Health Canada Issues Somavert WarningJun 11, 2008 | Parker Waichman LLP
Canadian regulatory authorities have warned that Somavert, a drug used to treat a life-threatening hormonal disorder, has been linked to liver problems when it is used in conjunction with octreotide acetate.
Somavert, made by Pfizer Inc., is used to treat acromegaly. Acromegaly is a hormonal disorder that results from too much growth hormone in the body. Acromegaly is most often diagnosed in middle-aged adults, although symptoms can appear at any age. If not treated, acromegaly can result in serious illness and premature death. The most serious health consequences of acromegaly are type 2 diabetes, high blood pressure, increased risk of cardiovascular disease, and arthritis. Patients with acromegaly are also at increased risk for colon polyps, which may develop into colon cancer if not removed.
Somavert is a manufactured protein similar to human growth hormone (GH). Somavert binds to the same receptor in the body as growth hormone, and blocks the effects of growth hormone. Somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy, and other medical therapies, or for whom these therapies are not appropriate. Octreotide acetate is another type of medicine from a group of drugs called somatostatin analogues, which are also used to treat acromegaly. Health Canada has not approved the combination of Somavert and somatostatin analogues for the treatment of acromegaly because the safety and efficacy of this combination have not been established.
According to Health Canada, 3 out of 26 patients treated with a combination of Somavert and octreotide acetate had much higher than normal liver test results. Two of these patients received higher doses than usually recommended of octreotide acetate (30 mg every 2 weeks) combined with a normal dose of Somavert (10 mg daily). All three patients completely recovered once both drugs were stopped. Studies published in medical journals found similar results using normal doses of somatostatin analogues.
Health Canada advised physicians to request that blood tests be done before starting treatment with Somavert and regularly during the course of treatment to check how patients are responding to their medicine, to change the dose if necessary and to check for liver problems.
Patients should contact their doctor immediately if they notice sudden yellowing of the skin or whites of the eyes, or darkening of the urine, as well as unexplained fatigue, nausea, vomiting, loss of appetite or pain in the stomach area.