Accutane Lawsuit
From Pharmacy Drug Guide
Accutane is the brand name for Hoffmann-LaRoche's oral isotretinoin. Approved by the FDA in the 1980s, the prescription drug was very effective in treating severe nodular acne that did not respond to other treatments, including antibiotics.[1]
From a class of drugs called retinoids, Accutane works by blocking production of oil in the patient's skin. Manufacturer Hoffmann-LaRoche withdrew brand-name Accutane from the market in the United States and some other countries in 2009.[2]
Rather than addressing lawsuits charging that Accutane had caused serious side effects, the firm noted that the withdrawal was in response to competition from generic isotretinoin, marketed since 2002. Isotretinoin is manufactured by Barr Laboratories Inc.; Genpharm, Inc.; Mylan Pharmaceuticals, Inc.; and Ranbaxy Laboratories, Inc.[2]
 Flikr:Saluda UdeA | |
| Brand name for | Isotretinoin |
|---|---|
| Manufacturer | Hoffmann-LaRoche, Inc. |
| Prescribed for | Severe nodular acne that does not respond to other treatment |
| Complications | Birth defects, psychiatric disorders, inflammatory bowel disease, loss of bone density[3][4] |
| Warnings | Must not be used in pregnancy; women of reproductive age must use two forms of birth control[1] |
| Recall Date | Withdrawn from U.S. market in 2009; still available in other countries and as generic[5][2] |
| Class Action Lawsuit Filed | None filed to date[2] |
| Disclaimer | The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician. |
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Accutane Side Effects
Accutane/isotretinoin causes severe side effects. The potential for fetal damage or miscarriage is so well known that a group called iPLEDGE was formed to help ensure that Accutane users do not conceive. Neither Accutane nor generic isotretinoin can be prescribed by anyone other than a iPLEDGE-trained physician, and the drug can only be administered by iPLEDGE-trained pharmacists. All Accutane users must also join iPLEDGE and sign a strenuous consent form agreeing not to become pregnant or to breastfeed an infant during therapy and for a time after the medication is stopped.[1]
Other side effects that do not involve pregnancy have led to successful lawsuits against the manufacturer, especially the development of inflammatory bowel disease, or IBD, after taking Accutane.[2] Complainants have noted that the manufacturer knew of a link between IBD and Accutane for nearly 30 years but did not do enough to warn patients of the potential.[5]
Accutane Settlements and Class Action Lawsuit
According to the online pharmaceutical database DrugWatch.com, some lawsuit settlements have favored the plaintiffs, with millions of dollars in judgments for pain and suffering with inflammatory bowel disease.[5]
While plaintiffs have filed hundreds of lawsuits against Roche Pharmaceuticals, claiming harm from Accutane, there has been no class action suit filed to date.[5]
Accutane Warnings and Recalls
- Generic isotretinoin is still available in the US, abroad, and online. Experts strongly advise that patients only take isotretinoin as prescribed for them by a specialist, purchasing the drug from trusted sources.[6] Refills require a new prescription.
- Women who might become pregnant must take regular pregnancy tests and use two forms of birth control while they are on Accutane or isotretinoin.[1]
- Isotretinoin can appear in the sperm of males, potentially causing fetal harm.[1]
- Isotretinoin contains parabens, which may cause allergies in some patients.[1]
- Accutane can cause users to become more sensitive to sunlight. Therefore, patients using the drug are advised to protect their skin with clothing ir sunscreen, and to avoid exposure to the sun or to sun lamps.[1]
- Accutane can reduce the ability to see in dark lighting. This can continue even after the patient stops taking the drug, and can affect the ability to safely operate a motor vehicle at night.[1]
- Accutane can cause damage to the bones, causing them to thicken or become weak. This may increase the risk of breakage or other injury during physical activity. Accutane patients are advised to discuss any sports or exercise with their physicians.[1]
- In 2005, the FDA warned of psychiatric side effects, including suicidal ideas and activities.[6]
Drug Side Effects
Also See: Accutane Side Effects, Accutane and Pregnancy, Vioxx Lawsuit, Fosamax Lawsuit, Pristiq
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References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 http://www.nlm.nih.gov/medlineplus/druginfo/meds/a681043.html#why
- ↑ 2.0 2.1 2.2 2.3 2.4 http://www.rocheusa.com/portal/synergy/static/file/synergy/alfproxy/download/1414-cd2ddc12b4d211deadd62f6357bc6b3c/last/roche
- ↑ http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=15484#BMD
- ↑ http://www.drugwatch.com/lawsuit/
- ↑ 5.0 5.1 5.2 5.3 http://www.drugwatch.com/accutane/recall.php
- ↑ 6.0 6.1 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm
