suicides

The FDA concluded Roche had not acted in good faith when relating information regarding Accutane use in pregnant women. Roche knew about Accutane side effects while failing to fully disclose the dangers to the FDA, physicians, and patients.

Accutane causes severe birth defects and even fetal death and the FDA concluded Roche did not adequately communicate the dangers to women using Accutane.

Roche knew about the birth defects that could occur with Accutane and pregnant women years before ever getting the 1982 FDA approval. Despite this knowledge, the FDA and Roche SMART program aimed at preventing fetal death and birth defects in women using Accutane was not implemented until 2000. The SMART program was developed only after a 1998 FDA memo recommended "active consideration of removal of Accutane from the market."

Now Accutane is also linked to an increased occurrence of inflammatory bowel disease and lupus

Roche disregarded its internal doctor's recommendation that users of the drug are monitored for signs of depression and that a warning indicating this is added to the label because "such Accutane warnings could cost the firm sales or prompt lawsuits."

Roche's global head of drug safety, Martin Huber, testified in a pretrial deposition for a Florida case that the firm's internal analysis showed Accutane "probably caused" depression and other psychiatric illnesses in some patients, according to the court file summary of his deposition.

According to the summary of Zabrowski's deposition testimony, Schifferdecker wrote a report recommending changes in Accutane's U.S. label and core data sheet, the internal company document used by Roche to ensure consistency of the firm's products worldwide.

Legal summaries of depositions by Roche's global head of drug regulatory affairs, Daniel Zabrowski, as well as other Roche officials, show that a company doctor, Peter Schifferdecker, who studied the drug's links to depression at the Corporate headquarter is Switzerland in 1997, recommended Accutane's U.S. label warn users "should be supervised for signs of depression during therapy and, if necessary, referred for appropriate treatment."

Zabrowski testified Roche's marketing division was worried the monitoring warning on Accutane's U.S. label could hurt sales. Medical consultants in the marketing department revised Schifferdecker's report to remove the reference to monitoring, which was then sent to the FDA for approval

Currently, Roche is the target of about 70 lawsuits for allegations of adverse reactions because of Accutane. Plaintiffs claim Accutane adverse effects include suicides, depression, birth defects and gastrointestinal injuries.

Around 90 percent all Accutane patients are considered to have mild acne and should have been using an alternate treatment.

Roche was issued a warning letter after the FDA found the Accutane promotional advertisements to contain "false and misleading" information.

At the December 11, 2002 House Oversight and Investigation Subcommittee Hearing on Safety Issues Relating to Accutane, Congressman Peter Deutsch told Roche North American president and CEO, George Abercrombie that, "what you just said is not a truthful statement" when he claimed the company did try to make consumers aware that Accutane is specifically intended to treat severe acne.

Natural Accutane Alternatives

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