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Demand outstrips supply for ADHD drugs in US

Shire, Teva and Sandoz among companies unable to get hold of enough active ingredient

Pharmaceutical companies can't get hold of enough active ingredient to meet growing demand for attention-deficit hyperactivity disorder (ADHD) in the US market.

Various branded and generic ADHD medicines - including Shire's Adderall XR and generic ADHD drugs from Teva, CorePharma and Sandoz - feature in the FDA's current list of drugs in short supply.

The main reason appears to be difficulty in getting hold of mixed amphetamine salts – the active pharmaceutical ingredient (API) used in the products

However, some companies are also citing an increase in demand for ADHD products.

Supply of mixed amphetamine salts is tightly controlled by the US Drug Enforcement Administration (DEA), which sets annual quotas in order to limit the potential for the API to be diverted into the manufacture of illicit drugs.

The DEA has to estimate the expected demand for the API in a given year, but the agency seems to have calculated too low a figure for 2011 and manufacturers now estimate that shortages will extend into 2012.

Shire says that it has supplies in hand for all dosage strengths of its Adderall XR product, but is being affected by API supply issues and uneven product distribution patterns. Teva, CorePharma and Sandoz say stocks are low and they are releasing product as it becomes available.

There are currently more than 200 medicines in short supply in the US, including a number of cancer medicines, and President Barack Obama recently issued an executive order instructing the US Food and Drug Administration (FDA) and Department of Justice to take action on the issue.

The FDA was asked to expand its reporting of potential prescription drug shortages, speed up review of new manufacturing sites, drug suppliers, and manufacturing changes, and provide early disclosure of any shortfall in manufacturing capacity. 

Safety review in adults positive
Meanwhile, the FDA has provided updated information from an ongoing safety review of medications used to treat ADHD in adults, many of which are known to cause increases in heart rate and blood pressure.

That profile had led to concerns that they may prove hazardous in adults with cardiovascular disease.

However, a recently-completed study that evaluated heart attacks and sudden deaths in a sample of adults, as well as a second study that assessed strokes in these adults, has not shown an increased risk of serious adverse cardiovascular events, said the agency.

The FDA's guidance on the use of the medicines is unchanged, it said.

At present, the agency recommends that healthcare professionals exercise care when considering ADHD treatment for patients with serious heart problems, while all adults on these drugs should be periodically monitored for changes in heart rate or blood pressure.

3rd January 2012

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