Accutane Linked To Birth Defects

Accutane has been known potential to cause birth defects when used by women before or during pregnancy. Accutane has now been potentially linked to depression, mood disorders, or suicide. If you or anyone you care about has used or is using accutane they may be at risk for these side effects. If you or anyone you care about has experienced these side effects you may have a claim for damages against the makers of the drug. Please feel free to contact us to discuss your potential claim. For more information we are including these two recent articles from Rueters on some of the latest up to date information on accutane.

Accutane May Be Linked to Birth Defects

GAITHERSBURG, Md. (Reuters) - U.S. officials should restrict use of the prescription acne drug Accutane to reduce the number of women taking it who become pregnant and risk birth defects, an advisory panel said Monday.

Accutane, made by Roche Holding Ltd. Hoffmann-La Roche unit, has been on the U.S. market for nearly two decades and has a widely-known potential to cause birth defects.

Despite extensive efforts by the Food and Drug Administration and the manufacturer, researchers record scores of pregnancies among Accutane users each year.

To reduce those numbers, the FDA panel recommended that the agency limit prescribing privileges to doctors who join a registry and follow steps to help women avoid pregnancy.

That would include distributing educational pamphlets, obtaining patient signatures on consent forms and affirming that women prescribed Accutane have had negative pregnancy tests.

Under the panel recommendations, patients also would have to join a registry and pledge that they knew of Accutane's risks and the need to use birth control. The FDA usually follows its panels' advice.

Prescriptions for Accutane, which is Roche's number-two selling product, have risen in the past several years. About half of users are women, and most of the female patients are in their child-bearing years.

About 1 in 4 fetuses exposed to Accutane have some type of deformity, including heart, central nervous system and facial defects, researchers estimate.

FDA officials said evidence showed that warnings to date, which have included several letters to doctors over the years, have not been effective enough and new measures were needed.

"In this case, education alone has not done the job," said the FDA's Dr. Amarilys Vega.

But because the drug is the only highly effective treatment for some cases of severe acne, regulators, dermatologists and the manufacturer want to keep it on the market with the goal of eliminating any pregnancies.

In addition to reducing pregnancies, the measures the panel supported aim to help regulators tally the number of Accutane users who become pregnant. Currently, researchers only track a portion of women who take Accutane.

A study by Boston University's Slone Epidemiology Unit, which has tracked about 350,000 female Accutane users for Roche, found 1,019 pregnancies since 1989. That amounted to about 2.8 pregnancies per 1,000 Accutane users.

Nearly all women surveyed said they were aware that Accutane causes birth defects. Among those that got pregnant, they reported that their contraception failed or they did not always use it properly.

Now, Accutane comes with a two-and-a-half-page warning about the risks of pregnancy. In addition, Roche also provides doctors with consent forms and pamphlets explaining birth defect risks, a video and other materials about birth control and urine pregnancy tests. Many of those measures were put in place in 1988.

Doctors are not required to use the materials, however, and the Slone survey found that not all of the measures were being used.

In the study, 23 percent of women did not report signing a consent form and 25 percent did not report having a pregnancy test before starting Accutane treatment.

But Roche, as well as the leading U.S. dermatologists' association, warned that placing restrictions on Accutane could drive people to unauthorized sources, such as Internet pharmacies, that would not provide extensive warnings about birth defect risks.

Mandatory programs the FDA is considering "are still untested. There are unknown benefits and unquantifiable risks," said Roche vice president Russell Ellison.

The company said it would meet with FDA officials to discuss the panel recommendations but said it believed new restrictions were unnecessary.

Tuesday, the panel is set to review psychological side effects that may be associated with Accutane and a new formulation of the drug.

Accutane may be linked to mood disorders,depression or suicide

GAITHERSBURG, Md., Sept. 19 (Reuters) - A federal advisory panel Tuesday recommended further study to shed light on whether some psychiatric problems may be linked to Roche Holding Ltd.'s (ROCZg.S) prescription acne drug Accutane.

Patients and physicians also could benefit from new efforts to make them aware that Accutane may be linked to cases of depression, mood disorders or suicide, panel members said. Some suggested a plain-English pamphlet attached to Accutane bottles explaining signs of depression or other problems.

Since 1998, Accutane has come with a warning that users have reported depression, suicidal thoughts or mood disorders. But the label notes that the link is uncertain.

Neither the Food and Drug Administration nor Roche could provide evidence settling the question of whether there is a certain connection. A large number of patients taking Accutane are teenagers, a group already commonly affected by depression.

The data "suggest an association with Accutane but do not allow a definitive determination," said Diane Wysowski of the FDA.

Accutane, made by Roche unit Hoffmann-La Roche Inc., has been sold in the United States for nearly two decades and is widely known to cause birth defects. On Monday, the advisory panel urged health officials to limit prescriptions for Accutane in order to minimize pregnancies among women treated with the drug.

The panel, a group of outside experts that advises the FDA, said evidence of psychiatric side effects were much less certain and did not require such extensive measures.

Further study might provide clues, particularly by providing signs of whether particular Accutane patients are more at risk for psychiatric effects, panel members said.

Also, a federally approved medication guide that gives consumer-friendly information about depression could help patients recognize signs and adjust doses or discontinue treatment if necessary, panel members said. The committee also recommended additional efforts advising doctors to inform patients of and be aware of signs of depression.

The FDA usually follows its panels' advice.

Roche vice president Russell Ellison agreed that data on side effects was difficult to evaluate but told the panel "evidence does not support a causal link" between the drug and psychiatric problems.

The company will discuss whether new studies would yield helpful information, Ellison said after the meeting.

Roche also presented data on a new once-a-day formulation of Accutane, Roche's second-best-selling product, that can be taken with or without food. Directions for the current version of Accutane are for twice-a-day with food.

Roche said the new formulation may be more convenient for patients. The FDA is considering whether to approve the newer version, but the agency did not ask the panel's input on whether it should go to market.

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