Pharmaceutical News: Pharmaceutical company recalls high blood pressure drugs over dangerous labelling mix-up

Pharmaceutical company recalls high blood pressure drugs over dangerous labelling mix-up

A pharmaceutical company has launched a voluntary recall of a drug which may have been mislabelled — with possible “life-threatening” consequences for patients with high blood pressure, says Health Canada.

Following a complaint by a pharmacist regarding a prescription product containing the wrong medication, Mylan Pharmaceuticals is recalling one lot of Mylan-Minocycline 50 mg capsules and Mylan-Amlodipine 5 mg tablets, both sold in bottles of 100.

The risk, says Health Canada, is that patients sensitive to tetracyclines or minocycline may be taking minocycline in error, due to mislabelled bottles.

“In addition, a patient who requires MYLAN-AMLODIPINE for their high blood pressure or angina will not get the medication needed to help them treat these conditions,” said a Health Canada statement.

Mylan-Amlodipine is used to treat high blood pressure and chest pains. Mylan-Minocycline is used to treat certain types of skin infections, urinary tract infections, gallbladder infections, and respiratory tract infections such as bronchitis, pneumonia, and sinusitis.

According to Mylan Pharmaceuticals, the company was contacted in mid-March by a pharmacist who reported that she had ordered four 100-count bottles of Mylan-Minocycline and received one bottle labelled as Mylan-Amlodipine which actually contained Mylan-Minocycline tablets.

The company says its quality investigation, which is ongoing, revealed a labelling error in which the labels for the Mylan-Amlodipine 5 mg tablets were mixed in with labels for the Mylan-Minocycline 50 mg capsules.

The company is advising pharmacists and wholesalers to return all quantities of lot number 1037180 to Mylan Pharmaceuticals.

Health Canada urges consumers to contact their doctors of pharmacists with any questions, and to contact Health Canada to report any adverse reactions possibly linked to the drugs.

Cortex Pharmaceuticals (CORX.OB) Shares Surge on Q4, FY2010 Results, Recent Business Highlights

Cortex Pharmaceuticals Inc., a neuroscience company focused on novel drug therapies for treating psychiatric disorders, neurological diseases and sleep apnea, surged more than 21% to close at $0.15 today after the company announced its fourth-quarter and year-end results for 2010.

The company reported a net loss applicable to common stock of $(984,000), or $(0.01) per share for the quarter ended December 31, 2010, compared with a net loss of $(1.59 million), or $(0.02) per share for the corresponding prior year period. For the fiscal year ended December 31, 2010, Cortex reported net income applicable to common stock of $(1.62 million), or $(0.02) per share, compared to a net loss of $(10.78 million), or $(0.19) per share, for the corresponding prior year period.

For the year ended December 31, 2010, operating results reflect revenues from the Company’s earlier transaction with Biovail Laboratories International SRL in March 2010 when Cortex sold its rights to CX717 and certain other AMPAKINE® compounds to Biovail as a potential treatment for respiratory depression and vaso-occlusive crises associated with sickle cell disease, an orphan drug indication. Cortex received $10 million from Biovail during 2010.

For the year ended December 31, 2009, the net loss applicable to common stock includes non-cash charges of approximately $(2.34 million), or $(0.04) per share, related to the beneficial conversion feature of preferred stock issued by the company in April 2009 and July 2009.

The company also noted recent business highlights, including top-line results from an exploratory clinical study with AMPAKINE CX1739 in subjects with sleep apnea.

Cortex also announced it received word from Servier, France’s largest privately held pharmaceutical company, of its intent to move forward into phase I clinical studies with the jointly-discovered High Impact AMPAKINE S47445 (CX1632).

The company also noted that it regained worldwide rights to develop and commercialize AMPAKINE compounds for the treatment of schizophrenia and depression; obtained exclusive worldwide rights from the University of California for the combination of AMPAKINE and mGluR5 compounds for the treatment of various conditions; and received a grant from The Michael J. Fox Foundation for Parkinson’s Research to test selected compounds from the AMPAKINE platform for their ability to restore brain function in animal models of Parkinson’s disease.

New CEO of pharmaceutical giant Omnicare promising turnaround

The new CEO of Cincinnati-area pharmaceutical supply giant Omnicare Inc. says he’s ready to put the company back on a growth track and reduce its hefty losses, the Cincinnati Enquirer reports.

John Figueroa took control of Covington, Ky.-based Omnicare (NYSE:OCR) three months ago after its former chief abruptly retired in July. By 2013, he said he’s hoping the company is pulling in double-digit earnings growth as it diversifies and shifts away from practices that contributed to a more than $100 million loss in 2010, the paper reported.

Figueroa acknowledged that officials on both sides of the Ohio River are negotiating as the company looks to consolidate its 700 employees in four regional offices. Omnicare is committed, however, to staying in the Cincinnati region, he said.

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