06/03/2008- Spokane, WA: Joanne C. wants to determine how long she had been taken double doses of Digitek before it was recalled. Neither her pharmacist nor doctor has the answer. And it is unlikely that Actavis--the manufacturer--even knows, since it seemed to have minimal control over its operations in China. "I realize we all have to die some day but let’s not hurry it up," says Joanne.

Joanne has been on Digitek since 2000 and she enjoyed relatively good health—until a few months ago. "My doctor thought I had bronchitis so he prescribed an antibiotic," says Joanne. "But I kept feeling worse and had to be taken to emergency." She spent six hours in ER having a battery of tests, from x-rays to blood work, and was shocked with the diagnosis: Joanne has atrial fibrillation (also known as "a-fib")—a condition in which the heart beats either faster or slower than normal. In Joanne’s case, her heart was racing.

"My heart beat was 170 a minute," says Joanne, "and the doctor thought I was going into heart failure. They gave me a medication that brought my heart rhythm down to 93 and let me come home, but I was scared." And rightly so because this diagnosis was bad news: although a-fib can usually be managed with proper treatment, it is rarely cured.

Joanne was back in ER one month later, this time with horrific headaches. A tumor was suspected so she had a CAT Scan. The good news: no tumor. Bad news: bad heart, but she already knew that. However, nobody could explain why she had a bad heart. Joanne may have found the reason when she went online and found out headaches are a side effect from overdosing on Digitek. And she has had trouble breathing.

"I have been extremely tired since I came back from the hospital," says Joanne. " I find it hard to do anything and I have a lot of nausea that comes and goes. I get dizzy and lightheaded and when I have gone out, even to walk a few blocks, I have almost fainted."

Even though Joanne is 73, she was healthy and active up until a few months ago. "I used to go shopping and could carry a sack of groceries home, but now even my purse is a burden. In fact I don’t know how I can stay alive, I feel so bad.

"Around the beginning of May, my pharmacist called and told me about the recall.
'This is Jeff from Shopco, don’t take any more Digitek and bring back all that you have left,' he said.

I was shocked and arranged for a ride to Shopco that same day.
'Jeff, do you think this recall is the reason that I wound up in ER?'
'It very well could be, I wouldn’t doubt it,' he replied.

He gave me Lanoxin, but there was such a run on Digitek that he could only give me 23 pills. The following week he called and let me know there was more Lanoxin and I got 100 more pills.

Why did the manufacturer lie about making the drug here in the US when it was really being made in China? I live in Washington and it was the second state to ban lead paint in toys from China (California was the first) so why don’t they ban pharmaceuticals from China? If I had my way, I would ban all drugs from China and force the pharmaceutical companies to make it here. There are so many recalls, why doesn’t our government stop it?

I want to know why our own government allows this to happen. I was really surprised to find out that Digitek was made in China –the label on my prescription just says Mylan pharmaceuticals, a US company. That is false labeling; it gives people a false sense of security. I asked Jeff – my pharmacist at Shopco— how I could trust meds after this incident. I am scared off all meds now because I don’t know where they come from.

I want to say this to [Actavis], the drug maker: how dare you buy drugs from China and not have better checks in place. I read online how people have dropped dead from taking too much Digitek."

Two lawsuits were recently filed (end of May) in West Virginia: one alleges that a patient died and another was injured after taking twice the approved amount of Digitek (also known as Digoxin). The lawsuits state that Digitek "has a narrow therapeutic index, and thus, has a limited margin between effectiveness and toxicity." Both patients consumed twice the federally approved levels of Digitek.

The lawsuits further allege that the pharmaceutical companies "have a history of failing to reliably establish the identity, strength, quality and purity of drug products they release for public consumption."

In West Virginia, Digitek is distributed by Mylan Pharmaceuticals. The manufacturer, Actavis Group, is an international generic pharmaceutical company based in Reykjavik, Iceland. Actavis recalled Digitek after discovering the tables were double the "appropriate thickness", but not before they were sold throughout the US to thousands of patients.