Experts perplexed over why Sharapova was taking banned heart drug

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Sponsors Begin to Drop Maria Sharapova

The medicine Maria Sharapova says she has taken for 10 years due to a family history of heart issues and diabetes is an old drug sold in just a few Eastern European countries that can also boost exercise tolerance.

The tennis star tested positive for the banned drug meldonium, or Mildronate, in a sample taken on January 26, the day of her Australian Open quarter finals defeat to Serena Williams.

She said her family doctor had first given her the drug 10 years ago after she frequently became sick, had irregular electrocardiogram results, a magnesium deficiency and a family history of diabetes.

The 28-year old Russian, a five-time grand slam champion and the highest paid woman in sports, will be provisionally suspended starting March 12, the International Tennis Federation (ITF) said.

For the health conditions Sharapova says she has, however, doctors say the scientific evidence for Mildronate is limited compared with many medicines widely available in Europe and the United States, where Sharapova trains, which have full regulatory backing and years of robust safety and efficacy data.

LATVIAN DRUG

Meldonium is cheap and available over the counter without a prescription in some eastern European countries, where it is marketed as Mildronate by the Latvian pharmaceutical firm Grindeks (GRD1R.RI).

The drug, originally developed by scientists at the Latvian Institute of Organic Synthesis, is not licensed by two of the world's biggest medicines regulators: the Food and Drug Administration (FDA) in the United States where Sharapova trains, and the EU's European Medicines Agency.

A spokeswoman for Grindeks said the firm had not applied for a license for Mildronate from either the FDA or the EMA, but said the drug is registered in Latvia, Lithuania, Russia and other countries of the former Soviet Union.

She said it is designed to treat patients with certain cardiovascular diseases, including angina, chronic heart failure, cardiomyopathy and other cardiovascular disorders.

Grindeks' also promotes it for people with reduced working capacity from physical or psycho-emotional "overload", and during recovery from cerebrovascular disorders, head injury and encephalitis. It is not indicated for diabetes.

Tim Chico, a consultant cardiologist at Britain's Sheffield University, said it was unlikely that such a young and extremely fit woman would be suffering from a serious heart condition like angina, or would be able to play top level tennis if she were.

Asked how long the drug should be given to a patient, the Grindeks spokeswoman said in an emailed statement: "Depending on the patient health condition, treatment course of meldonium preparations may vary from 4 to 6 weeks". Such courses could be repeated two or three times in a year.

In an emailed reply to questions from Reuters about her medical reasons for using the drug, Sharapova's lawyer John Haggerty said: "While I cannot go into detail out of respect for the ITF process, I can confirm that Ms Sharapova had abnormal EKG tests in 2006 and was also diagnosed with asthenia (a lack of energy or strength), decreased immunity and diabetes indicators."

"She also had a family history of heart conditions," Haggerty said. "The Mildronate and the other medicines recommended by her doctor treated these conditions."

Munir Pirmohamed, a professor of molecular and clinical pharmacology at Britain's University of Liverpool, said the crucial issue with Mildronate for him is its lack of approval from EU and U.S. regulators.

"As a physician, this is not something I have, or would ever, prescribe," he said.

Others noted it was rare for a doctor treating illness to prescribe a drug that is unavailable in the country where the patient lives.

"Sharapova has been a U.S. resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there," said Tom Bassindale, a lecturer in forensic science at Sheffield Hallam University.

Sharapova's agent Max Eisenbud was not available at his Miami office and did not immediately reply to an email seeking comment.

HELPS MUSCLES COPE

Whatever its medical benefits, research suggests Mildronate may have potential as a performance-enhancing drug for sports.

It reduces the level of a metabolite called carnetine in muscles, and by doing that helps muscles cope better with high levels of stress and low oxygen levels.

"Because it effects the cellular metabolism, it would increase energy production within cells and therefore make oxygen utilization more efficient," said Pirmohamed.

In a 2010 academic paper published in a review journal called Seminars in Cardiovascular Medicine and cited on the Grindeks company website, it has been shown to improve exercise tolerance in patients with heart problems.

The World Anti-Doping Agency, which banned the drug in January after previously having it on a "watch list", ranks it as a prohibited metabolic modulator and cites "evidence of its use by athletes with the intention of enhancing performance."

Grindeks says the drug could protect athletes from cell damage, but says it would be unlikely to improve their competitive performance.

It would be "reasonable to recommend (sports people) to use meldonium as a cell protector to avoid heart failure or muscle damage in case of unwanted overload," the spokeswoman said.

Athletes "should not expect increase of physical capacity, but, for sure, they will be protected against ischemic damages of cells in case of overload."

