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Entries in GlaxoSmithKline (4)

Thursday
Mar172011

Pursuit of Better Hairline Costs Some Men Their Sex Lives 

Bananastock/Getty(WASHINGTON) -- The baldness drug finasteride has left some young, otherwise healthy men with persistent impotence, diminished sex drive and depression long after they've stopped taking it, according to emerging medical studies and patient reports, as well as lawsuits filed in the United States and Canada.

Millions of men have taken five-mg finasteride tablets since the U.S. Food and Drug Administration in 1992 approved Merck and Co. Inc's Proscar for non-cancerous enlargement of the prostate gland. Millions more have taken finasteride since FDA's 1997 approval of Propecia, Merck's lower-dose (one mg) formulation for male-pattern baldness, which affects about half of all men.

In 2002, the FDA approved GlaxoSmithKline's closely related drug dutasteride (Avodart) to shrink enlarged prostates, further expanding the market for name-brand and generic 5-alpha reductase inhibitors. The drugs block an enzyme that converts the male sex hormone testosterone to dihydrotestosterone, which is toxic to hair follicles, but important for healthy sexual functioning.

Although the generally rare sexual side effects of finasteride and dutasteride have been mentioned at urology meetings, information about potentially irreversible consequences hasn't yet reached the larger community of prescribing physicians, such as dermatologists and primary care doctors -- or their patients, said researcher Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine.

For an article published in the March issue of the Journal of Sexual Medicine, Traish and a BU colleague, along with endocrinologists from Peabody, Mass.; Germany and Norway, reviewed available scientific studies on the adverse effects of finasteride and dutasteride. Although the overall percentage of men reporting sexual side effects was small, ranging from 5 percent to 23 percent, Traish said half of them never had their side effects go away.

"We found out that we're really ignoring the important part, especially those in whom the problem becomes persistent," Traish said in an interview Wednesday. "That's the group that everybody forgot. We have to worry about the consequences for people who are going to suffer -- even after they discontinue the drug -- from continuous loss of libido and potential depression." Other observed effects included reduced ejaculation and smaller volume of semen.

Copyright 2011 ABC News Radio

Wednesday
Feb022011

Man Sues Drug Maker Over Gambling, Gay Sex Addiction

Photo Courtesy - Getty Images(NANTES, France) -- Didier Jambart, 51, of Nantes, France, is suing the British pharmaceutical company GlaxoSmithKline, claiming the drug he took to treat his Parkinson's symptoms, Requip, turned him into a gambling and gay sex addict.

The married father of two said he blew through his family's savings and even took to stealing to finance his online gambling habit, the French Press Agency reported.  He also became addicted to gay sex and risky sexual encounters that led to him being raped, his lawyers said.

Parkinson's disease destroys neurons deep within the brain that release the "feel-good" neurotransmitter dopamine.  Requip belongs to a class of drugs called dopamine agonists that relieve motor symptoms, such as shaking, stiffness, slowness and trouble balancing, by activating dopamine receptors.  But the drugs have side effects that, while rare, are serious.

"There are plenty of reports of people developing side effects from Parkinson's drugs, such as hypersexuality, gambling and excessive shopping," said Dr. David Standaert, professor and interim chairman of neurology and director of the Center for Neurodegeneration and Experimental Therapeutics at the University of Alabama at Birmingham.  "It's uncommon, but very dramatic when it happens."

It's estimated that 13.6 percent of people with Parkinson's disease who take dopamine agonists experience behavioral side effects, according to Dr. Mark Stacy, a neurologist at Duke University Medical Center, who first linked the drugs to gambling in 2000.

Copyright 2011 ABC News Radio

Thursday
Nov112010

Former GSK Lawyer Charged in Wellbutrin Cover-Up

Photo Courtesy of Getty Images(WASHINGTON) -- The U.S. Department of Justice has charged a former vice president and lawyer at GlaxoSmithKline with trying to cover up evidence that the company was illegally marketing the depression drug Wellbutrin as a weight-loss aid, reports MedPage Today.

Lauren Stevens of Durham, N.C. was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the FDA, according to the FDA.

The indictment doesn't name the company or the drug, but a lawyer for Stevens confirmed to The Wall Street Journal that Stevens was a vice president at GlaxoSmithKline and that the indictment relates to Wellbutrin and an ongoing investigation into the company marketing the depression drug to treat weight loss -- a health issue for which it is not approved.

A spokeswoman for GlaxoSmithKline confirmed that Stevens was employed in the company's legal department and that she is now retired.

Copyright 2010 ABC News Radio

Thursday
Sep232010

Diabetes Drug Will Be Restricted Due to Heart Risk Concerns

Photo Courtesy - ABC News(NEW YORK) -- The U.S. Food and Drug Administration announced Thursday it will significantly restrict the use of the diabetes drug rosiglitizone, popularly known as Avandia, after subsequent reviews of the drug suggest a higher risk of heart attack.  The FDA will require stringent monitoring requirements for the drug's manufacturer, GlaxoSmithKline, under the agency's Risk Evaluation and Mitigation Strategies.  Under the new restrictions, patients currently taking Avandia will be able to continue doing so, but will have to sign a consent form stating they understand the potential risks involved.  "Patients will only be allowed to use [Avandia] if they acknowledge and document the risk of this drug," said Dr. Joshua Sharfstein, FDA principal deputy commissioner.  Doctors may only consider prescribing Avandia to patients if they have exhausted all other medications, including the drug's market competitor, Actos.

Copyright 2010 ABC News Radio







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