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Problems with drug withdrawals

Bayer’s decision to withdraw cerivastatin (Lipobay) from the market last week has continued to cause problems for patients, pharmacists and the pharmaceutical industry as a whole. Cerivastatin has now joined a list of products, once viewed as having rosy prospects, pulled suddenly from the market because side effects have caused unanticipated problems.

Drug withdrawals cause many problems. They leave patients (both those taking the product in question and those on similar ones) worried about what might happen to them. They provide yet another urgent task for overworked pharmacists and doctors to deal with. They dent the reputation of the pharmaceutical company involved and leave a shadow over the industry as a whole. In the case of Bayer, as with Boots Pharmaceuticals and flosequinan (Manoplax), the withdrawal of such a key product could lead to the sale or demerger of a long-standing pharmaceutical division.

It is sometimes asked if it is really necessary to withdraw a drug from the market because of side effects. Although some patients obviously suffer because of the drug, many more see benefits — particularly if the drug is the only one available to treat the particular problem. But, the potential legal implications of leaving a “killer drug” on the market appear to be weighing more heavily on the corporate minds of pharmaceutical companies than in the past, possibly outweighing any duty to continue supplying effective medicines to patients in need. Regulatory authorities need to look at the way in which drug withdrawals are handled and whether more can be done to prevent such extreme steps from occurring.

For those working in the pharmaceutical industry, the sudden withdrawal of a product from the market is a nightmare made real. Years of planning and development appear to evaporate overnight and the stability of the company can be called into question, as with Bayer, particularly if other established products are nearing patent expiry.

Pharmacists can make many contributions to drug safety in their role as medicines experts. Problems have occurred, as with cerivastatin, when prescribing guidance is not adhered to, or when changes to such guidance do not feed through to prescribing practice. Restrictions on the prescribing of certain product strengths or combinations are introduced to protect patients. Pharmacists and prescribers need to work together to make sure they are observed. If adverse events do occur they should be reported to manufacturers and regulatory authorities as quickly as possible, so that guidance can be changed, if necessary.

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