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New Delhi: Drug maker Ranbaxy Laboratories Ltd is withdrawing a single batch of a version of Roche Holding AG’s Accutane acne medicine from the US market for the second time this year.

Gurgaon-based Ranbaxy voluntarily recalled 40 mg capsules of isotretinoin, the chemical ingredient in Accutane, the company said in a statement on Friday. “A single batch was withdrawn from the US market earlier this year,” Atul Sobti, chief executive officer, said in a July investor call.

Roche, based in Basel, Switzerland, said in June that it was pulling Accutane from the US market because of competition from generic versions. The decision came after juries awarded at least $33 million (around Rs155 crore) in damages to users who blamed the drug for causing bowel disease.

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More common accutane side effects may include:
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Some people taking Accutane have had problems regulating their blood sugar level.
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- You may participate in a program that includes an initial free pregnancy test and birth control counseling session;

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You should not donate blood during your therapy with Accutane and for a month after you stop taking it.
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- You must test negative for pregnancy within 2 weeks before starting Accutane, and you must start Accutane on the second or third day of your menstrual period;
- Accutane is a powerful, "last resort'' medication for severe acne;
- You have been invited to participate in a survey of women being treated with Accutane.

- You have read and understood the Accutane patient brochure and asked your doctor any questions you had;
Some people taking Accutane, including some who simultaneously took tetracycline, have experienced headache, nausea, and visual disturbances caused by increased pressure within the skull. See a doctor immediately if you have these symptoms; if the doctor finds swelling of the optic nerve at the back of your eye, you must stop taking Accutane at once and see a neurologist for further care.
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- You are not currently pregnant and do not plan to become pregnant for at least 30 days after you finish taking Accutane; |

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- If you become pregnant, you must immediately stop taking Accutane and see your doctor;
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Special warnings about this medication:
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- If you take Accutane, you must use effective birth control from 1 month before the start of treatment through 1 month after the end of treatment;
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Less common accutane side effects may include:


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When you first start taking Accutane, it is possible that your acne will get worse before it starts to get better.
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- You must not take Accutane if you are pregnant or may become pregnant during treatment;
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You should stop taking Accutane immediately if you have abdominal pain, bleeding from the rectum, or severe diarrhea. You may have an inflammatory disease of the bowel.
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You may not be able to tolerate your contact lenses during and after your therapy with Accutane.
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If you are a woman of childbearing age and you are considering taking Accutane, you will be given both spoken and written warnings about the importance of avoiding pregnancy during the treatment. You will be asked to sign a consent form noting that:
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Because Accutane can cause severe birth defects, including mental retardation and physical malformations, a woman must not become pregnant while taking it. If you are a woman of childbearing age, your doctor will ask you to sign a detailed consent form before you start taking Accutane. If you accidentally become pregnant while taking the medication, you should immediately consult your doctor.
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- If you get pregnant while taking Accutane, your baby will be at high risk for birth defects;
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Bowel inflammation and pain, chest pain, decreased night vision, decreased tolerance to contact lenses, delay in wound healing, depression, fatigue, headache, nausea, peeling palms or soles, rash, skin infections, stomach and intestinal discomfort, sunburn-sensitive skin, thinning hair, urinary discomfort, vision problems, vomiting
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Be careful driving at night. Some people have experienced a sudden decrease in night vision.