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One of our fellow members (DIESELMAN) has found information regarding the product Serostim and the chance of a fake batch in the U.S.
Thanks Frankie!
Drugs & Herbs > Drug Alerts
Drug Alert: Serono Learns of Another Fake Batch of Its AIDS Drug
Reviewed by Dr Dominique S. Walton
On May 17, 2001, drug maker Serono announced it had learned of another counterfeit batch of the company's drug Serostim, which someone is trying to pass off as being the actual injected drug that doctors use to treat wasting problems in AIDS patients. About 6,000 patients use it in this country.
The company says the fake is masquerading as Serono's Serostim 6 mg for injection. Its generic name is somatropin, and it is derived from rDNA.
The company has sent a letter to doctors to warn them about the counterfeit drug. The letter can be seen on the FDA's web site.
Product Name: Serostim
Generic Name: somatropin
What to do:
If you or someone you know is being treated with Serostim, look at the lot number. Any package labeled Serostim and bearing the lot number MNH605A should be considered fake, says the company. Consult your doctor at once, and return the phony drug to the pharmacy where you purchased it so it can be replaced.
The company says it doesn't know if the imposter is safe or effective. Be sure to discuss your treatment needs with your doctor, considering you may have been using a counterfeit drug unknowingly, and you may not have been getting the desired effects of the real drug.
You also can contact Serono at (888) 275-7376.
Serono had to make a similar announcement about a fake batch of its Serostim drug back in January.
On Jan. 22, 2001, the company announced a fake batch of Serostim showed up in seven states. Ten people purchased it in California, and the FDA had found it in Ohio, Kentucky, Michigan, New Jersey, Florida, and Missouri. The FDA was conducting a criminal investigation.
In that earlier incidence, it was believed that the fake drug could be dangerous. At the time of the January announcement, just skin irritations and redness had been reported. But again, AIDS patients who were unknowingly taking the look-alike were at risk of their disease worsening because they were not taking real Serostim.
How to Tell the Difference:
The fake version was packaged in boxes that closely resembled the real thing. It had the lot number MNK612A -- which was an actual identification number that could be found on legitimate batches of Serostim. But the fakes had an expiration date of 08/02. The real expiration of Serostim with that lot number is 08/01.
These were other clues:
The real Serostim box contained two vials. One vial holds the drug -- which looked like a little eighth-of-an-inch white cake sitting at the bottom. The other vial held fluid used to dilute the drug down to the right dose. The phony medicine's drug vial contained a white snowy powder all through the vial and sometimes stuck to the stopper.
The real drug's dilutant vial was labeled with the lot number 99H124. The fake dilution fluid had a lot number, too, but it's 99h124. Patients had to check for a capital H.
The fake product had a dark blue label with the lot number and expiration date attached to one end of the outer carton. The real Serostim did not have an attached label but had a dark blue box printed right on the carton. The lot number and expiration were printed on this blue box.
Other Instructions Released With the First Alert:
The FDA had asked Serono to broaden its warning to all AIDS patients, to make sure word got out. The company began warning AIDS groups and pharmacists in December 2000.
Additional Information:
Note that somatropin (rDNA origin) is made by Genentech under the brand name Nutropin AQ, but it is used to treat growth failures in children. Genentech also has been having problems with someone circulating phony versions of its somatropin product. See the separate alert about Genentech's problems with look-alike drugs ("Genentech Warns of Counterfeit Nutroprin AQ").
Drugs & Herbs > Drug Alerts
Drug Alert: Genentech Warns of Counterfeit Nutropin AQ
Reviewed by Dr. Dominique S. Walton
On May 22, 2001, Genentech Inc., announced it had learned that a look-alike was being passed off as the company's injected drug Nutropin AQ. The real Genentech drug is a human growth hormone used to treat these conditions:
Growth hormone deficiency;
Growth failure associated with chronic renal insufficiency prior to kidney transplantation;
Short stature associated with Turner syndrome.
The company does not know what the impostor is and notes it may pose a serious health risk to patients who use it.
To help you tell the difference between the real drug and the impostor, a company press release shows side-by-side comparisons of real and phony Nutropin AQ.
Here is more information about the drug and the recent discovery of the counterfeit version of it:
Brand name: Nutropin AQ
Generic name: somatropin (rDNA origin)
The company is alerting doctors and pharmacists about the phony product.
What to do:
If you purchase this drug or know someone who does, check to make sure you have the genuine Nutropin AQ. Compare the product you have with the descriptions and pictures released in the company's recent announcement mentioned above. There are differences between the ways the cartons are folded, how the inserts look, how the vial labels were printed, as well as differences in the physical dimensions and shapes of the bottle, stopper, and flip cap, and whether the solutions look clear or cloudy.
Consult your doctor or pharmacist if you are unsure about the batch you might have. Discuss if you need a replacement as well as whether you need any adjustments to therapy in case you have been using the impostor.
You also can reach the Genentech Customer Service Department at (800) 551-2231.
Additional information:
Note that somatropin (rDNA origin) is also made by Serono under the brand name Serostim, but it is used to treat wasting illnesses in AIDS patients. Serono also has been having problems with unknown people passing off counterfeit versions of their product. See the separate alert about Serono's problems with look-alike drugs ("Serono Learns of Another Fake Batch of It's AIDS Drug").
