Here are some safety advisory and news for your speed update.

•    HSA Detected Excessive Levels of Pb in CPM
•    Finasteride & Risk of Male CA Breast cancer
•    US FDA Warning on Propylthiouracil - Hepatic Damage
•   US FDA Warning on Clopidogrel - Lower Effectiveness in Some People
 

•    HSA Detected Excessive Levels of Pb in CPM
The HSA has detected excessive levels of lead in a batch of Chinese Proprietary Medicine (CPM) labelled “Zhongya Brand Tzepao Sanpien Pill” (????????) during HSA's regular product quality sampling checks for marketed health products. Lead, when consumed in large amounts or over a prolonged period of time, may result in lead toxicity and the symptoms may include abdominal pain, vomiting, muscle weakness and cramps. For more info, click here .




•    Finasteride & Risk of Male CA Breast cancer
HSA would like to bring to the attention of healthcare professionals the potential risk of male breast cancer associated with finasteride. In December 2009, the UK MHRA completed a review of data from clinical trials and post-marketing reports on the risk of breast cancer in men taking different strengths of finasteride for various medical conditions, and concluded that an increased risk of male breast cancer associated with finasteride use cannot be excluded. Healthcare professionals are advised to inform their patients taking finasteride to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge to their doctors. For full story, click here .

•    US FDA Warning on Propylthiouracil - Hepatic Damage
FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication.
FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with proplythiouracil when compared to methimazole. FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil use. Although both proplythiouracil and methimazole are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on propylthiouracil therapy for symptoms and signs of liver injury,  especially during the first six months after initiation of therapy. Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available. For more info, visit FDA website.

•   US FDA Warning on Clopidogrel - Lower Effectiveness in Some People
A boxed warning has been added to the drug label for Plavix (clopidogrel), an anti-blood-clotting medication.
Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and heart-related death in people with disease of the heart or blood vessels (cardiovascular disease). Some people do not convert Plavix to its active form as well as other people. These “poor metabolizers” may not get the same benefit from Plavix. The boxed warning will include information to
•    warn about reduced effectiveness in people who are poor metabolizers of Plavix.
•    inform health care professionals that tests are available to identify genetic differences that may identify poor metabolizers of Plavix.
•    advise health care professionals to consider using other anti-platelet medications or different dosing for Plavix in people identified as poor metabolizers.
Recommendations:
•    Do not stop taking Plavix unless told to by your health care professional.
•    Talk to your health care professional if you have any concerns about Plavix or to find out if you should be tested for being a poor metabolizer.
For more information, see here.

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