October 30, 2018

Kathy Whiteside teased her husband in a text early one morning because he didn't say good-bye before leaving their south Doniphan home to baby-sit their grandchildren. It was four days before Easter and Kathy hadn't felt well recently because of a chest cold...

Kathy Whiteside teased her husband in a text early one morning because he didn't say good-bye before leaving their south Doniphan home to baby-sit their grandchildren.

It was four days before Easter and Kathy hadn't felt well recently because of a chest cold.

Randy Whiteside had hoped his wife was asleep in the living room when he quietly fixed a cup of coffee and headed out before dawn.

Sweethearts since high school, the pair normally baby-sat their son's 3-year-old twin girls together.

Randy volunteered to go alone that day so Kathy could rest.

Kathy Whiteside, 65, died later that morning from a self-inflicted gunshot wound.

Her family blames the antibiotic levofloxacin, which belongs to a class of antibiotics called flouroquinolones.

The Federal Drug Administration moved in July to strengthen the warning labeling on flouroquinolones because of the risks of adverse mental health reactions.

The maker of one type, Levaquin, stopped manufacturing the tablets in the United States in December 2017. Opponents of the medication have accused Janssen, a division of Johnson & Johnson, of quietly pulling the drug amidst lawsuits and increased FDA concerns.

Janssen says the move was made because of a "wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs," a representative said Friday.

Unexpired Levaquin already in pharmacies and hospitals could be available until Sept. 30, 2020, the company said.

There are many generic forms of the medicine now, according to the company.

A request made earlier this month to the FDA for updated information regarding Levaquin and flouroquinolone complaints was not fulfilled as of press time.

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A normal morning

The Whitesides' daughter, Donna Owen, talked to Kathy a few hours after Randy left. Donna called her mother every weekday on the way to work at a Doniphan school.

Kathy told Donna she was worried about the side effects of a strong antibiotic her doctor had prescribed the day before. She took the first 500 milligram dose of the medicine the day she received it.

Its most prominent warning concerned possible tendon damage. Kathy had struggled for years with pain in her shoulders.

There was a nine-minute conversation with her brother at 9:30. They talked about fishing, a love they shared with their late father.

Randy texted Kathy at 10:07 a.m. She didn't respond.

By 11 that morning, the people who loved her were concerned Kathy couldn't be reached by cellphone or home phone.

She must finally be sleeping, they reasoned.

Randy Whiteside arrived at their home that evening to find his wife of 45 years dead. He believes Kathy died sometime that morning, after she stopped responding to their calls and texts.

The couple would have celebrated their 46th wedding anniversary this month.

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Purpose in tragedy

Randy wants to make sure everyone knows how serious side effects can be.

"I'm doing better. As long as I can honor Kathy's memory and be the best I can be, and maybe inform some people along the way," Randy said in June, the week Kathy's tombstone was delivered. Their children picked it out. "... way too young and early for this to happen."

There were 32.5 million prescriptions written in the United States in 2015 for flouroquinolones, according to the most recent data available from the Centers for Disease Control and Prevention.

It is the fourth most popular class of antibiotics in the country.

Adverse reactions to flouroquinolones have been reported often enough to earn a nickname. It's called being 'floxed.'

In 2008, the FDA issued a black-box warning -- their strongest -- because of possible tendon rupture.

The risk of irreversible nerve damage was added as a black-box warning in 2013.

A petition was filed in 2014 asking the the FDA to increase warnings related to "serious psychiatric events" by Dr. Charles Bennett, then the SmartState endowed chair for medication safety and efficacy at the South Carolina College of Pharmacy.

A study funded by SmartState, the American Cancer Society and other groups reported in 2016 that the FDA had received nearly 211,000 adverse event reports on these antibiotics over an 18-year period. Psychiatric adverse events made up 10 percent of levofloxacin complaints, according to the study, which was published in the Journal of Community and Supportive Oncology.

"What you do in a case like suicide, especially in my case and my kids' case, is you try to wrap your brain around this and try to figure it out... Kathy wasn't depressed. She wasn't a depressed person," said Randy.

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Easter plans

Kathy, who loved to cook and garden, had Randy pick up a turkey and a ham that Monday for Easter dinner. She was expecting her children and grandchildren, as well as her sister and brother-in-law from Kansas City.

Their son, Keith Whiteside, offered Tuesday to host the dinner. It would save Kathy the clean up and work.

Kathy said no. Filling her home with family was what she loved most, she said.

Kathy had also picked up some new Christmas lights that week, after Donna called to tell her about a sale.

She had short-term and long-term plans, Randy said.

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Looking back

As Randy has gone over and over those last hours, he says now he can see signs something was wrong with Kathy's behavior.

Kathy texted Randy around 8 Tuesday night to ask if he was almost home. Randy was gone until around 10 p.m. every Tuesday for an auto auction in Poplar Bluff.