Genome<>
One of our fellow members (DIESELMAN) has found information regarding the product Serostim and the chance of a fake batch in the U.S.
Thanks Frankie!
Drugs & Herbs > Drug Alerts
Drug Alert: Serono Learns of Another Fake Batch of Its AIDS Drug
Reviewed by Dr Dominique S. Walton
On May 17, 2001, drug maker Serono announced it had learned of another counterfeit batch of the company's drug Serostim, which someone is trying to pass off as being the actual injected drug that doctors use to treat wasting problems in AIDS patients. About 6,000 patients use it in this country.
The company says the fake is masquerading as Serono's Serostim 6 mg for injection. Its generic name is somatropin, and it is derived from rDNA.
The company has sent a letter to doctors to warn them about the counterfeit drug. The letter can be seen on the FDA's web site.
Product Name: Serostim
Generic Name: somatropin
What to do:
If you or someone you know is being treated with Serostim, look at the lot number. Any package labeled Serostim and bearing the lot number MNH605A should be considered fake, says the company. Consult your doctor at once, and return the phony drug to the pharmacy where you purchased it so it can be replaced.
The company says it doesn't know if the imposter is safe or effective. Be sure to discuss your treatment needs with your doctor, considering you may have been using a counterfeit drug unknowingly, and you may not have been getting the desired effects of the real drug.
You also can contact Serono at (888) 275-7376.
Serono had to make a similar announcement about a fake batch of its Serostim drug back in January.
On Jan. 22, 2001, the company announced a fake batch of Serostim showed up in seven states. Ten people purchased it in California, and the FDA had found it in Ohio, Kentucky, Michigan, New Jersey, Florida, and Missouri. The FDA was conducting a criminal investigation.
In that earlier incidence, it was believed that the fake drug could be dangerous. At the time of the January announcement, just skin irritations and redness had been reported. But again, AIDS patients who were unknowingly taking the look-alike were at risk of their disease worsening because they were not taking real Serostim.
How to Tell the Difference:
The fake version was packaged in boxes that closely resembled the real thing. It had the lot number MNK612A -- which was an actual identification number that could be found on legitimate batches of Serostim. But the fakes had an expiration date of 08/02. The real expiration of Serostim with that lot number is 08/01.
These were other clues:
The real Serostim box contained two vials. One vial holds the drug -- which looked like a little eighth-of-an-inch white cake sitting at the bottom. The other vial held fluid used to dilute the drug down to the right dose. The phony medicine's drug vial contained a white snowy powder all through the vial and sometimes stuck to the stopper.
The real drug's dilutant vial was labeled with the lot number 99H124. The fake dilution fluid had a lot number, too, but it's 99h124. Patients had to check for a capital H.
The fake product had a dark blue label with the lot number and expiration date attached to one end of the outer carton. The real Serostim did not have an attached label but had a dark blue box printed right on the carton. The lot number and expiration were printed on this blue box.
Other Instructions Released With the First Alert:
The FDA had asked Serono to broaden its warning to all AIDS patients, to make sure word got out. The company began warning AIDS groups and pharmacists in December 2000.
Additional Information:
Note that somatropin (rDNA origin) is made by Genentech under the brand name Nutropin AQ, but it is used to treat growth failures in children. Genentech also has been having problems with someone circulating phony versions of its somatropin product. See the separate alert about Genentech's problems with look-alike drugs ("Genentech Warns of Counterfeit Nutroprin AQ").
Drugs & Herbs > Drug Alerts
Drug Alert: Genentech Warns of Counterfeit Nutropin AQ
Reviewed by Dr. Dominique S. Walton
On May 22, 2001, Genentech Inc., announced it had learned that a look-alike was being passed off as the company's injected drug Nutropin AQ. The real Genentech drug is a human growth hormone used to treat these conditions:
Growth hormone deficiency;
Growth failure associated with chronic renal insufficiency prior to kidney transplantation;
Short stature associated with Turner syndrome.
The company does not know what the impostor is and notes it may pose a serious health risk to patients who use it.
To help you tell the difference between the real drug and the impostor, a company press release shows side-by-side comparisons of real and phony Nutropin AQ.
Here is more information about the drug and the recent discovery of the counterfeit version of it:
Brand name: Nutropin AQ
Generic name: somatropin (rDNA origin)
The company is alerting doctors and pharmacists about the phony product.
What to do:
If you purchase this drug or know someone who does, check to make sure you have the genuine Nutropin AQ. Compare the product you have with the descriptions and pictures released in the company's recent announcement mentioned above. There are differences between the ways the cartons are folded, how the inserts look, how the vial labels were printed, as well as differences in the physical dimensions and shapes of the bottle, stopper, and flip cap, and whether the solutions look clear or cloudy.
Consult your doctor or pharmacist if you are unsure about the batch you might have. Discuss if you need a replacement as well as whether you need any adjustments to therapy in case you have been using the impostor.
You also can reach the Genentech Customer Service Department at (800) 551-2231.
Additional information:
Note that somatropin (rDNA origin) is also made by Serono under the brand name Serostim, but it is used to treat wasting illnesses in AIDS patients. Serono also has been having problems with unknown people passing off counterfeit versions of their product. See the separate alert about Serono's problems with look-alike drugs ("Serono Learns of Another Fake Batch of It's AIDS Drug").
Genome<>
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