Re: SOLGANaL

May 16, 2003

It seems there is a manufacturing problem with Solganal. It was recalled for

lack of sterility. Have you considered MYOCHRYSINE? Mainly three compounds

of gold are in clinical use. These are aurothioglucose, gold sodium

thiomalate and auranofin. Aurothioglucose (SOLGANAL) and Gold sodium

thiomalate (MYOCHRYSINE), both contain approximately 50% of gold by weight

(For instance, gold sodium thiomalate is C4H3O4Na2SAu. Thus the molecular

weight of the molecule comes to 390 of which 197 is gold, making it almost

50% by weight). Solganal is sold as a sterile suspension in a suitable fixed

oil. Commercial preparations contain 50 mg/ml. Myochrysine is available as a

sterile aqueous solution for injection. The usual dose is 10 mg of either of

these compounds in the first week as a test dose, followed by 25 mg in the

second and third weeks.

We know how awful it is to have a manufacturing problem with meds that work

for us. We had a problem with Enbrel shortage for quite a long time due to

manufacturing delays and it affected a great deal of people. I hope your

friend can use Myochrysine or something else the doctor finds to replace it

with.

a

> Hello everyone. I just joined up because my good friend has RA and

> is in despair because she has only a few doses of Solganal (gold

> injections) left and it appears that it has been discontinued by the

> manufacturer, Schering, and recalled by the FDA. My reasons for

> posting this are: (1) we'd be grateful for any information leading to

> the procurement of Solganal or aurothioglucose - anywhere on the

> planet!, (2) I'm looking to form a group of persons who have relied

> on Solganal in the past and are wondering what was really behind its

> demise. It's one of the least expensive medications around and

> seemed to have worked for many others. My friend is beside herself

> because Solganal has caused her symptoms to disappear for years. Any

> help or leads would be greatly appreciated -- and please email me if

> you are also someone who has or had the same predicament. in

> California

>

May 17, 2003

" Solganal Deleted From Schering's Drug List

The ACR has worked for many months to assist members in obtaining

adequate supplies of Solganal, an oil-based form of injectable gold and

long-standing treatment for RA. As of late May, Schering-Plough has

deleted this product from its list of medications.

This follows an FDA sanction and a $500 million fine against the

manufacturer for non-compliance in specific manufacturing processes. Lee

S. Simon, MD, an ACR member and the FDA's Division Director of

Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products reports

that Schering had repeatedly ignored prior warnings from the FDA and had

not taken the steps necessary to bring several manufacturing plants,

including the plant in Puerto Rico that formerly manufactured Solganal,

into compliance. As a result, Solganal will no longer be available to

patients.

Alternative therapies that may be considered to replace this product

include other DMARDs such as gold sodium thiomalate, hydroxychloroquine,

sulfasalazine, methotrexate, leflunomide, and the newer class of

biologic response modifiers that includes infliximab, etanercept and

anakinra. For more detailed information regarding other therapies,

please refer to the ACR's " Guidelines for the Management of Rheumatoid

Arthritis, " published in the February 2002 issue of Arthritis &

Rheumatism. "

Source:

https://www.rheumatology.org/acrnews/2002/0702.htm#case

I'm very sorry about your friend's predicament, . I hope she can

find an effective substitute for the Solganal.

[ ] SOLGANaL