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She texted him Wednesday morning, the day she died, with a complaint that her new nail polish was as bad as the old bottle. She never opened the new bottle, Randy said. She had picked up the old polish and never realized it.

The nail polish she did apply was a mess and not like her at all, he said.

The note she left her family, he said, was in her handwriting, but looked like it was written by a child in places.

"Her motor skills were messed up," Randy said.

Donna's husband, Mike, told his wife the same thing.

"On the right side, she had written legibly, but it looked like a second grader, short simple sentences," Donna said. "On the left-hand side, it was totally different handwriting. You couldn't make it out. ... He said, 'that there tells me she wasn't in her right mind.'

"Anyone who knows my mom, knows she wouldn't have caused me and my children that kind of grief."

Kathy wrote that she loved her children, but that she didn't want to be here anymore.

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Generating awareness

"The main thing is, that as a husband, you can't fix this," said Randy. "You can't fix it. ... You can't fix anything like this. But I can be a conduit of information and data. That's why I want to do this."

Since Kathy's death, the family says they have heard many stories from their friends and neighbors about bad reactions to flouroquinolones.

"The awareness issue is my main thing. The doctors are going to have to be more vocal, even just a little bit more vocal, about what they're prescribing," said Donna.

She is more cautious now about the medications her family takes.

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FINDING problems

Suicide ideation involving levofloxacin was almost twice as frequent between 2006-2015 when compared to 2002-2005, the 2016 journal article reported.

Researchers also said their results paralleled a 2001 survey. Interviews of 45 patients at that time found 33 percent saw an adverse reaction with 24 hours of taking the medication. The majority reported problems that occurred within one week.

Symptoms lasted longer than three months in 71 percent of cases and more than a year in 58 percent of the cases.

The authors reported their findings were in "stark contrast" to existing product labels.

Whiteside has become a committed advocate for awareness of the possible side effects of flouroquinolones, but says he has found little in the FDA complaint process to be useful.

"I got in touch with the FDA to file an official complaint. They were nice enough. I spent several minutes talking with them. ... They emailed me a four page form to fill out...," said Randy. "The kicker is, when you sent it off electronically, you don't even know if they got it. ... Not one word from them whatsoever."

The FDA said they would not be in touch unless they had questions. They did not.

Randy hopes Kathy's story will help another family. He wants as many people to hear it, see it and learn of it as possible.

"You think you've got an infection ... you think, well, you can take an antibiotic. There isn't anything wrong with an antibiotic. That's the public perception of antibiotics, I guarantee you," he said.

If his dad's advocacy can spare even one family the pain they have felt, that's important, Keith Whiteside said.

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Proper use

Even doctors who support stronger warnings on these antibiotics do not support a ban. Bennett, with the South Carolina watchdog group, has said Levaquin can be important, especially in treating infections during chemotherapy.

What is important, many doctors have said of any antibiotic, is proper use, without over-prescription.

More than 269 million antibiotic prescriptions were written in the United States in 2015, according to the FDA, enough to give four out of every five people one prescription.

The FDA also hosts programs regarding responsible antibiotic prescribing.

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Honoring Kathy

Today, in the home Randy and Kathy shared, he also tries to honor her memory by preparing the big family dinners she liked to cook and staying close with those she loved.

"She was her happiest whenever she had all them kids around her," said Randy, who started dating Kathy, his "older woman," when he was 15 and she was 16.

They married the year he graduated from high school.

"You pray for God's calm and peace to get you through and he has," said Randy, describing his wife as a prayer warrior. "I've seen God has worked with my children and my grandchildren, and I'm so thankful.

"You have your moments. You try to be strong ... and remember the great, beautiful, wonderful memories."

Donna tries, especially for the sake of her children, to focus on the many good memories they have from the year, and the years, before her mother died.

There was the 45th anniversary party that just seemed to come together last October.

There were the ballgames for her sons, where Kathy would yell at the referees, Donna laughed, adding, "Anything I would say quietly, she would echo ... loudly."

Then there was the spur-of-the-moment 65th birthday dinner for her mother at Red Lobster in Jonesboro. It was the last time Donna and her children saw Kathy.

"You've got to do it for your kids. I want them to have full, enriched lives and I don't want this to cheat them of that. And I know she wouldn't, so I can't," said Donna. "I've got to do things so that they know things will be okay."

Keith wants to teach his children the lessons he learned from his mother, about spending time with family and focusing on the things that are truly important in life. Keith was traveling in Arkansas the day before Kathy died and they talked on the phone several times. Daily phone calls weren't unusual for the close knit family, he said.

He and his now 6-year-old son often fish together, a skill both learned from Kathy. His son frequently quotes his Nana, 'the best fisherman in the whole United States.'

"You try to be the tough dad and keep your emotions in check with your kids," Keith said, adding everyone has struggled. "My little girls (now 4) cried for probably two and a half, three months, every night missing Nana."

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