MARIA SHARAPOVA THROUGH THE YEARS:

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Maria Sharapova through the years
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Experts perplexed over why Sharapova was taking banned heart drug
LOS ANGELES, CA - MARCH 07: Tennis player Maria Sharapova reacts as she addresses the media regarding a failed drug test at The LA Hotel Downtown on March 7, 2016 in Los Angeles, California. Sharapova, a five-time major champion, is currently the 7th ranked player on the WTA tour. Sharapova, withdrew from this weekÂs BNP Paribas Open at Indian Wells due to injury. (Photo by Kevork Djansezian/Getty Images)
Maria Sharapova of Russia gets set for a serve from Monica Seles during their match Thursday, March 7, 2002, in Indian Wells, Calif. Seles won the match 6-0, 6-2. (AP Photo/Mark J. Terrill)
Maria Sharapova of Russia reacts after missing a shot during her semi-final match against Monica Seles of the United States in the Hong Kong Ladies Challenge tennis tournament in Hong Kong Friday, Jan. 3, 2003. Seles won 6-3, 6-0. (AP Photo/Vincent Yu)
Russia's Maria Sharapova returns to Yugoslavia's Jelena Dokic, during their Women's Singles, third round match on the Number One Court, on the sixth day of the All England Lawn Tennis Championships at Wimbledon, Saturday, June 28, 2003. Sharapova won the match 6-4, 6-4.(AP Photo/Dave Caulkin)
Russian tennis player Maria Sharapova, center, smiles during a demonstration session at Hong Kong's Victoria Tennis Court Sunday, Jan. 4, 2004. Sharapova will have friendly match with Venus Williams and Chanda Rubin of the United States, and Russia's Elena Dementieva on Jan. 8-10. (AP Photo/Vincent Yu)
Russia's Maria Sharapova reacts after defeating Yulia Beygeizimer of the Ukraine in their Women's Singles, first round match at Wimbledon, Monday June 21, 2004. (AP Photo/Sang Tan) ** EDITORIAL USE ONLY **
Maria Sharapova, of Russia, serves to Amelie Mauresmo (not shown), of France, during their semifinal match at the WTA Championships at Staples Center in Los Angeles, Saturday, Nov. 12, 2005. Mauresmo won, 7-6, 6-3. (AP Photo/Chris Carlson)
Maria Sharapova from Russia serves against Justine Henin-Hardenne from Belgium during her WTA Championships tennis tournament semi-final match in Madrid, Saturday, Nov. 11, 2006. Justine Henin-Hardenne won the match in two sets 6-2, 7-6. (AP Photo/Bernat Armangue)
Russia's Maria Sharapova celebrates winning her match against fellow countrywoman Anna Chakvetadze during the Sony Ericsson Championships match in Madrid, Saturday, Nov. 10, 2007. Sharapova won 6-2, 6-2. (AP Photo/Daniel Ochoa de Olza)
Russia's tennis player Maria Sharapova looks on during a press conference, Saturday Dec. 29, 2007, in Singapore where she will play against compatriot Anna Chakvetadze at an exhibition match on Sunday. (AP Photo/Wong Maye-E)
Maria Sharapova, of Russia, returns the ball against Daniela Hantuchova at the Pacific Life Open tennis tournament in Indian Wells, Calif., Wednesday, March 19, 2008. (AP Photo/Mark Avery)
Tennis Player Maria Sharapova unveils a limited edition Canon PowerShot diamond encrusted camera on Wednesday, Aug. 20, 2008, in New York. (AP Photo/Peter Kramer)
Maria Sharapova of Russia holds the trophy after the final match against Jelena Jankovic of Serbia at the Pan Pacific Open tennis tournament in Tokyo, Japan, Saturday, Oct. 3, 2009. Former No. 1-ranked Sharapova won her first tournament since returning from a 10-month injury layoff when Jankovic was forced to retire in the first set. Jankovic retired with an injured right arm trailing 5-2 in the first set. (AP Photo/Itsuo Inouye)
Russia's Maria Sharapova waves to the public after defeating compatriot Ksenia Pervak during their first round match of the French Open tennis tournament at the Roland Garros stadium in Paris, Tuesday, May 25, 2010. (AP Photo/Laurent Baheux)
Professional tennis player Maria Sharapova watches the New Jersey Nets vs. the Charlotte Bobcats in the second quarter of an NBA basketball game, Monday, April 11, 2011 in Newark, N.J. (AP Photo/Julio Cortez)
Maria Sharapova of Russia reacts during a tennnis match against Samantha Stosur of Australia at the WTA championship in Istanbul, Turkey, Tuesday, Oct. 25, 2011. Sharapova lost to Stosur 6-1, 7-5. (AP Photo/Vadim Ghirda)
Maria Sharapova of Russia, serves to Roberta Vinci of Italy, during their match at the BNP Paribas Open tennis tournament, Tuesday, March 13, 2012, in Indian Wells, Calif. (AP Photo/Mark J. Terrill)
Russia's Maria Sharapova looks up after beating Australian Samantha Stosur 6-7, 7-6, 7-6 during their quarterfinal match at the Porsche tennis Grand Prix in Stuttgart, Germany, Friday, April 27, 2012. (AP Photo/Michael Probst)
Maria Sharapova arrives at the 3.1 Phillip Lim for Target launch event at Spring Studio on Thursday, Sept. 5, 2013 in New York. (Photo by Dario Cantatore/Invision/AP)
Maria Sharapova of the Manila Mavericks autographs large tennis balls of fans following her win over Kristina Mladenovic of the UAE Royals in their IPTL (International Premier Tennis League) Women's Singles match Friday, Nov. 28, 2014 at the Mall of Asia Arena at suburban Pasay city, south of Manila, Philippines. The IPTL, featuring four teams, introduces a new format in tennis and a chance for a championship prize of $1-million dollars. (AP Photo/Bullit Marquez)
Maria Sharapova of Russia celebrates after defeating Flavia Pennetta of Italy during their singles match at the WTA tennis finals in Singapore on Thursday, Oct. 29, 2015. (AP Photo/Wong Maye-E)
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