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FDA warns public on fake muscle relaxant

By: - Reporter / @mj_uyINQ
/ 07:16 PM August 16, 2015

The Food and Drug Administration (FDA) has warned the public against the possible presence in the local market of a counterfeit muscle relaxant drug that has caused the hospitalization of more than 400 people in Central Africa.

In an advisory, the FDA said the World Health Organization recently issued a medical product alert on the adverse reactions caused by the following fake Diazepam tablets in Central Africa:  Diazepam BP 5 mg tablet (Solina) with Batch No. SBG038 and manufacturing and expiry dates Sept. 2014 and August 2017, respectively; and Diazepam BP 5mg tablet (Diazepam Tablets) with Batch No. 2332 and manufacturing and expiry dates Nov. 2013 and Oct. 2016, respectively.

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“The said products have caused acute dystonic reaction (involuntary muscle contractions) affecting the muscles of the face, neck and tongue to over 400 patients in the north east region of Congo,” said the FDA bulletin signed by Health Secretary Janette Garin, also acting general of the regulatory agency.

The reaction lasted for three to four days without treatment but some cases were recurring and have resulted in a maximum of 40 hospital admissions per week, said the advisory.

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Garin warned health care professionals and the public in general to be vigilant against the counterfeit drugs that might have reached the Philippine market.

“The presence of these products poses danger or injury to the consuming public and the importation, selling or offering for sale of such is in direct violation of the Food and Drug Administration Act of 2009 and the Special Law on Counterfeit Drugs,” she said.

She also directed all FDA field regulatory officers to seize these counterfeit drugs found in the market and urged local government units and law enforcement agencies to ensure that these products would not be sold or offered for sale in their areas of jurisdiction.

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TAGS: acute dystonic reaction, Central Africa, Counterfeit Drugs, counterfeit muscle relaxant, Crime, Department of Health, Diazepam, FDA, Food and Drug Administration, Food and Drug Administration Act of 2009, Health, hospitalization, involuntary muscle contraction, Janette Garin, Medicines, muscle relaxant, news, pharmaceutical drugs, public advisory, Special Law on Counterfeit Drugs, violation of laws, World Health Organization
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