![]() loss of consciousness (not being able to respond to sound or touch).Rhabdomyolysis (breakdown of muscles).jaundice (yellowing of the skin or whites of your eyes).swelling in your abdomen, ankles, or legs.Liver problems, such as elevated levels of liver enzymes (proteins).Serious side effects and their symptoms can include: ![]() Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. ![]() Call your doctor right away if you have serious side effects. Serious side effects from Zocor aren’t common, but they can occur. † For more information on this side effect, see “Side effect details” below. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Zocor’s prescribing information. * This is a partial list of mild side effects from Zocor. But if they become more severe or don’t go away, talk with your doctor or pharmacist. Most of these side effects may go away within a few days or a couple of weeks. upper respiratory infection, † such as bronchitis and sinusitis.gastritis (swelling of the stomach lining).If you would like to report to the FDA a side effect you’ve had with Zocor, you can do so through MedWatch. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. They can give you tips on how to deal with any side effects that may be bothersome. These lists don’t include all possible side effects.įor more information on the possible side effects of Zocor, talk with your doctor or pharmacist. The following lists contain some of the key side effects that may occur while taking Zocor. The US Food and Drug Adminsitration is considering whether statins should be made available OTC.Zocor can cause mild or serious side effects. Sir Charles George, medical director of the British Heart Foundation said he is confident OTC statins will save lives. “OTC statins give otherwise healthy consumers the opportunity to take proactive steps to reduce their risk of a heart attack,” says the company spokesperson. says the National Health Service does not have unlimited resources and must prioritize whom it treats. “If it works as well as is being claimed, then why is it only being made available to those who can afford it?” Iheanacho asked. Zocor Heart-Pro costs £170.00 (Can$402) annually. The medication is also contraindicated if taken with certain other drugs.ĭTB also criticized the move on the basis of cost. While simvastatin has a good safety profile, myopathy, rhabdomyolysis and hepatic reactions are rare but severe side effects. The Royal College of General Practitioners says that without stricter rules, consumers may be sold medication they don't need. “Some could be wrongly classed and treated as being at only moderate risk of a heart attack, when in reality their risk is very much higher,” states DTB. Pharmacists rely on gender, age and self-reported risk factors before deciding whether to sell patients the drug. “To advocate a new controlled clinical study with the precise dose and population selected for self-medication is not supportable ethically, since the result is completely predictable on the basis of the existing body of evidence,” said a spokesperson for McNeil Ltd., a subsidiary of Johnson & Johnson MSD, the manufacturer of simvastatin.ĭTB says that claim may be too optimistic because it is based on studies of people who already had coronary heart disease.ĭTB also says the OTC protocol used to assess risk is flawed. ![]() The regulatory agency acknowledges there have been no trials of simvastatin 10-mg in the target population, but says there is good evidence it will reduce the risk of a coronary event by a third after 3 years' use. “People are, in effect, being used as guinea pigs for such treatment, and being charged for the privilege,” says Dr. In reviewing the change to OTC status, the DTB states that the lack of long-term efficacy trials to support the regulator's rationale is “alarming.” Simvastatin is available without a prescription but requires consultation with a pharmacist. Patients targeted are those at a 10% to 15% risk of an event in 10 years. The regulatory agency made the move to improve access to a medication that reduces the risk of a first major coronary event in people at moderate risk of coronary artery disease. The Medicines and Healthcare products regulatory Agency reclassified simvastatin (Zocor Heart-Pro) from prescription-only to OTC status for a 10-mg dosage in July 2004.
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